Moderator

The age-adjusted prevalence of any sexual problem is 43% among US women. A full 22% of these women experience sexually related personal distress.¹ With publication of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition² has come a shift in classification and, at times, management approach for reported female sexual dysfunction. When women report to their clinicians decreased sexual desire or arousal or pain at penetration, the management is no longer guided by a linear model of sexual response (excitation, plateau, orgasm, and resolution) but rather by a more nuanced and complex biopsychosocial approach. In this model, diagnosis and management strategies to address bothersome sexual concerns consider the whole woman in the context of her physical and psychosocial health. The patient’s age, medical history, and relationship status are among the factors that could affect management of the problem. In an effort to explore this management approach, I used this Update on Female Sexual Dysfunction as an opportunity to convene a roundtable of several experts, representing varying backgrounds and practice vantage points, to discuss 5 cases of sexual problems that you as a busy clinician may encounter in your practice.

Genital atrophy in a sexually inactive 61-year-old woman

Barbara S. Levy, MD: Two years after her husband's death, which followed several years of illness, your 61-year-old patient mentions at her well woman visit that she anticipates becoming sexually active again. She has not used systemic or vaginal hormone therapy. During pelvic examination, atrophic external genital changes are present, and use of an ultrathin (thinner than a Pederson) speculum reveals vaginal epithelial atrophic changes. A single-digit bimanual exam can be performed with moderate patient discomfort; the patient cannot tolerate a 2-digit bimanual exam. She expresses concern about being able to engage in penile/vaginal sexual intercourse. 

Dr. Kaunitz, what is important for you to ask this patient, and what concerns you most on her physical exam?

Andrew M. Kaunitz, MD: First, it is important to recognize the patient's expectations and desires. As the case suggests, but further questioning could clarify, she would like to be able to comfortably engage in sexual intercourse with a new partner, but penetration may be difficult (and definitely painful for her) unless treatment is pursued. This combination of mucosal and vestibular atrophic changes (genitourinary syndrome of menopause [GSM], or vulvovaginal atrophy [VVA]) plus the absence of penetration for many years can be a double whammy situation for menopausal women. In this case it has led to extensive contracture of the introitus, and if it is not addressed will cause sexual dysfunction.

Dr. Levy: In addition we need to clarify whether or not a history of breast cancer or some other thing may impact the care we provide. How would you approach talking with this patient in order to manage her care?

Dr. Kaunitz: One step is to see how motivated she is to address this, as it is not something that, as gynecologists, we can snap our fingers and the situation will be resolved. If the patient is motivated to treat the atrophic changes with medical treatment, in the form of low-dose vaginal estrogen, and dilation, either on her own if she's highly motivated to do so, or in my practice more commonly with the support of a women's physical therapist, over time she should be able to comfortably engage in sexual intercourse with penetration. If this is what she wants, we can help steer her in the right direction.

Sheryl Kingsberg, PhD: You know that this woman is motivated by virtue of her initiating the topic herself. Patients are often embarrassed talking about sexual issues, or they are not sure that their gynecologist is comfortable with it. After all, they think, if this is the right place to discuss sexual problems, why didn't he or she ask me?  Clinicians must be aware that it is their responsibility to ask about sexual function and not leave it for the patient to open the door.

Dr. Kaunitz: Great point.

Cheryl B. Iglesia, MD: Gratefully, a lot of the atrophic changes this patient demonstrates are reversible. However, other autoimmune diseases (eg, lichen planus, which can affect the vaginal epithelium, or lichen sclerosus, which can affect the clitoris, labia, and vulva) can also cause constriction, and in severe cases, complete obliteration of the vagina and introitus. Women may not be sexually active, and for each annual exam their clinician uses a smaller and smaller speculum--to the point that they cannot even access the cervix anymore--and the vagina can close off. Clinicians may not realize that you need something other than estrogen; with lichen planus you need steroid suppository treatment, and with lichen sclerosus you need topical steroid treatment. So these autoimmune conditions should also be in the differential and, with appropriate treatment, the sexual effects can be reversible.

Michael Krychman, MD: I agree. The vulva can be a great mimicker and, according to the history and physical exam, at some point a vulvoscopy, and even potential biopsies, may be warranted as clinically indicated.

The concept of a comprehensive approach, as Dr. Kingsberg had previously mentioned, involves not only sexual medicine but also evaluating the patient's biopsychosocial variables that may impact her condition.  We also need to set realistic expectations. Some women may benefit from off-label use of medications besides estrogen, including topical testosterone. Informed consent is very important with these treatments. I also have had much clinical success with intravaginal diazepam/lorazepam for pelvic floor hypertonus.

In addition, certainly I agree that pelvic floor physical therapy (PT) is a vital treatment component for this patient and, not to diminish its importance, but many women cannot afford, nor do they have the time or opportunity, to go to pelvic floor PT. As clinicians, we can develop and implement effective programs, even in the office, to educate the patient to help herself as well.

Dr. Kaunitz: Absolutely. Also, if, in a clinical setting consistent with atrophic changes, an ObGyn physician is comfortable that vulvovaginal changes noted on exam represent GSM/atrophic changes, I do not feel vulvoscopy is warranted.

Dr. Levy: In conclusion, we need to be aware that pelvic floor PT may not be available everywhere and that a woman's own digits and her partner can also be incorporated into this treatment.

Something that we have all talked about in other venues, but have not looked at in the larger sphere here, is whether there is value to seeing women annually and performing pelvic exams. As Dr. Kingsberg mentioned, this is a highly motivated patient. We have many patients out there who are silent sufferers. The physical exam is an opportunity for us to recognize and address this problem.

Kimberly Martens for OBG Management

Dyspareunia and low sexual desire in a breast cancer survivor

Dr. Levy: In this case, a 36-year-old woman with BRCA1−positive breast cancer has vaginal dryness, painful intercourse, and lowered sexual interest since her treatment, which included chemotherapy after bilateral mastectomies. She has a bilateral salpingo-oophorectomy(BSO) scheduled for primary prevention of her ovarian cancer risk.

Dr. Kingsberg, what is important for you to know to help guide case management?

Dr. Kingsberg: This woman is actually presenting with 2 sexual problems: dyspareunia, which is probably secondary to VVA or GSM, and low sexual desire. Key questions are: 1) When was symptom onset--acquired after treatment or lifelong? 2) Did she develop the dyspareunia and as a result of having pain during sex lost desire to have sex? Or, did she lose desire and then, without it, had no arousal and therefore pain with penetration developed? It also could be that she has 2 distinct problems, VVA and hypoactive sexual desire disorder (HSDD), in which case you need to think about treating both. Finally, we do not actually know if she is having penetrative intercourse or even if she has a partner.

A vulvovaginal exam would give clues as to whether she has VVA, and hormone levels would indicate if she now has chemo-induced menopause. If she is not in menopause now, she certainly is going to be with her BSO. The hormonal changes due to menopause actually can be primarily responsible for both the dyspareunia and HSDD. Management of both symptoms really needs to be based on shared decision making with the patient--with which treatment for which conditions coming first, based on what is causing her the most distress.

I would encourage this woman to treat her VVA since GSM does have long-term physiologic consequences if untreated. The American College of Obstetricians and Gynecologists (ACOG) recommends nonhormonal treatments as first-line treatments, with vaginal estrogen considered if these therapies fail.³ If lubricants and moisturizers and other nonhormonal options are not sufficient, you could consider local estrogen, even though she is a breast cancer survivor, as well as ospemiphene.

If she is distressed by her loss of sexual desire, you can choose to treat her for HSDD. Flibanserin is the first FDA-approved treatment for HSDD. It is only approved in premenopausal women, so it would be considered off-label use if she is postmenopausal (even though she is quite young). You also could consider exogenous testosterone off-label, after consulting with her oncologist.

In addition to the obvious physiologic etiology of her pain and her low desire, the biopsychosocial aspects to consider are: 1) changes to her body image, as she has had bilateral mastectomies, 2) her anxiety about the cancer diagnosis, and 3) concerns about her relationship if she has one--her partner's reactions to her illness and the quality of the relationship outside the bedroom.

Dr. Iglesia: I am seeing here in our nation's capital a lot of advertisements for laser therapy for GSM. I caution women about this because providers are charging a lot of money for this therapy when we do not have long-term safety and effectiveness data for it.

Our group is currently conducting a randomized controlled trial, looking at vaginal estrogen cream versus laser therapy for GSM here at Medstar Health--one of the first in the country as part of a multisite trial. But the North American Menopause Society (NAMS) has come out with a pretty strong statement,⁴ as has ACOG,⁵ on this therapy, and I caution people about overzealously offering a very costly procedure targeted to a very vulnerable population, especially to women with personal histories of estrogen-sensitive cancers.

Dr. Krychman: I agree. Very often cancer patients are preyed upon by those offering emerging unproven technologies or medications. We have to work as a coordinated comprehensive team, whether it's a sexual medicine expert, psychologist, urogynecologist, gynecologist, or oncologist, and incorporate the patient's needs and expectations and risk tolerance coupled with treatment efficacy and safety.

Dr. Levy: This was a complex case. The biopsychosocial model is critical here. It's important that we are not siloes in our medical management approach and that we try to help this patient embrace the complexity of her situation. It's not only that she has cancer at age 36; there is a possible guilt factor if she has children and passed that gene on.

Another point that we began to talk about is the fact that in this country we tend to be early adopters of new technology. In our discussion with patients, we should focus on what we know and the risk of the unknowns related to some of the treatment options. But let's discuss lasers a little more later on.

Diminished arousal and orgasmic intensity in a patient taking SSRIs

Dr. Levy: In this next case, a 44-year-old woman in a 15-year marriage notices a change in her orgasmic intensity and latency. She has a supportive husband, and they are attentive to each other's sexual needs. However, she notices a change in her arousal and orgasmic intensity, which has diminished over the last year. She reports that the time to orgasm or latency has increased and both she and her partner are frustrated and getting concerned. She has a history of depression that has been managed by selective serotonin reuptake inhibitors for the past 5 years and has no depressive symptoms currently.

Dr. Krychman, what are you considering before beginning to talk with this patient?

Dr. Krychman: My approach really is a comprehensive one, looking not only at the underlying medical issues but also at the psychological and dynamic relationship facets. We of course also want to look at medications: Has she changed her dose or the timing of when she takes it? Is this a new onset? Finally, we want to know why this is coming to the forefront now. Is it because it is getting worse, or is it because there is some significant issue that is going on in the relationship?

Regarding the physical exam, it is important to rule out underlying genital pelvic pathology. Young women can get changes in the integrity of the pelvic floor, in what I would call the orgasmic matrix--the clitoral tissue, the body, the crura (or arms of the clitoris)--we want to examine and be reassured that her genital anatomy is normal and that there is no underlying pathology that could signal an underlying abnormal hormonal profile. Young women certainly can get lowered estrogen effects at the genital/pelvic tissues (including the labia and vulva), and intravaginally as well. Sometimes women will have pelvic floor hypertonus, as we see with other urinary issues. A thorough pelvic exam is quite vital.

Let's not forget the body that is attached to the genitals; we want to rule out chronic medical disease that may impact her: hypertension, diabetes, or hypercholesterolemia. Untreated, these conditions may directly impact the arousal physiologic mechanisms.

Dr. Levy: In doing this patient's physical exam I would be looking for significant weight gain, and even asking about her partner's weight. Body image can be a huge issue. If she has a history of depression, if she is suffering from a body image problem, she can be feeling unattractive. In my experience this can be a common thing to affect women in their mid-40s.

How would you manage this case?

Dr. Krychman: It is important to divide it up in terms of a conservative to aggressive approach. We want to find out about the relationship. For instance, is the sexual dynamic scripted (ie, boring and predictable)? Is she distracted and frustrated or is she getting enough of the type of stimulation that she likes and enjoys? There certainly are a lot of new devices that are available, whether a self-stimulator or vibrator, the Fiera, or other stimulating devices, that may be important to incorporate into the sexual repertoire. If there is underlying pathology, we want to evaluate and treat that. She may need to be primed, so to speak, with systemic hormones. And does she have issues related to other effects of hormonal deprivation, even local effects? Does she have clitoral atrophy?

There are neutraceuticals that are currently available, whether topical arousal gels or ointments, and we as clinicians need to be critical and evaluate their benefit/risk and look at the data concerning these products. In addition, women who have changes in arousal and in orgasmic intensity and latency may be very frustrated. They describe it as climbing up to a peak but never getting over the top, and this frustration may lead to participant spectatoring, so incorporating a certified sex therapist or counselor is sometimes very critical.

Finally, there are a lot of snake oils, charmers, and charlatan unproven procedures--injecting fillers or other substances into the clitoris are a few examples. I would be a critical clinician, examine the evidence, look at the benefit/risk before advocating an intervention that does not have good clinical data to support its use--a comprehensive approach of sexual medicine as well as sexual psychology.

Dr. Kingsberg: Additionally, we know she is in a long-term relationship--15 years; we want to acknowledge the partner. We talked about the partner's weight, but what about his erectile function? Does he have changes in sexual function that are affecting her, and she is the one carrying the "symptom"?

Looking at each piece separately helps a clinician from getting overwhelmed by the patient who comes in reporting distress with orgasmic dysfunction. We have no pharmacologic FDA-approved treatments, so it can feel off-putting for a clinician to try to fix the reported issue. Looking at each component to help her figure out the underlying cause can be helpful.

Dr. Iglesia: With aging, there can be changes in blood flow, not to mention the hormonal and even peripheral nerve changes, that require more stimulation in order to achieve the desired response. I echo concern about expensive procedures being offered with no evidence, such as the "O" or "G" shot, that can cost up to thousands of dollars.

The other procedure that gives me a lot of angst is clitoral unhooding. The 3 parts of the clitoris are sensitive in terms of innervation and blood flow, and cutting around that delicate tissue goes against the surgical principles required for preserving nerves and blood flow.

New onset pain post−prolapse surgery with TOT sling placement

Dr. Levy: For this case, let's consider a 42-year-old woman (P3) who is 6 months post− vaginal hysterectomy. The surgery included ovarian preservation combined with anterior and posterior repair for prolapse as well as apical uterosacral ligament suspension for stage 2 uterovaginal prolapse. A transobturator sling was used.

Extensive preop evaluation was performed, with confirmed symptomatic prolapse. She had no stress incontinence symptoms but did have confirmed occult stress incontinence.

Surgery was uneventful. She resumed intercourse at 8 weeks, but she now has pain with both initial entry and deep penetration. Lubricants and changes in position have not helped. She is in a stable relationship with her husband of 17 years, and she is worried that the sling mesh might be the culprit. On exam, she has no atrophy, pH is 4.5, vaginal length is 8 cm, and there is no prolapse. There is no mesh exposure noted, although she reports slight tenderness with palpation of the right sling arm beneath the right pubic bone.

Dr. Iglesia, what are the patient history questions important to ask here?
 
Dr. Iglesia: This is not an uncommon scenario--elective surgical correction of  occult or latent stress incontinence after surgical correction for pelvic organ prolapse. Now this patient here has no more prolapse complaints; however, she has a new symptom. There are many different causes of dyspareunia; we cannot just assume it is the sling mesh (although with all the legal representation advertisements for those who have had mesh placed, it can certainly be at the top of the patient's mind, causing anxiety and fear).

Multiple trials have looked at prophylactic surgery for incontinence at the time of prolapse repairs. This woman happened to be one of those patients who did not have incontinence symptoms, and they put a sling in. A recent large trial examined women with vaginal prolapse who underwent hysterectomy and suspension.⁶ (They compared 2 different suspensions.) What is interesting is that 25% of women with prolapse do have baseline pain. However, at 24 months, de novo pain can occur in 10% of women--just from the apical suspension. So, here, it could be the prolapse suspension. Or, in terms of the transobturator sling, long-term data do tell us that the de novo dyspareunia rate ranges on the magnitude of 1% to 9%.⁷ What is important here is figuring out the cause of the dyspareunia.

Dr. Levy: One of the important points you raised already was that 25% of these women have preoperative pain. So figuring out what her functioning was before surgery and incorporating that into our assessment postop would be pretty important I would think.

