Pelvic Floor Dysfunction

NEW SACRAL NEUROMODULATION DEVICE

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CERVICAL SEAL FOR HYSTEROSCOPIC DEVICES

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UNIVERSAL CYSTOSCOPY SIMPLIFIED

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Globally, there are 410,000 cases of GBS every year. GBS is most common in newborns; women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. An estimated 10% to 30% of pregnant women carry the GBS bacteria. The disease can manifest as sepsis, pneumonia, and meningitis, with potentially fatal outcomes for some. A maternal vaccine may prevent 231,000 infant and maternal GBS cases, says Pfizer.

According to Pfizer, RSV causes more hospitalizations each year than influenza among young children, with an estimated 33 million cases globally each year in children less than age 5 years.

FOR MORE INFORMATION, VISIT: https://www.pfizer.com/

NEW SACRAL NEUROMODULATION DEVICE

FOR MORE INFORMATION, VISIT: https://www.axonics.com/

CERVICAL SEAL FOR HYSTEROSCOPIC DEVICES

For more information, visit: https://gynsurgicalsolutions.com/product/omni-lok/

UNIVERSAL CYSTOSCOPY SIMPLIFIED

FOR MORE INFORMATION, VISIT: https://cystosure.com/

NEXT FRONTIER IN VACCINE IMMUNIZATION

Globally, there are 410,000 cases of GBS every year. GBS is most common in newborns; women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. An estimated 10% to 30% of pregnant women carry the GBS bacteria. The disease can manifest as sepsis, pneumonia, and meningitis, with potentially fatal outcomes for some. A maternal vaccine may prevent 231,000 infant and maternal GBS cases, says Pfizer.

According to Pfizer, RSV causes more hospitalizations each year than influenza among young children, with an estimated 33 million cases globally each year in children less than age 5 years.

FOR MORE INFORMATION, VISIT: https://www.pfizer.com/

NEW SACRAL NEUROMODULATION DEVICE

FOR MORE INFORMATION, VISIT: https://www.axonics.com/

CERVICAL SEAL FOR HYSTEROSCOPIC DEVICES

For more information, visit: https://gynsurgicalsolutions.com/product/omni-lok/

UNIVERSAL CYSTOSCOPY SIMPLIFIED

FOR MORE INFORMATION, VISIT: https://cystosure.com/

NEXT FRONTIER IN VACCINE IMMUNIZATION

Globally, there are 410,000 cases of GBS every year. GBS is most common in newborns; women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. An estimated 10% to 30% of pregnant women carry the GBS bacteria. The disease can manifest as sepsis, pneumonia, and meningitis, with potentially fatal outcomes for some. A maternal vaccine may prevent 231,000 infant and maternal GBS cases, says Pfizer.

According to Pfizer, RSV causes more hospitalizations each year than influenza among young children, with an estimated 33 million cases globally each year in children less than age 5 years.

FOR MORE INFORMATION, VISIT: https://www.pfizer.com/

Propst K, Mellen C, O’Sullivan DM, et al. Timing of office-based pessary care: a randomized controlled trial. Obstet Gynecol. 2019 Dec 5. Doi: 10.1097/AOG.0000000000003580.

EXPERT COMMENTARY

Vaginal pessaries are a common and effective approach for managing pelvic organ prolapse (POP) as well as stress urinary incontinence (SUI). Vaginal mucosal erosions, however, may complicate pessary use. The risk for erosions may be associated with the frequency of pessary change, which involves removing the pessary, washing it, and replacing it in the vagina. Existing data do not address the frequency of pessary change. Recently, however, investigators conducted a randomized noninferiority trial to evaluate the effect of pessary visit intervals on the development of vaginal epithelial abnormalities.

Details of the study

At a single US hospital, Propst and colleagues randomly assigned women who used pessaries for POP, SUI, or both to routine pessary care (offices visits every 12 weeks) or to extended interval pessary care (office visits every 24 weeks). The women used ring, incontinence dish, or Gelhorn pessaries, did not change their pessaries on their own, and had no vaginal mucosal abnormalities.

A total of 130 women were randomly assigned, 64 to the routine care group and 66 to the extended interval care group. The mean age was 79 years and 90% were white, 4.6% were black, and 4% were Hispanic. Approximately 74% of the women used vaginal estrogen.

The primary outcome was the rate of vaginal epithelial abnormalities, including epithelial breaks or erosions. The predetermined noninferiority margin was set at 7.5%.

Results. At the 48-week follow-up, the rate of epithelial erosion was 7.4% in the routine care group and 1.7% in the extended interval care group, thus meeting the prespecified criteria for noninferiority of extended interval pessary care.

Women in each care group reported a similar amount of bothersome vaginal discharge. This was reported on a 5-point scale, with higher numbers indicating greater degree of bother. The mean scores were 1.39 in the routine care group and 1.34 in the extended interval care group. No other pessary-related adverse events occurred in either care group.

Study strengths and limitations

This trial provides good evidence that the timing of office pessary care can be extended to 24 weeks without compromising outcomes. However, since nearly three-quarters of the study participants used vaginal estrogen, the results may not be applicable to pessary users who do not use vaginal estrogen.

Propst K, Mellen C, O’Sullivan DM, et al. Timing of office-based pessary care: a randomized controlled trial. Obstet Gynecol. 2019 Dec 5. Doi: 10.1097/AOG.0000000000003580.

EXPERT COMMENTARY

Vaginal pessaries are a common and effective approach for managing pelvic organ prolapse (POP) as well as stress urinary incontinence (SUI). Vaginal mucosal erosions, however, may complicate pessary use. The risk for erosions may be associated with the frequency of pessary change, which involves removing the pessary, washing it, and replacing it in the vagina. Existing data do not address the frequency of pessary change. Recently, however, investigators conducted a randomized noninferiority trial to evaluate the effect of pessary visit intervals on the development of vaginal epithelial abnormalities.

Details of the study

At a single US hospital, Propst and colleagues randomly assigned women who used pessaries for POP, SUI, or both to routine pessary care (offices visits every 12 weeks) or to extended interval pessary care (office visits every 24 weeks). The women used ring, incontinence dish, or Gelhorn pessaries, did not change their pessaries on their own, and had no vaginal mucosal abnormalities.

A total of 130 women were randomly assigned, 64 to the routine care group and 66 to the extended interval care group. The mean age was 79 years and 90% were white, 4.6% were black, and 4% were Hispanic. Approximately 74% of the women used vaginal estrogen.

The primary outcome was the rate of vaginal epithelial abnormalities, including epithelial breaks or erosions. The predetermined noninferiority margin was set at 7.5%.

Results. At the 48-week follow-up, the rate of epithelial erosion was 7.4% in the routine care group and 1.7% in the extended interval care group, thus meeting the prespecified criteria for noninferiority of extended interval pessary care.

Women in each care group reported a similar amount of bothersome vaginal discharge. This was reported on a 5-point scale, with higher numbers indicating greater degree of bother. The mean scores were 1.39 in the routine care group and 1.34 in the extended interval care group. No other pessary-related adverse events occurred in either care group.

Study strengths and limitations

This trial provides good evidence that the timing of office pessary care can be extended to 24 weeks without compromising outcomes. However, since nearly three-quarters of the study participants used vaginal estrogen, the results may not be applicable to pessary users who do not use vaginal estrogen.

Propst K, Mellen C, O’Sullivan DM, et al. Timing of office-based pessary care: a randomized controlled trial. Obstet Gynecol. 2019 Dec 5. Doi: 10.1097/AOG.0000000000003580.

EXPERT COMMENTARY

Vaginal pessaries are a common and effective approach for managing pelvic organ prolapse (POP) as well as stress urinary incontinence (SUI). Vaginal mucosal erosions, however, may complicate pessary use. The risk for erosions may be associated with the frequency of pessary change, which involves removing the pessary, washing it, and replacing it in the vagina. Existing data do not address the frequency of pessary change. Recently, however, investigators conducted a randomized noninferiority trial to evaluate the effect of pessary visit intervals on the development of vaginal epithelial abnormalities.

Details of the study

At a single US hospital, Propst and colleagues randomly assigned women who used pessaries for POP, SUI, or both to routine pessary care (offices visits every 12 weeks) or to extended interval pessary care (office visits every 24 weeks). The women used ring, incontinence dish, or Gelhorn pessaries, did not change their pessaries on their own, and had no vaginal mucosal abnormalities.

A total of 130 women were randomly assigned, 64 to the routine care group and 66 to the extended interval care group. The mean age was 79 years and 90% were white, 4.6% were black, and 4% were Hispanic. Approximately 74% of the women used vaginal estrogen.

The primary outcome was the rate of vaginal epithelial abnormalities, including epithelial breaks or erosions. The predetermined noninferiority margin was set at 7.5%.

Results. At the 48-week follow-up, the rate of epithelial erosion was 7.4% in the routine care group and 1.7% in the extended interval care group, thus meeting the prespecified criteria for noninferiority of extended interval pessary care.

Women in each care group reported a similar amount of bothersome vaginal discharge. This was reported on a 5-point scale, with higher numbers indicating greater degree of bother. The mean scores were 1.39 in the routine care group and 1.34 in the extended interval care group. No other pessary-related adverse events occurred in either care group.

Study strengths and limitations

This trial provides good evidence that the timing of office pessary care can be extended to 24 weeks without compromising outcomes. However, since nearly three-quarters of the study participants used vaginal estrogen, the results may not be applicable to pessary users who do not use vaginal estrogen.

Case 1 Multiparous woman presents with heavy regular menses

Over the past several years, a 34-year-old woman has noted increasing intensity and duration of menstrual flow, which now persists for 8 days and includes clots “the size of quarters” and soaks a pad within 1 hour. Sometimes she misses or leaves work on her heaviest days of flow. She reports that menstrual cramps prior to and during flow are increasingly bothersome and do not respond adequately to ibuprofen. She intermittently uses condoms for contraception. She does not wish to be pregnant currently; however, she recently entered into a new relationship and may wish to conceive in the future.

On bimanual examination, the uterus appears bulky. Her hemoglobin is 10.9 g/dL with low mean corpuscular volume and a serum ferritin level indicating iron depletion. Pelvic ultrasonography suggests uterine adenomyosis; no fibroids are imaged (FIGURE 1).

You advise the patient to take ferrous sulfate 325 mg every other day. After discussion with the patient regarding different treatment options, she chooses to proceed with placement of a 52-mg levonorgestrel (LNG) intrauterine device (IUD; Mirena or Liletta).

Case 2 Older adolescent presents with irregular bleeding

A 19-year-old patient reports approximately 6 bleeding episodes each year. She reports the duration of her bleeding as variable, and sometimes the bleeding is heavy with small clots passed. She has been previously diagnosed with polycystic ovary syndrome (PCOS). Combination estrogen-progestin oral contraceptives have been prescribed several times in the past, but she always has discontinued them due to nausea. The patient is in a same-sex relationship and does not anticipate being sexually active with a male. She reports having to shave her mustache and chin twice weekly for the past 1 to 2 years.

On physical examination, the patient is obese (body mass index [BMI], 32 kg/m²), facial acne and hirsutism are present, and hair extends from the mons toward the umbilicus. Bimanual examination reveals a normal size, mobile, nontender uterus without obvious adnexal pathology. Pelvic ultrasonography demonstrates a normal-appearing uterus with multiplanar endometrium (consistent with proliferative changes) (FIGURE 2). Ovarian imaging demonstrates ≥12 follicles per image (FIGURE 3).

About one-third of all women experience abnormal uterine bleeding (AUB) sometime during their lifetime and AUB can impair quality of life.¹ Surgical management, including hysterectomy and endometrial ablation, plays an important role in the management of AUB in patients who do not desire future pregnancies. However, many cases of AUB occur in women who may not have completed childbearing or in women who prefer to avoid surgery.² AUB can be managed effectively medically in most cases.¹ Accordingly, in this review, we focus on nonsurgical management of AUB.

Continue to: Because previously used terms, including...

Because previously used terms, including menorrhagia and meno-metrorrhagia, were inconsistently defined and confusing, the International Federation of Gynecology and Obstetrics introduced updated terminology in 2011 to better describe and characterize AUB in nonpregnant women. Heavy menstrual bleeding (HMB) refers to ovulatory (cyclic) bleeding that is more than 8 days’ duration, or sufficiently heavy to impair a woman’s quality of life. HMB is a pattern of AUB distinct from the irregular bleeding pattern typically caused by ovulatory dysfunction (AUB-O).¹

Clinical evaluation

Obtain menstrual history. In addition to a medical, surgical, and gynecologic history, a thorough menstrual history should be obtained to further characterize the patient’s bleeding pattern. In contrast to the cyclical or ovulatory bleeding seen with HMB, bleeding associated with inconsistent ovulation (AUB-O) is unpredictable or irregular, and is commonly associated with PCOS. AUB-O is also encountered in recently menarchal girls (secondary to immaturity of the hypothalamic-pituitary-gonadal axis) and in those who are perimenopausal. In addition, medications that can induce hyperprolactinemia (such as certain antipsychotics) can cause AUB-O.

Evaluate for all sources of bleeding. Be sure to evaluate for extrauterine causes of bleeding, including the cervix, vagina, vulva, or the urinary or gastrointestinal tracts for bleeding. Intermenstrual bleeding occurring between normal regular menses may be caused by an endometrial polyp, submucosal fibroid, endometritis, or an IUD. The patient report of postcoital bleeding suggests that cervical disease (cervicitis, polyp, or malignancy) may be present. Uterine leiomyoma or adenomyosis represent common causes of HMB. However, HMB also may be caused by a copper IUD, coagulation disorders (including von Willebrand disease), or use of anticoagulant medications. Hormonal contraceptives also can cause irregular bleeding.

Perform a pelvic examination and measure vital signs. The presence of fever suggests the possible presence of pelvic inflammatory disease (PID), while orthostatic hypotension raises the possibility of hypovolemia. When vaginal speculum examination is performed, a cervical cause of abnormal bleeding may be noted. The presence of fresh or old blood or finding clots in the vaginal vault or at the cervical os are all consistent with AUB. A bimanual examination that reveals an enlarged or lobular uterus suggests leiomyoma or adenomyosis. Cervical or adnexal tenderness is often noted in women with PID, which itself may be associated with endometritis. The presence of hyperandrogenic signs on physical examination (eg, acne, hirsutism, or clitoromegaly) suggests PCOS. The finding of galactorrhea suggests that hyperprolactinemia may be present.

Laboratory assessment

Test for pregnancy, cervical disease, and sexually transmitted infection when appropriate. Pregnancy testing is appropriate for women with AUB aged 55 years or younger. If patients with AUB are not up to date with normal cervical cancer screening results, cervical cytology and/or human papillomavirus testing should be performed. Testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis should be performed in patients:

• younger than 25 years
• when the history indicates new or multiple sexual partners, or
• when vaginal discharge, cervicitis, cervical motion, or adnexal tenderness is present.

Continue to: Obtain a complete blood count and serum ferritin levels...

Obtain a complete blood count and serum ferritin levels. In women presenting with HMB, iron depletion and iron deficiency anemia are common. The finding of leukocytosis raises the possibility of PID or postpartum endometritis. In women with presumptive AUB-O, checking the levels of thyroid-stimulating hormone, free T4, and prolactin should be performed.

Screen for a hemostasis disorder. Women with excessive menstrual bleeding should be clinically screened for an underlying disorder of hemostasis (TABLE 1).³ When a hemostasis disorder is suspected, initial laboratory evaluation includes a partial thromboplastin time, prothrombin time, activated partial thromboplastin time, and fibrinogen. Women who have a positive clinical screen for a possible bleeding disorder or abnormal initial laboratory test results for disorders of hemostasis should undergo further laboratory evaluation, including von Willebrand factor antigen, ristocetin cofactor assay, and factor VIII. Consultation with a hematologist should be considered in these cases.

Perform endometrial biopsy when indicated

After excluding pregnancy, endometrial biopsy (through pipelle biospy or brush sampling; FIGURE 4) should be performed in women with AUB who are at increased risk for endometrial neoplasia. The prevalence of endometrial neoplasia is substantially higher among women ≥45 years of age⁴ and among patients with AUB who are also obese (BMI, ≥30 kg/m²).⁵ In addition, AUB patients with unopposed estrogen exposure (presumed anovulation/PCOS), as well as those with persistent AUB or failed medical management, should undergo endometrial biopsy.⁶

Utilize transvaginal ultrasonography

Transvaginal ultrasonography is often useful in the evaluation of patients with AUB, as it may identify uterine fibroids or adenomyosis, suggest intracavitary pathology (such as an endometrial polyp or submucosal fibroid), or raise the possibility of PCOS. In virginal patients or those in whom vaginal ultrasound is not appropriate, abdominal pelvic ultrasonography represents appropriate imaging. If unenhanced ultrasound suggests endometrial polyps or fibroids within the endometrial cavity, an office-based saline infusion sonogram (sonohysterogram) (FIGURE 5) or hysteroscopy should be performed. Targeted endometrial sampling and biopsy of intracavitary pathology can be performed at the time of hysteroscopy.

Treatment

When HMB impairs quality of life, is bothersome to the patient, or results in anemia, treatment is appropriate. Although bleeding episodes in women with AUB-O may be infrequent (as with Case 2), treatment prevents heavy or prolonged bleeding episodes as well as endometrial neoplasia that may otherwise occur in anovulatory women.

Many women with AUB can be managed medically. However, treatment choices will vary with respect to the patient’s desire for future fertility, medical comorbidities, personal preferences, and financial barriers. While many women may prefer outpatient medical management (TABLE 2),^7-14 others might desire surgical therapy, including endometrial ablation or hysterectomy.

Oral contraceptives

Combination estrogen-progestin oral contraceptives represent appropriate initial therapy for many women in the reproductive-age group with AUB, whether women have HMB or AUB-O. However, contraceptive doses of estrogen are not appropriate for some women with risk factors for cardiovascular disease, including those who smoke cigarettes and are age ≥35 years or those who have hypertension (TABLE 3).^15,16

Continue to: Menopausal dosages of HT...

Menopausal dosages of HT

If use of contraceptive doses of estrogen is not appropriate, continuous off-label use of menopausal combination formulations (physiologic dosage) of hormonal therapy (HT; ie, lower doses of estrogen than contraceptives) may be effective in reducing or eliminating AUB. Options for menopausal combination formulations include generic ethinyl estradiol 5 µg/norethindrone acetate 1 mg or estradiol 1 mg/norethindrone acetate 0.5 mg.⁷ High-dose oral progestin therapy (norethindrone acetate 5 mg tablet once daily or medroxyprogesterone acetate 10 mg tablets 1–3 times daily) also can be used when combination contraceptives are contraindicated and may be more effective than lower-dose combination formulations.

Package labeling, as well as some guidelines, indicate that oral progestins used to treat AUB should be taken cyclically.⁸ However, continuous daily use is easier for many patients and may be more effective in reducing bleeding. Accordingly, we counsel patients with AUB who are using progestins and who do not wish to conceive to take these medications continuously. High-dose oral progestin therapy may cause bloating, dysphoria, and increased appetite/weight gain. Women initiating hormonal management (including the progestin IUDs detailed below) for AUB should be counseled that irregular or even continuous light bleeding/spotting is common initially, but this bleeding pattern typically decreases with continued use.

IUDs

The LNG 52 mg IUD (Mirena or Liletta) effectively treats HMB, reducing bleeding in a manner comparable to that of endometrial ablation.^9,10 The Mirena IUD is approved for treatment of HMB in women desiring intrauterine contraception. In contrast to oral medications, use of progestin IUDs does not involve daily administration and may represent an attractive option for women with HMB who would like to avoid surgery or preserve fertility. With ongoing use, continuous oral or intrauterine hormonal management may result in amenorrhea in some women with AUB.

When the LNG 52 mg IUD is used to treat HMB, the menstrual suppression impact may begin to attenuate after approximately 4 years of use; in this setting, replacing the IUD often restores effective menstrual suppression.¹¹ The LNG 52 mg IUD effectively suppresses menses in women with coagulation disorders; if menstrual suppression with the progestin IUD is not adequate in this setting, it may be appropriate to add an oral combination estrogen-progestin contraceptive or high-dose oral progestin.^11,12

NSAIDs and tranexamic acid

Off-label use of nonsteroidal anti-inflammatory drugs (naproxen 500–1,000 mg daily for 5 days beginning at the onset of menstrual flow or tranexamic acid two 650-mg tablets 3 times daily for up to 5 days during episodes of heavy flow) can suppress HMB and is useful for women who prefer to avoid or have contraindications to hormonal treatments.^13,14 Unfortunately, these agents are not as effective as hormonal management in treating AUB.

Iron supplementation is often needed

Iron depletion commonly results from HMB, often resulting in iron deficiency anemia. When iron depletion (readily identified by checking a serum ferritin level) or iron deficiency anemia is identified, iron supplementation should be recommended. Every-other-day administration of iron supplements maximizes iron absorption while minimizing the adverse effects of unabsorbed iron, such as nausea. Sixty mg of elemental iron (ferrous sulfate 325 mg) administered every other day represents an inexpensive and effective treatment for iron deficiency/anemia.¹⁷ In patients who cannot tolerate oral iron supplementation or for those in whom oral therapy is not appropriate or effective, newer intravenous iron formulations are safe and effective.¹⁸

Continue to: Case 1 Follow-up...

Case 1 Follow-up

The patient noted marked improvement in her menstrual cramps following LNG-containing IUD placement. Although she also reported that she no longer experienced heavy menstrual flow or cramps, she was bothered by frequent, unpredictable light bleeding/spotting. You prescribed norethindrone acetate (NETA) 5-mg tablet orally once daily, to be used in addition to her IUD. After using the IUD with concomitant NETA for 2 months’ duration, she noted that her bleeding/spotting almost completely resolved; however, she did report feeling irritable with use of the progestin tablets. She subsequently stopped the NETA tablets and, after 6 months of additional follow-up, reported only minimal spotting and no cramps.

At this later follow-up visit, you noted that her hemoglobin level increased to 12.6 g/dL, and the ferritin level no longer indicated iron depletion. After the IUD had been in place for 4 years, she reported that she was beginning to experience frequent light bleeding again. A follow-up vaginal sonogram noted a well-positioned IUD, there was no suggestion of intracavitary pathology, and adenomyosis continued to be imaged. She underwent IUD removal and placement of a new LNG 52 mg IUD. This resulted in marked reduction in her bleeding.

Case 2 Follow-up

Two weeks after beginning continuous oral progestin therapy, the patient called reporting frequent irregular bleeding. She was reassured that this was not unexpected and encouraged to continue oral progestin therapy. During a 3-month follow-up visit, the patient noted little, if any, bleeding over the previous 2 months and was pleased with this result. She continued to note acne and hirsutism and asked about the possibility of adding spironolactone to her oral progestin regimen.

Case 1 Multiparous woman presents with heavy regular menses

Over the past several years, a 34-year-old woman has noted increasing intensity and duration of menstrual flow, which now persists for 8 days and includes clots “the size of quarters” and soaks a pad within 1 hour. Sometimes she misses or leaves work on her heaviest days of flow. She reports that menstrual cramps prior to and during flow are increasingly bothersome and do not respond adequately to ibuprofen. She intermittently uses condoms for contraception. She does not wish to be pregnant currently; however, she recently entered into a new relationship and may wish to conceive in the future.

On bimanual examination, the uterus appears bulky. Her hemoglobin is 10.9 g/dL with low mean corpuscular volume and a serum ferritin level indicating iron depletion. Pelvic ultrasonography suggests uterine adenomyosis; no fibroids are imaged (FIGURE 1).

You advise the patient to take ferrous sulfate 325 mg every other day. After discussion with the patient regarding different treatment options, she chooses to proceed with placement of a 52-mg levonorgestrel (LNG) intrauterine device (IUD; Mirena or Liletta).

Case 2 Older adolescent presents with irregular bleeding

A 19-year-old patient reports approximately 6 bleeding episodes each year. She reports the duration of her bleeding as variable, and sometimes the bleeding is heavy with small clots passed. She has been previously diagnosed with polycystic ovary syndrome (PCOS). Combination estrogen-progestin oral contraceptives have been prescribed several times in the past, but she always has discontinued them due to nausea. The patient is in a same-sex relationship and does not anticipate being sexually active with a male. She reports having to shave her mustache and chin twice weekly for the past 1 to 2 years.