Dr. Iglesia: Yes, you need to understand what her typical encounter was before the surgery and how things have changed now that the prolapse is not in the way. Changes obviously can occur with scar tissue, which over time will improve. If she is perimenopausal and starts to get epithelial changes, we can fix that. The question then becomes, "Is the pain emanating from the mesh?"

When examining this patient, it is not uncommon for me to be able to feel "banjo" strings if the mesh is too tight or close to the surface. It is not exposed but it's palpable, and the patient may feel a ridge during penetration. You can ask the patient if pain occurs with different penetration positions. In addition, explore associated neurologic symptoms (numbness or muscle pain in the thigh).

Dr. Kingsberg: There were 2 different sources of pain--on initial entry and at deep penetration. You want to make sure you address both. Importantly, did one precede the other? For instance, if women have pain with penetration they can then end up with an arousal disorder (the length of the vagina cannot increase as much as it might otherwise) and dystonia secondary to the pain with penetration. The timing of the pain--did it all happen at the same time, or did she start out with pain at one point and did it move to something else--is another critical piece of the history.

Dr. Iglesia: It does take a detailed history and physical exam to identify myofascial trigger points. In this case there seems to be pinpoint tenderness directly on the part of the mesh that is not exposed on the right. There are people who feel you should remove the whole mesh, including the arms. Others feel, okay, we can work on these trigger points, with injections, physical therapy, extra lubrication, and neuromodulatory medications. Only then would they think about potentially excising the sling or a portion thereof.

Dr. Krychman: Keep in mind that, even if you do remove the sling, her pain may not subside, if it is secondary to an underlying issue. Because of media sensationalism, she could be focusing on the sling. It is important to set realistic expectations. I often see vulvar pathology or even provoked vestibulodynia that can present with a deep dyspareunia. The concept of collision dyspareunia or introital discomfort or pain on insertion has far reaching implications. We need to look at the patient in totality, ruling out underlying issues related to the bladder, even the colon.

Patient inquires about the benefits of laser treatment for vaginal health

Dr. Levy: Let's move to this last case: A 47-year-old patient who reports lack of sexual satisfaction and attributes it to a loose vagina says, "I've heard about surgery and laser treatment and radiofrequency devices for vaginal health. What are the benefits and risks of these procedures, and will they correct the issues that I'm experiencing?"

How do you approach this patient?

Dr. Krychman: I want to know why this is of paramount importance to her. Is this her actual complaint or is it society's unrealistic expectation of sexual pleasure and performance placed upon her? Or is this a relationship issue surfacing, compounded by physiologic changes? With good communication techniques, like "ask, tell, ask" or effective use of silence (not interrupting), patients will lead us to the reason and the rationale.

Dr. Levy: I have seen a lot of advertising to women, now showing pictures of genitalia, perhaps creating an expectation that we should look infantile in some way. We are creating a sense of beauty and acceptablevisualization of the vagina and vulva that are completely unrealistic. It's fascinating on one hand but it is also disturbing in that some of the direct-to-consumer marketing going on is creating a sense of unease in women who are otherwise perfectly satisfied. Now they take a look at their sagging skin, maybe after having 2 or 3 children, and although they may not look the same they function not so badly perhaps. I think we are creating a distress and an illness model that is interesting to discuss.

Dr. Iglesia, you are in the midst of a randomized trial, giving an informed consent to participants about the expectations for this potential intervention. How do you explain to women what these laser and radiofrequency devices are expected to do and why they might or might not work?

Dr. Iglesia: We are doing a randomized trial for menopausal women who have GSM. We are comparing estrogen cream with fractional CO2 laser therapy. I also am involved in another randomized trial for lichen sclerosus. I am not involved in the cosmetic use of a laser for people who feel their vaginas are just "loose." Like you, Dr. Levy, I am very concerned about the images that women are seeing of the idealized vulva and vagina, and about the rise of cosmetic gynecology, much of which is being performed by plastic surgeons or dermatologists.

A recent article looked at the number of women who are doing pubic hair grooming; the prevalance is about 80% here in America.⁸ So people have a clear view of what is down there, and then they compare it to what they see in pornographic images on the Internet and want to look like a Barbie doll. That is disturbing because women, particularly young women, do not realize what happens with GSM changes to the vulva and vagina. On the other hand, these laser machines are very expensive, and some doctors are charging thousands of dollars and promising cosmetic and functional results for which we lack long-term, comparative data.

The laser that we are studying is one by Cynosure called Mona Lisa, which works with fractional CO2 and has very low depth of penetration. The concept is that, with microdot therapy (on the order of micrometers), pinpoint destruction will foster regeneration of new collagen and blood flow to the vagina and vulva. We are still in the midst of analyzing this.

Dr. Krychman: I caution people not to lump devices together. There is a significant difference between laser and radiofrequency--especially in the depth of tissue penetration, and level of evidence as well. There are companies performing randomized clinical trials, with well designed sham controls, and have demonstrated clinical efficacy. We need to be cautious of a procedure that is saying it's the best thing since sliced bread, curing interstitial cystitis, dyspareunia, and lichen sclerosus and improving orgasm, lubrication, and arousal. These far reaching, off-label claims are concerning and misleading.

Dr. Levy: I think the important things are 1) shared decision making with the patient and 2) disclosure of what we do not know, which are the long-term results and outcomes and possible downstream negative effects of some of these treatments, since the data we have are so short term.

Dr. Kingsberg: Basics are important. You talked about the pressure for cosmetic appearance, but is that really what is going on for this particular patient? Is she describing a sexual dysfunction when she talks about lack of satisfaction? You need to operationally define that term. Does she have problems with arousal or orgasm or desire and those are what underlie her lack of satisfaction? Is the key to management helping her come to terms with body image issues or to treat a sexual dysfunction? If it truly is a sexual dysfunction, then you can have the shared decision making on preferred treatment approach.

Dr. Levy: This has been an enlightening discussion. Thank all of you for your expertise and clinical acumen.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

The age-adjusted prevalence of any sexual problem is 43% among US women. A full 22% of these women experience sexually related personal distress.¹ With publication of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition² has come a shift in classification and, at times, management approach for reported female sexual dysfunction. When women report to their clinicians decreased sexual desire or arousal or pain at penetration, the management is no longer guided by a linear model of sexual response (excitation, plateau, orgasm, and resolution) but rather by a more nuanced and complex biopsychosocial approach. In this model, diagnosis and management strategies to address bothersome sexual concerns consider the whole woman in the context of her physical and psychosocial health. The patient’s age, medical history, and relationship status are among the factors that could affect management of the problem. In an effort to explore this management approach, I used this Update on Female Sexual Dysfunction as an opportunity to convene a roundtable of several experts, representing varying backgrounds and practice vantage points, to discuss 5 cases of sexual problems that you as a busy clinician may encounter in your practice.

Genital atrophy in a sexually inactive 61-year-old woman

Barbara S. Levy, MD: Two years after her husband's death, which followed several years of illness, your 61-year-old patient mentions at her well woman visit that she anticipates becoming sexually active again. She has not used systemic or vaginal hormone therapy. During pelvic examination, atrophic external genital changes are present, and use of an ultrathin (thinner than a Pederson) speculum reveals vaginal epithelial atrophic changes. A single-digit bimanual exam can be performed with moderate patient discomfort; the patient cannot tolerate a 2-digit bimanual exam. She expresses concern about being able to engage in penile/vaginal sexual intercourse. 

Dr. Kaunitz, what is important for you to ask this patient, and what concerns you most on her physical exam?

Andrew M. Kaunitz, MD: First, it is important to recognize the patient's expectations and desires. As the case suggests, but further questioning could clarify, she would like to be able to comfortably engage in sexual intercourse with a new partner, but penetration may be difficult (and definitely painful for her) unless treatment is pursued. This combination of mucosal and vestibular atrophic changes (genitourinary syndrome of menopause [GSM], or vulvovaginal atrophy [VVA]) plus the absence of penetration for many years can be a double whammy situation for menopausal women. In this case it has led to extensive contracture of the introitus, and if it is not addressed will cause sexual dysfunction.

Dr. Levy: In addition we need to clarify whether or not a history of breast cancer or some other thing may impact the care we provide. How would you approach talking with this patient in order to manage her care?

Dr. Kaunitz: One step is to see how motivated she is to address this, as it is not something that, as gynecologists, we can snap our fingers and the situation will be resolved. If the patient is motivated to treat the atrophic changes with medical treatment, in the form of low-dose vaginal estrogen, and dilation, either on her own if she's highly motivated to do so, or in my practice more commonly with the support of a women's physical therapist, over time she should be able to comfortably engage in sexual intercourse with penetration. If this is what she wants, we can help steer her in the right direction.

Sheryl Kingsberg, PhD: You know that this woman is motivated by virtue of her initiating the topic herself. Patients are often embarrassed talking about sexual issues, or they are not sure that their gynecologist is comfortable with it. After all, they think, if this is the right place to discuss sexual problems, why didn't he or she ask me?  Clinicians must be aware that it is their responsibility to ask about sexual function and not leave it for the patient to open the door.

Dr. Kaunitz: Great point.

Cheryl B. Iglesia, MD: Gratefully, a lot of the atrophic changes this patient demonstrates are reversible. However, other autoimmune diseases (eg, lichen planus, which can affect the vaginal epithelium, or lichen sclerosus, which can affect the clitoris, labia, and vulva) can also cause constriction, and in severe cases, complete obliteration of the vagina and introitus. Women may not be sexually active, and for each annual exam their clinician uses a smaller and smaller speculum--to the point that they cannot even access the cervix anymore--and the vagina can close off. Clinicians may not realize that you need something other than estrogen; with lichen planus you need steroid suppository treatment, and with lichen sclerosus you need topical steroid treatment. So these autoimmune conditions should also be in the differential and, with appropriate treatment, the sexual effects can be reversible.

Michael Krychman, MD: I agree. The vulva can be a great mimicker and, according to the history and physical exam, at some point a vulvoscopy, and even potential biopsies, may be warranted as clinically indicated.

The concept of a comprehensive approach, as Dr. Kingsberg had previously mentioned, involves not only sexual medicine but also evaluating the patient's biopsychosocial variables that may impact her condition.  We also need to set realistic expectations. Some women may benefit from off-label use of medications besides estrogen, including topical testosterone. Informed consent is very important with these treatments. I also have had much clinical success with intravaginal diazepam/lorazepam for pelvic floor hypertonus.

In addition, certainly I agree that pelvic floor physical therapy (PT) is a vital treatment component for this patient and, not to diminish its importance, but many women cannot afford, nor do they have the time or opportunity, to go to pelvic floor PT. As clinicians, we can develop and implement effective programs, even in the office, to educate the patient to help herself as well.

Dr. Kaunitz: Absolutely. Also, if, in a clinical setting consistent with atrophic changes, an ObGyn physician is comfortable that vulvovaginal changes noted on exam represent GSM/atrophic changes, I do not feel vulvoscopy is warranted.

Dr. Levy: In conclusion, we need to be aware that pelvic floor PT may not be available everywhere and that a woman's own digits and her partner can also be incorporated into this treatment.

Something that we have all talked about in other venues, but have not looked at in the larger sphere here, is whether there is value to seeing women annually and performing pelvic exams. As Dr. Kingsberg mentioned, this is a highly motivated patient. We have many patients out there who are silent sufferers. The physical exam is an opportunity for us to recognize and address this problem.

Kimberly Martens for OBG Management

Dyspareunia and low sexual desire in a breast cancer survivor

Dr. Levy: In this case, a 36-year-old woman with BRCA1−positive breast cancer has vaginal dryness, painful intercourse, and lowered sexual interest since her treatment, which included chemotherapy after bilateral mastectomies. She has a bilateral salpingo-oophorectomy(BSO) scheduled for primary prevention of her ovarian cancer risk.

Dr. Kingsberg, what is important for you to know to help guide case management?

Dr. Kingsberg: This woman is actually presenting with 2 sexual problems: dyspareunia, which is probably secondary to VVA or GSM, and low sexual desire. Key questions are: 1) When was symptom onset--acquired after treatment or lifelong? 2) Did she develop the dyspareunia and as a result of having pain during sex lost desire to have sex? Or, did she lose desire and then, without it, had no arousal and therefore pain with penetration developed? It also could be that she has 2 distinct problems, VVA and hypoactive sexual desire disorder (HSDD), in which case you need to think about treating both. Finally, we do not actually know if she is having penetrative intercourse or even if she has a partner.

A vulvovaginal exam would give clues as to whether she has VVA, and hormone levels would indicate if she now has chemo-induced menopause. If she is not in menopause now, she certainly is going to be with her BSO. The hormonal changes due to menopause actually can be primarily responsible for both the dyspareunia and HSDD. Management of both symptoms really needs to be based on shared decision making with the patient--with which treatment for which conditions coming first, based on what is causing her the most distress.

I would encourage this woman to treat her VVA since GSM does have long-term physiologic consequences if untreated. The American College of Obstetricians and Gynecologists (ACOG) recommends nonhormonal treatments as first-line treatments, with vaginal estrogen considered if these therapies fail.³ If lubricants and moisturizers and other nonhormonal options are not sufficient, you could consider local estrogen, even though she is a breast cancer survivor, as well as ospemiphene.

If she is distressed by her loss of sexual desire, you can choose to treat her for HSDD. Flibanserin is the first FDA-approved treatment for HSDD. It is only approved in premenopausal women, so it would be considered off-label use if she is postmenopausal (even though she is quite young). You also could consider exogenous testosterone off-label, after consulting with her oncologist.

In addition to the obvious physiologic etiology of her pain and her low desire, the biopsychosocial aspects to consider are: 1) changes to her body image, as she has had bilateral mastectomies, 2) her anxiety about the cancer diagnosis, and 3) concerns about her relationship if she has one--her partner's reactions to her illness and the quality of the relationship outside the bedroom.

Dr. Iglesia: I am seeing here in our nation's capital a lot of advertisements for laser therapy for GSM. I caution women about this because providers are charging a lot of money for this therapy when we do not have long-term safety and effectiveness data for it.

Our group is currently conducting a randomized controlled trial, looking at vaginal estrogen cream versus laser therapy for GSM here at Medstar Health--one of the first in the country as part of a multisite trial. But the North American Menopause Society (NAMS) has come out with a pretty strong statement,⁴ as has ACOG,⁵ on this therapy, and I caution people about overzealously offering a very costly procedure targeted to a very vulnerable population, especially to women with personal histories of estrogen-sensitive cancers.

Dr. Krychman: I agree. Very often cancer patients are preyed upon by those offering emerging unproven technologies or medications. We have to work as a coordinated comprehensive team, whether it's a sexual medicine expert, psychologist, urogynecologist, gynecologist, or oncologist, and incorporate the patient's needs and expectations and risk tolerance coupled with treatment efficacy and safety.

Dr. Levy: This was a complex case. The biopsychosocial model is critical here. It's important that we are not siloes in our medical management approach and that we try to help this patient embrace the complexity of her situation. It's not only that she has cancer at age 36; there is a possible guilt factor if she has children and passed that gene on.

Another point that we began to talk about is the fact that in this country we tend to be early adopters of new technology. In our discussion with patients, we should focus on what we know and the risk of the unknowns related to some of the treatment options. But let's discuss lasers a little more later on.

Diminished arousal and orgasmic intensity in a patient taking SSRIs

Dr. Levy: In this next case, a 44-year-old woman in a 15-year marriage notices a change in her orgasmic intensity and latency. She has a supportive husband, and they are attentive to each other's sexual needs. However, she notices a change in her arousal and orgasmic intensity, which has diminished over the last year. She reports that the time to orgasm or latency has increased and both she and her partner are frustrated and getting concerned. She has a history of depression that has been managed by selective serotonin reuptake inhibitors for the past 5 years and has no depressive symptoms currently.

Dr. Krychman, what are you considering before beginning to talk with this patient?

Dr. Krychman: My approach really is a comprehensive one, looking not only at the underlying medical issues but also at the psychological and dynamic relationship facets. We of course also want to look at medications: Has she changed her dose or the timing of when she takes it? Is this a new onset? Finally, we want to know why this is coming to the forefront now. Is it because it is getting worse, or is it because there is some significant issue that is going on in the relationship?

Regarding the physical exam, it is important to rule out underlying genital pelvic pathology. Young women can get changes in the integrity of the pelvic floor, in what I would call the orgasmic matrix--the clitoral tissue, the body, the crura (or arms of the clitoris)--we want to examine and be reassured that her genital anatomy is normal and that there is no underlying pathology that could signal an underlying abnormal hormonal profile. Young women certainly can get lowered estrogen effects at the genital/pelvic tissues (including the labia and vulva), and intravaginally as well. Sometimes women will have pelvic floor hypertonus, as we see with other urinary issues. A thorough pelvic exam is quite vital.

Let's not forget the body that is attached to the genitals; we want to rule out chronic medical disease that may impact her: hypertension, diabetes, or hypercholesterolemia. Untreated, these conditions may directly impact the arousal physiologic mechanisms.

Dr. Levy: In doing this patient's physical exam I would be looking for significant weight gain, and even asking about her partner's weight. Body image can be a huge issue. If she has a history of depression, if she is suffering from a body image problem, she can be feeling unattractive. In my experience this can be a common thing to affect women in their mid-40s.

How would you manage this case?

Dr. Krychman: It is important to divide it up in terms of a conservative to aggressive approach. We want to find out about the relationship. For instance, is the sexual dynamic scripted (ie, boring and predictable)? Is she distracted and frustrated or is she getting enough of the type of stimulation that she likes and enjoys? There certainly are a lot of new devices that are available, whether a self-stimulator or vibrator, the Fiera, or other stimulating devices, that may be important to incorporate into the sexual repertoire. If there is underlying pathology, we want to evaluate and treat that. She may need to be primed, so to speak, with systemic hormones. And does she have issues related to other effects of hormonal deprivation, even local effects? Does she have clitoral atrophy?

There are neutraceuticals that are currently available, whether topical arousal gels or ointments, and we as clinicians need to be critical and evaluate their benefit/risk and look at the data concerning these products. In addition, women who have changes in arousal and in orgasmic intensity and latency may be very frustrated. They describe it as climbing up to a peak but never getting over the top, and this frustration may lead to participant spectatoring, so incorporating a certified sex therapist or counselor is sometimes very critical.

Finally, there are a lot of snake oils, charmers, and charlatan unproven procedures--injecting fillers or other substances into the clitoris are a few examples. I would be a critical clinician, examine the evidence, look at the benefit/risk before advocating an intervention that does not have good clinical data to support its use--a comprehensive approach of sexual medicine as well as sexual psychology.

Dr. Kingsberg: Additionally, we know she is in a long-term relationship--15 years; we want to acknowledge the partner. We talked about the partner's weight, but what about his erectile function? Does he have changes in sexual function that are affecting her, and she is the one carrying the "symptom"?

Looking at each piece separately helps a clinician from getting overwhelmed by the patient who comes in reporting distress with orgasmic dysfunction. We have no pharmacologic FDA-approved treatments, so it can feel off-putting for a clinician to try to fix the reported issue. Looking at each component to help her figure out the underlying cause can be helpful.

Dr. Iglesia: With aging, there can be changes in blood flow, not to mention the hormonal and even peripheral nerve changes, that require more stimulation in order to achieve the desired response. I echo concern about expensive procedures being offered with no evidence, such as the "O" or "G" shot, that can cost up to thousands of dollars.

The other procedure that gives me a lot of angst is clitoral unhooding. The 3 parts of the clitoris are sensitive in terms of innervation and blood flow, and cutting around that delicate tissue goes against the surgical principles required for preserving nerves and blood flow.

New onset pain post−prolapse surgery with TOT sling placement

Dr. Levy: For this case, let's consider a 42-year-old woman (P3) who is 6 months post− vaginal hysterectomy. The surgery included ovarian preservation combined with anterior and posterior repair for prolapse as well as apical uterosacral ligament suspension for stage 2 uterovaginal prolapse. A transobturator sling was used.

Extensive preop evaluation was performed, with confirmed symptomatic prolapse. She had no stress incontinence symptoms but did have confirmed occult stress incontinence.

Surgery was uneventful. She resumed intercourse at 8 weeks, but she now has pain with both initial entry and deep penetration. Lubricants and changes in position have not helped. She is in a stable relationship with her husband of 17 years, and she is worried that the sling mesh might be the culprit. On exam, she has no atrophy, pH is 4.5, vaginal length is 8 cm, and there is no prolapse. There is no mesh exposure noted, although she reports slight tenderness with palpation of the right sling arm beneath the right pubic bone.

Dr. Iglesia, what are the patient history questions important to ask here?
 
Dr. Iglesia: This is not an uncommon scenario--elective surgical correction of  occult or latent stress incontinence after surgical correction for pelvic organ prolapse. Now this patient here has no more prolapse complaints; however, she has a new symptom. There are many different causes of dyspareunia; we cannot just assume it is the sling mesh (although with all the legal representation advertisements for those who have had mesh placed, it can certainly be at the top of the patient's mind, causing anxiety and fear).

Multiple trials have looked at prophylactic surgery for incontinence at the time of prolapse repairs. This woman happened to be one of those patients who did not have incontinence symptoms, and they put a sling in. A recent large trial examined women with vaginal prolapse who underwent hysterectomy and suspension.⁶ (They compared 2 different suspensions.) What is interesting is that 25% of women with prolapse do have baseline pain. However, at 24 months, de novo pain can occur in 10% of women--just from the apical suspension. So, here, it could be the prolapse suspension. Or, in terms of the transobturator sling, long-term data do tell us that the de novo dyspareunia rate ranges on the magnitude of 1% to 9%.⁷ What is important here is figuring out the cause of the dyspareunia.

Dr. Levy: One of the important points you raised already was that 25% of these women have preoperative pain. So figuring out what her functioning was before surgery and incorporating that into our assessment postop would be pretty important I would think.

Dr. Iglesia: Yes, you need to understand what her typical encounter was before the surgery and how things have changed now that the prolapse is not in the way. Changes obviously can occur with scar tissue, which over time will improve. If she is perimenopausal and starts to get epithelial changes, we can fix that. The question then becomes, "Is the pain emanating from the mesh?"

When examining this patient, it is not uncommon for me to be able to feel "banjo" strings if the mesh is too tight or close to the surface. It is not exposed but it's palpable, and the patient may feel a ridge during penetration. You can ask the patient if pain occurs with different penetration positions. In addition, explore associated neurologic symptoms (numbness or muscle pain in the thigh).

Dr. Kingsberg: There were 2 different sources of pain--on initial entry and at deep penetration. You want to make sure you address both. Importantly, did one precede the other? For instance, if women have pain with penetration they can then end up with an arousal disorder (the length of the vagina cannot increase as much as it might otherwise) and dystonia secondary to the pain with penetration. The timing of the pain--did it all happen at the same time, or did she start out with pain at one point and did it move to something else--is another critical piece of the history.

Dr. Iglesia: It does take a detailed history and physical exam to identify myofascial trigger points. In this case there seems to be pinpoint tenderness directly on the part of the mesh that is not exposed on the right. There are people who feel you should remove the whole mesh, including the arms. Others feel, okay, we can work on these trigger points, with injections, physical therapy, extra lubrication, and neuromodulatory medications. Only then would they think about potentially excising the sling or a portion thereof.

Dr. Krychman: Keep in mind that, even if you do remove the sling, her pain may not subside, if it is secondary to an underlying issue. Because of media sensationalism, she could be focusing on the sling. It is important to set realistic expectations. I often see vulvar pathology or even provoked vestibulodynia that can present with a deep dyspareunia. The concept of collision dyspareunia or introital discomfort or pain on insertion has far reaching implications. We need to look at the patient in totality, ruling out underlying issues related to the bladder, even the colon.

Patient inquires about the benefits of laser treatment for vaginal health

Dr. Levy: Let's move to this last case: A 47-year-old patient who reports lack of sexual satisfaction and attributes it to a loose vagina says, "I've heard about surgery and laser treatment and radiofrequency devices for vaginal health. What are the benefits and risks of these procedures, and will they correct the issues that I'm experiencing?"

How do you approach this patient?

Dr. Krychman: I want to know why this is of paramount importance to her. Is this her actual complaint or is it society's unrealistic expectation of sexual pleasure and performance placed upon her? Or is this a relationship issue surfacing, compounded by physiologic changes? With good communication techniques, like "ask, tell, ask" or effective use of silence (not interrupting), patients will lead us to the reason and the rationale.

Dr. Levy: I have seen a lot of advertising to women, now showing pictures of genitalia, perhaps creating an expectation that we should look infantile in some way. We are creating a sense of beauty and acceptablevisualization of the vagina and vulva that are completely unrealistic. It's fascinating on one hand but it is also disturbing in that some of the direct-to-consumer marketing going on is creating a sense of unease in women who are otherwise perfectly satisfied. Now they take a look at their sagging skin, maybe after having 2 or 3 children, and although they may not look the same they function not so badly perhaps. I think we are creating a distress and an illness model that is interesting to discuss.

Dr. Iglesia, you are in the midst of a randomized trial, giving an informed consent to participants about the expectations for this potential intervention. How do you explain to women what these laser and radiofrequency devices are expected to do and why they might or might not work?

Dr. Iglesia: We are doing a randomized trial for menopausal women who have GSM. We are comparing estrogen cream with fractional CO2 laser therapy. I also am involved in another randomized trial for lichen sclerosus. I am not involved in the cosmetic use of a laser for people who feel their vaginas are just "loose." Like you, Dr. Levy, I am very concerned about the images that women are seeing of the idealized vulva and vagina, and about the rise of cosmetic gynecology, much of which is being performed by plastic surgeons or dermatologists.

A recent article looked at the number of women who are doing pubic hair grooming; the prevalance is about 80% here in America.⁸ So people have a clear view of what is down there, and then they compare it to what they see in pornographic images on the Internet and want to look like a Barbie doll. That is disturbing because women, particularly young women, do not realize what happens with GSM changes to the vulva and vagina. On the other hand, these laser machines are very expensive, and some doctors are charging thousands of dollars and promising cosmetic and functional results for which we lack long-term, comparative data.

The laser that we are studying is one by Cynosure called Mona Lisa, which works with fractional CO2 and has very low depth of penetration. The concept is that, with microdot therapy (on the order of micrometers), pinpoint destruction will foster regeneration of new collagen and blood flow to the vagina and vulva. We are still in the midst of analyzing this.

Dr. Krychman: I caution people not to lump devices together. There is a significant difference between laser and radiofrequency--especially in the depth of tissue penetration, and level of evidence as well. There are companies performing randomized clinical trials, with well designed sham controls, and have demonstrated clinical efficacy. We need to be cautious of a procedure that is saying it's the best thing since sliced bread, curing interstitial cystitis, dyspareunia, and lichen sclerosus and improving orgasm, lubrication, and arousal. These far reaching, off-label claims are concerning and misleading.

Dr. Levy: I think the important things are 1) shared decision making with the patient and 2) disclosure of what we do not know, which are the long-term results and outcomes and possible downstream negative effects of some of these treatments, since the data we have are so short term.

Dr. Kingsberg: Basics are important. You talked about the pressure for cosmetic appearance, but is that really what is going on for this particular patient? Is she describing a sexual dysfunction when she talks about lack of satisfaction? You need to operationally define that term. Does she have problems with arousal or orgasm or desire and those are what underlie her lack of satisfaction? Is the key to management helping her come to terms with body image issues or to treat a sexual dysfunction? If it truly is a sexual dysfunction, then you can have the shared decision making on preferred treatment approach.

Dr. Levy: This has been an enlightening discussion. Thank all of you for your expertise and clinical acumen.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

The age-adjusted prevalence of any sexual problem is 43% among US women. A full 22% of these women experience sexually related personal distress.¹ With publication of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition² has come a shift in classification and, at times, management approach for reported female sexual dysfunction. When women report to their clinicians decreased sexual desire or arousal or pain at penetration, the management is no longer guided by a linear model of sexual response (excitation, plateau, orgasm, and resolution) but rather by a more nuanced and complex biopsychosocial approach. In this model, diagnosis and management strategies to address bothersome sexual concerns consider the whole woman in the context of her physical and psychosocial health. The patient’s age, medical history, and relationship status are among the factors that could affect management of the problem. In an effort to explore this management approach, I used this Update on Female Sexual Dysfunction as an opportunity to convene a roundtable of several experts, representing varying backgrounds and practice vantage points, to discuss 5 cases of sexual problems that you as a busy clinician may encounter in your practice.

Genital atrophy in a sexually inactive 61-year-old woman

Barbara S. Levy, MD: Two years after her husband's death, which followed several years of illness, your 61-year-old patient mentions at her well woman visit that she anticipates becoming sexually active again. She has not used systemic or vaginal hormone therapy. During pelvic examination, atrophic external genital changes are present, and use of an ultrathin (thinner than a Pederson) speculum reveals vaginal epithelial atrophic changes. A single-digit bimanual exam can be performed with moderate patient discomfort; the patient cannot tolerate a 2-digit bimanual exam. She expresses concern about being able to engage in penile/vaginal sexual intercourse. 

Dr. Kaunitz, what is important for you to ask this patient, and what concerns you most on her physical exam?

Andrew M. Kaunitz, MD: First, it is important to recognize the patient's expectations and desires. As the case suggests, but further questioning could clarify, she would like to be able to comfortably engage in sexual intercourse with a new partner, but penetration may be difficult (and definitely painful for her) unless treatment is pursued. This combination of mucosal and vestibular atrophic changes (genitourinary syndrome of menopause [GSM], or vulvovaginal atrophy [VVA]) plus the absence of penetration for many years can be a double whammy situation for menopausal women. In this case it has led to extensive contracture of the introitus, and if it is not addressed will cause sexual dysfunction.

Dr. Levy: In addition we need to clarify whether or not a history of breast cancer or some other thing may impact the care we provide. How would you approach talking with this patient in order to manage her care?

Dr. Kaunitz: One step is to see how motivated she is to address this, as it is not something that, as gynecologists, we can snap our fingers and the situation will be resolved. If the patient is motivated to treat the atrophic changes with medical treatment, in the form of low-dose vaginal estrogen, and dilation, either on her own if she's highly motivated to do so, or in my practice more commonly with the support of a women's physical therapist, over time she should be able to comfortably engage in sexual intercourse with penetration. If this is what she wants, we can help steer her in the right direction.

Sheryl Kingsberg, PhD: You know that this woman is motivated by virtue of her initiating the topic herself. Patients are often embarrassed talking about sexual issues, or they are not sure that their gynecologist is comfortable with it. After all, they think, if this is the right place to discuss sexual problems, why didn't he or she ask me?  Clinicians must be aware that it is their responsibility to ask about sexual function and not leave it for the patient to open the door.

Dr. Kaunitz: Great point.

Cheryl B. Iglesia, MD: Gratefully, a lot of the atrophic changes this patient demonstrates are reversible. However, other autoimmune diseases (eg, lichen planus, which can affect the vaginal epithelium, or lichen sclerosus, which can affect the clitoris, labia, and vulva) can also cause constriction, and in severe cases, complete obliteration of the vagina and introitus. Women may not be sexually active, and for each annual exam their clinician uses a smaller and smaller speculum--to the point that they cannot even access the cervix anymore--and the vagina can close off. Clinicians may not realize that you need something other than estrogen; with lichen planus you need steroid suppository treatment, and with lichen sclerosus you need topical steroid treatment. So these autoimmune conditions should also be in the differential and, with appropriate treatment, the sexual effects can be reversible.

Michael Krychman, MD: I agree. The vulva can be a great mimicker and, according to the history and physical exam, at some point a vulvoscopy, and even potential biopsies, may be warranted as clinically indicated.