On physical examination, the patient is obese (body mass index [BMI], 32 kg/m²), facial acne and hirsutism are present, and hair extends from the mons toward the umbilicus. Bimanual examination reveals a normal size, mobile, nontender uterus without obvious adnexal pathology. Pelvic ultrasonography demonstrates a normal-appearing uterus with multiplanar endometrium (consistent with proliferative changes) (FIGURE 2). Ovarian imaging demonstrates ≥12 follicles per image (FIGURE 3).

About one-third of all women experience abnormal uterine bleeding (AUB) sometime during their lifetime and AUB can impair quality of life.¹ Surgical management, including hysterectomy and endometrial ablation, plays an important role in the management of AUB in patients who do not desire future pregnancies. However, many cases of AUB occur in women who may not have completed childbearing or in women who prefer to avoid surgery.² AUB can be managed effectively medically in most cases.¹ Accordingly, in this review, we focus on nonsurgical management of AUB.

Continue to: Because previously used terms, including...

Because previously used terms, including menorrhagia and meno-metrorrhagia, were inconsistently defined and confusing, the International Federation of Gynecology and Obstetrics introduced updated terminology in 2011 to better describe and characterize AUB in nonpregnant women. Heavy menstrual bleeding (HMB) refers to ovulatory (cyclic) bleeding that is more than 8 days’ duration, or sufficiently heavy to impair a woman’s quality of life. HMB is a pattern of AUB distinct from the irregular bleeding pattern typically caused by ovulatory dysfunction (AUB-O).¹

Clinical evaluation

Obtain menstrual history. In addition to a medical, surgical, and gynecologic history, a thorough menstrual history should be obtained to further characterize the patient’s bleeding pattern. In contrast to the cyclical or ovulatory bleeding seen with HMB, bleeding associated with inconsistent ovulation (AUB-O) is unpredictable or irregular, and is commonly associated with PCOS. AUB-O is also encountered in recently menarchal girls (secondary to immaturity of the hypothalamic-pituitary-gonadal axis) and in those who are perimenopausal. In addition, medications that can induce hyperprolactinemia (such as certain antipsychotics) can cause AUB-O.

Evaluate for all sources of bleeding. Be sure to evaluate for extrauterine causes of bleeding, including the cervix, vagina, vulva, or the urinary or gastrointestinal tracts for bleeding. Intermenstrual bleeding occurring between normal regular menses may be caused by an endometrial polyp, submucosal fibroid, endometritis, or an IUD. The patient report of postcoital bleeding suggests that cervical disease (cervicitis, polyp, or malignancy) may be present. Uterine leiomyoma or adenomyosis represent common causes of HMB. However, HMB also may be caused by a copper IUD, coagulation disorders (including von Willebrand disease), or use of anticoagulant medications. Hormonal contraceptives also can cause irregular bleeding.

Perform a pelvic examination and measure vital signs. The presence of fever suggests the possible presence of pelvic inflammatory disease (PID), while orthostatic hypotension raises the possibility of hypovolemia. When vaginal speculum examination is performed, a cervical cause of abnormal bleeding may be noted. The presence of fresh or old blood or finding clots in the vaginal vault or at the cervical os are all consistent with AUB. A bimanual examination that reveals an enlarged or lobular uterus suggests leiomyoma or adenomyosis. Cervical or adnexal tenderness is often noted in women with PID, which itself may be associated with endometritis. The presence of hyperandrogenic signs on physical examination (eg, acne, hirsutism, or clitoromegaly) suggests PCOS. The finding of galactorrhea suggests that hyperprolactinemia may be present.

Laboratory assessment

Test for pregnancy, cervical disease, and sexually transmitted infection when appropriate. Pregnancy testing is appropriate for women with AUB aged 55 years or younger. If patients with AUB are not up to date with normal cervical cancer screening results, cervical cytology and/or human papillomavirus testing should be performed. Testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis should be performed in patients:

• younger than 25 years
• when the history indicates new or multiple sexual partners, or
• when vaginal discharge, cervicitis, cervical motion, or adnexal tenderness is present.

Continue to: Obtain a complete blood count and serum ferritin levels...

Obtain a complete blood count and serum ferritin levels. In women presenting with HMB, iron depletion and iron deficiency anemia are common. The finding of leukocytosis raises the possibility of PID or postpartum endometritis. In women with presumptive AUB-O, checking the levels of thyroid-stimulating hormone, free T4, and prolactin should be performed.

Screen for a hemostasis disorder. Women with excessive menstrual bleeding should be clinically screened for an underlying disorder of hemostasis (TABLE 1).³ When a hemostasis disorder is suspected, initial laboratory evaluation includes a partial thromboplastin time, prothrombin time, activated partial thromboplastin time, and fibrinogen. Women who have a positive clinical screen for a possible bleeding disorder or abnormal initial laboratory test results for disorders of hemostasis should undergo further laboratory evaluation, including von Willebrand factor antigen, ristocetin cofactor assay, and factor VIII. Consultation with a hematologist should be considered in these cases.

Perform endometrial biopsy when indicated

After excluding pregnancy, endometrial biopsy (through pipelle biospy or brush sampling; FIGURE 4) should be performed in women with AUB who are at increased risk for endometrial neoplasia. The prevalence of endometrial neoplasia is substantially higher among women ≥45 years of age⁴ and among patients with AUB who are also obese (BMI, ≥30 kg/m²).⁵ In addition, AUB patients with unopposed estrogen exposure (presumed anovulation/PCOS), as well as those with persistent AUB or failed medical management, should undergo endometrial biopsy.⁶

Utilize transvaginal ultrasonography

Transvaginal ultrasonography is often useful in the evaluation of patients with AUB, as it may identify uterine fibroids or adenomyosis, suggest intracavitary pathology (such as an endometrial polyp or submucosal fibroid), or raise the possibility of PCOS. In virginal patients or those in whom vaginal ultrasound is not appropriate, abdominal pelvic ultrasonography represents appropriate imaging. If unenhanced ultrasound suggests endometrial polyps or fibroids within the endometrial cavity, an office-based saline infusion sonogram (sonohysterogram) (FIGURE 5) or hysteroscopy should be performed. Targeted endometrial sampling and biopsy of intracavitary pathology can be performed at the time of hysteroscopy.

Treatment

When HMB impairs quality of life, is bothersome to the patient, or results in anemia, treatment is appropriate. Although bleeding episodes in women with AUB-O may be infrequent (as with Case 2), treatment prevents heavy or prolonged bleeding episodes as well as endometrial neoplasia that may otherwise occur in anovulatory women.

Many women with AUB can be managed medically. However, treatment choices will vary with respect to the patient’s desire for future fertility, medical comorbidities, personal preferences, and financial barriers. While many women may prefer outpatient medical management (TABLE 2),^7-14 others might desire surgical therapy, including endometrial ablation or hysterectomy.

Oral contraceptives

Combination estrogen-progestin oral contraceptives represent appropriate initial therapy for many women in the reproductive-age group with AUB, whether women have HMB or AUB-O. However, contraceptive doses of estrogen are not appropriate for some women with risk factors for cardiovascular disease, including those who smoke cigarettes and are age ≥35 years or those who have hypertension (TABLE 3).^15,16

Continue to: Menopausal dosages of HT...

Menopausal dosages of HT

If use of contraceptive doses of estrogen is not appropriate, continuous off-label use of menopausal combination formulations (physiologic dosage) of hormonal therapy (HT; ie, lower doses of estrogen than contraceptives) may be effective in reducing or eliminating AUB. Options for menopausal combination formulations include generic ethinyl estradiol 5 µg/norethindrone acetate 1 mg or estradiol 1 mg/norethindrone acetate 0.5 mg.⁷ High-dose oral progestin therapy (norethindrone acetate 5 mg tablet once daily or medroxyprogesterone acetate 10 mg tablets 1–3 times daily) also can be used when combination contraceptives are contraindicated and may be more effective than lower-dose combination formulations.

Package labeling, as well as some guidelines, indicate that oral progestins used to treat AUB should be taken cyclically.⁸ However, continuous daily use is easier for many patients and may be more effective in reducing bleeding. Accordingly, we counsel patients with AUB who are using progestins and who do not wish to conceive to take these medications continuously. High-dose oral progestin therapy may cause bloating, dysphoria, and increased appetite/weight gain. Women initiating hormonal management (including the progestin IUDs detailed below) for AUB should be counseled that irregular or even continuous light bleeding/spotting is common initially, but this bleeding pattern typically decreases with continued use.

IUDs

The LNG 52 mg IUD (Mirena or Liletta) effectively treats HMB, reducing bleeding in a manner comparable to that of endometrial ablation.^9,10 The Mirena IUD is approved for treatment of HMB in women desiring intrauterine contraception. In contrast to oral medications, use of progestin IUDs does not involve daily administration and may represent an attractive option for women with HMB who would like to avoid surgery or preserve fertility. With ongoing use, continuous oral or intrauterine hormonal management may result in amenorrhea in some women with AUB.

When the LNG 52 mg IUD is used to treat HMB, the menstrual suppression impact may begin to attenuate after approximately 4 years of use; in this setting, replacing the IUD often restores effective menstrual suppression.¹¹ The LNG 52 mg IUD effectively suppresses menses in women with coagulation disorders; if menstrual suppression with the progestin IUD is not adequate in this setting, it may be appropriate to add an oral combination estrogen-progestin contraceptive or high-dose oral progestin.^11,12

NSAIDs and tranexamic acid

Off-label use of nonsteroidal anti-inflammatory drugs (naproxen 500–1,000 mg daily for 5 days beginning at the onset of menstrual flow or tranexamic acid two 650-mg tablets 3 times daily for up to 5 days during episodes of heavy flow) can suppress HMB and is useful for women who prefer to avoid or have contraindications to hormonal treatments.^13,14 Unfortunately, these agents are not as effective as hormonal management in treating AUB.

Iron supplementation is often needed

Iron depletion commonly results from HMB, often resulting in iron deficiency anemia. When iron depletion (readily identified by checking a serum ferritin level) or iron deficiency anemia is identified, iron supplementation should be recommended. Every-other-day administration of iron supplements maximizes iron absorption while minimizing the adverse effects of unabsorbed iron, such as nausea. Sixty mg of elemental iron (ferrous sulfate 325 mg) administered every other day represents an inexpensive and effective treatment for iron deficiency/anemia.¹⁷ In patients who cannot tolerate oral iron supplementation or for those in whom oral therapy is not appropriate or effective, newer intravenous iron formulations are safe and effective.¹⁸

Continue to: Case 1 Follow-up...

Case 1 Follow-up

The patient noted marked improvement in her menstrual cramps following LNG-containing IUD placement. Although she also reported that she no longer experienced heavy menstrual flow or cramps, she was bothered by frequent, unpredictable light bleeding/spotting. You prescribed norethindrone acetate (NETA) 5-mg tablet orally once daily, to be used in addition to her IUD. After using the IUD with concomitant NETA for 2 months’ duration, she noted that her bleeding/spotting almost completely resolved; however, she did report feeling irritable with use of the progestin tablets. She subsequently stopped the NETA tablets and, after 6 months of additional follow-up, reported only minimal spotting and no cramps.

At this later follow-up visit, you noted that her hemoglobin level increased to 12.6 g/dL, and the ferritin level no longer indicated iron depletion. After the IUD had been in place for 4 years, she reported that she was beginning to experience frequent light bleeding again. A follow-up vaginal sonogram noted a well-positioned IUD, there was no suggestion of intracavitary pathology, and adenomyosis continued to be imaged. She underwent IUD removal and placement of a new LNG 52 mg IUD. This resulted in marked reduction in her bleeding.

Case 2 Follow-up

Two weeks after beginning continuous oral progestin therapy, the patient called reporting frequent irregular bleeding. She was reassured that this was not unexpected and encouraged to continue oral progestin therapy. During a 3-month follow-up visit, the patient noted little, if any, bleeding over the previous 2 months and was pleased with this result. She continued to note acne and hirsutism and asked about the possibility of adding spironolactone to her oral progestin regimen.

Case 1 Multiparous woman presents with heavy regular menses

Over the past several years, a 34-year-old woman has noted increasing intensity and duration of menstrual flow, which now persists for 8 days and includes clots “the size of quarters” and soaks a pad within 1 hour. Sometimes she misses or leaves work on her heaviest days of flow. She reports that menstrual cramps prior to and during flow are increasingly bothersome and do not respond adequately to ibuprofen. She intermittently uses condoms for contraception. She does not wish to be pregnant currently; however, she recently entered into a new relationship and may wish to conceive in the future.

On bimanual examination, the uterus appears bulky. Her hemoglobin is 10.9 g/dL with low mean corpuscular volume and a serum ferritin level indicating iron depletion. Pelvic ultrasonography suggests uterine adenomyosis; no fibroids are imaged (FIGURE 1).

You advise the patient to take ferrous sulfate 325 mg every other day. After discussion with the patient regarding different treatment options, she chooses to proceed with placement of a 52-mg levonorgestrel (LNG) intrauterine device (IUD; Mirena or Liletta).

Case 2 Older adolescent presents with irregular bleeding

A 19-year-old patient reports approximately 6 bleeding episodes each year. She reports the duration of her bleeding as variable, and sometimes the bleeding is heavy with small clots passed. She has been previously diagnosed with polycystic ovary syndrome (PCOS). Combination estrogen-progestin oral contraceptives have been prescribed several times in the past, but she always has discontinued them due to nausea. The patient is in a same-sex relationship and does not anticipate being sexually active with a male. She reports having to shave her mustache and chin twice weekly for the past 1 to 2 years.

On physical examination, the patient is obese (body mass index [BMI], 32 kg/m²), facial acne and hirsutism are present, and hair extends from the mons toward the umbilicus. Bimanual examination reveals a normal size, mobile, nontender uterus without obvious adnexal pathology. Pelvic ultrasonography demonstrates a normal-appearing uterus with multiplanar endometrium (consistent with proliferative changes) (FIGURE 2). Ovarian imaging demonstrates ≥12 follicles per image (FIGURE 3).

About one-third of all women experience abnormal uterine bleeding (AUB) sometime during their lifetime and AUB can impair quality of life.¹ Surgical management, including hysterectomy and endometrial ablation, plays an important role in the management of AUB in patients who do not desire future pregnancies. However, many cases of AUB occur in women who may not have completed childbearing or in women who prefer to avoid surgery.² AUB can be managed effectively medically in most cases.¹ Accordingly, in this review, we focus on nonsurgical management of AUB.

Continue to: Because previously used terms, including...

Because previously used terms, including menorrhagia and meno-metrorrhagia, were inconsistently defined and confusing, the International Federation of Gynecology and Obstetrics introduced updated terminology in 2011 to better describe and characterize AUB in nonpregnant women. Heavy menstrual bleeding (HMB) refers to ovulatory (cyclic) bleeding that is more than 8 days’ duration, or sufficiently heavy to impair a woman’s quality of life. HMB is a pattern of AUB distinct from the irregular bleeding pattern typically caused by ovulatory dysfunction (AUB-O).¹

Clinical evaluation

Obtain menstrual history. In addition to a medical, surgical, and gynecologic history, a thorough menstrual history should be obtained to further characterize the patient’s bleeding pattern. In contrast to the cyclical or ovulatory bleeding seen with HMB, bleeding associated with inconsistent ovulation (AUB-O) is unpredictable or irregular, and is commonly associated with PCOS. AUB-O is also encountered in recently menarchal girls (secondary to immaturity of the hypothalamic-pituitary-gonadal axis) and in those who are perimenopausal. In addition, medications that can induce hyperprolactinemia (such as certain antipsychotics) can cause AUB-O.

Evaluate for all sources of bleeding. Be sure to evaluate for extrauterine causes of bleeding, including the cervix, vagina, vulva, or the urinary or gastrointestinal tracts for bleeding. Intermenstrual bleeding occurring between normal regular menses may be caused by an endometrial polyp, submucosal fibroid, endometritis, or an IUD. The patient report of postcoital bleeding suggests that cervical disease (cervicitis, polyp, or malignancy) may be present. Uterine leiomyoma or adenomyosis represent common causes of HMB. However, HMB also may be caused by a copper IUD, coagulation disorders (including von Willebrand disease), or use of anticoagulant medications. Hormonal contraceptives also can cause irregular bleeding.

Perform a pelvic examination and measure vital signs. The presence of fever suggests the possible presence of pelvic inflammatory disease (PID), while orthostatic hypotension raises the possibility of hypovolemia. When vaginal speculum examination is performed, a cervical cause of abnormal bleeding may be noted. The presence of fresh or old blood or finding clots in the vaginal vault or at the cervical os are all consistent with AUB. A bimanual examination that reveals an enlarged or lobular uterus suggests leiomyoma or adenomyosis. Cervical or adnexal tenderness is often noted in women with PID, which itself may be associated with endometritis. The presence of hyperandrogenic signs on physical examination (eg, acne, hirsutism, or clitoromegaly) suggests PCOS. The finding of galactorrhea suggests that hyperprolactinemia may be present.

Laboratory assessment

Test for pregnancy, cervical disease, and sexually transmitted infection when appropriate. Pregnancy testing is appropriate for women with AUB aged 55 years or younger. If patients with AUB are not up to date with normal cervical cancer screening results, cervical cytology and/or human papillomavirus testing should be performed. Testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis should be performed in patients:

• younger than 25 years
• when the history indicates new or multiple sexual partners, or
• when vaginal discharge, cervicitis, cervical motion, or adnexal tenderness is present.

Continue to: Obtain a complete blood count and serum ferritin levels...

Obtain a complete blood count and serum ferritin levels. In women presenting with HMB, iron depletion and iron deficiency anemia are common. The finding of leukocytosis raises the possibility of PID or postpartum endometritis. In women with presumptive AUB-O, checking the levels of thyroid-stimulating hormone, free T4, and prolactin should be performed.

Screen for a hemostasis disorder. Women with excessive menstrual bleeding should be clinically screened for an underlying disorder of hemostasis (TABLE 1).³ When a hemostasis disorder is suspected, initial laboratory evaluation includes a partial thromboplastin time, prothrombin time, activated partial thromboplastin time, and fibrinogen. Women who have a positive clinical screen for a possible bleeding disorder or abnormal initial laboratory test results for disorders of hemostasis should undergo further laboratory evaluation, including von Willebrand factor antigen, ristocetin cofactor assay, and factor VIII. Consultation with a hematologist should be considered in these cases.

Perform endometrial biopsy when indicated

After excluding pregnancy, endometrial biopsy (through pipelle biospy or brush sampling; FIGURE 4) should be performed in women with AUB who are at increased risk for endometrial neoplasia. The prevalence of endometrial neoplasia is substantially higher among women ≥45 years of age⁴ and among patients with AUB who are also obese (BMI, ≥30 kg/m²).⁵ In addition, AUB patients with unopposed estrogen exposure (presumed anovulation/PCOS), as well as those with persistent AUB or failed medical management, should undergo endometrial biopsy.⁶

Utilize transvaginal ultrasonography

Transvaginal ultrasonography is often useful in the evaluation of patients with AUB, as it may identify uterine fibroids or adenomyosis, suggest intracavitary pathology (such as an endometrial polyp or submucosal fibroid), or raise the possibility of PCOS. In virginal patients or those in whom vaginal ultrasound is not appropriate, abdominal pelvic ultrasonography represents appropriate imaging. If unenhanced ultrasound suggests endometrial polyps or fibroids within the endometrial cavity, an office-based saline infusion sonogram (sonohysterogram) (FIGURE 5) or hysteroscopy should be performed. Targeted endometrial sampling and biopsy of intracavitary pathology can be performed at the time of hysteroscopy.

Treatment

When HMB impairs quality of life, is bothersome to the patient, or results in anemia, treatment is appropriate. Although bleeding episodes in women with AUB-O may be infrequent (as with Case 2), treatment prevents heavy or prolonged bleeding episodes as well as endometrial neoplasia that may otherwise occur in anovulatory women.

Many women with AUB can be managed medically. However, treatment choices will vary with respect to the patient’s desire for future fertility, medical comorbidities, personal preferences, and financial barriers. While many women may prefer outpatient medical management (TABLE 2),^7-14 others might desire surgical therapy, including endometrial ablation or hysterectomy.

Oral contraceptives

Combination estrogen-progestin oral contraceptives represent appropriate initial therapy for many women in the reproductive-age group with AUB, whether women have HMB or AUB-O. However, contraceptive doses of estrogen are not appropriate for some women with risk factors for cardiovascular disease, including those who smoke cigarettes and are age ≥35 years or those who have hypertension (TABLE 3).^15,16

Continue to: Menopausal dosages of HT...

Menopausal dosages of HT

If use of contraceptive doses of estrogen is not appropriate, continuous off-label use of menopausal combination formulations (physiologic dosage) of hormonal therapy (HT; ie, lower doses of estrogen than contraceptives) may be effective in reducing or eliminating AUB. Options for menopausal combination formulations include generic ethinyl estradiol 5 µg/norethindrone acetate 1 mg or estradiol 1 mg/norethindrone acetate 0.5 mg.⁷ High-dose oral progestin therapy (norethindrone acetate 5 mg tablet once daily or medroxyprogesterone acetate 10 mg tablets 1–3 times daily) also can be used when combination contraceptives are contraindicated and may be more effective than lower-dose combination formulations.

Package labeling, as well as some guidelines, indicate that oral progestins used to treat AUB should be taken cyclically.⁸ However, continuous daily use is easier for many patients and may be more effective in reducing bleeding. Accordingly, we counsel patients with AUB who are using progestins and who do not wish to conceive to take these medications continuously. High-dose oral progestin therapy may cause bloating, dysphoria, and increased appetite/weight gain. Women initiating hormonal management (including the progestin IUDs detailed below) for AUB should be counseled that irregular or even continuous light bleeding/spotting is common initially, but this bleeding pattern typically decreases with continued use.

IUDs

The LNG 52 mg IUD (Mirena or Liletta) effectively treats HMB, reducing bleeding in a manner comparable to that of endometrial ablation.^9,10 The Mirena IUD is approved for treatment of HMB in women desiring intrauterine contraception. In contrast to oral medications, use of progestin IUDs does not involve daily administration and may represent an attractive option for women with HMB who would like to avoid surgery or preserve fertility. With ongoing use, continuous oral or intrauterine hormonal management may result in amenorrhea in some women with AUB.

When the LNG 52 mg IUD is used to treat HMB, the menstrual suppression impact may begin to attenuate after approximately 4 years of use; in this setting, replacing the IUD often restores effective menstrual suppression.¹¹ The LNG 52 mg IUD effectively suppresses menses in women with coagulation disorders; if menstrual suppression with the progestin IUD is not adequate in this setting, it may be appropriate to add an oral combination estrogen-progestin contraceptive or high-dose oral progestin.^11,12

NSAIDs and tranexamic acid

Off-label use of nonsteroidal anti-inflammatory drugs (naproxen 500–1,000 mg daily for 5 days beginning at the onset of menstrual flow or tranexamic acid two 650-mg tablets 3 times daily for up to 5 days during episodes of heavy flow) can suppress HMB and is useful for women who prefer to avoid or have contraindications to hormonal treatments.^13,14 Unfortunately, these agents are not as effective as hormonal management in treating AUB.

Iron supplementation is often needed

Iron depletion commonly results from HMB, often resulting in iron deficiency anemia. When iron depletion (readily identified by checking a serum ferritin level) or iron deficiency anemia is identified, iron supplementation should be recommended. Every-other-day administration of iron supplements maximizes iron absorption while minimizing the adverse effects of unabsorbed iron, such as nausea. Sixty mg of elemental iron (ferrous sulfate 325 mg) administered every other day represents an inexpensive and effective treatment for iron deficiency/anemia.¹⁷ In patients who cannot tolerate oral iron supplementation or for those in whom oral therapy is not appropriate or effective, newer intravenous iron formulations are safe and effective.¹⁸

Continue to: Case 1 Follow-up...

Case 1 Follow-up

The patient noted marked improvement in her menstrual cramps following LNG-containing IUD placement. Although she also reported that she no longer experienced heavy menstrual flow or cramps, she was bothered by frequent, unpredictable light bleeding/spotting. You prescribed norethindrone acetate (NETA) 5-mg tablet orally once daily, to be used in addition to her IUD. After using the IUD with concomitant NETA for 2 months’ duration, she noted that her bleeding/spotting almost completely resolved; however, she did report feeling irritable with use of the progestin tablets. She subsequently stopped the NETA tablets and, after 6 months of additional follow-up, reported only minimal spotting and no cramps.