The concept of a comprehensive approach, as Dr. Kingsberg had previously mentioned, involves not only sexual medicine but also evaluating the patient's biopsychosocial variables that may impact her condition.  We also need to set realistic expectations. Some women may benefit from off-label use of medications besides estrogen, including topical testosterone. Informed consent is very important with these treatments. I also have had much clinical success with intravaginal diazepam/lorazepam for pelvic floor hypertonus.

In addition, certainly I agree that pelvic floor physical therapy (PT) is a vital treatment component for this patient and, not to diminish its importance, but many women cannot afford, nor do they have the time or opportunity, to go to pelvic floor PT. As clinicians, we can develop and implement effective programs, even in the office, to educate the patient to help herself as well.

Dr. Kaunitz: Absolutely. Also, if, in a clinical setting consistent with atrophic changes, an ObGyn physician is comfortable that vulvovaginal changes noted on exam represent GSM/atrophic changes, I do not feel vulvoscopy is warranted.

Dr. Levy: In conclusion, we need to be aware that pelvic floor PT may not be available everywhere and that a woman's own digits and her partner can also be incorporated into this treatment.

Something that we have all talked about in other venues, but have not looked at in the larger sphere here, is whether there is value to seeing women annually and performing pelvic exams. As Dr. Kingsberg mentioned, this is a highly motivated patient. We have many patients out there who are silent sufferers. The physical exam is an opportunity for us to recognize and address this problem.

Kimberly Martens for OBG Management

Dyspareunia and low sexual desire in a breast cancer survivor

Dr. Levy: In this case, a 36-year-old woman with BRCA1−positive breast cancer has vaginal dryness, painful intercourse, and lowered sexual interest since her treatment, which included chemotherapy after bilateral mastectomies. She has a bilateral salpingo-oophorectomy(BSO) scheduled for primary prevention of her ovarian cancer risk.

Dr. Kingsberg, what is important for you to know to help guide case management?

Dr. Kingsberg: This woman is actually presenting with 2 sexual problems: dyspareunia, which is probably secondary to VVA or GSM, and low sexual desire. Key questions are: 1) When was symptom onset--acquired after treatment or lifelong? 2) Did she develop the dyspareunia and as a result of having pain during sex lost desire to have sex? Or, did she lose desire and then, without it, had no arousal and therefore pain with penetration developed? It also could be that she has 2 distinct problems, VVA and hypoactive sexual desire disorder (HSDD), in which case you need to think about treating both. Finally, we do not actually know if she is having penetrative intercourse or even if she has a partner.

A vulvovaginal exam would give clues as to whether she has VVA, and hormone levels would indicate if she now has chemo-induced menopause. If she is not in menopause now, she certainly is going to be with her BSO. The hormonal changes due to menopause actually can be primarily responsible for both the dyspareunia and HSDD. Management of both symptoms really needs to be based on shared decision making with the patient--with which treatment for which conditions coming first, based on what is causing her the most distress.

I would encourage this woman to treat her VVA since GSM does have long-term physiologic consequences if untreated. The American College of Obstetricians and Gynecologists (ACOG) recommends nonhormonal treatments as first-line treatments, with vaginal estrogen considered if these therapies fail.³ If lubricants and moisturizers and other nonhormonal options are not sufficient, you could consider local estrogen, even though she is a breast cancer survivor, as well as ospemiphene.

If she is distressed by her loss of sexual desire, you can choose to treat her for HSDD. Flibanserin is the first FDA-approved treatment for HSDD. It is only approved in premenopausal women, so it would be considered off-label use if she is postmenopausal (even though she is quite young). You also could consider exogenous testosterone off-label, after consulting with her oncologist.

In addition to the obvious physiologic etiology of her pain and her low desire, the biopsychosocial aspects to consider are: 1) changes to her body image, as she has had bilateral mastectomies, 2) her anxiety about the cancer diagnosis, and 3) concerns about her relationship if she has one--her partner's reactions to her illness and the quality of the relationship outside the bedroom.

Dr. Iglesia: I am seeing here in our nation's capital a lot of advertisements for laser therapy for GSM. I caution women about this because providers are charging a lot of money for this therapy when we do not have long-term safety and effectiveness data for it.

Our group is currently conducting a randomized controlled trial, looking at vaginal estrogen cream versus laser therapy for GSM here at Medstar Health--one of the first in the country as part of a multisite trial. But the North American Menopause Society (NAMS) has come out with a pretty strong statement,⁴ as has ACOG,⁵ on this therapy, and I caution people about overzealously offering a very costly procedure targeted to a very vulnerable population, especially to women with personal histories of estrogen-sensitive cancers.

Dr. Krychman: I agree. Very often cancer patients are preyed upon by those offering emerging unproven technologies or medications. We have to work as a coordinated comprehensive team, whether it's a sexual medicine expert, psychologist, urogynecologist, gynecologist, or oncologist, and incorporate the patient's needs and expectations and risk tolerance coupled with treatment efficacy and safety.

Dr. Levy: This was a complex case. The biopsychosocial model is critical here. It's important that we are not siloes in our medical management approach and that we try to help this patient embrace the complexity of her situation. It's not only that she has cancer at age 36; there is a possible guilt factor if she has children and passed that gene on.

Another point that we began to talk about is the fact that in this country we tend to be early adopters of new technology. In our discussion with patients, we should focus on what we know and the risk of the unknowns related to some of the treatment options. But let's discuss lasers a little more later on.

Diminished arousal and orgasmic intensity in a patient taking SSRIs

Dr. Levy: In this next case, a 44-year-old woman in a 15-year marriage notices a change in her orgasmic intensity and latency. She has a supportive husband, and they are attentive to each other's sexual needs. However, she notices a change in her arousal and orgasmic intensity, which has diminished over the last year. She reports that the time to orgasm or latency has increased and both she and her partner are frustrated and getting concerned. She has a history of depression that has been managed by selective serotonin reuptake inhibitors for the past 5 years and has no depressive symptoms currently.

Dr. Krychman, what are you considering before beginning to talk with this patient?

Dr. Krychman: My approach really is a comprehensive one, looking not only at the underlying medical issues but also at the psychological and dynamic relationship facets. We of course also want to look at medications: Has she changed her dose or the timing of when she takes it? Is this a new onset? Finally, we want to know why this is coming to the forefront now. Is it because it is getting worse, or is it because there is some significant issue that is going on in the relationship?

Regarding the physical exam, it is important to rule out underlying genital pelvic pathology. Young women can get changes in the integrity of the pelvic floor, in what I would call the orgasmic matrix--the clitoral tissue, the body, the crura (or arms of the clitoris)--we want to examine and be reassured that her genital anatomy is normal and that there is no underlying pathology that could signal an underlying abnormal hormonal profile. Young women certainly can get lowered estrogen effects at the genital/pelvic tissues (including the labia and vulva), and intravaginally as well. Sometimes women will have pelvic floor hypertonus, as we see with other urinary issues. A thorough pelvic exam is quite vital.

Let's not forget the body that is attached to the genitals; we want to rule out chronic medical disease that may impact her: hypertension, diabetes, or hypercholesterolemia. Untreated, these conditions may directly impact the arousal physiologic mechanisms.

Dr. Levy: In doing this patient's physical exam I would be looking for significant weight gain, and even asking about her partner's weight. Body image can be a huge issue. If she has a history of depression, if she is suffering from a body image problem, she can be feeling unattractive. In my experience this can be a common thing to affect women in their mid-40s.

How would you manage this case?

Dr. Krychman: It is important to divide it up in terms of a conservative to aggressive approach. We want to find out about the relationship. For instance, is the sexual dynamic scripted (ie, boring and predictable)? Is she distracted and frustrated or is she getting enough of the type of stimulation that she likes and enjoys? There certainly are a lot of new devices that are available, whether a self-stimulator or vibrator, the Fiera, or other stimulating devices, that may be important to incorporate into the sexual repertoire. If there is underlying pathology, we want to evaluate and treat that. She may need to be primed, so to speak, with systemic hormones. And does she have issues related to other effects of hormonal deprivation, even local effects? Does she have clitoral atrophy?

There are neutraceuticals that are currently available, whether topical arousal gels or ointments, and we as clinicians need to be critical and evaluate their benefit/risk and look at the data concerning these products. In addition, women who have changes in arousal and in orgasmic intensity and latency may be very frustrated. They describe it as climbing up to a peak but never getting over the top, and this frustration may lead to participant spectatoring, so incorporating a certified sex therapist or counselor is sometimes very critical.

Finally, there are a lot of snake oils, charmers, and charlatan unproven procedures--injecting fillers or other substances into the clitoris are a few examples. I would be a critical clinician, examine the evidence, look at the benefit/risk before advocating an intervention that does not have good clinical data to support its use--a comprehensive approach of sexual medicine as well as sexual psychology.

Dr. Kingsberg: Additionally, we know she is in a long-term relationship--15 years; we want to acknowledge the partner. We talked about the partner's weight, but what about his erectile function? Does he have changes in sexual function that are affecting her, and she is the one carrying the "symptom"?

Looking at each piece separately helps a clinician from getting overwhelmed by the patient who comes in reporting distress with orgasmic dysfunction. We have no pharmacologic FDA-approved treatments, so it can feel off-putting for a clinician to try to fix the reported issue. Looking at each component to help her figure out the underlying cause can be helpful.

Dr. Iglesia: With aging, there can be changes in blood flow, not to mention the hormonal and even peripheral nerve changes, that require more stimulation in order to achieve the desired response. I echo concern about expensive procedures being offered with no evidence, such as the "O" or "G" shot, that can cost up to thousands of dollars.

The other procedure that gives me a lot of angst is clitoral unhooding. The 3 parts of the clitoris are sensitive in terms of innervation and blood flow, and cutting around that delicate tissue goes against the surgical principles required for preserving nerves and blood flow.

New onset pain post−prolapse surgery with TOT sling placement

Dr. Levy: For this case, let's consider a 42-year-old woman (P3) who is 6 months post− vaginal hysterectomy. The surgery included ovarian preservation combined with anterior and posterior repair for prolapse as well as apical uterosacral ligament suspension for stage 2 uterovaginal prolapse. A transobturator sling was used.

Extensive preop evaluation was performed, with confirmed symptomatic prolapse. She had no stress incontinence symptoms but did have confirmed occult stress incontinence.

Surgery was uneventful. She resumed intercourse at 8 weeks, but she now has pain with both initial entry and deep penetration. Lubricants and changes in position have not helped. She is in a stable relationship with her husband of 17 years, and she is worried that the sling mesh might be the culprit. On exam, she has no atrophy, pH is 4.5, vaginal length is 8 cm, and there is no prolapse. There is no mesh exposure noted, although she reports slight tenderness with palpation of the right sling arm beneath the right pubic bone.

Dr. Iglesia, what are the patient history questions important to ask here?
 
Dr. Iglesia: This is not an uncommon scenario--elective surgical correction of  occult or latent stress incontinence after surgical correction for pelvic organ prolapse. Now this patient here has no more prolapse complaints; however, she has a new symptom. There are many different causes of dyspareunia; we cannot just assume it is the sling mesh (although with all the legal representation advertisements for those who have had mesh placed, it can certainly be at the top of the patient's mind, causing anxiety and fear).

Multiple trials have looked at prophylactic surgery for incontinence at the time of prolapse repairs. This woman happened to be one of those patients who did not have incontinence symptoms, and they put a sling in. A recent large trial examined women with vaginal prolapse who underwent hysterectomy and suspension.⁶ (They compared 2 different suspensions.) What is interesting is that 25% of women with prolapse do have baseline pain. However, at 24 months, de novo pain can occur in 10% of women--just from the apical suspension. So, here, it could be the prolapse suspension. Or, in terms of the transobturator sling, long-term data do tell us that the de novo dyspareunia rate ranges on the magnitude of 1% to 9%.⁷ What is important here is figuring out the cause of the dyspareunia.

Dr. Levy: One of the important points you raised already was that 25% of these women have preoperative pain. So figuring out what her functioning was before surgery and incorporating that into our assessment postop would be pretty important I would think.

Dr. Iglesia: Yes, you need to understand what her typical encounter was before the surgery and how things have changed now that the prolapse is not in the way. Changes obviously can occur with scar tissue, which over time will improve. If she is perimenopausal and starts to get epithelial changes, we can fix that. The question then becomes, "Is the pain emanating from the mesh?"

When examining this patient, it is not uncommon for me to be able to feel "banjo" strings if the mesh is too tight or close to the surface. It is not exposed but it's palpable, and the patient may feel a ridge during penetration. You can ask the patient if pain occurs with different penetration positions. In addition, explore associated neurologic symptoms (numbness or muscle pain in the thigh).

Dr. Kingsberg: There were 2 different sources of pain--on initial entry and at deep penetration. You want to make sure you address both. Importantly, did one precede the other? For instance, if women have pain with penetration they can then end up with an arousal disorder (the length of the vagina cannot increase as much as it might otherwise) and dystonia secondary to the pain with penetration. The timing of the pain--did it all happen at the same time, or did she start out with pain at one point and did it move to something else--is another critical piece of the history.

Dr. Iglesia: It does take a detailed history and physical exam to identify myofascial trigger points. In this case there seems to be pinpoint tenderness directly on the part of the mesh that is not exposed on the right. There are people who feel you should remove the whole mesh, including the arms. Others feel, okay, we can work on these trigger points, with injections, physical therapy, extra lubrication, and neuromodulatory medications. Only then would they think about potentially excising the sling or a portion thereof.

Dr. Krychman: Keep in mind that, even if you do remove the sling, her pain may not subside, if it is secondary to an underlying issue. Because of media sensationalism, she could be focusing on the sling. It is important to set realistic expectations. I often see vulvar pathology or even provoked vestibulodynia that can present with a deep dyspareunia. The concept of collision dyspareunia or introital discomfort or pain on insertion has far reaching implications. We need to look at the patient in totality, ruling out underlying issues related to the bladder, even the colon.

Patient inquires about the benefits of laser treatment for vaginal health

Dr. Levy: Let's move to this last case: A 47-year-old patient who reports lack of sexual satisfaction and attributes it to a loose vagina says, "I've heard about surgery and laser treatment and radiofrequency devices for vaginal health. What are the benefits and risks of these procedures, and will they correct the issues that I'm experiencing?"

How do you approach this patient?

Dr. Krychman: I want to know why this is of paramount importance to her. Is this her actual complaint or is it society's unrealistic expectation of sexual pleasure and performance placed upon her? Or is this a relationship issue surfacing, compounded by physiologic changes? With good communication techniques, like "ask, tell, ask" or effective use of silence (not interrupting), patients will lead us to the reason and the rationale.

Dr. Levy: I have seen a lot of advertising to women, now showing pictures of genitalia, perhaps creating an expectation that we should look infantile in some way. We are creating a sense of beauty and acceptablevisualization of the vagina and vulva that are completely unrealistic. It's fascinating on one hand but it is also disturbing in that some of the direct-to-consumer marketing going on is creating a sense of unease in women who are otherwise perfectly satisfied. Now they take a look at their sagging skin, maybe after having 2 or 3 children, and although they may not look the same they function not so badly perhaps. I think we are creating a distress and an illness model that is interesting to discuss.

Dr. Iglesia, you are in the midst of a randomized trial, giving an informed consent to participants about the expectations for this potential intervention. How do you explain to women what these laser and radiofrequency devices are expected to do and why they might or might not work?

Dr. Iglesia: We are doing a randomized trial for menopausal women who have GSM. We are comparing estrogen cream with fractional CO2 laser therapy. I also am involved in another randomized trial for lichen sclerosus. I am not involved in the cosmetic use of a laser for people who feel their vaginas are just "loose." Like you, Dr. Levy, I am very concerned about the images that women are seeing of the idealized vulva and vagina, and about the rise of cosmetic gynecology, much of which is being performed by plastic surgeons or dermatologists.

A recent article looked at the number of women who are doing pubic hair grooming; the prevalance is about 80% here in America.⁸ So people have a clear view of what is down there, and then they compare it to what they see in pornographic images on the Internet and want to look like a Barbie doll. That is disturbing because women, particularly young women, do not realize what happens with GSM changes to the vulva and vagina. On the other hand, these laser machines are very expensive, and some doctors are charging thousands of dollars and promising cosmetic and functional results for which we lack long-term, comparative data.