At this later follow-up visit, you noted that her hemoglobin level increased to 12.6 g/dL, and the ferritin level no longer indicated iron depletion. After the IUD had been in place for 4 years, she reported that she was beginning to experience frequent light bleeding again. A follow-up vaginal sonogram noted a well-positioned IUD, there was no suggestion of intracavitary pathology, and adenomyosis continued to be imaged. She underwent IUD removal and placement of a new LNG 52 mg IUD. This resulted in marked reduction in her bleeding.

Case 2 Follow-up

Two weeks after beginning continuous oral progestin therapy, the patient called reporting frequent irregular bleeding. She was reassured that this was not unexpected and encouraged to continue oral progestin therapy. During a 3-month follow-up visit, the patient noted little, if any, bleeding over the previous 2 months and was pleased with this result. She continued to note acne and hirsutism and asked about the possibility of adding spironolactone to her oral progestin regimen.

Urinary incontinence affects approximately 50% of women, with up to 80% of these women experiencing stress urinary incontinence (SUI) at some point in their lives.^1-3 While conservative measures can offer some improvement in symptoms, the mainstay of treatment for SUI is surgical intervention.^4,5 The lifetime risk of undergoing surgery for SUI is 13.6%, and surgery leads to a major improvement in quality of life and productivity.^1,6

Types of slings used for SUI

Sling procedures are the most commonly used surgical approach for the treatment of SUI. Two types of urethral slings are used: the midurethral sling and the autologous fascial (pubovaginal) sling. The midurethral sling, which is the most frequently used sling today, can be further characterized as the retropubic sling, the transobturator sling, and the mini sling (FIGURE 1).

Retropubic sling

A retropubic sling is a midurethral mesh sling that is placed beneath the urethra at the midpoint between the urethral meatus and the bladder neck. The arms of the sling extend behind the pubic symphysis, providing a hammock-like support that helps prevent leakage with increased abdominal pressures. The retropubic sling is the most commonly used type of sling. For women presenting with uncomplicated SUI who desire surgical correction, it often is the best choice for providing long-term treatment success.⁷

Transobturator sling

A transobturator sling is a midurethral mesh sling that is placed beneath the urethra as described above, but the arms of the sling extend outward through the obturator foramen and into the groin. This enables support of the midurethra, but this sling is less likely to result in such complications as bladder perforation or postoperative urinary retention. Transobturator slings also are associated with lower rates of voiding dysfunction and urinary urgency than retropubic slings.^7-9 However, transobturator slings have higher rates of groin pain, and they are less effective in maintaining long-term cure of SUI.⁷

First introduced in 1996, the midurethral sling quickly grew in popularity for the treatment of SUI because of its high success rates and its minimally invasive approach.¹⁰ Both retropubic and transobturator slings are safe, extensively researched surgical approaches for the management of SUI.³ Midurethral slings have a very high rate of incontinence cure (80%–90%) and extremely high patient satisfaction rates (85%–90%), as even patients without complete cure report meaningful symptomatic improvement.^7,8,11

Single-incision (mini) sling

A single-incision sling is a midurethral mesh sling that is designed to be shorter in length than standard midurethral slings. The placed sling lies under the midurethra and extends toward the superior edge of the obturator foramen but does not penetrate it. The sling is held in place by small pledgets on either side of the mesh hammock that anchor it in place to the obturator internus muscular fascia. Because this “mini” sling was introduced in 2006, fewer long-term data are available for this sling than for standard midurethral slings.

Continue to: Autologous (fascial) sling...

Autologous (fascial) sling

An autologous sling is a retropubic sling made from the patient’s own fascia; it is harvested from either the fascia lata of the lateral thigh or the rectus fascia of the abdomen. The sling is placed beneath the urethra in the bladder neck region, and sutures affixed to the sling edges pass behind the pubic symphysis and through the abdominal fascia to anchor it in place.

Choose a sling based on the clinical situation and patient goals

Consider the unique features of each sling when selecting the proper sling; this should be a shared decision with the patient after thorough counseling. Below, we present 4 clinical cases to exemplify scenarios in which different slings are appropriate, and we review the rationale for each selection.

CASE 1 SUI that interferes with exercise routine

Ms. P. is a 46-year-old (G3P3) active mother. She loves to exercise, but she has been working out less frequently because of embarrassing urinary leakage that occurs with activity. She has tried pelvic floor exercises and changing her fluid intake habits, but improvements have been minimal with these interventions. On evaluation, she has a positive cough stress test with a recently emptied bladder and a normal postvoid residual volume.

What type of sling would be best?

Because this patient is young, active, and has significant leakage with an empty bladder, a sling with good long-term treatment success is likely to provide her with the best results (Figure 1). We therefore offered her a retropubic midurethral sling. The retropubic approach is preferred here as it is less likely than the transobturator sling to cause groin/thigh pain, which is an important consideration in this young, active patient.

Further testing is not needed

For women with uncomplicated SUI who demonstrate leakage with stress (coughing, Valsalva stress test) and who have a normal postvoid residual volume, additional testing, such as urodynamic evaluation, is not necessary.¹² These patients can be counseled on the range of conservative management options and as well as surgical inventions.

CASE 2 Return of SUI symptoms after transobturator sling placement

Ms. E. is a 70-year-old woman who had a transobturator sling placed 5 years ago. Initially, her SUI symptoms improved after surgery. Recently, however, she noticed a return of her SUI, which she finds bothersome and limiting to her quality of life.

How would you manage this patient?

While midurethral slings are highly effective, there are instances in which patients will have symptom recurrence. For women who already have a midurethral sling, consider the following important questions.

Is this truly recurrent SUI, or is it a new process?

Like any reconstructive procedure, midurethral sling success rates decline over time and recurrent SUI can develop.⁷ However, it also is possible for urge urinary incontinence to develop as a new process, and it is important to distinguish which type of urinary incontinence your patient has prior to counseling about treatment options.

To further evaluate patients with recurrent incontinence and a prior sling, we recommend urodynamic studies with cystoscopy (in addition to a detailed history and physical exam). This not only helps rule out other forms of incontinence, such as overactive bladder, but also evaluates for possible mesh erosion into the urethra or bladder, which can cause irritative voiding symptoms and incontinence.

Continue to: What type of sling did the patient have initially...

What type of sling did the patient have initially, and how does this impact a repeat procedure?

Regardless of the initial sling type used, repeat midurethral sling procedures have a significantly lower cure rate than primary midurethral sling procedures.¹³ Retropubic slings are more effective than transobturator slings for patients with recurrent SUI who have failed a prior sling. When a patient presents with recurrent SUI after a prior transobturator sling, the best option for a repeat procedure is usually a retropubic sling, as it achieves higher objective and subjective cure rates.^13,14 (See FIGURE 2 for a comparison of retropubic and transobturator slings.)


Should I remove the old sling prior to placing a new one?

While it is recommended to remove the vaginal portion of the sling if the patient has a mesh exposure or is experiencing other symptoms, such as pain or bleeding, removal of the old sling is not necessarily indicated prior to (or during) a repeat incontinence procedure.^15,16 Removing the sling, removing a portion of the sling, or leaving the sling in situ are all reasonable options.

CASE 3 Treated SUI has mesh exposure

Ms. R. is a 60-year-old woman with a history of SUI that was previously managed with a retropubic midurethral sling placed at an outside hospital. She is a smoker and has developed a vaginal mesh exposure. Although she would like the mesh removed, she does not want her incontinence to come back. She tells you that she does not think she would be able to quit smoking.

What would be a reasonable next option for Ms. R.?

While complications from a midurethral sling are rare, mesh exposures occur in approximately 2% of patients, and urinary retention requiring release of the sling occurs in about 1% of patients.^3,6 It often helps to clarify for patients that the US Food and Drug Administration public health advisories on the use of transvaginal mesh have been directed specifically toward the use of transvaginal mesh for the treatment of pelvic organ prolapse (POP), not the use of mesh for midurethral slings for SUI or transabdominal mesh for POP.^10,17

When considering use of a mesh sling, a thorough discussion of the potential risks, as well as the benefits and alternatives, is imperative. Patients must personally balance the probability of benefit with the potential risk of complications, and while physicians can help outline the benefits and risks through shared decision-making, ultimately it is the patient who should make this decision.

Certain patient populations may be at higher risk for mesh complications¹⁸ (See "Risk factors for mesh-related complications," below). These complications are managed in various ways (FIGURE 3). Patients who have experienced mesh complications previously are typically not good candidates for a repeat mesh sling, particularly when the risk factor for complications cannot be modified.

A mesh sling alternative

The most effective way to manage SUI in patients who are not good candidates for a mesh sling is to consider employing a sling that uses the patient’s own tissue.^19-21 Common approaches include harvesting a graft of rectus fascia through a Pfannenstiel skin incision or using fascia lata from the patient’s iliotibial band in the lateral thigh. Autologous slings are safe and effective, and even after a mesh sling has failed, autologous slings have an almost 70% cure rate for SUI.^20,21

Continue to: Timing of mesh removal and placement of an autologous fascial sling...

Timing of mesh removal and placement of an autologous fascial sling

Either concomitant or delayed placement of a pubovaginal sling is acceptable when removing mesh, though this should be a joint decision with the patient after counseling. If the risk for surgical complications is modifiable (for example, poorly controlled diabetes that could be improved with blood glucose control), it may be advisable to delay the fascial sling until the risk factors have been addressed. Similarly, if the reason for mesh removal is pain, it may be advisable to remove the mesh prior to placing a new sling to ensure that the pain resolves completely. Otherwise, if pain persists, it can be unclear whether the new sling is contributing to the pain, and this may lead to difficulties treating pain or incontinence in the future.

In this patient, who was an active smoker, we excised the exposed mesh and concomitantly placed an autologous fascial sling utilizing rectus fascia. This maintained continence without introducing mesh in a high-risk patient.

CASE 4 POP and occult SUI

Ms. B. is a 79-year-old woman with stage 3 POP planned for surgical repair. While she does not report urinary leakage, preoperative urodynamic testing revealed occult SUI with reduction of her prolapse. Her priorities are to avoid needing another surgery and to limit the chances of postoperative leakage, but she is nervous about her postoperative recovery and wants to avoid pain.

What approach would be appropriate?

Consider a mini sling for this patient

The single-incision (mini) sling is an option to consider for patients with mild incontinence or for those without evidence of intrinsic sphincter deficiency. It is also a good option for those who want to avoid the additional incisions required for full-length slings.

While currently there is not sufficient evidence to clearly state if single-incision slings are equivalent to other slings, recent studies show that single-incision slings appear to be safe and effective in the short term, with possibly fewer complications than traditional transobturator slings.^22-24 As patients are often concerned about the potential for groin pain with a transobturator sling, a single-incision sling is an acceptable alternative that avoids groin incisions and also avoids the retropubic space.

Patient counseling is crucial

Regardless of the route, sling procedures are highly effective and safe for treating women with SUI.³ Understanding the characteristics of each type of sling and the distinct surgical approaches enables informed counseling for patients who are navigating the treatment options for SUI.

Urinary incontinence affects approximately 50% of women, with up to 80% of these women experiencing stress urinary incontinence (SUI) at some point in their lives.^1-3 While conservative measures can offer some improvement in symptoms, the mainstay of treatment for SUI is surgical intervention.^4,5 The lifetime risk of undergoing surgery for SUI is 13.6%, and surgery leads to a major improvement in quality of life and productivity.^1,6

Types of slings used for SUI

Sling procedures are the most commonly used surgical approach for the treatment of SUI. Two types of urethral slings are used: the midurethral sling and the autologous fascial (pubovaginal) sling. The midurethral sling, which is the most frequently used sling today, can be further characterized as the retropubic sling, the transobturator sling, and the mini sling (FIGURE 1).

Retropubic sling

A retropubic sling is a midurethral mesh sling that is placed beneath the urethra at the midpoint between the urethral meatus and the bladder neck. The arms of the sling extend behind the pubic symphysis, providing a hammock-like support that helps prevent leakage with increased abdominal pressures. The retropubic sling is the most commonly used type of sling. For women presenting with uncomplicated SUI who desire surgical correction, it often is the best choice for providing long-term treatment success.⁷

Transobturator sling

A transobturator sling is a midurethral mesh sling that is placed beneath the urethra as described above, but the arms of the sling extend outward through the obturator foramen and into the groin. This enables support of the midurethra, but this sling is less likely to result in such complications as bladder perforation or postoperative urinary retention. Transobturator slings also are associated with lower rates of voiding dysfunction and urinary urgency than retropubic slings.^7-9 However, transobturator slings have higher rates of groin pain, and they are less effective in maintaining long-term cure of SUI.⁷

First introduced in 1996, the midurethral sling quickly grew in popularity for the treatment of SUI because of its high success rates and its minimally invasive approach.¹⁰ Both retropubic and transobturator slings are safe, extensively researched surgical approaches for the management of SUI.³ Midurethral slings have a very high rate of incontinence cure (80%–90%) and extremely high patient satisfaction rates (85%–90%), as even patients without complete cure report meaningful symptomatic improvement.^7,8,11

Single-incision (mini) sling

A single-incision sling is a midurethral mesh sling that is designed to be shorter in length than standard midurethral slings. The placed sling lies under the midurethra and extends toward the superior edge of the obturator foramen but does not penetrate it. The sling is held in place by small pledgets on either side of the mesh hammock that anchor it in place to the obturator internus muscular fascia. Because this “mini” sling was introduced in 2006, fewer long-term data are available for this sling than for standard midurethral slings.

Continue to: Autologous (fascial) sling...

Autologous (fascial) sling

An autologous sling is a retropubic sling made from the patient’s own fascia; it is harvested from either the fascia lata of the lateral thigh or the rectus fascia of the abdomen. The sling is placed beneath the urethra in the bladder neck region, and sutures affixed to the sling edges pass behind the pubic symphysis and through the abdominal fascia to anchor it in place.

Choose a sling based on the clinical situation and patient goals

Consider the unique features of each sling when selecting the proper sling; this should be a shared decision with the patient after thorough counseling. Below, we present 4 clinical cases to exemplify scenarios in which different slings are appropriate, and we review the rationale for each selection.

CASE 1 SUI that interferes with exercise routine

Ms. P. is a 46-year-old (G3P3) active mother. She loves to exercise, but she has been working out less frequently because of embarrassing urinary leakage that occurs with activity. She has tried pelvic floor exercises and changing her fluid intake habits, but improvements have been minimal with these interventions. On evaluation, she has a positive cough stress test with a recently emptied bladder and a normal postvoid residual volume.

What type of sling would be best?

Because this patient is young, active, and has significant leakage with an empty bladder, a sling with good long-term treatment success is likely to provide her with the best results (Figure 1). We therefore offered her a retropubic midurethral sling. The retropubic approach is preferred here as it is less likely than the transobturator sling to cause groin/thigh pain, which is an important consideration in this young, active patient.

Further testing is not needed

For women with uncomplicated SUI who demonstrate leakage with stress (coughing, Valsalva stress test) and who have a normal postvoid residual volume, additional testing, such as urodynamic evaluation, is not necessary.¹² These patients can be counseled on the range of conservative management options and as well as surgical inventions.

CASE 2 Return of SUI symptoms after transobturator sling placement

Ms. E. is a 70-year-old woman who had a transobturator sling placed 5 years ago. Initially, her SUI symptoms improved after surgery. Recently, however, she noticed a return of her SUI, which she finds bothersome and limiting to her quality of life.

How would you manage this patient?

While midurethral slings are highly effective, there are instances in which patients will have symptom recurrence. For women who already have a midurethral sling, consider the following important questions.

Is this truly recurrent SUI, or is it a new process?

Like any reconstructive procedure, midurethral sling success rates decline over time and recurrent SUI can develop.⁷ However, it also is possible for urge urinary incontinence to develop as a new process, and it is important to distinguish which type of urinary incontinence your patient has prior to counseling about treatment options.

To further evaluate patients with recurrent incontinence and a prior sling, we recommend urodynamic studies with cystoscopy (in addition to a detailed history and physical exam). This not only helps rule out other forms of incontinence, such as overactive bladder, but also evaluates for possible mesh erosion into the urethra or bladder, which can cause irritative voiding symptoms and incontinence.

Continue to: What type of sling did the patient have initially...

What type of sling did the patient have initially, and how does this impact a repeat procedure?

Regardless of the initial sling type used, repeat midurethral sling procedures have a significantly lower cure rate than primary midurethral sling procedures.¹³ Retropubic slings are more effective than transobturator slings for patients with recurrent SUI who have failed a prior sling. When a patient presents with recurrent SUI after a prior transobturator sling, the best option for a repeat procedure is usually a retropubic sling, as it achieves higher objective and subjective cure rates.^13,14 (See FIGURE 2 for a comparison of retropubic and transobturator slings.)


Should I remove the old sling prior to placing a new one?

While it is recommended to remove the vaginal portion of the sling if the patient has a mesh exposure or is experiencing other symptoms, such as pain or bleeding, removal of the old sling is not necessarily indicated prior to (or during) a repeat incontinence procedure.^15,16 Removing the sling, removing a portion of the sling, or leaving the sling in situ are all reasonable options.

CASE 3 Treated SUI has mesh exposure

Ms. R. is a 60-year-old woman with a history of SUI that was previously managed with a retropubic midurethral sling placed at an outside hospital. She is a smoker and has developed a vaginal mesh exposure. Although she would like the mesh removed, she does not want her incontinence to come back. She tells you that she does not think she would be able to quit smoking.

What would be a reasonable next option for Ms. R.?

While complications from a midurethral sling are rare, mesh exposures occur in approximately 2% of patients, and urinary retention requiring release of the sling occurs in about 1% of patients.^3,6 It often helps to clarify for patients that the US Food and Drug Administration public health advisories on the use of transvaginal mesh have been directed specifically toward the use of transvaginal mesh for the treatment of pelvic organ prolapse (POP), not the use of mesh for midurethral slings for SUI or transabdominal mesh for POP.^10,17

When considering use of a mesh sling, a thorough discussion of the potential risks, as well as the benefits and alternatives, is imperative. Patients must personally balance the probability of benefit with the potential risk of complications, and while physicians can help outline the benefits and risks through shared decision-making, ultimately it is the patient who should make this decision.

Certain patient populations may be at higher risk for mesh complications¹⁸ (See "Risk factors for mesh-related complications," below). These complications are managed in various ways (FIGURE 3). Patients who have experienced mesh complications previously are typically not good candidates for a repeat mesh sling, particularly when the risk factor for complications cannot be modified.

A mesh sling alternative

The most effective way to manage SUI in patients who are not good candidates for a mesh sling is to consider employing a sling that uses the patient’s own tissue.^19-21 Common approaches include harvesting a graft of rectus fascia through a Pfannenstiel skin incision or using fascia lata from the patient’s iliotibial band in the lateral thigh. Autologous slings are safe and effective, and even after a mesh sling has failed, autologous slings have an almost 70% cure rate for SUI.^20,21

Continue to: Timing of mesh removal and placement of an autologous fascial sling...

Timing of mesh removal and placement of an autologous fascial sling

Either concomitant or delayed placement of a pubovaginal sling is acceptable when removing mesh, though this should be a joint decision with the patient after counseling. If the risk for surgical complications is modifiable (for example, poorly controlled diabetes that could be improved with blood glucose control), it may be advisable to delay the fascial sling until the risk factors have been addressed. Similarly, if the reason for mesh removal is pain, it may be advisable to remove the mesh prior to placing a new sling to ensure that the pain resolves completely. Otherwise, if pain persists, it can be unclear whether the new sling is contributing to the pain, and this may lead to difficulties treating pain or incontinence in the future.

In this patient, who was an active smoker, we excised the exposed mesh and concomitantly placed an autologous fascial sling utilizing rectus fascia. This maintained continence without introducing mesh in a high-risk patient.

CASE 4 POP and occult SUI

Ms. B. is a 79-year-old woman with stage 3 POP planned for surgical repair. While she does not report urinary leakage, preoperative urodynamic testing revealed occult SUI with reduction of her prolapse. Her priorities are to avoid needing another surgery and to limit the chances of postoperative leakage, but she is nervous about her postoperative recovery and wants to avoid pain.

What approach would be appropriate?

Consider a mini sling for this patient

The single-incision (mini) sling is an option to consider for patients with mild incontinence or for those without evidence of intrinsic sphincter deficiency. It is also a good option for those who want to avoid the additional incisions required for full-length slings.

While currently there is not sufficient evidence to clearly state if single-incision slings are equivalent to other slings, recent studies show that single-incision slings appear to be safe and effective in the short term, with possibly fewer complications than traditional transobturator slings.^22-24 As patients are often concerned about the potential for groin pain with a transobturator sling, a single-incision sling is an acceptable alternative that avoids groin incisions and also avoids the retropubic space.

Patient counseling is crucial

Regardless of the route, sling procedures are highly effective and safe for treating women with SUI.³ Understanding the characteristics of each type of sling and the distinct surgical approaches enables informed counseling for patients who are navigating the treatment options for SUI.

Urinary incontinence affects approximately 50% of women, with up to 80% of these women experiencing stress urinary incontinence (SUI) at some point in their lives.^1-3 While conservative measures can offer some improvement in symptoms, the mainstay of treatment for SUI is surgical intervention.^4,5 The lifetime risk of undergoing surgery for SUI is 13.6%, and surgery leads to a major improvement in quality of life and productivity.^1,6

Types of slings used for SUI

Sling procedures are the most commonly used surgical approach for the treatment of SUI. Two types of urethral slings are used: the midurethral sling and the autologous fascial (pubovaginal) sling. The midurethral sling, which is the most frequently used sling today, can be further characterized as the retropubic sling, the transobturator sling, and the mini sling (FIGURE 1).

Retropubic sling

A retropubic sling is a midurethral mesh sling that is placed beneath the urethra at the midpoint between the urethral meatus and the bladder neck. The arms of the sling extend behind the pubic symphysis, providing a hammock-like support that helps prevent leakage with increased abdominal pressures. The retropubic sling is the most commonly used type of sling. For women presenting with uncomplicated SUI who desire surgical correction, it often is the best choice for providing long-term treatment success.⁷

Transobturator sling

A transobturator sling is a midurethral mesh sling that is placed beneath the urethra as described above, but the arms of the sling extend outward through the obturator foramen and into the groin. This enables support of the midurethra, but this sling is less likely to result in such complications as bladder perforation or postoperative urinary retention. Transobturator slings also are associated with lower rates of voiding dysfunction and urinary urgency than retropubic slings.^7-9 However, transobturator slings have higher rates of groin pain, and they are less effective in maintaining long-term cure of SUI.⁷

First introduced in 1996, the midurethral sling quickly grew in popularity for the treatment of SUI because of its high success rates and its minimally invasive approach.¹⁰ Both retropubic and transobturator slings are safe, extensively researched surgical approaches for the management of SUI.³ Midurethral slings have a very high rate of incontinence cure (80%–90%) and extremely high patient satisfaction rates (85%–90%), as even patients without complete cure report meaningful symptomatic improvement.^7,8,11

Single-incision (mini) sling

A single-incision sling is a midurethral mesh sling that is designed to be shorter in length than standard midurethral slings. The placed sling lies under the midurethra and extends toward the superior edge of the obturator foramen but does not penetrate it. The sling is held in place by small pledgets on either side of the mesh hammock that anchor it in place to the obturator internus muscular fascia. Because this “mini” sling was introduced in 2006, fewer long-term data are available for this sling than for standard midurethral slings.

Continue to: Autologous (fascial) sling...

Autologous (fascial) sling

An autologous sling is a retropubic sling made from the patient’s own fascia; it is harvested from either the fascia lata of the lateral thigh or the rectus fascia of the abdomen. The sling is placed beneath the urethra in the bladder neck region, and sutures affixed to the sling edges pass behind the pubic symphysis and through the abdominal fascia to anchor it in place.

Choose a sling based on the clinical situation and patient goals

Consider the unique features of each sling when selecting the proper sling; this should be a shared decision with the patient after thorough counseling. Below, we present 4 clinical cases to exemplify scenarios in which different slings are appropriate, and we review the rationale for each selection.