The laser that we are studying is one by Cynosure called Mona Lisa, which works with fractional CO2 and has very low depth of penetration. The concept is that, with microdot therapy (on the order of micrometers), pinpoint destruction will foster regeneration of new collagen and blood flow to the vagina and vulva. We are still in the midst of analyzing this.

Dr. Krychman: I caution people not to lump devices together. There is a significant difference between laser and radiofrequency--especially in the depth of tissue penetration, and level of evidence as well. There are companies performing randomized clinical trials, with well designed sham controls, and have demonstrated clinical efficacy. We need to be cautious of a procedure that is saying it's the best thing since sliced bread, curing interstitial cystitis, dyspareunia, and lichen sclerosus and improving orgasm, lubrication, and arousal. These far reaching, off-label claims are concerning and misleading.

Dr. Levy: I think the important things are 1) shared decision making with the patient and 2) disclosure of what we do not know, which are the long-term results and outcomes and possible downstream negative effects of some of these treatments, since the data we have are so short term.

Dr. Kingsberg: Basics are important. You talked about the pressure for cosmetic appearance, but is that really what is going on for this particular patient? Is she describing a sexual dysfunction when she talks about lack of satisfaction? You need to operationally define that term. Does she have problems with arousal or orgasm or desire and those are what underlie her lack of satisfaction? Is the key to management helping her come to terms with body image issues or to treat a sexual dysfunction? If it truly is a sexual dysfunction, then you can have the shared decision making on preferred treatment approach.

Dr. Levy: This has been an enlightening discussion. Thank all of you for your expertise and clinical acumen.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Hear Dr Phillips discuss the key points of this series

Vaginal placement of mesh for the correction of pelvic organ prolapse is not an entirely benign procedure. As Mickey M. Karram, MD, and an expert panel discuss in this article—the second of a two-part series—complications secondary to mesh placement can be a challenge to correct and often make life miserable for patients who experience them. Here, these experts address mesh erosion, extrusion, and other serious complications; discuss ways to prevent them; and offer strategies for managing them when they arise.

In Part 1, which appeared in the January 2009 issue of OBG Management, the panel discussed the increasing use of mesh in prolapse repair—in particular, the proliferation of mesh kits.

How common is erosion?

DR. KARRAM: The literature seems to indicate that, even in the best of hands, there is an extrusion, or erosion, rate of between 5% and 17% when mesh is used. Would you agree with this statistic?

DR. LUCENTE: Not completely. The vaginal exposure rate can be as low as 2%, as reported by our center and others, when the mesh is properly placed below all histologic layers of the vaginal wall, as it is when it is “delivered” to the pelvis via the transabdominal route.^1,2

At the other end of the scale, an exposure rate above 17% has been reported when mesh is improperly placed within the vaginal wall—that is, just below the mucosa, as some surgeons have described in the methodology section of their abstract or article.^3,4

THE OBG MANAGEMENT EXPERT PANEL

MICKEY M. KARRAM, MD, moderator, is Director of Urogynecology at Good Samaritan Hospital and Voluntary Professor of ObGyn at the University of Cincinnati School of Medicine in Cincinnati, Ohio.

SHLOMO RAZ, MD, is Professor of Urology and Chief of Pelvic Medicine and Reconstructive Urology at UCLA School of Medicine in Los Angeles.

VINCENT LUCENTE, MD, MBA, is Founder and Director of the Institute for Female Pelvic Medicine and Reconstructive Surgery in Allentown, Pa, and Clinical Professor of ObGyn at Temple University School of Medicine in Philadelphia.

MARK D. WALTERS, MD, is Professor and Vice Chair of Gynecology, Section of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, at the Cleveland Clinic in Cleveland, Ohio.

We have found that complete, full-thickness dissection of the vaginal wall into the true pelvic space (vesicovaginal and rectovaginal), utilizing small vaginal incisions and limiting hysterectomy and the trimming of vaginal mucosa, can promote a very low vaginal-exposure rate.

DR. WALTERS: Some surgeons tell me that their own extrusion or erosion rate is lower than the published rate of 5% to 17%, but it is impossible to be certain of the long-term outcome in any patient unless she is followed carefully. The patient may consult another physician about her complications. The primary surgeon—even an expert—often does not know the actual mesh complication rate.

That said, I am sure that some surgeons are particularly adept at using mesh kits for prolapse repair, thereby keeping their mesh complication rate low. The 5% to 17% number is what most gynecologic surgeons should expect for their patients.

DR. RAZ: The complication rates are clearly underreported since very few centers of excellence report on complications and the majority of users don’t report them. Also, the reported complication rate concerns short-term erosion. I imagine that, as time passes and vaginal tissue becomes more atrophic, the incidence of erosion will increase.

Are simple measures enough to resolve erosion?

DR. KARRAM: There seems to be a general perception that most extrusions or erosions can be easily managed in the office by placing estrogen or trimming. In our experience, that approach has been successful in a minority of cases only.

What have you seen?

DR. WALTERS: At the Cleveland Clinic, as at most tertiary care referral centers, we often see the worst cases of extrusion or erosion related to mesh. Estrogen helps in some cases of simple mesh exposure, especially after sacrocolpopexy. If estrogen is going to be effective, however, the problem should clear up relatively quickly; if it isn’t effective after a month or two of therapy, estrogen is unlikely to ever be successful.

When it comes to related problems, such as ridges or strictures in the vagina, dyspareunia, penile pain with insertion, and vaginal burning pain, I have not found simple trimming and estrogen to be effective.

DR. KARRAM: It’s also unlikely that simple excision or placement of estrogen will be successful over the long term. When an extrusion or erosion occurs, we are generally seeing only the tip of the iceberg. That’s because mesh is placed in a certain plane. Although only part of the mesh may be exposed, the entire mesh is likely to be affected because it lies in the same plane.

Also, because of the special nature of vaginal flora, it is unlikely that a foreign body is going to be successfully managed by simple excision or placement of estrogen.

DR. LUCENTE: Management of vaginal exposure really depends on the size of the exposure, its location, and whether there is underlying infection or ischemia of host tissue. When the exposure is small (<1 cm in diameter) and in the midline, with the mesh lying flat below the plane of the vaginal wall, we have been very successful using a conservative approach.

However, even the tiniest of exposures needs to be surgically excised if it traverses the vaginal sulcus. Obviously, any mesh erosion into viscera such as the bladder and bowel also requires surgical intervention. Host-tissue factors always play a contributing role.

I also want to point out that the manner in which exposure is managed depends to some extent on whether the mesh was properly placed. Exposures that arise when mesh is implanted improperly are difficult to correct and usually require complete removal.

Although we, too, started off with an exposure rate around 8%, it is now very low, thanks to technical advancements.

DR. RAZ: A very small vaginal erosion of a mesh sling can sometimes be managed in the office by excision. The cases referred to our service generally involve more extensive areas of exposure that will not be resolved by local treatment.

Is risk of injury operator-dependent?

DR. KARRAM: We’re all seeing very severe complications secondary to mesh placement. Would each of you give your opinion as to whether the severe complications such as significant pain, dyspareunia, and injury of important structures are mostly technical or inherent to mesh placement. Would they happen in the best of hands?

DR. LUCENTE: The more severe complications, for the most part, are very much related to technique. Not that they cannot happen in the very best of hands, but they are extremely rare when technique is meticulous.

Over a 4-year period, after well over 1,000 transvaginal mesh surgeries at our center, we had no death, ICU admission, or transfusion, and our intraoperative complication rate was only 3%, most commonly involving simple cystotomy without long-term consequence. This compares very favorably to the nearly 12% complication rate reported recently in the CARE trial for abdominal sacral colpopexy.⁵

Our primary challenge today is preventing postoperative dyspareunia. Our rate of new-onset dyspareunia is approximately 3.5%. This complication is, I think, more likely to be related to the inherent material properties of mesh, such as elasticity and flexural rigidity, and to host-tissue response to the material itself.

DR. RAZ: I think that the majority of complications are operator-dependent. Thin dissection of the vaginal wall and unrecognized bladder, urethral, and vaginal perforation are the most common reasons for the complications. Mesh does not move after surgery; if there is a problem, it means that the mesh was misplaced.

Another problem is that industry, in an effort to sell more kits, is pushing physicians who are unfamiliar with the principles of pelvic reconstruction to perform this complex procedure. Repair of major vaginal prolapse is not a simple sling procedure.

In addition, there is a greater likelihood of complications in patients who have severe atrophic tissues. These patients should not be candidates for mesh reconstruction.

DR. WALTERS: Many of the complications that we see with mesh are certainly operator-dependent. For example, mesh that is placed under too much tension leaves the vagina tight and stiff, and mesh that is placed with ripples and ridges causes irregularities in the vagina that are often painful, especially during intercourse.

I do not believe that mesh “erodes” into the bladder, urethra, or rectum, but that it is placed there inadvertently and overlooked intraoperatively (FIGURES 1 and 2), Visceral erosion can occur if the primary surgeon made a cystotomy or proctotomy before proceeding with the mesh kit, and the mesh eventually wore through the repaired area.

There are also some problems that are inherent to mesh, and that occur even in the best hands and after surgeries that are performed very competently. Some mesh exposures are inevitable, as are some cases of dyspareunia and rare cases of vaginal burning and pain. In addition, I am seeing more de novo SUI [stress urinary incontinence] with anterior mesh kits. Although this is not really a complication, it does lead to dissatisfaction in patients and merits efforts to prevent it.

DR. KARRAM: Yes. With the current state of mesh, I believe pain and dyspareunia are almost inevitable in some cases.

DR. LUCENTE: Another problem that is currently underaddressed is scar plating along the surface of the mesh. Such plating forms more readily in the absence of mechanical movement or distention during the early stages of wound healing. To make a comparison, even the best reconstructive orthopedic surgeons cannot achieve optimal functional outcomes with an implant surgery without intense postoperative physical therapy, which may simply involve range of motion or movement.

Most everyone is familiar with the capsular fibrosis and contraction that develop around a breast implant if there isn’t immediate postoperative massaging of the breast tissue and implant during wound repair. I am confident that the rate of dyspareunia will decline over time if specialists in reconstructive pelvic surgery pay closer attention to optimizing vaginal length, preserving the cervix (in women with relatively shorter vaginal length), and ensuring optimal apical attachment (that is, above the ischial spine) in younger, sexually active patients.

DR. RAZ: I think it is the surgeon rather than the surgery who causes most complications. In its effort to sell kits, industry sometimes puts them in the hands of surgeons who are not well prepared for the task. This operation can be quite complex, and you cannot create a pelvic surgeon from a physician who is unfamiliar with the anatomy. If you cannot manage the potential complications, you should not perform this type of surgery.

FIGURE 1 When mesh “erodes” into the urethra

Two images of mesh in the urethra. There is some uncertainty here whether mesh that has penetrated the urethra eroded through vaginal tissue or was placed there inadvertently and overlooked intraoperatively.

FIGURE 2 Mesh in the bladder

A segment of tension-free vaginal tape has penetrated into the bladder.

Should mesh be removed at the time of injury?

DR. KARRAM: As we discuss specific complications, let’s start with the most severe, which I would say relate to the inadvertent placement of mesh through important structures such as bowel, bladder, or ureters. If this were to happen and be diagnosed intraoperatively, what would you recommend that the surgeon do—abort the procedure or simply remove the mesh or trocar and attempt to pass it again safely?

DR. LUCENTE: That is a difficult question to answer because so much depends on various intraoperative factors.

I am much more comfortable proceeding with surgery after intraoperative bladder injury than after bowel or rectal injury. We have successfully corrected cystotomies that were small, did not encroach on the ureter, and were easily repaired without tension—and we have seen no fistula formation as a result.

The key is to maintain a high index of suspicion throughout the procedure. We have always diagnosed injuries before mesh is delivered—either during dissection or during passage of the needle or trocar. We have not experienced any ureteral injuries aside from “kinking” of one ureter, which was easily corrected with simple readjustment of the mesh.

If, at any time, we were concerned about potential infection, fistula, or a more severe complication that would be aggravated by proceeding with the operation, we would abort the procedure. However, we would be likely to proceed with an alternative operation to address the pelvic-support defect so that the patient would not awaken with intraoperative injury and no surgical treatment for her primary complaint.

We conduct informed consent in such a way as to preserve our flexibility to adapt the surgical plan to execute the reparative work that is necessary despite the development of a non–life-threatening complication during surgery. In the event of any injury to the bowel that would involve gross spillage of fecal material, of course, I would abort placement of synthetic mesh.

DR. WALTERS: If I placed one of the trocars through the bladder or bowel, I would probably remove it, reposition it, and continue with the surgery. With bladder perforation, this approach is generally no problem, but I would usually leave a Foley catheter in place for 1 week of continuous bladder drainage.

If I placed the trocar through the rectum, I would probably oversew the proctotomy, irrigate the space, and continue with the mesh repair. If I had an outright laceration in the bladder or rectum as part of the dissection, I would repair it and consider converting the surgery to prolapse repair without mesh.

The most dreaded complication: the foreshortened vagina

DR. KARRAM: It would seem that the most difficult complication to deal with is the foreshortened, firm, painful vagina. A patient who has these problems may be perceived, at times, as a pelvic “cripple.” Is this an accepted, albeit rare, complication? Or can it be avoided?

DR. LUCENTE: This is the most feared complication arising from the use of synthetic mesh. I do believe it can almost always be avoided—but I never say never. The key is to pay full attention to considerations of vaginal length before surgery, including, first, preservation of the cervix, and, second, placing the mesh loosely, properly sized, and attached with optimization of apical support to preserve vaginal length.

I also believe that use of second-generation meshes that are lighter, more elastic, and more flexible helps reduce this complication when the mesh is properly placed by a surgeon well trained in the technique.

When the vagina is foreshortened, the sooner it is revised, the better the chance that pain will resolve, whether the mesh is removed or released.

DR. RAZ: Mesh infection, capsular formation, dissection of a thin vaginal wall, and excess vaginal-wall excision lead to the short, firm, and painful vagina. The use and abuse of mesh has created a new subspecialty to manage mesh complications. The PFS syndrome (painful, firm, and short vagina) is one of the most difficult complications to treat because, in many cases, it cannot be reversed without major surgery.

DR. WALTERS: Women who have a foreshortened, firm, or painful vagina after mesh augmentation almost always need to have the mesh removed with reconstruction of the vaginal canal. I have never seen a successful outcome in this type of patient without complete or near-complete removal of the mesh.

Hear Dr Phillips discuss the key points of this series

Vaginal placement of mesh for the correction of pelvic organ prolapse is not an entirely benign procedure. As Mickey M. Karram, MD, and an expert panel discuss in this article—the second of a two-part series—complications secondary to mesh placement can be a challenge to correct and often make life miserable for patients who experience them. Here, these experts address mesh erosion, extrusion, and other serious complications; discuss ways to prevent them; and offer strategies for managing them when they arise.

In Part 1, which appeared in the January 2009 issue of OBG Management, the panel discussed the increasing use of mesh in prolapse repair—in particular, the proliferation of mesh kits.

How common is erosion?

DR. KARRAM: The literature seems to indicate that, even in the best of hands, there is an extrusion, or erosion, rate of between 5% and 17% when mesh is used. Would you agree with this statistic?

DR. LUCENTE: Not completely. The vaginal exposure rate can be as low as 2%, as reported by our center and others, when the mesh is properly placed below all histologic layers of the vaginal wall, as it is when it is “delivered” to the pelvis via the transabdominal route.^1,2

At the other end of the scale, an exposure rate above 17% has been reported when mesh is improperly placed within the vaginal wall—that is, just below the mucosa, as some surgeons have described in the methodology section of their abstract or article.^3,4

THE OBG MANAGEMENT EXPERT PANEL

MICKEY M. KARRAM, MD, moderator, is Director of Urogynecology at Good Samaritan Hospital and Voluntary Professor of ObGyn at the University of Cincinnati School of Medicine in Cincinnati, Ohio.