CASE 1 SUI that interferes with exercise routine

Ms. P. is a 46-year-old (G3P3) active mother. She loves to exercise, but she has been working out less frequently because of embarrassing urinary leakage that occurs with activity. She has tried pelvic floor exercises and changing her fluid intake habits, but improvements have been minimal with these interventions. On evaluation, she has a positive cough stress test with a recently emptied bladder and a normal postvoid residual volume.

What type of sling would be best?

Because this patient is young, active, and has significant leakage with an empty bladder, a sling with good long-term treatment success is likely to provide her with the best results (Figure 1). We therefore offered her a retropubic midurethral sling. The retropubic approach is preferred here as it is less likely than the transobturator sling to cause groin/thigh pain, which is an important consideration in this young, active patient.

Further testing is not needed

For women with uncomplicated SUI who demonstrate leakage with stress (coughing, Valsalva stress test) and who have a normal postvoid residual volume, additional testing, such as urodynamic evaluation, is not necessary.¹² These patients can be counseled on the range of conservative management options and as well as surgical inventions.

CASE 2 Return of SUI symptoms after transobturator sling placement

Ms. E. is a 70-year-old woman who had a transobturator sling placed 5 years ago. Initially, her SUI symptoms improved after surgery. Recently, however, she noticed a return of her SUI, which she finds bothersome and limiting to her quality of life.

How would you manage this patient?

While midurethral slings are highly effective, there are instances in which patients will have symptom recurrence. For women who already have a midurethral sling, consider the following important questions.

Is this truly recurrent SUI, or is it a new process?

Like any reconstructive procedure, midurethral sling success rates decline over time and recurrent SUI can develop.⁷ However, it also is possible for urge urinary incontinence to develop as a new process, and it is important to distinguish which type of urinary incontinence your patient has prior to counseling about treatment options.

To further evaluate patients with recurrent incontinence and a prior sling, we recommend urodynamic studies with cystoscopy (in addition to a detailed history and physical exam). This not only helps rule out other forms of incontinence, such as overactive bladder, but also evaluates for possible mesh erosion into the urethra or bladder, which can cause irritative voiding symptoms and incontinence.

Continue to: What type of sling did the patient have initially...

What type of sling did the patient have initially, and how does this impact a repeat procedure?

Regardless of the initial sling type used, repeat midurethral sling procedures have a significantly lower cure rate than primary midurethral sling procedures.¹³ Retropubic slings are more effective than transobturator slings for patients with recurrent SUI who have failed a prior sling. When a patient presents with recurrent SUI after a prior transobturator sling, the best option for a repeat procedure is usually a retropubic sling, as it achieves higher objective and subjective cure rates.^13,14 (See FIGURE 2 for a comparison of retropubic and transobturator slings.)


Should I remove the old sling prior to placing a new one?

While it is recommended to remove the vaginal portion of the sling if the patient has a mesh exposure or is experiencing other symptoms, such as pain or bleeding, removal of the old sling is not necessarily indicated prior to (or during) a repeat incontinence procedure.^15,16 Removing the sling, removing a portion of the sling, or leaving the sling in situ are all reasonable options.

CASE 3 Treated SUI has mesh exposure

Ms. R. is a 60-year-old woman with a history of SUI that was previously managed with a retropubic midurethral sling placed at an outside hospital. She is a smoker and has developed a vaginal mesh exposure. Although she would like the mesh removed, she does not want her incontinence to come back. She tells you that she does not think she would be able to quit smoking.

What would be a reasonable next option for Ms. R.?

While complications from a midurethral sling are rare, mesh exposures occur in approximately 2% of patients, and urinary retention requiring release of the sling occurs in about 1% of patients.^3,6 It often helps to clarify for patients that the US Food and Drug Administration public health advisories on the use of transvaginal mesh have been directed specifically toward the use of transvaginal mesh for the treatment of pelvic organ prolapse (POP), not the use of mesh for midurethral slings for SUI or transabdominal mesh for POP.^10,17

When considering use of a mesh sling, a thorough discussion of the potential risks, as well as the benefits and alternatives, is imperative. Patients must personally balance the probability of benefit with the potential risk of complications, and while physicians can help outline the benefits and risks through shared decision-making, ultimately it is the patient who should make this decision.

Certain patient populations may be at higher risk for mesh complications¹⁸ (See "Risk factors for mesh-related complications," below). These complications are managed in various ways (FIGURE 3). Patients who have experienced mesh complications previously are typically not good candidates for a repeat mesh sling, particularly when the risk factor for complications cannot be modified.

A mesh sling alternative

The most effective way to manage SUI in patients who are not good candidates for a mesh sling is to consider employing a sling that uses the patient’s own tissue.^19-21 Common approaches include harvesting a graft of rectus fascia through a Pfannenstiel skin incision or using fascia lata from the patient’s iliotibial band in the lateral thigh. Autologous slings are safe and effective, and even after a mesh sling has failed, autologous slings have an almost 70% cure rate for SUI.^20,21

Continue to: Timing of mesh removal and placement of an autologous fascial sling...

Timing of mesh removal and placement of an autologous fascial sling

Either concomitant or delayed placement of a pubovaginal sling is acceptable when removing mesh, though this should be a joint decision with the patient after counseling. If the risk for surgical complications is modifiable (for example, poorly controlled diabetes that could be improved with blood glucose control), it may be advisable to delay the fascial sling until the risk factors have been addressed. Similarly, if the reason for mesh removal is pain, it may be advisable to remove the mesh prior to placing a new sling to ensure that the pain resolves completely. Otherwise, if pain persists, it can be unclear whether the new sling is contributing to the pain, and this may lead to difficulties treating pain or incontinence in the future.

In this patient, who was an active smoker, we excised the exposed mesh and concomitantly placed an autologous fascial sling utilizing rectus fascia. This maintained continence without introducing mesh in a high-risk patient.

CASE 4 POP and occult SUI

Ms. B. is a 79-year-old woman with stage 3 POP planned for surgical repair. While she does not report urinary leakage, preoperative urodynamic testing revealed occult SUI with reduction of her prolapse. Her priorities are to avoid needing another surgery and to limit the chances of postoperative leakage, but she is nervous about her postoperative recovery and wants to avoid pain.

What approach would be appropriate?

Consider a mini sling for this patient

The single-incision (mini) sling is an option to consider for patients with mild incontinence or for those without evidence of intrinsic sphincter deficiency. It is also a good option for those who want to avoid the additional incisions required for full-length slings.

While currently there is not sufficient evidence to clearly state if single-incision slings are equivalent to other slings, recent studies show that single-incision slings appear to be safe and effective in the short term, with possibly fewer complications than traditional transobturator slings.^22-24 As patients are often concerned about the potential for groin pain with a transobturator sling, a single-incision sling is an acceptable alternative that avoids groin incisions and also avoids the retropubic space.

Patient counseling is crucial

Regardless of the route, sling procedures are highly effective and safe for treating women with SUI.³ Understanding the characteristics of each type of sling and the distinct surgical approaches enables informed counseling for patients who are navigating the treatment options for SUI.

Fecal incontinence (FI), also known as accidental bowel leakage, is the involuntary loss of feces, which includes both liquid and solid stool as defined by the International Continence Society (ICS) and the International Urogynecological Association (IUGA).^1,2 Fecal incontinence is common, occurring in 7% to 25% of community-dwelling women, and it increases with age.^2-6 The condition is rarely addressed, with only 30% of women seeking care.^6-8 This is due to patient embarrassment and the lack of a reliable screening tool. However, FI affects quality of life and mental health, and the associated economic burden likely will rise given the increased prevalence of FI among older women.^2,4,7,9

Fecal incontinence occurs due to poor stool consistency, anal and pelvic muscle weakness, reduced rectal compliance, reduced or increased rectal sensation, or bowel inflammation or dysfunction. Many conditions can cause FI (TABLE 1).^5,10,11 It is therefore important to elicit a full medical history with a focus on specific bowel symptoms, such as stool consistency type (TABLE 2),¹² FI frequency, and duration of symptoms, as well as to perform a complete examination to identify any readily reversible or malignant causes. A colonoscopy is recommended for individuals who meet screening criteria or present with a change in bowel symptoms, such as diarrhea, bleeding, or obstruction.^13,14

Fecal incontinence treatments include a range of approaches categorized from conservative, or first-line therapy, to fourth-line surgical managements (FIGURE 1).^1,10,13,14 In this Update, we review the results of 3 well-designed trials that enrolled women with frequent nonneurogenic FI. 

Common first- and second-line treatments produce equivalent improvements in FI symptoms at
6 months 

Jelovsek JE, Markland AD, Whitehead WE, et al; National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomized clinical trial. Lancet Gastroenterol Hepatol. 2019;4:698-710. 

In a multicenter, randomized trial of first- and second-line treatments for FI, Jelovsek and colleagues evaluated the efficacy of oral placebo, loperamide, pelvic floor physical therapy (PFPT) with biofeedback using anorectal manometry, or combination therapy over a 24-week period. 

Continue to: Four treatments compared...

Three hundred women with FI occurring monthly for 3 months were included in the trial. Women were excluded if they had a stool classification of type 1 or type 7 on the Bristol Stool Scale, inflammatory bowel disease (IBD), history of rectovaginal fistula or cloacal defect, rectal prolapse, prior bowel diversion, fecal impaction, neurologic disorder leading to incontinence, use of loperamide or diphenoxylate within the last 30 days, childbirth within the last 3 months, need for antiretroviral drugs, hepatic impairment, or chronic abdominal pain without diarrhea. 

Baseline characteristics and symptoms severity were similar among participants. The average age of the women was 63 years, with 79% white and 85% postmenopausal. Participants had a mean (SD) of 1.6 (1.8) leaks per day. 

Participants were randomly assigned in a 0.5:1:1:1 fashion to receive oral placebo, loperamide, oral placebo with PFPT/biofeedback, or loperamide with PFPT/biofeedback. All participants received a standardized educational pamphlet that outlined dietary and behavioral recommendations. 

Women assigned to PFPT/biofeedback received 6 sessions every other week. Loperamide was started at a dosage of 2 mg per day with the possibility of dose maintenance, escalation, reduction, or discontinuation. 

Study outcomes. The primary outcome was a change from baseline to 24 weeks in the Vaizey FI symptom severity score, which assesses fecal frequency, urgency, and use of pads and medications. Secondary outcomes included assessment of a 7-day bowel diary and other quality-of-life measures. Data at 24 weeks were available for 89% of the women. 

All treatment groups experienced improved FI symptoms 

Based on changes in Vaizey scores after 24 weeks of treatment, women in all treatment groups had similar improvement in symptoms severity. However, those who received loperamide and PFPT/biofeedback had decreased pad changes per week and more accident-free days compared with women treated with placebo and biofeedback. Quality of life at 24 weeks was not statistically different between treatment groups as improvement was seen in all groups, including those who received oral placebo and patient education. 

Adverse events. The proportion of gastrointestinal adverse effects was similar between treatment groups, ranging from 45% to 63%. Constipation was the most common adverse event overall and was more common in those taking loperamide, occurring in 51% of the loperamide plus PFPT/biofeedback group, 38% of those who received loperamide alone, 23% of the biofeedback with placebo group, and 12% of the placebo-alone group. 

Strengths and limitations. Strengths of this study include its multisite, large sample size, low dropout rate, and sufficiently powered design to compare various combinations of first- and second-line therapies in women with a mean baseline FI of 1.6 leaks per day. Another strength is the robustness of the PFPT/biofeedback sessions that used anorectal manometry. This may, however, limit the study's external validity given that clinical use of this device is likely rare. Additionally, the population was comprised largely of postmenopausal and white women, which may make the findings less generalizable to other populations. 

Continue to: Novel vaginal bowel control system...

Novel vaginal bowel control system is effective, durable over 12 months for FI treatment 

Richter HE, Dunivan G, Brown HW, et al. A 12-month clinical durability of effectiveness and safety evaluation of a vaginal bowel control system for the nonsurgical treatment of fecal incontinence. Female Pelvic Med Reconstr Surg. 2019;25:113-119. 

Richter and colleagues characterized clinical success, effect on quality of life, and durability over 12 months of a novel vaginal bowel control device (Eclipse System; Pelvalon) for FI in a prospective cohort study. The device is a silicone-coated vaginal insert with a detachable pump and balloon that deflects the rectovaginal septum posteriorly, thus impeding the passage of stool in the rectum (FIGURE 2). 

Study eligibility criteria and treatment protocol 

Women were eligible for the study if they had 4 or more episodes of fecal soiling on a 2-week bowel diary and had FI for at least 6 months. Participants were excluded if they had prolapse outside the hymen, rectovaginal fistula, IBD, congenital anorectal malformation, urinary or colorectal infection, chronic pelvic or anorectal pain, pregnancy or planning pregnancy in the next 5 months, unmanaged chronic watery diarrhea, presence of an open wound or tear in the vagina, significant urogenital atrophy, or any psychiatric or neurologic disorder that would hinder the ability to participate. 

Participants successfully fitted with the device (3 attempts were allowed) were entered into the study's run-in phase. Those who were successfully fitted and had a 50% or greater reduction in FI continued into the treatment phase with 12 months of follow-up. 

Of the 137 women eligible for device fitting, 62% were successfully fitted. The 73 (86%) women who had a 50% or greater reduction in FI during the run-in period comprised the intent-to-treat study population. On average, these women were 61.3 years of age, with 70% white and 82% postmenopausal. At baseline, they had a mean of 14.1 episodes of FI over 2 weeks. (Prior to enrollment, 97.3% of women attempted self-management strategies, 17.8% to 23% failed conservative therapy, and 7.8% to 13.7% failed surgical therapy.) The follow-up rate at 12 months was 74%. 

Study outcomes. The primary outcome was treatment success, defined as proportion of subjects with a 50% or greater reduction in FI episodes at 3 months; this outcome also was evaluated at 6 and 12 months. Secondary outcomes were the number of FI episodes and quality-of-life measures at 3, 6, and 12 months. 

Treatment success, patient satisfaction high 

In the treatment phase, women had sustained improvements in symptom severity and quality-of-life measures over 12 months. Treatment success was 73% at 3 months, 71% at 6 months, and 70% at 12 months. Complete continence was achieved in 46% of participants at 12 months, and major FI episodes (requiring immediate change of undergarments) decreased from 5.0 at baseline to 0.5 at 12 months. Quality-of-life measures were improved at 3 months, and improvement was sustained over 12 months. Satisfaction was 94% at 12 months. 

Adverse events. No serious device-related adverse events occurred. Mild device-related adverse events were experienced by 45% of women during the fitting process and by 38% during treatment period. These included vaginal wall injury such as hyperemia and erosion; vaginal or pelvic discomfort; vaginal infection; constipation; and lower urinary tract issues such as urinary tract infection, urinary incontinence, and voiding dysfunction. No adverse events led to treatment discontinuation. 

Strengths and limitations. Strengths of this study include that it was conducted at multiple clinical sites, had a large sample size, and had a 1-year follow-up period in a population with daily FI. A limitation was that only women who had a 50% or greater reduction in FI episodes during the run-in period were followed for 12 months; however, this was 86% of the original cohort. The use of a comparative group using other devices, such as anal plugs, would have strengthened this study. 

Continue to: Sacroneuromodulation for FI…

Sacral neuromodulation for FI is effective long-term 

Hull T, Giese C, Wexner SD, et al; for the SNS Study Group. Long-term durability of sacral nerve stimulation therapy for chronic fecal incontinence. Dis Colon Rectum. 2013;56:234-245. 

In this multicenter, prospective cohort study, Hull and colleagues evaluated the 5-year efficacy of sacral neuromodulation (SNM), also known as sacral nerve stimulation, for treatment of FI. This study followed an earlier investigation by Wexner and colleagues, which reported that 83% of 120 patients treated with SNM had a 50% or greater improvement in FI episodes at 12 months.¹⁶ 

Details of the study 

The investigators enrolled 133 participants (92% female) who had more than 2 episodes of FI per week for longer than 6 months (12 months after vaginal delivery). Participants were excluded if they had congenital anorectal malformations, prior rectal surgery within the past 12 months (or 24 months if due to cancer), defects greater than 120° of the external anal sphincter (EAS), IBD, unmanaged chronic watery diarrhea, stool consistency type 6 or type 7 on the Bristol Stool Scale, sequela of pelvic radiation, active anal abscess or fistula, pregnancy, or planned pregnancy. 

Eligible participants underwent a 2-stage procedure with the InterStim bowel control device (Medtronic). If participants experienced a 50% or greater reduction in incontinence episodes with a wearable external SNM device in the test stimulation (stage 1), they received the chronic SNM implant device (stage 2). 

Participants who underwent device implantation were followed at 1, 3, and 6 months and annually for 5 years or until they exited the study. Bowel diaries and quality of life assessments were completed at baseline and at follow-up. 

The primary outcome was therapeutic success, defined as 50% or greater improvement in FI episodes per week. 

A total of 120 participants (90%) underwent implantation of the chronic lead and neuromodulator, and 76 (63%) were followed for 5 years. Baseline characteristics available in the initial study of 133 participants showed that the mean age was 60.5 years; 25% had undergone a prior anal sphincteroplasty; and 16.5% and 10.5% had EAS or internal anal sphincter (IAS) defects, respectively, on endoanal ultrasonography.¹⁶ 

Therapeutic success was high at 5 years 

At the 5-year follow-up, 89% (64/72) of participants met therapeutic success, with a reduction in weekly FI episodes from 9.1 at baseline to 1.7 at 5 years. The number of incontinence pads required decreased, and more participants wore no pads at 5 years. In the intention-to-treat analysis, carrying forward the baseline FI rate in participants who lacked follow-up data, the therapeutic success rate was 69%. Quality-of-life measures improved at 5 years, both statistically and by minimal clinical difference. 

Adverse events. Sixty-eight percent of participants experienced device-related adverse events, including implant site pain, change in sensation of stimulation, change in efficacy, implant site infection, or neurostimulator battery depletion (neurostimulator use commonly expires after 3 to 5 years). Of these events, 80% were successfully treated with medications, reprogramming, or no intervention. The 5-year probability of device revision or replacement was 24.4%, and the 5-year probability of device explant was 19.0%. 

Strengths and limitations. Overall, this study was a well-designed, multicenter trial with long-term follow-up that showed significant improvement in FI with the use of SNM. Its strengths include the enrollment of postmenopausal women who had current defects in EAS and/or IAS on endoanal ultrasonography and 25% who had a prior sphincteroplasty. The findings therefore are relevant to the gynecologic population in whom anal sphincteroplasty would not be recommended. The study also accounted for dropouts and reported the adjusted success rate of 69% at 5 years in that group. 

The lack of a control arm to rule out the placebo effect is a limitation of this study, although randomized trials comparing the effect of SNM "on" versus "off" showed greater improvement with the device "on."¹⁷ 

Fecal incontinence (FI), also known as accidental bowel leakage, is the involuntary loss of feces, which includes both liquid and solid stool as defined by the International Continence Society (ICS) and the International Urogynecological Association (IUGA).^1,2 Fecal incontinence is common, occurring in 7% to 25% of community-dwelling women, and it increases with age.^2-6 The condition is rarely addressed, with only 30% of women seeking care.^6-8 This is due to patient embarrassment and the lack of a reliable screening tool. However, FI affects quality of life and mental health, and the associated economic burden likely will rise given the increased prevalence of FI among older women.^2,4,7,9

Fecal incontinence occurs due to poor stool consistency, anal and pelvic muscle weakness, reduced rectal compliance, reduced or increased rectal sensation, or bowel inflammation or dysfunction. Many conditions can cause FI (TABLE 1).^5,10,11 It is therefore important to elicit a full medical history with a focus on specific bowel symptoms, such as stool consistency type (TABLE 2),¹² FI frequency, and duration of symptoms, as well as to perform a complete examination to identify any readily reversible or malignant causes. A colonoscopy is recommended for individuals who meet screening criteria or present with a change in bowel symptoms, such as diarrhea, bleeding, or obstruction.^13,14

Fecal incontinence treatments include a range of approaches categorized from conservative, or first-line therapy, to fourth-line surgical managements (FIGURE 1).^1,10,13,14 In this Update, we review the results of 3 well-designed trials that enrolled women with frequent nonneurogenic FI. 

Common first- and second-line treatments produce equivalent improvements in FI symptoms at
6 months 

Jelovsek JE, Markland AD, Whitehead WE, et al; National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomized clinical trial. Lancet Gastroenterol Hepatol. 2019;4:698-710. 

In a multicenter, randomized trial of first- and second-line treatments for FI, Jelovsek and colleagues evaluated the efficacy of oral placebo, loperamide, pelvic floor physical therapy (PFPT) with biofeedback using anorectal manometry, or combination therapy over a 24-week period. 

Continue to: Four treatments compared...

Three hundred women with FI occurring monthly for 3 months were included in the trial. Women were excluded if they had a stool classification of type 1 or type 7 on the Bristol Stool Scale, inflammatory bowel disease (IBD), history of rectovaginal fistula or cloacal defect, rectal prolapse, prior bowel diversion, fecal impaction, neurologic disorder leading to incontinence, use of loperamide or diphenoxylate within the last 30 days, childbirth within the last 3 months, need for antiretroviral drugs, hepatic impairment, or chronic abdominal pain without diarrhea. 

Baseline characteristics and symptoms severity were similar among participants. The average age of the women was 63 years, with 79% white and 85% postmenopausal. Participants had a mean (SD) of 1.6 (1.8) leaks per day. 

Participants were randomly assigned in a 0.5:1:1:1 fashion to receive oral placebo, loperamide, oral placebo with PFPT/biofeedback, or loperamide with PFPT/biofeedback. All participants received a standardized educational pamphlet that outlined dietary and behavioral recommendations. 

Women assigned to PFPT/biofeedback received 6 sessions every other week. Loperamide was started at a dosage of 2 mg per day with the possibility of dose maintenance, escalation, reduction, or discontinuation. 

Study outcomes. The primary outcome was a change from baseline to 24 weeks in the Vaizey FI symptom severity score, which assesses fecal frequency, urgency, and use of pads and medications. Secondary outcomes included assessment of a 7-day bowel diary and other quality-of-life measures. Data at 24 weeks were available for 89% of the women. 

All treatment groups experienced improved FI symptoms 

Based on changes in Vaizey scores after 24 weeks of treatment, women in all treatment groups had similar improvement in symptoms severity. However, those who received loperamide and PFPT/biofeedback had decreased pad changes per week and more accident-free days compared with women treated with placebo and biofeedback. Quality of life at 24 weeks was not statistically different between treatment groups as improvement was seen in all groups, including those who received oral placebo and patient education. 

Adverse events. The proportion of gastrointestinal adverse effects was similar between treatment groups, ranging from 45% to 63%. Constipation was the most common adverse event overall and was more common in those taking loperamide, occurring in 51% of the loperamide plus PFPT/biofeedback group, 38% of those who received loperamide alone, 23% of the biofeedback with placebo group, and 12% of the placebo-alone group. 

Strengths and limitations. Strengths of this study include its multisite, large sample size, low dropout rate, and sufficiently powered design to compare various combinations of first- and second-line therapies in women with a mean baseline FI of 1.6 leaks per day. Another strength is the robustness of the PFPT/biofeedback sessions that used anorectal manometry. This may, however, limit the study's external validity given that clinical use of this device is likely rare. Additionally, the population was comprised largely of postmenopausal and white women, which may make the findings less generalizable to other populations. 

Continue to: Novel vaginal bowel control system...

Novel vaginal bowel control system is effective, durable over 12 months for FI treatment 

Richter HE, Dunivan G, Brown HW, et al. A 12-month clinical durability of effectiveness and safety evaluation of a vaginal bowel control system for the nonsurgical treatment of fecal incontinence. Female Pelvic Med Reconstr Surg. 2019;25:113-119. 

Richter and colleagues characterized clinical success, effect on quality of life, and durability over 12 months of a novel vaginal bowel control device (Eclipse System; Pelvalon) for FI in a prospective cohort study. The device is a silicone-coated vaginal insert with a detachable pump and balloon that deflects the rectovaginal septum posteriorly, thus impeding the passage of stool in the rectum (FIGURE 2). 

Study eligibility criteria and treatment protocol 

Women were eligible for the study if they had 4 or more episodes of fecal soiling on a 2-week bowel diary and had FI for at least 6 months. Participants were excluded if they had prolapse outside the hymen, rectovaginal fistula, IBD, congenital anorectal malformation, urinary or colorectal infection, chronic pelvic or anorectal pain, pregnancy or planning pregnancy in the next 5 months, unmanaged chronic watery diarrhea, presence of an open wound or tear in the vagina, significant urogenital atrophy, or any psychiatric or neurologic disorder that would hinder the ability to participate. 