SHLOMO RAZ, MD, is Professor of Urology and Chief of Pelvic Medicine and Reconstructive Urology at UCLA School of Medicine in Los Angeles.

VINCENT LUCENTE, MD, MBA, is Founder and Director of the Institute for Female Pelvic Medicine and Reconstructive Surgery in Allentown, Pa, and Clinical Professor of ObGyn at Temple University School of Medicine in Philadelphia.

MARK D. WALTERS, MD, is Professor and Vice Chair of Gynecology, Section of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, at the Cleveland Clinic in Cleveland, Ohio.

We have found that complete, full-thickness dissection of the vaginal wall into the true pelvic space (vesicovaginal and rectovaginal), utilizing small vaginal incisions and limiting hysterectomy and the trimming of vaginal mucosa, can promote a very low vaginal-exposure rate.

DR. WALTERS: Some surgeons tell me that their own extrusion or erosion rate is lower than the published rate of 5% to 17%, but it is impossible to be certain of the long-term outcome in any patient unless she is followed carefully. The patient may consult another physician about her complications. The primary surgeon—even an expert—often does not know the actual mesh complication rate.

That said, I am sure that some surgeons are particularly adept at using mesh kits for prolapse repair, thereby keeping their mesh complication rate low. The 5% to 17% number is what most gynecologic surgeons should expect for their patients.

DR. RAZ: The complication rates are clearly underreported since very few centers of excellence report on complications and the majority of users don’t report them. Also, the reported complication rate concerns short-term erosion. I imagine that, as time passes and vaginal tissue becomes more atrophic, the incidence of erosion will increase.

Are simple measures enough to resolve erosion?

DR. KARRAM: There seems to be a general perception that most extrusions or erosions can be easily managed in the office by placing estrogen or trimming. In our experience, that approach has been successful in a minority of cases only.

What have you seen?

DR. WALTERS: At the Cleveland Clinic, as at most tertiary care referral centers, we often see the worst cases of extrusion or erosion related to mesh. Estrogen helps in some cases of simple mesh exposure, especially after sacrocolpopexy. If estrogen is going to be effective, however, the problem should clear up relatively quickly; if it isn’t effective after a month or two of therapy, estrogen is unlikely to ever be successful.

When it comes to related problems, such as ridges or strictures in the vagina, dyspareunia, penile pain with insertion, and vaginal burning pain, I have not found simple trimming and estrogen to be effective.

DR. KARRAM: It’s also unlikely that simple excision or placement of estrogen will be successful over the long term. When an extrusion or erosion occurs, we are generally seeing only the tip of the iceberg. That’s because mesh is placed in a certain plane. Although only part of the mesh may be exposed, the entire mesh is likely to be affected because it lies in the same plane.

Also, because of the special nature of vaginal flora, it is unlikely that a foreign body is going to be successfully managed by simple excision or placement of estrogen.

DR. LUCENTE: Management of vaginal exposure really depends on the size of the exposure, its location, and whether there is underlying infection or ischemia of host tissue. When the exposure is small (<1 cm in diameter) and in the midline, with the mesh lying flat below the plane of the vaginal wall, we have been very successful using a conservative approach.

However, even the tiniest of exposures needs to be surgically excised if it traverses the vaginal sulcus. Obviously, any mesh erosion into viscera such as the bladder and bowel also requires surgical intervention. Host-tissue factors always play a contributing role.

I also want to point out that the manner in which exposure is managed depends to some extent on whether the mesh was properly placed. Exposures that arise when mesh is implanted improperly are difficult to correct and usually require complete removal.

Although we, too, started off with an exposure rate around 8%, it is now very low, thanks to technical advancements.

DR. RAZ: A very small vaginal erosion of a mesh sling can sometimes be managed in the office by excision. The cases referred to our service generally involve more extensive areas of exposure that will not be resolved by local treatment.

Is risk of injury operator-dependent?

DR. KARRAM: We’re all seeing very severe complications secondary to mesh placement. Would each of you give your opinion as to whether the severe complications such as significant pain, dyspareunia, and injury of important structures are mostly technical or inherent to mesh placement. Would they happen in the best of hands?

DR. LUCENTE: The more severe complications, for the most part, are very much related to technique. Not that they cannot happen in the very best of hands, but they are extremely rare when technique is meticulous.

Over a 4-year period, after well over 1,000 transvaginal mesh surgeries at our center, we had no death, ICU admission, or transfusion, and our intraoperative complication rate was only 3%, most commonly involving simple cystotomy without long-term consequence. This compares very favorably to the nearly 12% complication rate reported recently in the CARE trial for abdominal sacral colpopexy.⁵

Our primary challenge today is preventing postoperative dyspareunia. Our rate of new-onset dyspareunia is approximately 3.5%. This complication is, I think, more likely to be related to the inherent material properties of mesh, such as elasticity and flexural rigidity, and to host-tissue response to the material itself.

DR. RAZ: I think that the majority of complications are operator-dependent. Thin dissection of the vaginal wall and unrecognized bladder, urethral, and vaginal perforation are the most common reasons for the complications. Mesh does not move after surgery; if there is a problem, it means that the mesh was misplaced.

Another problem is that industry, in an effort to sell more kits, is pushing physicians who are unfamiliar with the principles of pelvic reconstruction to perform this complex procedure. Repair of major vaginal prolapse is not a simple sling procedure.

In addition, there is a greater likelihood of complications in patients who have severe atrophic tissues. These patients should not be candidates for mesh reconstruction.

DR. WALTERS: Many of the complications that we see with mesh are certainly operator-dependent. For example, mesh that is placed under too much tension leaves the vagina tight and stiff, and mesh that is placed with ripples and ridges causes irregularities in the vagina that are often painful, especially during intercourse.

I do not believe that mesh “erodes” into the bladder, urethra, or rectum, but that it is placed there inadvertently and overlooked intraoperatively (FIGURES 1 and 2), Visceral erosion can occur if the primary surgeon made a cystotomy or proctotomy before proceeding with the mesh kit, and the mesh eventually wore through the repaired area.

There are also some problems that are inherent to mesh, and that occur even in the best hands and after surgeries that are performed very competently. Some mesh exposures are inevitable, as are some cases of dyspareunia and rare cases of vaginal burning and pain. In addition, I am seeing more de novo SUI [stress urinary incontinence] with anterior mesh kits. Although this is not really a complication, it does lead to dissatisfaction in patients and merits efforts to prevent it.

DR. KARRAM: Yes. With the current state of mesh, I believe pain and dyspareunia are almost inevitable in some cases.

DR. LUCENTE: Another problem that is currently underaddressed is scar plating along the surface of the mesh. Such plating forms more readily in the absence of mechanical movement or distention during the early stages of wound healing. To make a comparison, even the best reconstructive orthopedic surgeons cannot achieve optimal functional outcomes with an implant surgery without intense postoperative physical therapy, which may simply involve range of motion or movement.

Most everyone is familiar with the capsular fibrosis and contraction that develop around a breast implant if there isn’t immediate postoperative massaging of the breast tissue and implant during wound repair. I am confident that the rate of dyspareunia will decline over time if specialists in reconstructive pelvic surgery pay closer attention to optimizing vaginal length, preserving the cervix (in women with relatively shorter vaginal length), and ensuring optimal apical attachment (that is, above the ischial spine) in younger, sexually active patients.

DR. RAZ: I think it is the surgeon rather than the surgery who causes most complications. In its effort to sell kits, industry sometimes puts them in the hands of surgeons who are not well prepared for the task. This operation can be quite complex, and you cannot create a pelvic surgeon from a physician who is unfamiliar with the anatomy. If you cannot manage the potential complications, you should not perform this type of surgery.

FIGURE 1 When mesh “erodes” into the urethra

Two images of mesh in the urethra. There is some uncertainty here whether mesh that has penetrated the urethra eroded through vaginal tissue or was placed there inadvertently and overlooked intraoperatively.

FIGURE 2 Mesh in the bladder

A segment of tension-free vaginal tape has penetrated into the bladder.

Should mesh be removed at the time of injury?

DR. KARRAM: As we discuss specific complications, let’s start with the most severe, which I would say relate to the inadvertent placement of mesh through important structures such as bowel, bladder, or ureters. If this were to happen and be diagnosed intraoperatively, what would you recommend that the surgeon do—abort the procedure or simply remove the mesh or trocar and attempt to pass it again safely?

DR. LUCENTE: That is a difficult question to answer because so much depends on various intraoperative factors.

I am much more comfortable proceeding with surgery after intraoperative bladder injury than after bowel or rectal injury. We have successfully corrected cystotomies that were small, did not encroach on the ureter, and were easily repaired without tension—and we have seen no fistula formation as a result.

The key is to maintain a high index of suspicion throughout the procedure. We have always diagnosed injuries before mesh is delivered—either during dissection or during passage of the needle or trocar. We have not experienced any ureteral injuries aside from “kinking” of one ureter, which was easily corrected with simple readjustment of the mesh.

If, at any time, we were concerned about potential infection, fistula, or a more severe complication that would be aggravated by proceeding with the operation, we would abort the procedure. However, we would be likely to proceed with an alternative operation to address the pelvic-support defect so that the patient would not awaken with intraoperative injury and no surgical treatment for her primary complaint.

We conduct informed consent in such a way as to preserve our flexibility to adapt the surgical plan to execute the reparative work that is necessary despite the development of a non–life-threatening complication during surgery. In the event of any injury to the bowel that would involve gross spillage of fecal material, of course, I would abort placement of synthetic mesh.

DR. WALTERS: If I placed one of the trocars through the bladder or bowel, I would probably remove it, reposition it, and continue with the surgery. With bladder perforation, this approach is generally no problem, but I would usually leave a Foley catheter in place for 1 week of continuous bladder drainage.

If I placed the trocar through the rectum, I would probably oversew the proctotomy, irrigate the space, and continue with the mesh repair. If I had an outright laceration in the bladder or rectum as part of the dissection, I would repair it and consider converting the surgery to prolapse repair without mesh.

The most dreaded complication: the foreshortened vagina

DR. KARRAM: It would seem that the most difficult complication to deal with is the foreshortened, firm, painful vagina. A patient who has these problems may be perceived, at times, as a pelvic “cripple.” Is this an accepted, albeit rare, complication? Or can it be avoided?

DR. LUCENTE: This is the most feared complication arising from the use of synthetic mesh. I do believe it can almost always be avoided—but I never say never. The key is to pay full attention to considerations of vaginal length before surgery, including, first, preservation of the cervix, and, second, placing the mesh loosely, properly sized, and attached with optimization of apical support to preserve vaginal length.

I also believe that use of second-generation meshes that are lighter, more elastic, and more flexible helps reduce this complication when the mesh is properly placed by a surgeon well trained in the technique.

When the vagina is foreshortened, the sooner it is revised, the better the chance that pain will resolve, whether the mesh is removed or released.

DR. RAZ: Mesh infection, capsular formation, dissection of a thin vaginal wall, and excess vaginal-wall excision lead to the short, firm, and painful vagina. The use and abuse of mesh has created a new subspecialty to manage mesh complications. The PFS syndrome (painful, firm, and short vagina) is one of the most difficult complications to treat because, in many cases, it cannot be reversed without major surgery.

DR. WALTERS: Women who have a foreshortened, firm, or painful vagina after mesh augmentation almost always need to have the mesh removed with reconstruction of the vaginal canal. I have never seen a successful outcome in this type of patient without complete or near-complete removal of the mesh.

Hear Dr Phillips discuss the key points of this series

Vaginal placement of mesh for the correction of pelvic organ prolapse is not an entirely benign procedure. As Mickey M. Karram, MD, and an expert panel discuss in this article—the second of a two-part series—complications secondary to mesh placement can be a challenge to correct and often make life miserable for patients who experience them. Here, these experts address mesh erosion, extrusion, and other serious complications; discuss ways to prevent them; and offer strategies for managing them when they arise.

In Part 1, which appeared in the January 2009 issue of OBG Management, the panel discussed the increasing use of mesh in prolapse repair—in particular, the proliferation of mesh kits.

How common is erosion?

DR. KARRAM: The literature seems to indicate that, even in the best of hands, there is an extrusion, or erosion, rate of between 5% and 17% when mesh is used. Would you agree with this statistic?

DR. LUCENTE: Not completely. The vaginal exposure rate can be as low as 2%, as reported by our center and others, when the mesh is properly placed below all histologic layers of the vaginal wall, as it is when it is “delivered” to the pelvis via the transabdominal route.^1,2

At the other end of the scale, an exposure rate above 17% has been reported when mesh is improperly placed within the vaginal wall—that is, just below the mucosa, as some surgeons have described in the methodology section of their abstract or article.^3,4

THE OBG MANAGEMENT EXPERT PANEL

MICKEY M. KARRAM, MD, moderator, is Director of Urogynecology at Good Samaritan Hospital and Voluntary Professor of ObGyn at the University of Cincinnati School of Medicine in Cincinnati, Ohio.

SHLOMO RAZ, MD, is Professor of Urology and Chief of Pelvic Medicine and Reconstructive Urology at UCLA School of Medicine in Los Angeles.

VINCENT LUCENTE, MD, MBA, is Founder and Director of the Institute for Female Pelvic Medicine and Reconstructive Surgery in Allentown, Pa, and Clinical Professor of ObGyn at Temple University School of Medicine in Philadelphia.

MARK D. WALTERS, MD, is Professor and Vice Chair of Gynecology, Section of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, at the Cleveland Clinic in Cleveland, Ohio.

We have found that complete, full-thickness dissection of the vaginal wall into the true pelvic space (vesicovaginal and rectovaginal), utilizing small vaginal incisions and limiting hysterectomy and the trimming of vaginal mucosa, can promote a very low vaginal-exposure rate.

DR. WALTERS: Some surgeons tell me that their own extrusion or erosion rate is lower than the published rate of 5% to 17%, but it is impossible to be certain of the long-term outcome in any patient unless she is followed carefully. The patient may consult another physician about her complications. The primary surgeon—even an expert—often does not know the actual mesh complication rate.

That said, I am sure that some surgeons are particularly adept at using mesh kits for prolapse repair, thereby keeping their mesh complication rate low. The 5% to 17% number is what most gynecologic surgeons should expect for their patients.

DR. RAZ: The complication rates are clearly underreported since very few centers of excellence report on complications and the majority of users don’t report them. Also, the reported complication rate concerns short-term erosion. I imagine that, as time passes and vaginal tissue becomes more atrophic, the incidence of erosion will increase.

Are simple measures enough to resolve erosion?

DR. KARRAM: There seems to be a general perception that most extrusions or erosions can be easily managed in the office by placing estrogen or trimming. In our experience, that approach has been successful in a minority of cases only.

What have you seen?

DR. WALTERS: At the Cleveland Clinic, as at most tertiary care referral centers, we often see the worst cases of extrusion or erosion related to mesh. Estrogen helps in some cases of simple mesh exposure, especially after sacrocolpopexy. If estrogen is going to be effective, however, the problem should clear up relatively quickly; if it isn’t effective after a month or two of therapy, estrogen is unlikely to ever be successful.

When it comes to related problems, such as ridges or strictures in the vagina, dyspareunia, penile pain with insertion, and vaginal burning pain, I have not found simple trimming and estrogen to be effective.

DR. KARRAM: It’s also unlikely that simple excision or placement of estrogen will be successful over the long term. When an extrusion or erosion occurs, we are generally seeing only the tip of the iceberg. That’s because mesh is placed in a certain plane. Although only part of the mesh may be exposed, the entire mesh is likely to be affected because it lies in the same plane.

Also, because of the special nature of vaginal flora, it is unlikely that a foreign body is going to be successfully managed by simple excision or placement of estrogen.

DR. LUCENTE: Management of vaginal exposure really depends on the size of the exposure, its location, and whether there is underlying infection or ischemia of host tissue. When the exposure is small (<1 cm in diameter) and in the midline, with the mesh lying flat below the plane of the vaginal wall, we have been very successful using a conservative approach.