Participants successfully fitted with the device (3 attempts were allowed) were entered into the study's run-in phase. Those who were successfully fitted and had a 50% or greater reduction in FI continued into the treatment phase with 12 months of follow-up. 

Of the 137 women eligible for device fitting, 62% were successfully fitted. The 73 (86%) women who had a 50% or greater reduction in FI during the run-in period comprised the intent-to-treat study population. On average, these women were 61.3 years of age, with 70% white and 82% postmenopausal. At baseline, they had a mean of 14.1 episodes of FI over 2 weeks. (Prior to enrollment, 97.3% of women attempted self-management strategies, 17.8% to 23% failed conservative therapy, and 7.8% to 13.7% failed surgical therapy.) The follow-up rate at 12 months was 74%. 

Study outcomes. The primary outcome was treatment success, defined as proportion of subjects with a 50% or greater reduction in FI episodes at 3 months; this outcome also was evaluated at 6 and 12 months. Secondary outcomes were the number of FI episodes and quality-of-life measures at 3, 6, and 12 months. 

Treatment success, patient satisfaction high 

In the treatment phase, women had sustained improvements in symptom severity and quality-of-life measures over 12 months. Treatment success was 73% at 3 months, 71% at 6 months, and 70% at 12 months. Complete continence was achieved in 46% of participants at 12 months, and major FI episodes (requiring immediate change of undergarments) decreased from 5.0 at baseline to 0.5 at 12 months. Quality-of-life measures were improved at 3 months, and improvement was sustained over 12 months. Satisfaction was 94% at 12 months. 

Adverse events. No serious device-related adverse events occurred. Mild device-related adverse events were experienced by 45% of women during the fitting process and by 38% during treatment period. These included vaginal wall injury such as hyperemia and erosion; vaginal or pelvic discomfort; vaginal infection; constipation; and lower urinary tract issues such as urinary tract infection, urinary incontinence, and voiding dysfunction. No adverse events led to treatment discontinuation. 

Strengths and limitations. Strengths of this study include that it was conducted at multiple clinical sites, had a large sample size, and had a 1-year follow-up period in a population with daily FI. A limitation was that only women who had a 50% or greater reduction in FI episodes during the run-in period were followed for 12 months; however, this was 86% of the original cohort. The use of a comparative group using other devices, such as anal plugs, would have strengthened this study. 

Continue to: Sacroneuromodulation for FI…

Sacral neuromodulation for FI is effective long-term 

Hull T, Giese C, Wexner SD, et al; for the SNS Study Group. Long-term durability of sacral nerve stimulation therapy for chronic fecal incontinence. Dis Colon Rectum. 2013;56:234-245. 

In this multicenter, prospective cohort study, Hull and colleagues evaluated the 5-year efficacy of sacral neuromodulation (SNM), also known as sacral nerve stimulation, for treatment of FI. This study followed an earlier investigation by Wexner and colleagues, which reported that 83% of 120 patients treated with SNM had a 50% or greater improvement in FI episodes at 12 months.¹⁶ 

Details of the study 

The investigators enrolled 133 participants (92% female) who had more than 2 episodes of FI per week for longer than 6 months (12 months after vaginal delivery). Participants were excluded if they had congenital anorectal malformations, prior rectal surgery within the past 12 months (or 24 months if due to cancer), defects greater than 120° of the external anal sphincter (EAS), IBD, unmanaged chronic watery diarrhea, stool consistency type 6 or type 7 on the Bristol Stool Scale, sequela of pelvic radiation, active anal abscess or fistula, pregnancy, or planned pregnancy. 

Eligible participants underwent a 2-stage procedure with the InterStim bowel control device (Medtronic). If participants experienced a 50% or greater reduction in incontinence episodes with a wearable external SNM device in the test stimulation (stage 1), they received the chronic SNM implant device (stage 2). 

Participants who underwent device implantation were followed at 1, 3, and 6 months and annually for 5 years or until they exited the study. Bowel diaries and quality of life assessments were completed at baseline and at follow-up. 

The primary outcome was therapeutic success, defined as 50% or greater improvement in FI episodes per week. 

A total of 120 participants (90%) underwent implantation of the chronic lead and neuromodulator, and 76 (63%) were followed for 5 years. Baseline characteristics available in the initial study of 133 participants showed that the mean age was 60.5 years; 25% had undergone a prior anal sphincteroplasty; and 16.5% and 10.5% had EAS or internal anal sphincter (IAS) defects, respectively, on endoanal ultrasonography.¹⁶ 

Therapeutic success was high at 5 years 

At the 5-year follow-up, 89% (64/72) of participants met therapeutic success, with a reduction in weekly FI episodes from 9.1 at baseline to 1.7 at 5 years. The number of incontinence pads required decreased, and more participants wore no pads at 5 years. In the intention-to-treat analysis, carrying forward the baseline FI rate in participants who lacked follow-up data, the therapeutic success rate was 69%. Quality-of-life measures improved at 5 years, both statistically and by minimal clinical difference. 

Adverse events. Sixty-eight percent of participants experienced device-related adverse events, including implant site pain, change in sensation of stimulation, change in efficacy, implant site infection, or neurostimulator battery depletion (neurostimulator use commonly expires after 3 to 5 years). Of these events, 80% were successfully treated with medications, reprogramming, or no intervention. The 5-year probability of device revision or replacement was 24.4%, and the 5-year probability of device explant was 19.0%. 

Strengths and limitations. Overall, this study was a well-designed, multicenter trial with long-term follow-up that showed significant improvement in FI with the use of SNM. Its strengths include the enrollment of postmenopausal women who had current defects in EAS and/or IAS on endoanal ultrasonography and 25% who had a prior sphincteroplasty. The findings therefore are relevant to the gynecologic population in whom anal sphincteroplasty would not be recommended. The study also accounted for dropouts and reported the adjusted success rate of 69% at 5 years in that group. 

The lack of a control arm to rule out the placebo effect is a limitation of this study, although randomized trials comparing the effect of SNM "on" versus "off" showed greater improvement with the device "on."¹⁷ 

Fecal incontinence (FI), also known as accidental bowel leakage, is the involuntary loss of feces, which includes both liquid and solid stool as defined by the International Continence Society (ICS) and the International Urogynecological Association (IUGA).^1,2 Fecal incontinence is common, occurring in 7% to 25% of community-dwelling women, and it increases with age.^2-6 The condition is rarely addressed, with only 30% of women seeking care.^6-8 This is due to patient embarrassment and the lack of a reliable screening tool. However, FI affects quality of life and mental health, and the associated economic burden likely will rise given the increased prevalence of FI among older women.^2,4,7,9

Fecal incontinence occurs due to poor stool consistency, anal and pelvic muscle weakness, reduced rectal compliance, reduced or increased rectal sensation, or bowel inflammation or dysfunction. Many conditions can cause FI (TABLE 1).^5,10,11 It is therefore important to elicit a full medical history with a focus on specific bowel symptoms, such as stool consistency type (TABLE 2),¹² FI frequency, and duration of symptoms, as well as to perform a complete examination to identify any readily reversible or malignant causes. A colonoscopy is recommended for individuals who meet screening criteria or present with a change in bowel symptoms, such as diarrhea, bleeding, or obstruction.^13,14

Fecal incontinence treatments include a range of approaches categorized from conservative, or first-line therapy, to fourth-line surgical managements (FIGURE 1).^1,10,13,14 In this Update, we review the results of 3 well-designed trials that enrolled women with frequent nonneurogenic FI. 

Common first- and second-line treatments produce equivalent improvements in FI symptoms at
6 months 

Jelovsek JE, Markland AD, Whitehead WE, et al; National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomized clinical trial. Lancet Gastroenterol Hepatol. 2019;4:698-710. 

In a multicenter, randomized trial of first- and second-line treatments for FI, Jelovsek and colleagues evaluated the efficacy of oral placebo, loperamide, pelvic floor physical therapy (PFPT) with biofeedback using anorectal manometry, or combination therapy over a 24-week period. 

Continue to: Four treatments compared...

Three hundred women with FI occurring monthly for 3 months were included in the trial. Women were excluded if they had a stool classification of type 1 or type 7 on the Bristol Stool Scale, inflammatory bowel disease (IBD), history of rectovaginal fistula or cloacal defect, rectal prolapse, prior bowel diversion, fecal impaction, neurologic disorder leading to incontinence, use of loperamide or diphenoxylate within the last 30 days, childbirth within the last 3 months, need for antiretroviral drugs, hepatic impairment, or chronic abdominal pain without diarrhea. 

Baseline characteristics and symptoms severity were similar among participants. The average age of the women was 63 years, with 79% white and 85% postmenopausal. Participants had a mean (SD) of 1.6 (1.8) leaks per day. 

Participants were randomly assigned in a 0.5:1:1:1 fashion to receive oral placebo, loperamide, oral placebo with PFPT/biofeedback, or loperamide with PFPT/biofeedback. All participants received a standardized educational pamphlet that outlined dietary and behavioral recommendations. 

Women assigned to PFPT/biofeedback received 6 sessions every other week. Loperamide was started at a dosage of 2 mg per day with the possibility of dose maintenance, escalation, reduction, or discontinuation. 

Study outcomes. The primary outcome was a change from baseline to 24 weeks in the Vaizey FI symptom severity score, which assesses fecal frequency, urgency, and use of pads and medications. Secondary outcomes included assessment of a 7-day bowel diary and other quality-of-life measures. Data at 24 weeks were available for 89% of the women. 

All treatment groups experienced improved FI symptoms 

Based on changes in Vaizey scores after 24 weeks of treatment, women in all treatment groups had similar improvement in symptoms severity. However, those who received loperamide and PFPT/biofeedback had decreased pad changes per week and more accident-free days compared with women treated with placebo and biofeedback. Quality of life at 24 weeks was not statistically different between treatment groups as improvement was seen in all groups, including those who received oral placebo and patient education. 

Adverse events. The proportion of gastrointestinal adverse effects was similar between treatment groups, ranging from 45% to 63%. Constipation was the most common adverse event overall and was more common in those taking loperamide, occurring in 51% of the loperamide plus PFPT/biofeedback group, 38% of those who received loperamide alone, 23% of the biofeedback with placebo group, and 12% of the placebo-alone group. 

Strengths and limitations. Strengths of this study include its multisite, large sample size, low dropout rate, and sufficiently powered design to compare various combinations of first- and second-line therapies in women with a mean baseline FI of 1.6 leaks per day. Another strength is the robustness of the PFPT/biofeedback sessions that used anorectal manometry. This may, however, limit the study's external validity given that clinical use of this device is likely rare. Additionally, the population was comprised largely of postmenopausal and white women, which may make the findings less generalizable to other populations. 

Continue to: Novel vaginal bowel control system...

Novel vaginal bowel control system is effective, durable over 12 months for FI treatment 

Richter HE, Dunivan G, Brown HW, et al. A 12-month clinical durability of effectiveness and safety evaluation of a vaginal bowel control system for the nonsurgical treatment of fecal incontinence. Female Pelvic Med Reconstr Surg. 2019;25:113-119. 

Richter and colleagues characterized clinical success, effect on quality of life, and durability over 12 months of a novel vaginal bowel control device (Eclipse System; Pelvalon) for FI in a prospective cohort study. The device is a silicone-coated vaginal insert with a detachable pump and balloon that deflects the rectovaginal septum posteriorly, thus impeding the passage of stool in the rectum (FIGURE 2). 

Study eligibility criteria and treatment protocol 

Women were eligible for the study if they had 4 or more episodes of fecal soiling on a 2-week bowel diary and had FI for at least 6 months. Participants were excluded if they had prolapse outside the hymen, rectovaginal fistula, IBD, congenital anorectal malformation, urinary or colorectal infection, chronic pelvic or anorectal pain, pregnancy or planning pregnancy in the next 5 months, unmanaged chronic watery diarrhea, presence of an open wound or tear in the vagina, significant urogenital atrophy, or any psychiatric or neurologic disorder that would hinder the ability to participate. 

Participants successfully fitted with the device (3 attempts were allowed) were entered into the study's run-in phase. Those who were successfully fitted and had a 50% or greater reduction in FI continued into the treatment phase with 12 months of follow-up. 

Of the 137 women eligible for device fitting, 62% were successfully fitted. The 73 (86%) women who had a 50% or greater reduction in FI during the run-in period comprised the intent-to-treat study population. On average, these women were 61.3 years of age, with 70% white and 82% postmenopausal. At baseline, they had a mean of 14.1 episodes of FI over 2 weeks. (Prior to enrollment, 97.3% of women attempted self-management strategies, 17.8% to 23% failed conservative therapy, and 7.8% to 13.7% failed surgical therapy.) The follow-up rate at 12 months was 74%. 

Study outcomes. The primary outcome was treatment success, defined as proportion of subjects with a 50% or greater reduction in FI episodes at 3 months; this outcome also was evaluated at 6 and 12 months. Secondary outcomes were the number of FI episodes and quality-of-life measures at 3, 6, and 12 months. 

Treatment success, patient satisfaction high 

In the treatment phase, women had sustained improvements in symptom severity and quality-of-life measures over 12 months. Treatment success was 73% at 3 months, 71% at 6 months, and 70% at 12 months. Complete continence was achieved in 46% of participants at 12 months, and major FI episodes (requiring immediate change of undergarments) decreased from 5.0 at baseline to 0.5 at 12 months. Quality-of-life measures were improved at 3 months, and improvement was sustained over 12 months. Satisfaction was 94% at 12 months. 

Adverse events. No serious device-related adverse events occurred. Mild device-related adverse events were experienced by 45% of women during the fitting process and by 38% during treatment period. These included vaginal wall injury such as hyperemia and erosion; vaginal or pelvic discomfort; vaginal infection; constipation; and lower urinary tract issues such as urinary tract infection, urinary incontinence, and voiding dysfunction. No adverse events led to treatment discontinuation. 

Strengths and limitations. Strengths of this study include that it was conducted at multiple clinical sites, had a large sample size, and had a 1-year follow-up period in a population with daily FI. A limitation was that only women who had a 50% or greater reduction in FI episodes during the run-in period were followed for 12 months; however, this was 86% of the original cohort. The use of a comparative group using other devices, such as anal plugs, would have strengthened this study. 

Continue to: Sacroneuromodulation for FI…

Sacral neuromodulation for FI is effective long-term 

Hull T, Giese C, Wexner SD, et al; for the SNS Study Group. Long-term durability of sacral nerve stimulation therapy for chronic fecal incontinence. Dis Colon Rectum. 2013;56:234-245. 

In this multicenter, prospective cohort study, Hull and colleagues evaluated the 5-year efficacy of sacral neuromodulation (SNM), also known as sacral nerve stimulation, for treatment of FI. This study followed an earlier investigation by Wexner and colleagues, which reported that 83% of 120 patients treated with SNM had a 50% or greater improvement in FI episodes at 12 months.¹⁶ 

Details of the study 

The investigators enrolled 133 participants (92% female) who had more than 2 episodes of FI per week for longer than 6 months (12 months after vaginal delivery). Participants were excluded if they had congenital anorectal malformations, prior rectal surgery within the past 12 months (or 24 months if due to cancer), defects greater than 120° of the external anal sphincter (EAS), IBD, unmanaged chronic watery diarrhea, stool consistency type 6 or type 7 on the Bristol Stool Scale, sequela of pelvic radiation, active anal abscess or fistula, pregnancy, or planned pregnancy. 

Eligible participants underwent a 2-stage procedure with the InterStim bowel control device (Medtronic). If participants experienced a 50% or greater reduction in incontinence episodes with a wearable external SNM device in the test stimulation (stage 1), they received the chronic SNM implant device (stage 2). 

Participants who underwent device implantation were followed at 1, 3, and 6 months and annually for 5 years or until they exited the study. Bowel diaries and quality of life assessments were completed at baseline and at follow-up. 

The primary outcome was therapeutic success, defined as 50% or greater improvement in FI episodes per week. 

A total of 120 participants (90%) underwent implantation of the chronic lead and neuromodulator, and 76 (63%) were followed for 5 years. Baseline characteristics available in the initial study of 133 participants showed that the mean age was 60.5 years; 25% had undergone a prior anal sphincteroplasty; and 16.5% and 10.5% had EAS or internal anal sphincter (IAS) defects, respectively, on endoanal ultrasonography.¹⁶ 

Therapeutic success was high at 5 years 

At the 5-year follow-up, 89% (64/72) of participants met therapeutic success, with a reduction in weekly FI episodes from 9.1 at baseline to 1.7 at 5 years. The number of incontinence pads required decreased, and more participants wore no pads at 5 years. In the intention-to-treat analysis, carrying forward the baseline FI rate in participants who lacked follow-up data, the therapeutic success rate was 69%. Quality-of-life measures improved at 5 years, both statistically and by minimal clinical difference. 

Adverse events. Sixty-eight percent of participants experienced device-related adverse events, including implant site pain, change in sensation of stimulation, change in efficacy, implant site infection, or neurostimulator battery depletion (neurostimulator use commonly expires after 3 to 5 years). Of these events, 80% were successfully treated with medications, reprogramming, or no intervention. The 5-year probability of device revision or replacement was 24.4%, and the 5-year probability of device explant was 19.0%. 

Strengths and limitations. Overall, this study was a well-designed, multicenter trial with long-term follow-up that showed significant improvement in FI with the use of SNM. Its strengths include the enrollment of postmenopausal women who had current defects in EAS and/or IAS on endoanal ultrasonography and 25% who had a prior sphincteroplasty. The findings therefore are relevant to the gynecologic population in whom anal sphincteroplasty would not be recommended. The study also accounted for dropouts and reported the adjusted success rate of 69% at 5 years in that group. 

The lack of a control arm to rule out the placebo effect is a limitation of this study, although randomized trials comparing the effect of SNM "on" versus "off" showed greater improvement with the device "on."¹⁷ 

“Take pride in your surgical work. Do it in such a way that you would be willing to sign your name to it…the operation was performed by me.”

—Raymond A. Lee, MD

The US Food and Drug Administration (FDA) recently ordered companies to cease selling transvaginal mesh intended for pelvic organ prolapse (POP) repair (but not for the treatment of stress urinary incontinence [SUI] or for abdominal sacrocolpopexy).^1,2 The FDA is also requiring companies preparing premarket approval applications for mesh products for the treatment of transvaginal POP to continue safety and efficacy follow-up in existing section 522 postmarket surveillance studies.³

It is, therefore, incumbent upon gynecologic surgeons to understand the surgical options that remain and perfect their surgical approach to POP to optimize patient outcomes. POP may be performed transvaginally or transabdominally, with each approach offering its own set of risks and benefits. The ability to perform both effectively allows the surgeon to tailor the approach to the condition and circumstances encountered. It is also important to realize that “cures” are elusive in POP surgery. While we can frequently alleviate patient symptoms and improve quality of life, a lifelong “cure” is an unrealistic goal for most prolapse procedures.

This article focuses on transvaginal native tissue repair,⁴ specifically the Mayo approach.

View related videos from Dr. Gebhart on apical suspension, anterior repair, and posterior repair techniques.

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Watch video here

Vaginal surgery fundamentals

Before we explore the details of the Mayo technique, let’s review some basic principles of vaginal surgery. First, it is important to make a good clinical diagnosis so that you know which compartments (apex, anterior, or posterior) are involved. Although single compartment defects exist, multicompartment defects are far more common. Failing to recognize all compartment defects often results in incomplete repair, which can mean recurrent prolapse and additional interventions.

Second, exposure is critical when performing surgery by any route. You must be able to see your surgical field completely in order to properly execute your surgical approach. Table height, lighting, and retraction are all important to surgical success.

Lastly, it is important to know how to effectively execute your intended procedure. Native tissue repair is often criticized for having a high failure rate. It makes sense that mesh augmentation offers greater durability of a repair, but an effective native tissue repair will also effectively treat the majority of patients. An ineffective repair does not benefit the patient and contributes to high failure rates.

Vaginal apex repairs

Data from the OPTIMAL trial suggest that uterosacral ligament suspension and sacrospinous ligament fixation are equally effective in treating apical prolapse.⁵ Our preference is a McCall culdoplasty (uterosacral ligament plication). It allows direct visualization (internally or externally) to place apical support stitches and plicates the ligaments in the midline of the vaginal cuff to help prevent enterocele protrusion. DeLancey has described the levels of support in the female pelvis and places importance on apical support.⁶ Keep in mind that anterior and posterior compartment prolapse is often accompanied by apical prolapse. Therefore, treating the apex is critical for overall success.

External vs internal McCall sutures: My technique. Envision the open vaginal cuff after completing a vaginal hysterectomy or after opening the vaginal cuff for a posthysterectomy vaginal vault prolapse (FIGURE 1). External (suture placed through the vaginal cuff epithelium into the peritoneal cavity, incorporating the uterosacral ligaments and intervening peritoneum, and ultimately brought back out through the posterior cuff and tied) or internal (suture placed in the intraperitoneal space, incorporating the uterosacral ligaments and intervening peritoneum, and tied internally) McCall sutures can be utilized (FIGURE 2). I prefer a combination of both. I use 0-polyglactin for external sutures, as the sutures will ultimately dissolve and not remain in the vaginal cavity. I usually place at least 2 external sutures with the lowest suture on the vaginal cuff being the deepest uterosacral stitch. Each subsequent suture is placed closer to the vaginal cuff and closer to the ends of the ligamentous stumps, starting deepest and working back toward the cuff with each stitch. I place 1 or 2 internal sutures (delayed absorbable or permanent) between my 2 external sutures. Because these sutures will be tied internally and located in the intraperitoneal space, permanent sutures may be used.

Continue to: Anterior compartment repairs...

Anterior compartment repairs

The anterior compartment seems the most susceptible to forces within the pelvis and is a common site of prolapse. Many theories exist as to what causes a cystocele—distension, displacement, detachment, etc. While paravaginal defects exist, I believe that most cystoceles arise horizontally at the base of the bladder as the anterior endopelvic fascia detaches from the apex or cervix. The tissue then attenuates as the hernia progresses.

For surgical success: Make certain your repair addresses re-establishing continuity of the anterior endopelvic fascia with the fascia and ligaments at the vaginal apex; it will increase your success in treating anterior compartment prolapse.

We prefer to mobilize the epithelium in the midline from the vaginal apex to the mid‑urethra (if performing a midurethral sling, we stop short of the bladder neck and perform a separate suburethral incision). When incising the epithelium in the midline, the underlying fascia is also split in the midline, creating a midline defect. Once the epithelium is split and mobilized laterally off the underlying fascia, we can begin reconstruction.

The midline fascial defect that was just created is closed with a running 2-0 polyglactin from just beneath the bladder neck down to and including the fascia and uterosacral ligaments at the apex. This is accomplished in an upside down ‘T’ orientation (FIGURE 3). It is critical that the fascia is reunited at the base or you will leave the patient with a hernia.

For surgical success: To check intraoperatively that the fascia is reunited at the base, try to place an index finger between the base of the cystocele repair and the apex. If you can insert your finger, that is where the hernia still exists. If you meet resistance with your finger, you are palpating reunification of the anterior and apical fascia.

Lastly, given that we have just dissected and then plicated the tissues beneath the bladder, I like to perform cystoscopy to be certain the bladder has not been violated. It is also important not to over-plicate the anterior fascia so that the sutures shear through the fascia and weaken the support or narrow the vaginal lumen.

Continue to: Posterior compartment repairs...

Posterior compartment repairs

Like with the anterior compartment, opinions differ as to the site of posterior compartment prolapse. Midline, lateral, distal, and site-specific defects and surgical approaches have been described. Research suggests that there is no benefit to the use of mesh in the posterior compartment.⁷ It is very important to recognize that over-plication of the posterior compartment can lead to narrowing/stricture and dyspareunia. Therefore, monitor vaginal caliber throughout repair of the posterior compartment.

Although we believe that a midline defect in the endopelvic fascia is primarily responsible for rectoceles, we also appreciate that the fascia must be reconstructed all the way to the perineal body and that narrowing the genital hiatus is very important and often underappreciated (FIGURE 5). Thus, perineal reconstruction is universally performed. I will emphasize again that reconstruction must be performed while also monitoring vaginal caliber. If it is too tight with the patient under anesthesia, it will be too tight when the patient recovers. Avoidance is the best option. If the patient does not desire a functional vagina (eg, an elderly patient), then narrowing is a desired goal.

Perineal reconstruction technique and tips for success

A retractor at 12 o’clock to support the apex and anterior wall can be helpful for visualization in the posterior compartment. We start with a v-shaped incision on the perineum. The width is determined by how much you want to build up the perineum and narrow the vagina (the wider the incision, the more building up of the perineal body and vaginal narrowing). A strip of epithelium is then mobilized in the midline (be careful not to excise too much). This dissection is carried all the way up the midline to just short of the tied apical suspension sutures at the posterior vaginal apex. The posterior dissection tends to be the most vascular in my experience.

Utilize cautery to obtain hemostasis along your dissection margins while protecting the underlying rectum. We have not found it necessary to dissect the posterior epithelium off the underlying fascia (that is an option at this point, however, if you feel more comfortable doing this). With an index finger in the vagina, compressing the rectum posteriorly, interrupted 1-0 polyglactin suture is placed through the epithelium and underlying fascia (avoiding the rectum) on one side, then the other, and then tied. The next sutures are placed utilizing the same technique, and the caliber of the vagina is noted with the placement of each suture (if it is too tight, then remove and replace the suture and recheck). It is important to realize you want to plicate the fascia in the midline and not perform an aggressive levatorplasty that could lead to muscle pain. Additionally, each suture should get the same purchase of tissue on each side, and the spacing of each suture should be uniform, like rungs on a ladder. Ultimately, the repair is carried down to the hymenal ring. At this point, the perineal reconstruction is performed, plicating the perineal body in the midline with deeper horizontal sutures and then closing the perineal skin with interrupted or subcuticular sutures (FIGURE 6). Completion of these repairs should orient the vagina toward the hollow of the sacrum (FIGURE 7), allowing downward forces to compress the vaginal supports posteriorly onto the pelvic floor instead of forcing it out the vaginal lumen (FIGURE 8).

Our patients generally stay in the hospital overnight, and we place a vaginal pack to provide topical pressure throughout the vagina overnight. We tell patients no lifting more than 15 lb and no intercourse for 6 weeks. While we do not tend to use hydrodissection in our repairs, it is a perfectly acceptable option.

Continue to: Commit to knowledge of native tissue techniques...

Commit to knowledge of native tissue techniques

Given the recent FDA ban on the sale of transvaginal mesh for POP and the public’s negative perception of mesh (based often on misleading information in the media), it is incumbent upon gynecologic surgeons to invest in learning or relearning effective native tissue techniques for the transvaginal treatment of POP. While not perfect, they offer an effective nonmesh treatment option for many of our patients.

“Take pride in your surgical work. Do it in such a way that you would be willing to sign your name to it…the operation was performed by me.”

—Raymond A. Lee, MD

The US Food and Drug Administration (FDA) recently ordered companies to cease selling transvaginal mesh intended for pelvic organ prolapse (POP) repair (but not for the treatment of stress urinary incontinence [SUI] or for abdominal sacrocolpopexy).^1,2 The FDA is also requiring companies preparing premarket approval applications for mesh products for the treatment of transvaginal POP to continue safety and efficacy follow-up in existing section 522 postmarket surveillance studies.³

It is, therefore, incumbent upon gynecologic surgeons to understand the surgical options that remain and perfect their surgical approach to POP to optimize patient outcomes. POP may be performed transvaginally or transabdominally, with each approach offering its own set of risks and benefits. The ability to perform both effectively allows the surgeon to tailor the approach to the condition and circumstances encountered. It is also important to realize that “cures” are elusive in POP surgery. While we can frequently alleviate patient symptoms and improve quality of life, a lifelong “cure” is an unrealistic goal for most prolapse procedures.

This article focuses on transvaginal native tissue repair,⁴ specifically the Mayo approach.

View related videos from Dr. Gebhart on apical suspension, anterior repair, and posterior repair techniques.

---

Watch video here

Vaginal surgery fundamentals

Before we explore the details of the Mayo technique, let’s review some basic principles of vaginal surgery. First, it is important to make a good clinical diagnosis so that you know which compartments (apex, anterior, or posterior) are involved. Although single compartment defects exist, multicompartment defects are far more common. Failing to recognize all compartment defects often results in incomplete repair, which can mean recurrent prolapse and additional interventions.

Second, exposure is critical when performing surgery by any route. You must be able to see your surgical field completely in order to properly execute your surgical approach. Table height, lighting, and retraction are all important to surgical success.

Lastly, it is important to know how to effectively execute your intended procedure. Native tissue repair is often criticized for having a high failure rate. It makes sense that mesh augmentation offers greater durability of a repair, but an effective native tissue repair will also effectively treat the majority of patients. An ineffective repair does not benefit the patient and contributes to high failure rates.

Vaginal apex repairs

Data from the OPTIMAL trial suggest that uterosacral ligament suspension and sacrospinous ligament fixation are equally effective in treating apical prolapse.⁵ Our preference is a McCall culdoplasty (uterosacral ligament plication). It allows direct visualization (internally or externally) to place apical support stitches and plicates the ligaments in the midline of the vaginal cuff to help prevent enterocele protrusion. DeLancey has described the levels of support in the female pelvis and places importance on apical support.⁶ Keep in mind that anterior and posterior compartment prolapse is often accompanied by apical prolapse. Therefore, treating the apex is critical for overall success.

External vs internal McCall sutures: My technique. Envision the open vaginal cuff after completing a vaginal hysterectomy or after opening the vaginal cuff for a posthysterectomy vaginal vault prolapse (FIGURE 1). External (suture placed through the vaginal cuff epithelium into the peritoneal cavity, incorporating the uterosacral ligaments and intervening peritoneum, and ultimately brought back out through the posterior cuff and tied) or internal (suture placed in the intraperitoneal space, incorporating the uterosacral ligaments and intervening peritoneum, and tied internally) McCall sutures can be utilized (FIGURE 2). I prefer a combination of both. I use 0-polyglactin for external sutures, as the sutures will ultimately dissolve and not remain in the vaginal cavity. I usually place at least 2 external sutures with the lowest suture on the vaginal cuff being the deepest uterosacral stitch. Each subsequent suture is placed closer to the vaginal cuff and closer to the ends of the ligamentous stumps, starting deepest and working back toward the cuff with each stitch. I place 1 or 2 internal sutures (delayed absorbable or permanent) between my 2 external sutures. Because these sutures will be tied internally and located in the intraperitoneal space, permanent sutures may be used.

Continue to: Anterior compartment repairs...

Anterior compartment repairs

The anterior compartment seems the most susceptible to forces within the pelvis and is a common site of prolapse. Many theories exist as to what causes a cystocele—distension, displacement, detachment, etc. While paravaginal defects exist, I believe that most cystoceles arise horizontally at the base of the bladder as the anterior endopelvic fascia detaches from the apex or cervix. The tissue then attenuates as the hernia progresses.

For surgical success: Make certain your repair addresses re-establishing continuity of the anterior endopelvic fascia with the fascia and ligaments at the vaginal apex; it will increase your success in treating anterior compartment prolapse.

We prefer to mobilize the epithelium in the midline from the vaginal apex to the mid‑urethra (if performing a midurethral sling, we stop short of the bladder neck and perform a separate suburethral incision). When incising the epithelium in the midline, the underlying fascia is also split in the midline, creating a midline defect. Once the epithelium is split and mobilized laterally off the underlying fascia, we can begin reconstruction.

The midline fascial defect that was just created is closed with a running 2-0 polyglactin from just beneath the bladder neck down to and including the fascia and uterosacral ligaments at the apex. This is accomplished in an upside down ‘T’ orientation (FIGURE 3). It is critical that the fascia is reunited at the base or you will leave the patient with a hernia.

For surgical success: To check intraoperatively that the fascia is reunited at the base, try to place an index finger between the base of the cystocele repair and the apex. If you can insert your finger, that is where the hernia still exists. If you meet resistance with your finger, you are palpating reunification of the anterior and apical fascia.

Lastly, given that we have just dissected and then plicated the tissues beneath the bladder, I like to perform cystoscopy to be certain the bladder has not been violated. It is also important not to over-plicate the anterior fascia so that the sutures shear through the fascia and weaken the support or narrow the vaginal lumen.

Continue to: Posterior compartment repairs...

Posterior compartment repairs

Like with the anterior compartment, opinions differ as to the site of posterior compartment prolapse. Midline, lateral, distal, and site-specific defects and surgical approaches have been described. Research suggests that there is no benefit to the use of mesh in the posterior compartment.⁷ It is very important to recognize that over-plication of the posterior compartment can lead to narrowing/stricture and dyspareunia. Therefore, monitor vaginal caliber throughout repair of the posterior compartment.

Although we believe that a midline defect in the endopelvic fascia is primarily responsible for rectoceles, we also appreciate that the fascia must be reconstructed all the way to the perineal body and that narrowing the genital hiatus is very important and often underappreciated (FIGURE 5). Thus, perineal reconstruction is universally performed. I will emphasize again that reconstruction must be performed while also monitoring vaginal caliber. If it is too tight with the patient under anesthesia, it will be too tight when the patient recovers. Avoidance is the best option. If the patient does not desire a functional vagina (eg, an elderly patient), then narrowing is a desired goal.

Perineal reconstruction technique and tips for success

A retractor at 12 o’clock to support the apex and anterior wall can be helpful for visualization in the posterior compartment. We start with a v-shaped incision on the perineum. The width is determined by how much you want to build up the perineum and narrow the vagina (the wider the incision, the more building up of the perineal body and vaginal narrowing). A strip of epithelium is then mobilized in the midline (be careful not to excise too much). This dissection is carried all the way up the midline to just short of the tied apical suspension sutures at the posterior vaginal apex. The posterior dissection tends to be the most vascular in my experience.

Utilize cautery to obtain hemostasis along your dissection margins while protecting the underlying rectum. We have not found it necessary to dissect the posterior epithelium off the underlying fascia (that is an option at this point, however, if you feel more comfortable doing this). With an index finger in the vagina, compressing the rectum posteriorly, interrupted 1-0 polyglactin suture is placed through the epithelium and underlying fascia (avoiding the rectum) on one side, then the other, and then tied. The next sutures are placed utilizing the same technique, and the caliber of the vagina is noted with the placement of each suture (if it is too tight, then remove and replace the suture and recheck). It is important to realize you want to plicate the fascia in the midline and not perform an aggressive levatorplasty that could lead to muscle pain. Additionally, each suture should get the same purchase of tissue on each side, and the spacing of each suture should be uniform, like rungs on a ladder. Ultimately, the repair is carried down to the hymenal ring. At this point, the perineal reconstruction is performed, plicating the perineal body in the midline with deeper horizontal sutures and then closing the perineal skin with interrupted or subcuticular sutures (FIGURE 6). Completion of these repairs should orient the vagina toward the hollow of the sacrum (FIGURE 7), allowing downward forces to compress the vaginal supports posteriorly onto the pelvic floor instead of forcing it out the vaginal lumen (FIGURE 8).

Our patients generally stay in the hospital overnight, and we place a vaginal pack to provide topical pressure throughout the vagina overnight. We tell patients no lifting more than 15 lb and no intercourse for 6 weeks. While we do not tend to use hydrodissection in our repairs, it is a perfectly acceptable option.

Continue to: Commit to knowledge of native tissue techniques...

Commit to knowledge of native tissue techniques

Given the recent FDA ban on the sale of transvaginal mesh for POP and the public’s negative perception of mesh (based often on misleading information in the media), it is incumbent upon gynecologic surgeons to invest in learning or relearning effective native tissue techniques for the transvaginal treatment of POP. While not perfect, they offer an effective nonmesh treatment option for many of our patients.

“Take pride in your surgical work. Do it in such a way that you would be willing to sign your name to it…the operation was performed by me.”

—Raymond A. Lee, MD

The US Food and Drug Administration (FDA) recently ordered companies to cease selling transvaginal mesh intended for pelvic organ prolapse (POP) repair (but not for the treatment of stress urinary incontinence [SUI] or for abdominal sacrocolpopexy).^1,2 The FDA is also requiring companies preparing premarket approval applications for mesh products for the treatment of transvaginal POP to continue safety and efficacy follow-up in existing section 522 postmarket surveillance studies.³

It is, therefore, incumbent upon gynecologic surgeons to understand the surgical options that remain and perfect their surgical approach to POP to optimize patient outcomes. POP may be performed transvaginally or transabdominally, with each approach offering its own set of risks and benefits. The ability to perform both effectively allows the surgeon to tailor the approach to the condition and circumstances encountered. It is also important to realize that “cures” are elusive in POP surgery. While we can frequently alleviate patient symptoms and improve quality of life, a lifelong “cure” is an unrealistic goal for most prolapse procedures.

This article focuses on transvaginal native tissue repair,⁴ specifically the Mayo approach.

View related videos from Dr. Gebhart on apical suspension, anterior repair, and posterior repair techniques.

---

Watch video here

Vaginal surgery fundamentals

Before we explore the details of the Mayo technique, let’s review some basic principles of vaginal surgery. First, it is important to make a good clinical diagnosis so that you know which compartments (apex, anterior, or posterior) are involved. Although single compartment defects exist, multicompartment defects are far more common. Failing to recognize all compartment defects often results in incomplete repair, which can mean recurrent prolapse and additional interventions.

Second, exposure is critical when performing surgery by any route. You must be able to see your surgical field completely in order to properly execute your surgical approach. Table height, lighting, and retraction are all important to surgical success.

Lastly, it is important to know how to effectively execute your intended procedure. Native tissue repair is often criticized for having a high failure rate. It makes sense that mesh augmentation offers greater durability of a repair, but an effective native tissue repair will also effectively treat the majority of patients. An ineffective repair does not benefit the patient and contributes to high failure rates.

Vaginal apex repairs

Data from the OPTIMAL trial suggest that uterosacral ligament suspension and sacrospinous ligament fixation are equally effective in treating apical prolapse.⁵ Our preference is a McCall culdoplasty (uterosacral ligament plication). It allows direct visualization (internally or externally) to place apical support stitches and plicates the ligaments in the midline of the vaginal cuff to help prevent enterocele protrusion. DeLancey has described the levels of support in the female pelvis and places importance on apical support.⁶ Keep in mind that anterior and posterior compartment prolapse is often accompanied by apical prolapse. Therefore, treating the apex is critical for overall success.

External vs internal McCall sutures: My technique. Envision the open vaginal cuff after completing a vaginal hysterectomy or after opening the vaginal cuff for a posthysterectomy vaginal vault prolapse (FIGURE 1). External (suture placed through the vaginal cuff epithelium into the peritoneal cavity, incorporating the uterosacral ligaments and intervening peritoneum, and ultimately brought back out through the posterior cuff and tied) or internal (suture placed in the intraperitoneal space, incorporating the uterosacral ligaments and intervening peritoneum, and tied internally) McCall sutures can be utilized (FIGURE 2). I prefer a combination of both. I use 0-polyglactin for external sutures, as the sutures will ultimately dissolve and not remain in the vaginal cavity. I usually place at least 2 external sutures with the lowest suture on the vaginal cuff being the deepest uterosacral stitch. Each subsequent suture is placed closer to the vaginal cuff and closer to the ends of the ligamentous stumps, starting deepest and working back toward the cuff with each stitch. I place 1 or 2 internal sutures (delayed absorbable or permanent) between my 2 external sutures. Because these sutures will be tied internally and located in the intraperitoneal space, permanent sutures may be used.

Continue to: Anterior compartment repairs...

Anterior compartment repairs

The anterior compartment seems the most susceptible to forces within the pelvis and is a common site of prolapse. Many theories exist as to what causes a cystocele—distension, displacement, detachment, etc. While paravaginal defects exist, I believe that most cystoceles arise horizontally at the base of the bladder as the anterior endopelvic fascia detaches from the apex or cervix. The tissue then attenuates as the hernia progresses.

For surgical success: Make certain your repair addresses re-establishing continuity of the anterior endopelvic fascia with the fascia and ligaments at the vaginal apex; it will increase your success in treating anterior compartment prolapse.

We prefer to mobilize the epithelium in the midline from the vaginal apex to the mid‑urethra (if performing a midurethral sling, we stop short of the bladder neck and perform a separate suburethral incision). When incising the epithelium in the midline, the underlying fascia is also split in the midline, creating a midline defect. Once the epithelium is split and mobilized laterally off the underlying fascia, we can begin reconstruction.

The midline fascial defect that was just created is closed with a running 2-0 polyglactin from just beneath the bladder neck down to and including the fascia and uterosacral ligaments at the apex. This is accomplished in an upside down ‘T’ orientation (FIGURE 3). It is critical that the fascia is reunited at the base or you will leave the patient with a hernia.

For surgical success: To check intraoperatively that the fascia is reunited at the base, try to place an index finger between the base of the cystocele repair and the apex. If you can insert your finger, that is where the hernia still exists. If you meet resistance with your finger, you are palpating reunification of the anterior and apical fascia.

Lastly, given that we have just dissected and then plicated the tissues beneath the bladder, I like to perform cystoscopy to be certain the bladder has not been violated. It is also important not to over-plicate the anterior fascia so that the sutures shear through the fascia and weaken the support or narrow the vaginal lumen.

Continue to: Posterior compartment repairs...

Posterior compartment repairs

Like with the anterior compartment, opinions differ as to the site of posterior compartment prolapse. Midline, lateral, distal, and site-specific defects and surgical approaches have been described. Research suggests that there is no benefit to the use of mesh in the posterior compartment.⁷ It is very important to recognize that over-plication of the posterior compartment can lead to narrowing/stricture and dyspareunia. Therefore, monitor vaginal caliber throughout repair of the posterior compartment.

Although we believe that a midline defect in the endopelvic fascia is primarily responsible for rectoceles, we also appreciate that the fascia must be reconstructed all the way to the perineal body and that narrowing the genital hiatus is very important and often underappreciated (FIGURE 5). Thus, perineal reconstruction is universally performed. I will emphasize again that reconstruction must be performed while also monitoring vaginal caliber. If it is too tight with the patient under anesthesia, it will be too tight when the patient recovers. Avoidance is the best option. If the patient does not desire a functional vagina (eg, an elderly patient), then narrowing is a desired goal.

Perineal reconstruction technique and tips for success

A retractor at 12 o’clock to support the apex and anterior wall can be helpful for visualization in the posterior compartment. We start with a v-shaped incision on the perineum. The width is determined by how much you want to build up the perineum and narrow the vagina (the wider the incision, the more building up of the perineal body and vaginal narrowing). A strip of epithelium is then mobilized in the midline (be careful not to excise too much). This dissection is carried all the way up the midline to just short of the tied apical suspension sutures at the posterior vaginal apex. The posterior dissection tends to be the most vascular in my experience.

Utilize cautery to obtain hemostasis along your dissection margins while protecting the underlying rectum. We have not found it necessary to dissect the posterior epithelium off the underlying fascia (that is an option at this point, however, if you feel more comfortable doing this). With an index finger in the vagina, compressing the rectum posteriorly, interrupted 1-0 polyglactin suture is placed through the epithelium and underlying fascia (avoiding the rectum) on one side, then the other, and then tied. The next sutures are placed utilizing the same technique, and the caliber of the vagina is noted with the placement of each suture (if it is too tight, then remove and replace the suture and recheck). It is important to realize you want to plicate the fascia in the midline and not perform an aggressive levatorplasty that could lead to muscle pain. Additionally, each suture should get the same purchase of tissue on each side, and the spacing of each suture should be uniform, like rungs on a ladder. Ultimately, the repair is carried down to the hymenal ring. At this point, the perineal reconstruction is performed, plicating the perineal body in the midline with deeper horizontal sutures and then closing the perineal skin with interrupted or subcuticular sutures (FIGURE 6). Completion of these repairs should orient the vagina toward the hollow of the sacrum (FIGURE 7), allowing downward forces to compress the vaginal supports posteriorly onto the pelvic floor instead of forcing it out the vaginal lumen (FIGURE 8).

Our patients generally stay in the hospital overnight, and we place a vaginal pack to provide topical pressure throughout the vagina overnight. We tell patients no lifting more than 15 lb and no intercourse for 6 weeks. While we do not tend to use hydrodissection in our repairs, it is a perfectly acceptable option.

Continue to: Commit to knowledge of native tissue techniques...

Commit to knowledge of native tissue techniques

Given the recent FDA ban on the sale of transvaginal mesh for POP and the public’s negative perception of mesh (based often on misleading information in the media), it is incumbent upon gynecologic surgeons to invest in learning or relearning effective native tissue techniques for the transvaginal treatment of POP. While not perfect, they offer an effective nonmesh treatment option for many of our patients.

CASE Complications with mesh placement for SUI

A 47-year-old woman (G4 P3013) presents 5 months posthysterectomy with evidence of urinary tract infection (UTI). Escherichia coli is isolated, and she responds to antibiotic therapy.

Her surgical history includes a mini-sling procedure using a needleless device and mesh placement in order to correct progressive worsening of loss of urine when coughing and sneezing. She also reported slight pelvic pain, dysuria, and urgency upon urination at that time. After subsequent development of pelvic organ prolapse (POP), she underwent the vaginal hysterectomy.

Following her UTI treatment, a host of problems occur for the patient, including pelvic pain and dyspareunia. Her male partner reports “feeling something during sex,” especially at the anterior vaginal wall. A plain radiograph of the abdomen identifies a 2 cm x 2 cm stone over the vaginal mesh. In consultation with female pelvic medicine and reconstructive surgery subspecialists, lithotripsy is performed, with the stone fragmented. The patient remains symptomatic, however.

The mesh is noted to be eroding through the vaginal wall. An attempt is made to excise the mesh, initially via transuretheral resection, then through a laparoscopic approach. Due to the mesh being embedded in the tissue, however, an open approach is undertaken. Extensive excision of the mesh and stone fragments is performed. Postoperatively, the patient reports “dry vagina,” with no other genitourinary complaints.

The patient sues. She sues the mesh manufacturer. She also seeks to sue the gynecologist who placed the sling and vaginal mesh (as she says she was not informed of “all the risks” of vaginal mesh placement. She is part of a class action lawsuit, along with thousands of other women.

WHAT’S THE VERDICT?

The device manufacturer settled out of court with the class action suit. (The gynecologist was never formally a defendant because the patient/plaintiff was advised to “drop the physician from the suit.”) The attorneys representing the class action received 40% of the award plus presented costs for the representation. The class as a whole received a little more than 50% of the negotiated award. The patient in this case received $60,000.

Medical background

Stress urinary incontinence (SUI) is a prevalent condition; it affects 35% of women.¹ Overall, 80% of women aged 80 or younger will undergo some form of surgery for POP during their lifetime.² The pathophysiology of SUI includes urethral hypermobility and intrinsic sphincter deficiency.³

Surgical correction for urinary incontinence: A timeline

Use of the gracilis muscle flap to surgically correct urinary incontinence was introduced in 1907. This technique has been replaced by today’s more common Burch procedure, which was first described in 1961. Surgical mesh use dates back to the 1950s, when it was primarily used for abdominal hernia repair. Tension-free tape was introduced in 1995.^4-6

Continue to: In the late 1990s the US Food and Drug Administration...

In the late 1990s the US Food and Drug Administration (FDA) permitted use of the first transvaginal meshes, which were designed to treat SUI—the midurethral sling. These mesh slings were so successful that similar meshes were developed to treat POP.⁷ Almost immediately there were problems with the new POP devices, and 3 years later Boston Scientific recalled its device.⁸ Nonetheless, the FDA cleared more than 150 devices using surgical mesh for urogynecologic indications (FIGURE).⁹

Mesh complications

Managing complications from intravesical mesh is a clinically challenging problem. Bladder perforation, stone formation, and penetration through the vagina can occur. Bladder-related complications can manifest as recurrent UTIs and obstructive urinary symptoms, especially in association with stone formation. From the gynecologic perspective, the more common complications with mesh utilization are pelvic pain, groin pain, dyspareunia, contracture and scarring of mesh, and narrowing of the vaginal canal.¹⁰ Mesh erosion problems will occur in an estimated 10% to 25% of transvaginal mesh POP implants.¹¹

In 2008, a comparison of transvaginal mesh to native tissue repair (suture-based) or other (biologic) grafts was published.¹² The bottom line: there is insufficient evidence to suggest that transvaginal mesh significantly improves outcomes for both posterior and apical defects.