However, even the tiniest of exposures needs to be surgically excised if it traverses the vaginal sulcus. Obviously, any mesh erosion into viscera such as the bladder and bowel also requires surgical intervention. Host-tissue factors always play a contributing role.

I also want to point out that the manner in which exposure is managed depends to some extent on whether the mesh was properly placed. Exposures that arise when mesh is implanted improperly are difficult to correct and usually require complete removal.

Although we, too, started off with an exposure rate around 8%, it is now very low, thanks to technical advancements.

DR. RAZ: A very small vaginal erosion of a mesh sling can sometimes be managed in the office by excision. The cases referred to our service generally involve more extensive areas of exposure that will not be resolved by local treatment.

Is risk of injury operator-dependent?

DR. KARRAM: We’re all seeing very severe complications secondary to mesh placement. Would each of you give your opinion as to whether the severe complications such as significant pain, dyspareunia, and injury of important structures are mostly technical or inherent to mesh placement. Would they happen in the best of hands?

DR. LUCENTE: The more severe complications, for the most part, are very much related to technique. Not that they cannot happen in the very best of hands, but they are extremely rare when technique is meticulous.

Over a 4-year period, after well over 1,000 transvaginal mesh surgeries at our center, we had no death, ICU admission, or transfusion, and our intraoperative complication rate was only 3%, most commonly involving simple cystotomy without long-term consequence. This compares very favorably to the nearly 12% complication rate reported recently in the CARE trial for abdominal sacral colpopexy.⁵

Our primary challenge today is preventing postoperative dyspareunia. Our rate of new-onset dyspareunia is approximately 3.5%. This complication is, I think, more likely to be related to the inherent material properties of mesh, such as elasticity and flexural rigidity, and to host-tissue response to the material itself.

DR. RAZ: I think that the majority of complications are operator-dependent. Thin dissection of the vaginal wall and unrecognized bladder, urethral, and vaginal perforation are the most common reasons for the complications. Mesh does not move after surgery; if there is a problem, it means that the mesh was misplaced.

Another problem is that industry, in an effort to sell more kits, is pushing physicians who are unfamiliar with the principles of pelvic reconstruction to perform this complex procedure. Repair of major vaginal prolapse is not a simple sling procedure.

In addition, there is a greater likelihood of complications in patients who have severe atrophic tissues. These patients should not be candidates for mesh reconstruction.

DR. WALTERS: Many of the complications that we see with mesh are certainly operator-dependent. For example, mesh that is placed under too much tension leaves the vagina tight and stiff, and mesh that is placed with ripples and ridges causes irregularities in the vagina that are often painful, especially during intercourse.

I do not believe that mesh “erodes” into the bladder, urethra, or rectum, but that it is placed there inadvertently and overlooked intraoperatively (FIGURES 1 and 2), Visceral erosion can occur if the primary surgeon made a cystotomy or proctotomy before proceeding with the mesh kit, and the mesh eventually wore through the repaired area.

There are also some problems that are inherent to mesh, and that occur even in the best hands and after surgeries that are performed very competently. Some mesh exposures are inevitable, as are some cases of dyspareunia and rare cases of vaginal burning and pain. In addition, I am seeing more de novo SUI [stress urinary incontinence] with anterior mesh kits. Although this is not really a complication, it does lead to dissatisfaction in patients and merits efforts to prevent it.

DR. KARRAM: Yes. With the current state of mesh, I believe pain and dyspareunia are almost inevitable in some cases.

DR. LUCENTE: Another problem that is currently underaddressed is scar plating along the surface of the mesh. Such plating forms more readily in the absence of mechanical movement or distention during the early stages of wound healing. To make a comparison, even the best reconstructive orthopedic surgeons cannot achieve optimal functional outcomes with an implant surgery without intense postoperative physical therapy, which may simply involve range of motion or movement.

Most everyone is familiar with the capsular fibrosis and contraction that develop around a breast implant if there isn’t immediate postoperative massaging of the breast tissue and implant during wound repair. I am confident that the rate of dyspareunia will decline over time if specialists in reconstructive pelvic surgery pay closer attention to optimizing vaginal length, preserving the cervix (in women with relatively shorter vaginal length), and ensuring optimal apical attachment (that is, above the ischial spine) in younger, sexually active patients.

DR. RAZ: I think it is the surgeon rather than the surgery who causes most complications. In its effort to sell kits, industry sometimes puts them in the hands of surgeons who are not well prepared for the task. This operation can be quite complex, and you cannot create a pelvic surgeon from a physician who is unfamiliar with the anatomy. If you cannot manage the potential complications, you should not perform this type of surgery.

FIGURE 1 When mesh “erodes” into the urethra

Two images of mesh in the urethra. There is some uncertainty here whether mesh that has penetrated the urethra eroded through vaginal tissue or was placed there inadvertently and overlooked intraoperatively.

FIGURE 2 Mesh in the bladder

A segment of tension-free vaginal tape has penetrated into the bladder.

Should mesh be removed at the time of injury?

DR. KARRAM: As we discuss specific complications, let’s start with the most severe, which I would say relate to the inadvertent placement of mesh through important structures such as bowel, bladder, or ureters. If this were to happen and be diagnosed intraoperatively, what would you recommend that the surgeon do—abort the procedure or simply remove the mesh or trocar and attempt to pass it again safely?

DR. LUCENTE: That is a difficult question to answer because so much depends on various intraoperative factors.

I am much more comfortable proceeding with surgery after intraoperative bladder injury than after bowel or rectal injury. We have successfully corrected cystotomies that were small, did not encroach on the ureter, and were easily repaired without tension—and we have seen no fistula formation as a result.

The key is to maintain a high index of suspicion throughout the procedure. We have always diagnosed injuries before mesh is delivered—either during dissection or during passage of the needle or trocar. We have not experienced any ureteral injuries aside from “kinking” of one ureter, which was easily corrected with simple readjustment of the mesh.

If, at any time, we were concerned about potential infection, fistula, or a more severe complication that would be aggravated by proceeding with the operation, we would abort the procedure. However, we would be likely to proceed with an alternative operation to address the pelvic-support defect so that the patient would not awaken with intraoperative injury and no surgical treatment for her primary complaint.

We conduct informed consent in such a way as to preserve our flexibility to adapt the surgical plan to execute the reparative work that is necessary despite the development of a non–life-threatening complication during surgery. In the event of any injury to the bowel that would involve gross spillage of fecal material, of course, I would abort placement of synthetic mesh.

DR. WALTERS: If I placed one of the trocars through the bladder or bowel, I would probably remove it, reposition it, and continue with the surgery. With bladder perforation, this approach is generally no problem, but I would usually leave a Foley catheter in place for 1 week of continuous bladder drainage.

If I placed the trocar through the rectum, I would probably oversew the proctotomy, irrigate the space, and continue with the mesh repair. If I had an outright laceration in the bladder or rectum as part of the dissection, I would repair it and consider converting the surgery to prolapse repair without mesh.

The most dreaded complication: the foreshortened vagina

DR. KARRAM: It would seem that the most difficult complication to deal with is the foreshortened, firm, painful vagina. A patient who has these problems may be perceived, at times, as a pelvic “cripple.” Is this an accepted, albeit rare, complication? Or can it be avoided?

DR. LUCENTE: This is the most feared complication arising from the use of synthetic mesh. I do believe it can almost always be avoided—but I never say never. The key is to pay full attention to considerations of vaginal length before surgery, including, first, preservation of the cervix, and, second, placing the mesh loosely, properly sized, and attached with optimization of apical support to preserve vaginal length.

I also believe that use of second-generation meshes that are lighter, more elastic, and more flexible helps reduce this complication when the mesh is properly placed by a surgeon well trained in the technique.

When the vagina is foreshortened, the sooner it is revised, the better the chance that pain will resolve, whether the mesh is removed or released.

DR. RAZ: Mesh infection, capsular formation, dissection of a thin vaginal wall, and excess vaginal-wall excision lead to the short, firm, and painful vagina. The use and abuse of mesh has created a new subspecialty to manage mesh complications. The PFS syndrome (painful, firm, and short vagina) is one of the most difficult complications to treat because, in many cases, it cannot be reversed without major surgery.

DR. WALTERS: Women who have a foreshortened, firm, or painful vagina after mesh augmentation almost always need to have the mesh removed with reconstruction of the vaginal canal. I have never seen a successful outcome in this type of patient without complete or near-complete removal of the mesh.

Mesh kits for repairing prolapse are proliferating like crazy, just as they did for midurethral sling procedures. But mesh augmentation of prolapse surgeries requires more than a prepackaged assortment of tools and materials. In this article, moderator Mickey M. Karram, MD, and a panel of nationally recognized urogynecologists and urologists describe the literature on mesh augmentation and discuss indications, contraindications, techniques, applicable cases, and the considerable training required.

In Part 2, which will appear in the February issue of OBG Management, the panel tackles the thorny topic of complications, including erosion, extrusion, foreshortening of the vagina, dyspareunia, and pain. Their discussion focuses on ways to avoid these problems, and methods for correcting them.

Do we have enough data?

DR. KARRAM: To start, let’s quickly review the peer-reviewed literature on the use of mesh augmentation during surgery for pelvic organ prolapse.

DR. WALTERS: Until recently, most data concerned open abdominal sacrocolpopexy (ASC) using polypropylene or Merseline mesh. There is significant clinical experience with this operation, and multiple cohort studies show long-term cure rates of 78% to 100% for apical prolapse.¹

At least two randomized controlled trials have compared open ASC with sutured vaginal colpopexy procedures, and ASC is certainly equal to—perhaps better than—all transvaginal sutured repairs.^2,3

With ASC, most recurrences affect the distal half of the vagina and involve one or more of the following:

• anterior or posterior vaginal wall prolapse (or both)
• stress urinary incontinence (SUI)
• distal rectocele.^1,3

Mesh erosion occurs in 3.4% of cases and is usually easily managed.¹ Other complications, including bowel injury, tend to be related to access, regardless of whether the operation is performed via laparotomy or laparoscopy.

Robotic sacrocolpopexy has become popular in recent years, and we will probably see data on this approach as we gain experience.

When it comes to vaginal mesh kits, the peer-reviewed literature is just beginning to expand, with many studies being presented at international meetings. For anterior and, possibly, apical vaginal prolapse, the cure rate after use of a mesh kit appears to be as high as, or higher than, the rate for sutured repairs.⁴ This high rate of anatomic cure is balanced somewhat by additional cost and complications involving mesh and the kits.

For posterior vaginal wall prolapse and rectocele, I firmly believe, based on our research and that of others, that sutured repairs are superior to graft-augmented surgery.⁵

When is mesh appropriate?

DR. KARRAM: What are the indications and contraindications for mesh augmentation of prolapse repair ( FIGURES 1 and 2 )?

DR. LUCENTE: I believe mesh is indicated in any patient in need of surgical repair of pelvic organ prolapse who is seeking optimal durability and is willing to accept the known risks of the surgery.

The issue becomes more complex when it comes to contraindications. Absolute contraindications are fairly obvious; they include medically unstable patients and those who may have an inactive infectious process within the pelvis or even undiagnosed abnormal uterine bleeding.

At our center, because the potential for dyspareunia and pelvic discomfort is our biggest concern, we have developed a profile of the patient who is more likely to develop these complaints. The profile includes any patient who has a chronic pain disorder of any type, but especially chronic pelvic pain disorders such as endometriosis and vulvodynia. Other risk factors appear to be a history of pelvic surgery involving any permanent material, suture or mesh, and young age.

So if we have a patient in her late 30s who has undergone reconstructive surgery using permanent sutures and who has an element of chronic pelvic pain, we would counsel her strongly to consider surgical options other than the use of synthetic mesh.

DR. WALTERS: The main indications for mesh-augmented prolapse repair are recurrent posthysterectomy vaginal vault prolapse, for which I usually perform ASC, and recurrent cystocele or anteriorapical prolapse, for which I use one of the anterior mesh kits.

I still think sutured repairs—by that, I mean uterosacral ligament or sacrospinous colpopexy with sutured rectocele repair—work best for recurrent posterior wall and posteriorapical prolapse. I don’t use mesh augmentation for rectocele.

The main contraindication to mesh augmentation, as I see it, is a history of mesh complications. If I am repairing a mesh complication such as erosion or pain, I do not place another mesh.

Medical issues that might increase mesh complications, such as diabetes, steroid use, or severe vaginal atrophy, would, at the very least, make me consider carefully whether mesh augmentation is appropriate. The literature is not clear on this, so mesh could still be used if the surgeon thinks it is necessary.

DR. KARRAM: I haven’t found a definitive indication for mesh augmentation. We have used biologic meshes empirically, but I am not convinced that they really add long-term durability, regardless of whether they are used in the anterior or posterior vaginal segment.

Our published durability rate for traditional suture-type repairs is in the range of 85% at 5 years out.⁶ Even if I assumed that mesh would give me 100% 5-year durability, this rate would have to be at the expense of some erosion, pain, and other complications unique to mesh. I do not think that the potential improvement in durability is worth these potential complications.

FIGURE 1 When the pelvic support system is intact, prolapse is rare

In the normal pelvis, organs are supported by a complex web of muscles, fascia, and connective tissue.

FIGURE 2 Mesh augmentation seeks to enhance the durability of repair

One type of mesh in final position. Mesh-augmented repair restores the vaginal apex and lends support to the walls of the vagina.

Which technique is best?

DR. KARRAM: If you are doing a lot of mesh repairs, you are obviously content with the results and feel that the few complications you are seeing are outweighed by the advantages mesh confers. How do you avoid extrusion and avert creation of a painful vagina?

DR. RAZ: Most of our cases are recurrent prolapse after failed vaginal or abdominal repair. I am indeed using a significant amount of soft polypropylene mesh for reconstructive procedures. As with the use of any other synthetic material, low-grade infection can develop after a few weeks or months. I use copious irrigation with antibiotic solution during reconstruction.

To avoid extrusion, I perform deep, rather than superficial, dissection of the vaginal wall to allow for better coverage of the mesh. For posterior mesh reconstruction, I cover the mesh with pararectal fascia to prevent erosion.

For mesh-augmented procedures, I cut the mesh myself in the operating room ( FIGURE 3 ). For a sling, I use a 10 cm × 1 cm soft polypropylene mesh. For a grade 3 or 4 cystocele, I use a trapezoid of soft polypropylene mesh with several points of fixation:

• at the sacrouterine ligament
• lateral to the obturator fascia
• distal to the bladder neck.

I always repair the vault at the same time.

For vault prolapse, I use a segment of soft polypropylene mesh in the shape of an apron with two arms (1 cm × 4 cm) and a central segment (4 cm × 7 cm). I support the vault using number 1-0 delayed absorbable suture and mesh. From outside the vaginal wall, in the posterolateral deep vaginal wall (inside the peritoneum), I incorporate the origin of the sacrouterine ligament and one arm of the mesh in the groove between the colon and levator ani, 15 cm from the introitus. I bring the suture 1 cm from the original entrance. A separate set of sutures brings the perirectal fascia together with the sacrouterine ligaments and perivesical fascia to close the peritoneal cavity. I tie the vault-suspension sutures, providing support to the cuff in a high posterior position (12 to 15 cm from the introitus).

In selected cases of significant recurrent rectocele, I use a rectangle of soft polypropylene mesh anchored to the origin of the sacrouterine ligament and distal to the perineal membrane. The mesh is covered by the pararectal fascia.

We have not seen vaginal, urethral, or bladder erosion in 1,800 cases of our distal urethral Prolene sling procedure using 10 cm × 1 cm soft mesh. In patients who have significant cystocele, vault prolapse, and recurrent rectocele, our vaginal erosion rate is 3%. We have never encountered rectal, bladder, or bowel perforation using our technique.

DR. LUCENTE: We often use mesh and are more than simply content with our results—we are extremely pleased, and so are our patients. Having said that, our techniques have definitely evolved over the past few years, as we’ve focused on how to decrease exposure and, more recently, optimize sexual function and vaginal comfort.