Legal background

Mesh used for surgical purposes is a medical device, which legally is a product—a special product to be sure, but a product nonetheless. Products are subject to product liability rules. Mesh is also subject to an FDA regulatory system. We will briefly discuss products liability and the regulation of devices, both of which have played important roles in mesh-related injuries.

Products liability

As a general matter, defective products subject their manufacturer and seller to liability. There are several legal theories regarding product liability: negligence (in which the defect was caused through carelessness), breach of warranty or guarantee (in addition to express warranties, there are a number of implied warranties for products, including that it is fit for its intended purpose), and strict liability (there was a defect in the product, but it may not have been because of negligence). The product may be defective in the way it was designed, manufactured, or packaged, or it may be defective because adequate instructions and warning were not given to consumers.

Of course, not every product involved in an injury is defective—most automobile accidents, for example, are not the result of any defect in the automobile. In medicine, almost no product (device or pharmaceutical) is entirely safe. In some ways they are unavoidably unsafe and bound to cause some injuries. But when injuries are caused by a defect in the product (design or manufacturing defect or failure to warn), then there may be products liability. Most products liability cases arise under state law.

FDA’s device regulations

Both drugs and medical devices are subject to FDA review and ordinarily require some form of FDA clearance before they may be marketed. In the case of devices, the FDA has 3 classes, with an increase in risk to the user from Class I to III. Various levels of FDA review are required before marketing of the device is permitted, again with the intensity of review increasing from I to III as follows:

• Class I devices pose the least risk, have the least regulation, and are subject to general controls (ie, manufacturing and marketing practices).
• Class II devices pose slightly higher risks and are subject to special controls in addition to the criteria for Class I.
• Class III devices pose the most risk to patients and require premarket approval (scientific review and studies are required to ensure efficacy and safety).¹³

Continue to: There are a number of limits on manufacturer liability for defective devices...

There are a number of limits on manufacturer liability for defective devices. For Class III devices, the thorough FDA review of the safety of a device may limit the ability of an injured patient to sue based on the state product liability laws.¹⁴ For the most part, this “preemption” of state law has not played a major role in mesh litigation because they were initially classified as Class II devices which did not require or include a detailed FDA review.¹⁵

The duty to warn of the dangers and risk of medical devices means that manufacturers (or sellers) of devices are obligated to inform health care providers and other medical personnel of the risks. Unlike other manufacturers, device manufacturers do not have to directly warn consumers—because physicians deal directly with patients and prescribe the devices. Therefore, the health care providers, rather than the manufacturers, are obligated to inform the patient.¹⁶ This is known as the learned intermediary rule. Manufacturers may still be liable for failure to warn if they do not convey to health care providers proper warnings.

Manufacturers and sellers are not the only entities that may be subject to liability caused by medical devices. Hospitals or other entities that stock and care for devices are responsible for maintaining the safety and functionality of devices in their care.

Health care providers also may be responsible for injuries from medical devices. Generally, that liability is based on negligence. Negligence may relate to selecting an improper device, installing or using it incorrectly, or failing to give the patient adequate information (or informed consent) about the device and alternatives to it.¹⁷

A look at the mesh mess

There are a lot of distressing problems and professional disappointments in dissecting the “mesh mess,” including a failure of the FDA to regulate effectively, the extended sale and promotion of intrinsic sphincter deficiency mesh products, the improper use of mesh by physicians even after the risks were known, and, in some instances, the taking advantage of injured patients by attorneys and businesses.¹⁸ A lot of finger pointing also has occurred.¹⁹ We will recount some of the lowlights of this unfortunate tale.

Continue to: The FDA, in the 1990s, classified the first POP and SUI mesh...

The FDA, in the 1990s, classified the first POP and SUI mesh as Class II after deciding these products were “substantially equivalent” to older surgical meshes. This, of course, proved not to be the case.²⁰ The FDA started receiving thousands of reports of adverse events and, in 2008, warned physicians to be vigilant for adverse events from the mesh. The FDA’s notification recommendations regarding mesh included the following¹³:

• Obtain specialized training for each mesh implantation technique, and be cognizant of risks.

• Be vigilant for potential adverse events from mesh, including erosion and infection.
• Be observant for complications associated with tools of transvaginal placement (ie, bowel, bladder, and vessel perforation).
• Inform patients that implantation of mesh is permanent and complications may require additional surgery for correction.
• Be aware that complications may affect quality of life—eg, pain with intercourse, scarring, and vaginal wall narrowing (POP repair).
• Provide patients with written copy of patient labeling from the surgical mesh manufacturer.

In 2011, the FDA issued a formal warning to providers that transvaginal mesh posed meaningful risks beyond nonmesh surgery. The FDA’s bulletin draws attention to how the mesh is placed more so than the material per se.^19,21 Mesh was a Class II device for sacrocolpopexy or midurethral sling and, similarly, the transvaginal kit was also a Class II device. Overall, use of mesh midurethral slings has been well received as treatment for SUI. The FDA also accepted it for POP, however, but with increasingly strong warnings. The FDA’s 2011 communication stated, “This update is to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare….Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”^7,13

In 2014 the FDA proposed reclassifying mesh to a Class III device, which would require that manufacturers obtain approval, based on safety and effectiveness, before selling mesh. Not until 2016 did the FDA actually reclassify the mess as Class III. Of course, during this time, mesh manufacturers were well aware of the substantial problems the products were causing.¹³

After serious problems with mesh became well known, and especially after FDA warnings, the use of mesh other than as indicated by the FDA was increasingly risky from a legal (as well as a health) standpoint. As long as mesh was still on the market, of course, it was available for use. But use of mesh for POP procedures without good indications in a way that was contrary to the FDA warnings might well be negligent.

Changes to informed consent

The FDA warnings also should have changed the informed consent for the use of mesh.²² Informed consent commonly consists of the following:

1. informing the patient of the proposed procedure
2. describing risks (and benefits) of the proposed process
3. explaining reasonable alternatives
4. noting the risks of taking no action.

Information that is material to a decision should be disclosed. If mesh were going to be used, after the problems of mesh were known and identified by the FDA (other than midurethral slings as treatment of SUI), the risks should have been clearly identified for patients, with alternatives outlined. The American College of Obstetricians and Gynecologists Committee on Ethics has 8 fundamental concepts with regard to informed consent that are worth keeping in mind²³:

1. Obtaining informed consent for medical treatment and research is an ethical requirement.
2. The process expresses respect for the patient as a person.
3. It protects patients against unwanted treatment and allows patients’ active involvement in medical planning and care.
4. Communication is of paramount importance.
5. Informed consent is a process and not a signature on a form.
6. A commitment to informed consent and to provision of medical benefit to the patient are linked to provision of care.
7. If obtaining informed consent is impossible, a designated surrogate should be identified representing the patient’s best interests.
8. Knowledge on the part of the provider regarding state and federal requirements is necessary.

Continue to: Lawsuits line up...

Lawsuits line up

The widespread use of a product with a significant percentage of injuries and eventually with warnings about injuries from use sounds like the formula for a lot of lawsuits. This certainly has happened. A large number of suits—both class actions and individual actions—were filed as a result of mesh injuries.²⁴ These suits were overwhelmingly against the manufacturer, although some included physicians.⁷ Device makers are more attractive defendants for several reasons. First, they have very deep pockets. In addition, jurors are generally much less sympathetic to large companies than to doctors. Large class actions meant that there were many different patients among the plaintiffs, and medical malpractice claims in most states have a number of trial difficulties not present in other product liability cases. Common defendants have included Johnson & Johnson, Boston Scientific, and Medtronic.

Some of the cases resulted in very large damage awards against manufacturers based on various kinds of product(s) liability. Many other cases were settled or tried with relatively small damages. There were, in addition, a number of instances in which the manufacturers were not liable. Of the 32 plaintiffs who have gone to trial thus far, 24 have obtained verdicts totaling $345 million ($14 million average). The cases that have settled have been for much less—perhaps $60,000 on average. A number of cases remain unresolved. To date, the estimate is that 100,000 women have received almost $8 billion from 7 device manufacturers to resolve claims.²⁵

Some state attorneys general have gotten into the process as well. Attorneys general from California, Kentucky, Mississippi, and Washington have filed lawsuits against Johnson & Johnson, claiming that they deceived doctors and patients about the risks of their pelvic mesh. The states claim that marketing and instructional literature should have contained more information about the risks. Some physicians in these states have expressed concern that these lawsuit risks may do more harm than good because the suits conflate mesh used to treat incontinence with the more risky mesh for POP.²⁶

The “ugly” of class action lawsuits

We have discussed both the sad (the injuries to patients) and the bad (the slow regulatory response and continuing injuries). (The ethics of the marketing by the manufacturers might also be raised as the bad.²⁷) Next, let’s look briefly at the ugly.

Some of the patients affected by mesh injuries have been victimized a second time by medical “lenders” and some of their attorneys. Press reports describe patients with modest awards paying 40% in attorney fees (on the high side for personal injury settlements) plus extravagant costs—leaving modest amounts of actual recovery.²⁵

Worse still, a process of “medical lending” has arisen in mesh cases.²⁸ Medical lenders may contact mesh victims offering to pay up front for surgery to remove mesh, and then place a lien against the settlement for repayment at a much higher rate. They might pay the surgeon $2,500 for the surgery, but place a lien on the settlement amount for $60,000.^29,30 In addition, there are allegations that lawyers may recruit the doctors to overstate the injuries or do unnecessary removal surgery because that will likely up the award.³¹ A quick Google search indicates dozens of offers of cash now for your mesh lawsuit (transvaginal and hernia repair).

The patient in our hypothetical case at the beginning had a fairly typical experience. She was a member of a class filing and received a modest settlement. The attorneys representing the class were allowed by the court to charge substantial attorneys’ fees and costs. The patient had the good sense to avoid medical lenders, although other members of the class did use medical lenders and are now filing complaints about the way they were treated by these lenders.

CASE Complications with mesh placement for SUI

A 47-year-old woman (G4 P3013) presents 5 months posthysterectomy with evidence of urinary tract infection (UTI). Escherichia coli is isolated, and she responds to antibiotic therapy.

Her surgical history includes a mini-sling procedure using a needleless device and mesh placement in order to correct progressive worsening of loss of urine when coughing and sneezing. She also reported slight pelvic pain, dysuria, and urgency upon urination at that time. After subsequent development of pelvic organ prolapse (POP), she underwent the vaginal hysterectomy.

Following her UTI treatment, a host of problems occur for the patient, including pelvic pain and dyspareunia. Her male partner reports “feeling something during sex,” especially at the anterior vaginal wall. A plain radiograph of the abdomen identifies a 2 cm x 2 cm stone over the vaginal mesh. In consultation with female pelvic medicine and reconstructive surgery subspecialists, lithotripsy is performed, with the stone fragmented. The patient remains symptomatic, however.

The mesh is noted to be eroding through the vaginal wall. An attempt is made to excise the mesh, initially via transuretheral resection, then through a laparoscopic approach. Due to the mesh being embedded in the tissue, however, an open approach is undertaken. Extensive excision of the mesh and stone fragments is performed. Postoperatively, the patient reports “dry vagina,” with no other genitourinary complaints.

The patient sues. She sues the mesh manufacturer. She also seeks to sue the gynecologist who placed the sling and vaginal mesh (as she says she was not informed of “all the risks” of vaginal mesh placement. She is part of a class action lawsuit, along with thousands of other women.

WHAT’S THE VERDICT?

The device manufacturer settled out of court with the class action suit. (The gynecologist was never formally a defendant because the patient/plaintiff was advised to “drop the physician from the suit.”) The attorneys representing the class action received 40% of the award plus presented costs for the representation. The class as a whole received a little more than 50% of the negotiated award. The patient in this case received $60,000.

Medical background

Stress urinary incontinence (SUI) is a prevalent condition; it affects 35% of women.¹ Overall, 80% of women aged 80 or younger will undergo some form of surgery for POP during their lifetime.² The pathophysiology of SUI includes urethral hypermobility and intrinsic sphincter deficiency.³

Surgical correction for urinary incontinence: A timeline

Use of the gracilis muscle flap to surgically correct urinary incontinence was introduced in 1907. This technique has been replaced by today’s more common Burch procedure, which was first described in 1961. Surgical mesh use dates back to the 1950s, when it was primarily used for abdominal hernia repair. Tension-free tape was introduced in 1995.^4-6

Continue to: In the late 1990s the US Food and Drug Administration...

In the late 1990s the US Food and Drug Administration (FDA) permitted use of the first transvaginal meshes, which were designed to treat SUI—the midurethral sling. These mesh slings were so successful that similar meshes were developed to treat POP.⁷ Almost immediately there were problems with the new POP devices, and 3 years later Boston Scientific recalled its device.⁸ Nonetheless, the FDA cleared more than 150 devices using surgical mesh for urogynecologic indications (FIGURE).⁹

Mesh complications

Managing complications from intravesical mesh is a clinically challenging problem. Bladder perforation, stone formation, and penetration through the vagina can occur. Bladder-related complications can manifest as recurrent UTIs and obstructive urinary symptoms, especially in association with stone formation. From the gynecologic perspective, the more common complications with mesh utilization are pelvic pain, groin pain, dyspareunia, contracture and scarring of mesh, and narrowing of the vaginal canal.¹⁰ Mesh erosion problems will occur in an estimated 10% to 25% of transvaginal mesh POP implants.¹¹

In 2008, a comparison of transvaginal mesh to native tissue repair (suture-based) or other (biologic) grafts was published.¹² The bottom line: there is insufficient evidence to suggest that transvaginal mesh significantly improves outcomes for both posterior and apical defects.

Legal background

Mesh used for surgical purposes is a medical device, which legally is a product—a special product to be sure, but a product nonetheless. Products are subject to product liability rules. Mesh is also subject to an FDA regulatory system. We will briefly discuss products liability and the regulation of devices, both of which have played important roles in mesh-related injuries.

Products liability

As a general matter, defective products subject their manufacturer and seller to liability. There are several legal theories regarding product liability: negligence (in which the defect was caused through carelessness), breach of warranty or guarantee (in addition to express warranties, there are a number of implied warranties for products, including that it is fit for its intended purpose), and strict liability (there was a defect in the product, but it may not have been because of negligence). The product may be defective in the way it was designed, manufactured, or packaged, or it may be defective because adequate instructions and warning were not given to consumers.

Of course, not every product involved in an injury is defective—most automobile accidents, for example, are not the result of any defect in the automobile. In medicine, almost no product (device or pharmaceutical) is entirely safe. In some ways they are unavoidably unsafe and bound to cause some injuries. But when injuries are caused by a defect in the product (design or manufacturing defect or failure to warn), then there may be products liability. Most products liability cases arise under state law.

FDA’s device regulations

Both drugs and medical devices are subject to FDA review and ordinarily require some form of FDA clearance before they may be marketed. In the case of devices, the FDA has 3 classes, with an increase in risk to the user from Class I to III. Various levels of FDA review are required before marketing of the device is permitted, again with the intensity of review increasing from I to III as follows:

• Class I devices pose the least risk, have the least regulation, and are subject to general controls (ie, manufacturing and marketing practices).
• Class II devices pose slightly higher risks and are subject to special controls in addition to the criteria for Class I.
• Class III devices pose the most risk to patients and require premarket approval (scientific review and studies are required to ensure efficacy and safety).¹³

Continue to: There are a number of limits on manufacturer liability for defective devices...

There are a number of limits on manufacturer liability for defective devices. For Class III devices, the thorough FDA review of the safety of a device may limit the ability of an injured patient to sue based on the state product liability laws.¹⁴ For the most part, this “preemption” of state law has not played a major role in mesh litigation because they were initially classified as Class II devices which did not require or include a detailed FDA review.¹⁵

The duty to warn of the dangers and risk of medical devices means that manufacturers (or sellers) of devices are obligated to inform health care providers and other medical personnel of the risks. Unlike other manufacturers, device manufacturers do not have to directly warn consumers—because physicians deal directly with patients and prescribe the devices. Therefore, the health care providers, rather than the manufacturers, are obligated to inform the patient.¹⁶ This is known as the learned intermediary rule. Manufacturers may still be liable for failure to warn if they do not convey to health care providers proper warnings.

Manufacturers and sellers are not the only entities that may be subject to liability caused by medical devices. Hospitals or other entities that stock and care for devices are responsible for maintaining the safety and functionality of devices in their care.

Health care providers also may be responsible for injuries from medical devices. Generally, that liability is based on negligence. Negligence may relate to selecting an improper device, installing or using it incorrectly, or failing to give the patient adequate information (or informed consent) about the device and alternatives to it.¹⁷

A look at the mesh mess

There are a lot of distressing problems and professional disappointments in dissecting the “mesh mess,” including a failure of the FDA to regulate effectively, the extended sale and promotion of intrinsic sphincter deficiency mesh products, the improper use of mesh by physicians even after the risks were known, and, in some instances, the taking advantage of injured patients by attorneys and businesses.¹⁸ A lot of finger pointing also has occurred.¹⁹ We will recount some of the lowlights of this unfortunate tale.

Continue to: The FDA, in the 1990s, classified the first POP and SUI mesh...

The FDA, in the 1990s, classified the first POP and SUI mesh as Class II after deciding these products were “substantially equivalent” to older surgical meshes. This, of course, proved not to be the case.²⁰ The FDA started receiving thousands of reports of adverse events and, in 2008, warned physicians to be vigilant for adverse events from the mesh. The FDA’s notification recommendations regarding mesh included the following¹³:

• Obtain specialized training for each mesh implantation technique, and be cognizant of risks.

• Be vigilant for potential adverse events from mesh, including erosion and infection.
• Be observant for complications associated with tools of transvaginal placement (ie, bowel, bladder, and vessel perforation).
• Inform patients that implantation of mesh is permanent and complications may require additional surgery for correction.
• Be aware that complications may affect quality of life—eg, pain with intercourse, scarring, and vaginal wall narrowing (POP repair).
• Provide patients with written copy of patient labeling from the surgical mesh manufacturer.

In 2011, the FDA issued a formal warning to providers that transvaginal mesh posed meaningful risks beyond nonmesh surgery. The FDA’s bulletin draws attention to how the mesh is placed more so than the material per se.^19,21 Mesh was a Class II device for sacrocolpopexy or midurethral sling and, similarly, the transvaginal kit was also a Class II device. Overall, use of mesh midurethral slings has been well received as treatment for SUI. The FDA also accepted it for POP, however, but with increasingly strong warnings. The FDA’s 2011 communication stated, “This update is to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare….Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”^7,13

In 2014 the FDA proposed reclassifying mesh to a Class III device, which would require that manufacturers obtain approval, based on safety and effectiveness, before selling mesh. Not until 2016 did the FDA actually reclassify the mess as Class III. Of course, during this time, mesh manufacturers were well aware of the substantial problems the products were causing.¹³

After serious problems with mesh became well known, and especially after FDA warnings, the use of mesh other than as indicated by the FDA was increasingly risky from a legal (as well as a health) standpoint. As long as mesh was still on the market, of course, it was available for use. But use of mesh for POP procedures without good indications in a way that was contrary to the FDA warnings might well be negligent.

Changes to informed consent

The FDA warnings also should have changed the informed consent for the use of mesh.²² Informed consent commonly consists of the following:

1. informing the patient of the proposed procedure
2. describing risks (and benefits) of the proposed process
3. explaining reasonable alternatives
4. noting the risks of taking no action.

Information that is material to a decision should be disclosed. If mesh were going to be used, after the problems of mesh were known and identified by the FDA (other than midurethral slings as treatment of SUI), the risks should have been clearly identified for patients, with alternatives outlined. The American College of Obstetricians and Gynecologists Committee on Ethics has 8 fundamental concepts with regard to informed consent that are worth keeping in mind²³:

1. Obtaining informed consent for medical treatment and research is an ethical requirement.
2. The process expresses respect for the patient as a person.
3. It protects patients against unwanted treatment and allows patients’ active involvement in medical planning and care.
4. Communication is of paramount importance.
5. Informed consent is a process and not a signature on a form.
6. A commitment to informed consent and to provision of medical benefit to the patient are linked to provision of care.
7. If obtaining informed consent is impossible, a designated surrogate should be identified representing the patient’s best interests.
8. Knowledge on the part of the provider regarding state and federal requirements is necessary.

Continue to: Lawsuits line up...

Lawsuits line up

The widespread use of a product with a significant percentage of injuries and eventually with warnings about injuries from use sounds like the formula for a lot of lawsuits. This certainly has happened. A large number of suits—both class actions and individual actions—were filed as a result of mesh injuries.²⁴ These suits were overwhelmingly against the manufacturer, although some included physicians.⁷ Device makers are more attractive defendants for several reasons. First, they have very deep pockets. In addition, jurors are generally much less sympathetic to large companies than to doctors. Large class actions meant that there were many different patients among the plaintiffs, and medical malpractice claims in most states have a number of trial difficulties not present in other product liability cases. Common defendants have included Johnson & Johnson, Boston Scientific, and Medtronic.

Some of the cases resulted in very large damage awards against manufacturers based on various kinds of product(s) liability. Many other cases were settled or tried with relatively small damages. There were, in addition, a number of instances in which the manufacturers were not liable. Of the 32 plaintiffs who have gone to trial thus far, 24 have obtained verdicts totaling $345 million ($14 million average). The cases that have settled have been for much less—perhaps $60,000 on average. A number of cases remain unresolved. To date, the estimate is that 100,000 women have received almost $8 billion from 7 device manufacturers to resolve claims.²⁵

Some state attorneys general have gotten into the process as well. Attorneys general from California, Kentucky, Mississippi, and Washington have filed lawsuits against Johnson & Johnson, claiming that they deceived doctors and patients about the risks of their pelvic mesh. The states claim that marketing and instructional literature should have contained more information about the risks. Some physicians in these states have expressed concern that these lawsuit risks may do more harm than good because the suits conflate mesh used to treat incontinence with the more risky mesh for POP.²⁶

The “ugly” of class action lawsuits

We have discussed both the sad (the injuries to patients) and the bad (the slow regulatory response and continuing injuries). (The ethics of the marketing by the manufacturers might also be raised as the bad.²⁷) Next, let’s look briefly at the ugly.

Some of the patients affected by mesh injuries have been victimized a second time by medical “lenders” and some of their attorneys. Press reports describe patients with modest awards paying 40% in attorney fees (on the high side for personal injury settlements) plus extravagant costs—leaving modest amounts of actual recovery.²⁵

Worse still, a process of “medical lending” has arisen in mesh cases.²⁸ Medical lenders may contact mesh victims offering to pay up front for surgery to remove mesh, and then place a lien against the settlement for repayment at a much higher rate. They might pay the surgeon $2,500 for the surgery, but place a lien on the settlement amount for $60,000.^29,30 In addition, there are allegations that lawyers may recruit the doctors to overstate the injuries or do unnecessary removal surgery because that will likely up the award.³¹ A quick Google search indicates dozens of offers of cash now for your mesh lawsuit (transvaginal and hernia repair).

The patient in our hypothetical case at the beginning had a fairly typical experience. She was a member of a class filing and received a modest settlement. The attorneys representing the class were allowed by the court to charge substantial attorneys’ fees and costs. The patient had the good sense to avoid medical lenders, although other members of the class did use medical lenders and are now filing complaints about the way they were treated by these lenders.

CASE Complications with mesh placement for SUI

A 47-year-old woman (G4 P3013) presents 5 months posthysterectomy with evidence of urinary tract infection (UTI). Escherichia coli is isolated, and she responds to antibiotic therapy.

Her surgical history includes a mini-sling procedure using a needleless device and mesh placement in order to correct progressive worsening of loss of urine when coughing and sneezing. She also reported slight pelvic pain, dysuria, and urgency upon urination at that time. After subsequent development of pelvic organ prolapse (POP), she underwent the vaginal hysterectomy.

Following her UTI treatment, a host of problems occur for the patient, including pelvic pain and dyspareunia. Her male partner reports “feeling something during sex,” especially at the anterior vaginal wall. A plain radiograph of the abdomen identifies a 2 cm x 2 cm stone over the vaginal mesh. In consultation with female pelvic medicine and reconstructive surgery subspecialists, lithotripsy is performed, with the stone fragmented. The patient remains symptomatic, however.

The mesh is noted to be eroding through the vaginal wall. An attempt is made to excise the mesh, initially via transuretheral resection, then through a laparoscopic approach. Due to the mesh being embedded in the tissue, however, an open approach is undertaken. Extensive excision of the mesh and stone fragments is performed. Postoperatively, the patient reports “dry vagina,” with no other genitourinary complaints.

The patient sues. She sues the mesh manufacturer. She also seeks to sue the gynecologist who placed the sling and vaginal mesh (as she says she was not informed of “all the risks” of vaginal mesh placement. She is part of a class action lawsuit, along with thousands of other women.

WHAT’S THE VERDICT?

The device manufacturer settled out of court with the class action suit. (The gynecologist was never formally a defendant because the patient/plaintiff was advised to “drop the physician from the suit.”) The attorneys representing the class action received 40% of the award plus presented costs for the representation. The class as a whole received a little more than 50% of the negotiated award. The patient in this case received $60,000.

Medical background

Stress urinary incontinence (SUI) is a prevalent condition; it affects 35% of women.¹ Overall, 80% of women aged 80 or younger will undergo some form of surgery for POP during their lifetime.² The pathophysiology of SUI includes urethral hypermobility and intrinsic sphincter deficiency.³

Surgical correction for urinary incontinence: A timeline

Use of the gracilis muscle flap to surgically correct urinary incontinence was introduced in 1907. This technique has been replaced by today’s more common Burch procedure, which was first described in 1961. Surgical mesh use dates back to the 1950s, when it was primarily used for abdominal hernia repair. Tension-free tape was introduced in 1995.^4-6

Continue to: In the late 1990s the US Food and Drug Administration...

In the late 1990s the US Food and Drug Administration (FDA) permitted use of the first transvaginal meshes, which were designed to treat SUI—the midurethral sling. These mesh slings were so successful that similar meshes were developed to treat POP.⁷ Almost immediately there were problems with the new POP devices, and 3 years later Boston Scientific recalled its device.⁸ Nonetheless, the FDA cleared more than 150 devices using surgical mesh for urogynecologic indications (FIGURE).⁹

Mesh complications

Managing complications from intravesical mesh is a clinically challenging problem. Bladder perforation, stone formation, and penetration through the vagina can occur. Bladder-related complications can manifest as recurrent UTIs and obstructive urinary symptoms, especially in association with stone formation. From the gynecologic perspective, the more common complications with mesh utilization are pelvic pain, groin pain, dyspareunia, contracture and scarring of mesh, and narrowing of the vaginal canal.¹⁰ Mesh erosion problems will occur in an estimated 10% to 25% of transvaginal mesh POP implants.¹¹

In 2008, a comparison of transvaginal mesh to native tissue repair (suture-based) or other (biologic) grafts was published.¹² The bottom line: there is insufficient evidence to suggest that transvaginal mesh significantly improves outcomes for both posterior and apical defects.

Legal background

Mesh used for surgical purposes is a medical device, which legally is a product—a special product to be sure, but a product nonetheless. Products are subject to product liability rules. Mesh is also subject to an FDA regulatory system. We will briefly discuss products liability and the regulation of devices, both of which have played important roles in mesh-related injuries.

Products liability

As a general matter, defective products subject their manufacturer and seller to liability. There are several legal theories regarding product liability: negligence (in which the defect was caused through carelessness), breach of warranty or guarantee (in addition to express warranties, there are a number of implied warranties for products, including that it is fit for its intended purpose), and strict liability (there was a defect in the product, but it may not have been because of negligence). The product may be defective in the way it was designed, manufactured, or packaged, or it may be defective because adequate instructions and warning were not given to consumers.

Of course, not every product involved in an injury is defective—most automobile accidents, for example, are not the result of any defect in the automobile. In medicine, almost no product (device or pharmaceutical) is entirely safe. In some ways they are unavoidably unsafe and bound to cause some injuries. But when injuries are caused by a defect in the product (design or manufacturing defect or failure to warn), then there may be products liability. Most products liability cases arise under state law.

FDA’s device regulations

Both drugs and medical devices are subject to FDA review and ordinarily require some form of FDA clearance before they may be marketed. In the case of devices, the FDA has 3 classes, with an increase in risk to the user from Class I to III. Various levels of FDA review are required before marketing of the device is permitted, again with the intensity of review increasing from I to III as follows:

• Class I devices pose the least risk, have the least regulation, and are subject to general controls (ie, manufacturing and marketing practices).
• Class II devices pose slightly higher risks and are subject to special controls in addition to the criteria for Class I.
• Class III devices pose the most risk to patients and require premarket approval (scientific review and studies are required to ensure efficacy and safety).¹³

Continue to: There are a number of limits on manufacturer liability for defective devices...

There are a number of limits on manufacturer liability for defective devices. For Class III devices, the thorough FDA review of the safety of a device may limit the ability of an injured patient to sue based on the state product liability laws.¹⁴ For the most part, this “preemption” of state law has not played a major role in mesh litigation because they were initially classified as Class II devices which did not require or include a detailed FDA review.¹⁵

The duty to warn of the dangers and risk of medical devices means that manufacturers (or sellers) of devices are obligated to inform health care providers and other medical personnel of the risks. Unlike other manufacturers, device manufacturers do not have to directly warn consumers—because physicians deal directly with patients and prescribe the devices. Therefore, the health care providers, rather than the manufacturers, are obligated to inform the patient.¹⁶ This is known as the learned intermediary rule. Manufacturers may still be liable for failure to warn if they do not convey to health care providers proper warnings.

Manufacturers and sellers are not the only entities that may be subject to liability caused by medical devices. Hospitals or other entities that stock and care for devices are responsible for maintaining the safety and functionality of devices in their care.

Health care providers also may be responsible for injuries from medical devices. Generally, that liability is based on negligence. Negligence may relate to selecting an improper device, installing or using it incorrectly, or failing to give the patient adequate information (or informed consent) about the device and alternatives to it.¹⁷

A look at the mesh mess

There are a lot of distressing problems and professional disappointments in dissecting the “mesh mess,” including a failure of the FDA to regulate effectively, the extended sale and promotion of intrinsic sphincter deficiency mesh products, the improper use of mesh by physicians even after the risks were known, and, in some instances, the taking advantage of injured patients by attorneys and businesses.¹⁸ A lot of finger pointing also has occurred.¹⁹ We will recount some of the lowlights of this unfortunate tale.

Continue to: The FDA, in the 1990s, classified the first POP and SUI mesh...

The FDA, in the 1990s, classified the first POP and SUI mesh as Class II after deciding these products were “substantially equivalent” to older surgical meshes. This, of course, proved not to be the case.²⁰ The FDA started receiving thousands of reports of adverse events and, in 2008, warned physicians to be vigilant for adverse events from the mesh. The FDA’s notification recommendations regarding mesh included the following¹³:

• Obtain specialized training for each mesh implantation technique, and be cognizant of risks.

• Be vigilant for potential adverse events from mesh, including erosion and infection.
• Be observant for complications associated with tools of transvaginal placement (ie, bowel, bladder, and vessel perforation).
• Inform patients that implantation of mesh is permanent and complications may require additional surgery for correction.
• Be aware that complications may affect quality of life—eg, pain with intercourse, scarring, and vaginal wall narrowing (POP repair).
• Provide patients with written copy of patient labeling from the surgical mesh manufacturer.

In 2011, the FDA issued a formal warning to providers that transvaginal mesh posed meaningful risks beyond nonmesh surgery. The FDA’s bulletin draws attention to how the mesh is placed more so than the material per se.^19,21 Mesh was a Class II device for sacrocolpopexy or midurethral sling and, similarly, the transvaginal kit was also a Class II device. Overall, use of mesh midurethral slings has been well received as treatment for SUI. The FDA also accepted it for POP, however, but with increasingly strong warnings. The FDA’s 2011 communication stated, “This update is to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare….Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”^7,13

In 2014 the FDA proposed reclassifying mesh to a Class III device, which would require that manufacturers obtain approval, based on safety and effectiveness, before selling mesh. Not until 2016 did the FDA actually reclassify the mess as Class III. Of course, during this time, mesh manufacturers were well aware of the substantial problems the products were causing.¹³

After serious problems with mesh became well known, and especially after FDA warnings, the use of mesh other than as indicated by the FDA was increasingly risky from a legal (as well as a health) standpoint. As long as mesh was still on the market, of course, it was available for use. But use of mesh for POP procedures without good indications in a way that was contrary to the FDA warnings might well be negligent.

Changes to informed consent

The FDA warnings also should have changed the informed consent for the use of mesh.²² Informed consent commonly consists of the following:

1. informing the patient of the proposed procedure
2. describing risks (and benefits) of the proposed process
3. explaining reasonable alternatives
4. noting the risks of taking no action.

Information that is material to a decision should be disclosed. If mesh were going to be used, after the problems of mesh were known and identified by the FDA (other than midurethral slings as treatment of SUI), the risks should have been clearly identified for patients, with alternatives outlined. The American College of Obstetricians and Gynecologists Committee on Ethics has 8 fundamental concepts with regard to informed consent that are worth keeping in mind²³:

1. Obtaining informed consent for medical treatment and research is an ethical requirement.
2. The process expresses respect for the patient as a person.
3. It protects patients against unwanted treatment and allows patients’ active involvement in medical planning and care.
4. Communication is of paramount importance.
5. Informed consent is a process and not a signature on a form.
6. A commitment to informed consent and to provision of medical benefit to the patient are linked to provision of care.
7. If obtaining informed consent is impossible, a designated surrogate should be identified representing the patient’s best interests.
8. Knowledge on the part of the provider regarding state and federal requirements is necessary.

Continue to: Lawsuits line up...

Lawsuits line up

The widespread use of a product with a significant percentage of injuries and eventually with warnings about injuries from use sounds like the formula for a lot of lawsuits. This certainly has happened. A large number of suits—both class actions and individual actions—were filed as a result of mesh injuries.²⁴ These suits were overwhelmingly against the manufacturer, although some included physicians.⁷ Device makers are more attractive defendants for several reasons. First, they have very deep pockets. In addition, jurors are generally much less sympathetic to large companies than to doctors. Large class actions meant that there were many different patients among the plaintiffs, and medical malpractice claims in most states have a number of trial difficulties not present in other product liability cases. Common defendants have included Johnson & Johnson, Boston Scientific, and Medtronic.

Some of the cases resulted in very large damage awards against manufacturers based on various kinds of product(s) liability. Many other cases were settled or tried with relatively small damages. There were, in addition, a number of instances in which the manufacturers were not liable. Of the 32 plaintiffs who have gone to trial thus far, 24 have obtained verdicts totaling $345 million ($14 million average). The cases that have settled have been for much less—perhaps $60,000 on average. A number of cases remain unresolved. To date, the estimate is that 100,000 women have received almost $8 billion from 7 device manufacturers to resolve claims.²⁵

Some state attorneys general have gotten into the process as well. Attorneys general from California, Kentucky, Mississippi, and Washington have filed lawsuits against Johnson & Johnson, claiming that they deceived doctors and patients about the risks of their pelvic mesh. The states claim that marketing and instructional literature should have contained more information about the risks. Some physicians in these states have expressed concern that these lawsuit risks may do more harm than good because the suits conflate mesh used to treat incontinence with the more risky mesh for POP.²⁶

The “ugly” of class action lawsuits

We have discussed both the sad (the injuries to patients) and the bad (the slow regulatory response and continuing injuries). (The ethics of the marketing by the manufacturers might also be raised as the bad.²⁷) Next, let’s look briefly at the ugly.

Some of the patients affected by mesh injuries have been victimized a second time by medical “lenders” and some of their attorneys. Press reports describe patients with modest awards paying 40% in attorney fees (on the high side for personal injury settlements) plus extravagant costs—leaving modest amounts of actual recovery.²⁵

Worse still, a process of “medical lending” has arisen in mesh cases.²⁸ Medical lenders may contact mesh victims offering to pay up front for surgery to remove mesh, and then place a lien against the settlement for repayment at a much higher rate. They might pay the surgeon $2,500 for the surgery, but place a lien on the settlement amount for $60,000.^29,30 In addition, there are allegations that lawyers may recruit the doctors to overstate the injuries or do unnecessary removal surgery because that will likely up the award.³¹ A quick Google search indicates dozens of offers of cash now for your mesh lawsuit (transvaginal and hernia repair).

The patient in our hypothetical case at the beginning had a fairly typical experience. She was a member of a class filing and received a modest settlement. The attorneys representing the class were allowed by the court to charge substantial attorneys’ fees and costs. The patient had the good sense to avoid medical lenders, although other members of the class did use medical lenders and are now filing complaints about the way they were treated by these lenders.

TUCSON, ARIZ. – The definition of a surgical cure for stress urinary incontinence (SUI) varies significantly from one clinical trial to another, but the best choice might be an International Consultation on Incontinence Questionnaire (ICIQ) score of 5 or less, according to a study that correlated a patient’s definition of success with various measures of success or failure.

Szepy/iStock/Getty Images

Adoption of a standard definition could make clinical trial results easier to interpret, as well as improve consistency in clinical practice.

The study was a planned secondary analysis of a randomized, controlled trial that compared midurethral sling to Burch colpopexy in women undergoing abdominal sacrocolpopexy. The original study found no difference in outcomes between the two approaches with respect to stress-specific incontinence rates at 6 months, although the midurethral sling was associated with better secondary, patient-reported outcomes.

That incongruity between objective and subjective outcomes raised questions. “I would frequently have the nurse tell me that a patient didn’t do well [on the stress incontinence test], but you would talk to the patient, and she was happy as could be. She wasn’t using pads, she was perfectly dry. So I thought there was a little bit of a disconnect between the definitions we were using, and what the patients wanted from the procedure,” Emanuel Trabuco, MD, said in an interview.

Dr. Trabuco is a consultant and the chair of the division of urogynecology at Mayo Clinic in Rochester, Minn. He presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.

Dr. Trabuco said he hopes that the finding validates ICIQ greater than or equal to 5 as a novel reference point for SUI surgery outcomes, because as things currently stand, different clinical trials use a range of different outcomes, and as the nurse’s experience shows, an objective outcome might not match patient perception. In fact, objective urinary incontinence tests may not be so objective at all.

“Urodynamics is inherently [challenging]. You can have women that come in with stress incontinence symptoms asking for treatment, and we do urodynamics and they don’t leak. It’s a false negative. Conversely, other women presenting with other issues like overactive bladder – you do urodynamics, and they leak. So that’s a false positive. We have this desire for objectivity, but the tests we have are neither sensitive nor specific,” said Dr. Trabuco.

The researchers examined 13 different methods of determining SUI cure, and then linked them to answers to two questions from 104 trial participants. The first question: “In your opinion, how successful has treatment for your urinary leakage been?” Responses ranged from 0 (not at all) to 10 (very successful). The second question: “Compared to how you were before your recent surgery, how are your urinary leakage symptoms now?” Responses ranged from 0 (much worse) to 10 (much better).

At 6 months, the largest Cohen’s d value for patient perception of symptom improvement was associated with ICIQ score greater than or equal to 5 (–13.5, mean ratings of 9.7 versus 4.6), which was better than definitions based on a negative cough stress test (–6.5) and the strict composite definition, which included a negative cough stress test, ICIQ = 0, and no retreatment (–6.4).

The researchers examined the correlation between each definition of SUI cure and the answers to the above questions, and found that the highest Cohen’s d values for agreement with patient’s perception of symptom improvement were: ICIQ score greater than or equal to 5 (Cohen’s d at 6 months, 12 months, and 24 months; –13.5; –13.0; –12.6, respectively); ICIQ score less than or equal to 5 with no (“not-at-all” or “somewhat”) SUI symptoms on Urinary Distress Inventory, Short Form (UDI-6) (–7.2; –7.2; and –8.1); and ICIQ score less than or equal to 5 with no SUI symptoms (never or rarely) on Medical, Epidemiologic, and Social aspects of Aging (MESA) urinary incontinence questionnaire (–7.0, –7.0, –6.4).

The results argue against the use of cough stress test, said Dr. Trabuco. “If you think about the time commitment that our patients give us to participate in a trial, we should make that participation as least onerous as we can. If the cough stress test doesn’t really add anything to patient perception of surgical success and improvement, why put the poor patient through a catheterization and a cough test and a prolonged visit? For all of those reasons, I hope this is something that others will look at and try to standardize,” said Dr. Trabuco.

Mayo Medical School, Rochester, Minn., funded the study. Dr. Trabuco has no relevant financial disclosures.

SOURCE: Trabuco E et al. SGS 2019, oral poster 14.

TUCSON, ARIZ. – The definition of a surgical cure for stress urinary incontinence (SUI) varies significantly from one clinical trial to another, but the best choice might be an International Consultation on Incontinence Questionnaire (ICIQ) score of 5 or less, according to a study that correlated a patient’s definition of success with various measures of success or failure.

Szepy/iStock/Getty Images

Adoption of a standard definition could make clinical trial results easier to interpret, as well as improve consistency in clinical practice.

The study was a planned secondary analysis of a randomized, controlled trial that compared midurethral sling to Burch colpopexy in women undergoing abdominal sacrocolpopexy. The original study found no difference in outcomes between the two approaches with respect to stress-specific incontinence rates at 6 months, although the midurethral sling was associated with better secondary, patient-reported outcomes.

That incongruity between objective and subjective outcomes raised questions. “I would frequently have the nurse tell me that a patient didn’t do well [on the stress incontinence test], but you would talk to the patient, and she was happy as could be. She wasn’t using pads, she was perfectly dry. So I thought there was a little bit of a disconnect between the definitions we were using, and what the patients wanted from the procedure,” Emanuel Trabuco, MD, said in an interview.

Dr. Trabuco is a consultant and the chair of the division of urogynecology at Mayo Clinic in Rochester, Minn. He presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.

Dr. Trabuco said he hopes that the finding validates ICIQ greater than or equal to 5 as a novel reference point for SUI surgery outcomes, because as things currently stand, different clinical trials use a range of different outcomes, and as the nurse’s experience shows, an objective outcome might not match patient perception. In fact, objective urinary incontinence tests may not be so objective at all.

“Urodynamics is inherently [challenging]. You can have women that come in with stress incontinence symptoms asking for treatment, and we do urodynamics and they don’t leak. It’s a false negative. Conversely, other women presenting with other issues like overactive bladder – you do urodynamics, and they leak. So that’s a false positive. We have this desire for objectivity, but the tests we have are neither sensitive nor specific,” said Dr. Trabuco.

The researchers examined 13 different methods of determining SUI cure, and then linked them to answers to two questions from 104 trial participants. The first question: “In your opinion, how successful has treatment for your urinary leakage been?” Responses ranged from 0 (not at all) to 10 (very successful). The second question: “Compared to how you were before your recent surgery, how are your urinary leakage symptoms now?” Responses ranged from 0 (much worse) to 10 (much better).

At 6 months, the largest Cohen’s d value for patient perception of symptom improvement was associated with ICIQ score greater than or equal to 5 (–13.5, mean ratings of 9.7 versus 4.6), which was better than definitions based on a negative cough stress test (–6.5) and the strict composite definition, which included a negative cough stress test, ICIQ = 0, and no retreatment (–6.4).

The researchers examined the correlation between each definition of SUI cure and the answers to the above questions, and found that the highest Cohen’s d values for agreement with patient’s perception of symptom improvement were: ICIQ score greater than or equal to 5 (Cohen’s d at 6 months, 12 months, and 24 months; –13.5; –13.0; –12.6, respectively); ICIQ score less than or equal to 5 with no (“not-at-all” or “somewhat”) SUI symptoms on Urinary Distress Inventory, Short Form (UDI-6) (–7.2; –7.2; and –8.1); and ICIQ score less than or equal to 5 with no SUI symptoms (never or rarely) on Medical, Epidemiologic, and Social aspects of Aging (MESA) urinary incontinence questionnaire (–7.0, –7.0, –6.4).

The results argue against the use of cough stress test, said Dr. Trabuco. “If you think about the time commitment that our patients give us to participate in a trial, we should make that participation as least onerous as we can. If the cough stress test doesn’t really add anything to patient perception of surgical success and improvement, why put the poor patient through a catheterization and a cough test and a prolonged visit? For all of those reasons, I hope this is something that others will look at and try to standardize,” said Dr. Trabuco.

Mayo Medical School, Rochester, Minn., funded the study. Dr. Trabuco has no relevant financial disclosures.

SOURCE: Trabuco E et al. SGS 2019, oral poster 14.

TUCSON, ARIZ. – The definition of a surgical cure for stress urinary incontinence (SUI) varies significantly from one clinical trial to another, but the best choice might be an International Consultation on Incontinence Questionnaire (ICIQ) score of 5 or less, according to a study that correlated a patient’s definition of success with various measures of success or failure.

Szepy/iStock/Getty Images

Adoption of a standard definition could make clinical trial results easier to interpret, as well as improve consistency in clinical practice.

The study was a planned secondary analysis of a randomized, controlled trial that compared midurethral sling to Burch colpopexy in women undergoing abdominal sacrocolpopexy. The original study found no difference in outcomes between the two approaches with respect to stress-specific incontinence rates at 6 months, although the midurethral sling was associated with better secondary, patient-reported outcomes.

That incongruity between objective and subjective outcomes raised questions. “I would frequently have the nurse tell me that a patient didn’t do well [on the stress incontinence test], but you would talk to the patient, and she was happy as could be. She wasn’t using pads, she was perfectly dry. So I thought there was a little bit of a disconnect between the definitions we were using, and what the patients wanted from the procedure,” Emanuel Trabuco, MD, said in an interview.

Dr. Trabuco is a consultant and the chair of the division of urogynecology at Mayo Clinic in Rochester, Minn. He presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.

Dr. Trabuco said he hopes that the finding validates ICIQ greater than or equal to 5 as a novel reference point for SUI surgery outcomes, because as things currently stand, different clinical trials use a range of different outcomes, and as the nurse’s experience shows, an objective outcome might not match patient perception. In fact, objective urinary incontinence tests may not be so objective at all.

“Urodynamics is inherently [challenging]. You can have women that come in with stress incontinence symptoms asking for treatment, and we do urodynamics and they don’t leak. It’s a false negative. Conversely, other women presenting with other issues like overactive bladder – you do urodynamics, and they leak. So that’s a false positive. We have this desire for objectivity, but the tests we have are neither sensitive nor specific,” said Dr. Trabuco.

The researchers examined 13 different methods of determining SUI cure, and then linked them to answers to two questions from 104 trial participants. The first question: “In your opinion, how successful has treatment for your urinary leakage been?” Responses ranged from 0 (not at all) to 10 (very successful). The second question: “Compared to how you were before your recent surgery, how are your urinary leakage symptoms now?” Responses ranged from 0 (much worse) to 10 (much better).

At 6 months, the largest Cohen’s d value for patient perception of symptom improvement was associated with ICIQ score greater than or equal to 5 (–13.5, mean ratings of 9.7 versus 4.6), which was better than definitions based on a negative cough stress test (–6.5) and the strict composite definition, which included a negative cough stress test, ICIQ = 0, and no retreatment (–6.4).

The researchers examined the correlation between each definition of SUI cure and the answers to the above questions, and found that the highest Cohen’s d values for agreement with patient’s perception of symptom improvement were: ICIQ score greater than or equal to 5 (Cohen’s d at 6 months, 12 months, and 24 months; –13.5; –13.0; –12.6, respectively); ICIQ score less than or equal to 5 with no (“not-at-all” or “somewhat”) SUI symptoms on Urinary Distress Inventory, Short Form (UDI-6) (–7.2; –7.2; and –8.1); and ICIQ score less than or equal to 5 with no SUI symptoms (never or rarely) on Medical, Epidemiologic, and Social aspects of Aging (MESA) urinary incontinence questionnaire (–7.0, –7.0, –6.4).

The results argue against the use of cough stress test, said Dr. Trabuco. “If you think about the time commitment that our patients give us to participate in a trial, we should make that participation as least onerous as we can. If the cough stress test doesn’t really add anything to patient perception of surgical success and improvement, why put the poor patient through a catheterization and a cough test and a prolonged visit? For all of those reasons, I hope this is something that others will look at and try to standardize,” said Dr. Trabuco.

Mayo Medical School, Rochester, Minn., funded the study. Dr. Trabuco has no relevant financial disclosures.

SOURCE: Trabuco E et al. SGS 2019, oral poster 14.