First, to avoid exposure, the most critical step is precise hydrodissection and distention of the true vesicovaginal space. This step can only be achieved through careful tactile guidance of the needle tip into the space, where it should remain while hydrodissection is performed. Always remember, sharp dissection “follows” hydrodissection. If you place the needle bevel within the vaginal wall, you will “split” the vaginal wall—as during standard colporrhaphy—which will lead to a high exposure rate.

Second, to avoid dyspareunia, it’s essential to pay close attention to POP-Q measurements, especially vaginal length, to ensure that the reconstruction restores the same length without foreshortening. This approach entails leaving the cervix in most patients who have a shorter vagina, and making sure that the mesh is secured above the ischial spine in younger, sexually active patients who have demonstrated a higher risk of postoperative deep, penetrating dyspareunia, compared with older, less sexually active patients.

Also paramount is to ensure that you have manually displaced the vagina inwardly as much as possible before deploying or setting the mesh. If you simply try to suture secure the mesh with the vagina incised open, without the ability to deploy the mesh with a closed, displaced vagina (to mimic deep penetration), it is difficult, if not impossible, to properly set the mesh for optimal comfort.

In the early days of midurethral pubovaginal slings using polypropylene, the adage was “looser is better than tighter.” This is even truer for transvaginal mesh.

DR. KARRAM: Dr. Walters, please describe your current surgical procedure of choice without mesh and explain why you haven’t adopted mesh for routine repairs.

DR. WALTERS: About 20% of my prolapse surgeries—usually for posthysterectomy or recurrent vaginal vault prolapse—involve ASC with placement of polypropylene mesh. I perform most of these cases through a Pfannenstiel incision, but I’ve also done them laparoscopically. Several of my partners perform ASC laparoscopically and robotically.

For the other 80% of my patients who have prolapse, I perform repairs transvaginally, usually using high bilateral uterosacralligament vaginal-vault suspension. We have learned to suture higher and slightly more medial on the uterosacral ligaments to attain greater vaginal depth and minimize ureteral obstruction. We use two or three sutures on each uterosacral ligament, usually a combination of permanent and delayed absorbable sutures.

I am also performing more sacrospinous ligament suspensions because this operation is being studied by the Pelvic Floor Disorders Network. Properly performed, it is an excellent surgery for apical prolapse. But, as with most of our surgeries for prolapse, recurrent anterior wall prolapse remains a problem.

Like you, Dr. Karram, we’ve studied our group’s anatomic and functional outcomes very carefully for more than 10 years and are mostly satisfied with our cure and complication rates. Although our anatomic outcomes with these surgeries are not always perfect, our reoperation rate for prolapse is only about 5%, with a high level of satisfaction in 88% to 92% of patients.

DR. RAZ: Unaugmented reconstruction fails in more than 30% of cases. Some patients who have significant prolapse and attenuated tissue think that this tissue will become healthier or stronger after reconstructive surgery, but that isn’t the case. In these situations, excision and plication make no clinical sense.

The problem is that we have yet to identify the ideal surrogate for poor-quality tissue. Most of us use polypropylene mesh in different variations. We need a better material that will be nonimmunogenic, well tolerated, and easily incorporated without erosion. Xenograft-like derivatives of dermis, or allografts such as cadaveric fascia, have failed over the long term because the body reabsorbs the graft without forming any new connective tissue.

FIGURE 3 Mesh can be cut in the OR to custom-fit a patient

Hand-cut mesh and points of placement.
PHOTO: SHLOMO RAZ, MD

Is a kit a valuable aid?

DR. KARRAM: If a surgeon wants to augment a repair, what are the advantages of a packaged mesh kit, compared with simply cutting the mesh and performing surgery without a kit?

DR. WALTERS: The advantages of a packaged mesh kit are the convenience involved and the ability to consistently perform the same operation with the same product. That facilitates learning, teaching, and research. It also helps us understand the published literature a little better because “custom” prolapse repairs are operator-dependent and difficult to apply generally to a population of surgeons.

These advantages are most clearly apparent with midurethral sling mesh kits, which have almost revolutionized surgery for stress incontinence. I don’t believe mesh kits for prolapse are there yet, but they certainly have potential.

DR. RAZ: I’m opposed to the use of kits. They are industry-driven. One company has made $1 billion selling them. Imagine a patient who undergoes placement of a sling kit ($1,000), cystocele kit ($1,500), and posterior mesh kit ($1,500). How can our healthcare system sustain this burden, especially when there is no real evidence that a kit improves the operation, and given the incredible complication rate that we see?

Moreover, the kits contain a single-use needle and passer and a precut segment of polypropylene mesh. But every patient is different and requires a unique size or shape of mesh. I don’t believe that a surgeon who knows pelvic anatomy needs a kit to perform mesh-augmented reconstruction. We can buy the same segment of mesh for $200 to $400, cut it as needed, and perform the same operation advertised by industry.

For surgeons who prefer a kit, the tools that are included should be made reusable.

DR. LUCENTE: In my opinion, the primary advantage of a commercially available transvaginal mesh delivery system—notice, I avoided the word “kit,” because I think there are plenty of negative connotations associated with it—is the ability to deliver the mesh in a “tension”-free manner.

One alternative that many people pursue is cutting the mesh to size and using sutures to hold it in place while tissue ingrowth occurs. However, the hernia literature suggests that suturing mesh in place increases the risk of postoperative discomfort at the site of implantation. The true cause of the discomfort remains unclear, but it is thought to arise from nerve tethering or traction at the pre-committed points of attachment before the host tissue and mesh interface have adjusted or settled with tissue ingrowth.

All neuropathic complications of mesh implantation have been shown in the current hernia literature to be increased with the use of sutures.⁷ Also, as previously mentioned, it is extremely difficult to set or adjust the mesh with the vaginal incision remaining “open,” which is a downside to suture techniques.

What training is necessary to use a kit?

DR. KARRAM: Mesh kits are aggressively promoted by industry, with close to half a dozen different kits to be available soon. What is the minimum amount of training one should have before utilizing these kits?

DR. WALTERS: The surgeon should at least know how to perform traditional sutured prolapse repairs and SUI surgery and be able to perform cystoscopy. Ideally, the surgeon should undergo training on a cadaver with a skilled and experienced user of the mesh kit. The surgeon also should carefully review the risks and benefits of mesh kits with the patient and inform the patient that he or she is in the early learning curve of a particular surgery. The informed patient should have a right to refuse mesh-augmented prolapse surgery after the consent process.

DR. LUCENTE: I’m glad you asked this question. I strongly believe that surgical expertise and proficiency within gynecology need to be more effectively addressed by us all. We have a situation in our field in which techniques and technology are widening the gap between what is possible and what the surgeon is comfortable doing safely.

It’s incumbent on all of us, especially those who are in a leadership position as a chairperson or chief of a division, to work with our physician staff and faculty to optimize surgical skill and patient outcomes, including safety, with new technologies.

As for the minimal amount of training needed, that’s extremely variable. It depends on the current skill set of the physician and his or her ability to pick up the mechanics of the surgery as it is taught through a cadaver lab or preceptorship. It’s regrettable that some physicians lack the objectivity and insight to judge their own skill set. This, again, is the time for a chairperson or chief of a division to step up to the plate and ensure proper credentialing and demonstration of proficiency.

It is unrealistic to expect industry to decide who should or should not utilize this truly breakthrough technology. That is our responsibility as physicians.

DR. KARRAM: At a minimum, I think any surgeon utilizing a kit should have a firm understanding of pelvic floor anatomy and experience performing traditional repairs:

• intraperitoneal procedures such as Mc-Call culdoplasty and uterosacral suspension
• sacrospinous suspension
• retropubic procedures and anti-incontinence operations such as pubovaginal slings.

This three-dimensional understanding of the pelvic floor is mandatory if one is to assume that blind passage of trocars through potentially dangerous spaces is the wave of the future.

DR. RAZ: You need to be a pelvic surgeon, know your anatomy, and know how to manage complications if you are going to use one of these kits. You should stick to the surgery that works best in your hands. Industry cannot teach you to be a good pelvic surgeon; it takes lifelong experience.

Mesh kits for repairing prolapse are proliferating like crazy, just as they did for midurethral sling procedures. But mesh augmentation of prolapse surgeries requires more than a prepackaged assortment of tools and materials. In this article, moderator Mickey M. Karram, MD, and a panel of nationally recognized urogynecologists and urologists describe the literature on mesh augmentation and discuss indications, contraindications, techniques, applicable cases, and the considerable training required.

In Part 2, which will appear in the February issue of OBG Management, the panel tackles the thorny topic of complications, including erosion, extrusion, foreshortening of the vagina, dyspareunia, and pain. Their discussion focuses on ways to avoid these problems, and methods for correcting them.

Do we have enough data?

DR. KARRAM: To start, let’s quickly review the peer-reviewed literature on the use of mesh augmentation during surgery for pelvic organ prolapse.

DR. WALTERS: Until recently, most data concerned open abdominal sacrocolpopexy (ASC) using polypropylene or Merseline mesh. There is significant clinical experience with this operation, and multiple cohort studies show long-term cure rates of 78% to 100% for apical prolapse.¹

At least two randomized controlled trials have compared open ASC with sutured vaginal colpopexy procedures, and ASC is certainly equal to—perhaps better than—all transvaginal sutured repairs.^2,3

With ASC, most recurrences affect the distal half of the vagina and involve one or more of the following:

• anterior or posterior vaginal wall prolapse (or both)
• stress urinary incontinence (SUI)
• distal rectocele.^1,3

Mesh erosion occurs in 3.4% of cases and is usually easily managed.¹ Other complications, including bowel injury, tend to be related to access, regardless of whether the operation is performed via laparotomy or laparoscopy.

Robotic sacrocolpopexy has become popular in recent years, and we will probably see data on this approach as we gain experience.

When it comes to vaginal mesh kits, the peer-reviewed literature is just beginning to expand, with many studies being presented at international meetings. For anterior and, possibly, apical vaginal prolapse, the cure rate after use of a mesh kit appears to be as high as, or higher than, the rate for sutured repairs.⁴ This high rate of anatomic cure is balanced somewhat by additional cost and complications involving mesh and the kits.

For posterior vaginal wall prolapse and rectocele, I firmly believe, based on our research and that of others, that sutured repairs are superior to graft-augmented surgery.⁵

When is mesh appropriate?

DR. KARRAM: What are the indications and contraindications for mesh augmentation of prolapse repair ( FIGURES 1 and 2 )?

DR. LUCENTE: I believe mesh is indicated in any patient in need of surgical repair of pelvic organ prolapse who is seeking optimal durability and is willing to accept the known risks of the surgery.

The issue becomes more complex when it comes to contraindications. Absolute contraindications are fairly obvious; they include medically unstable patients and those who may have an inactive infectious process within the pelvis or even undiagnosed abnormal uterine bleeding.

At our center, because the potential for dyspareunia and pelvic discomfort is our biggest concern, we have developed a profile of the patient who is more likely to develop these complaints. The profile includes any patient who has a chronic pain disorder of any type, but especially chronic pelvic pain disorders such as endometriosis and vulvodynia. Other risk factors appear to be a history of pelvic surgery involving any permanent material, suture or mesh, and young age.

So if we have a patient in her late 30s who has undergone reconstructive surgery using permanent sutures and who has an element of chronic pelvic pain, we would counsel her strongly to consider surgical options other than the use of synthetic mesh.

DR. WALTERS: The main indications for mesh-augmented prolapse repair are recurrent posthysterectomy vaginal vault prolapse, for which I usually perform ASC, and recurrent cystocele or anteriorapical prolapse, for which I use one of the anterior mesh kits.

I still think sutured repairs—by that, I mean uterosacral ligament or sacrospinous colpopexy with sutured rectocele repair—work best for recurrent posterior wall and posteriorapical prolapse. I don’t use mesh augmentation for rectocele.

The main contraindication to mesh augmentation, as I see it, is a history of mesh complications. If I am repairing a mesh complication such as erosion or pain, I do not place another mesh.

Medical issues that might increase mesh complications, such as diabetes, steroid use, or severe vaginal atrophy, would, at the very least, make me consider carefully whether mesh augmentation is appropriate. The literature is not clear on this, so mesh could still be used if the surgeon thinks it is necessary.

DR. KARRAM: I haven’t found a definitive indication for mesh augmentation. We have used biologic meshes empirically, but I am not convinced that they really add long-term durability, regardless of whether they are used in the anterior or posterior vaginal segment.

Our published durability rate for traditional suture-type repairs is in the range of 85% at 5 years out.⁶ Even if I assumed that mesh would give me 100% 5-year durability, this rate would have to be at the expense of some erosion, pain, and other complications unique to mesh. I do not think that the potential improvement in durability is worth these potential complications.

FIGURE 1 When the pelvic support system is intact, prolapse is rare

In the normal pelvis, organs are supported by a complex web of muscles, fascia, and connective tissue.

FIGURE 2 Mesh augmentation seeks to enhance the durability of repair

One type of mesh in final position. Mesh-augmented repair restores the vaginal apex and lends support to the walls of the vagina.

Which technique is best?

DR. KARRAM: If you are doing a lot of mesh repairs, you are obviously content with the results and feel that the few complications you are seeing are outweighed by the advantages mesh confers. How do you avoid extrusion and avert creation of a painful vagina?

DR. RAZ: Most of our cases are recurrent prolapse after failed vaginal or abdominal repair. I am indeed using a significant amount of soft polypropylene mesh for reconstructive procedures. As with the use of any other synthetic material, low-grade infection can develop after a few weeks or months. I use copious irrigation with antibiotic solution during reconstruction.

To avoid extrusion, I perform deep, rather than superficial, dissection of the vaginal wall to allow for better coverage of the mesh. For posterior mesh reconstruction, I cover the mesh with pararectal fascia to prevent erosion.

For mesh-augmented procedures, I cut the mesh myself in the operating room ( FIGURE 3 ). For a sling, I use a 10 cm × 1 cm soft polypropylene mesh. For a grade 3 or 4 cystocele, I use a trapezoid of soft polypropylene mesh with several points of fixation:

• at the sacrouterine ligament
• lateral to the obturator fascia
• distal to the bladder neck.

I always repair the vault at the same time.

For vault prolapse, I use a segment of soft polypropylene mesh in the shape of an apron with two arms (1 cm × 4 cm) and a central segment (4 cm × 7 cm). I support the vault using number 1-0 delayed absorbable suture and mesh. From outside the vaginal wall, in the posterolateral deep vaginal wall (inside the peritoneum), I incorporate the origin of the sacrouterine ligament and one arm of the mesh in the groove between the colon and levator ani, 15 cm from the introitus. I bring the suture 1 cm from the original entrance. A separate set of sutures brings the perirectal fascia together with the sacrouterine ligaments and perivesical fascia to close the peritoneal cavity. I tie the vault-suspension sutures, providing support to the cuff in a high posterior position (12 to 15 cm from the introitus).

In selected cases of significant recurrent rectocele, I use a rectangle of soft polypropylene mesh anchored to the origin of the sacrouterine ligament and distal to the perineal membrane. The mesh is covered by the pararectal fascia.

We have not seen vaginal, urethral, or bladder erosion in 1,800 cases of our distal urethral Prolene sling procedure using 10 cm × 1 cm soft mesh. In patients who have significant cystocele, vault prolapse, and recurrent rectocele, our vaginal erosion rate is 3%. We have never encountered rectal, bladder, or bowel perforation using our technique.

DR. LUCENTE: We often use mesh and are more than simply content with our results—we are extremely pleased, and so are our patients. Having said that, our techniques have definitely evolved over the past few years, as we’ve focused on how to decrease exposure and, more recently, optimize sexual function and vaginal comfort.

First, to avoid exposure, the most critical step is precise hydrodissection and distention of the true vesicovaginal space. This step can only be achieved through careful tactile guidance of the needle tip into the space, where it should remain while hydrodissection is performed. Always remember, sharp dissection “follows” hydrodissection. If you place the needle bevel within the vaginal wall, you will “split” the vaginal wall—as during standard colporrhaphy—which will lead to a high exposure rate.

Second, to avoid dyspareunia, it’s essential to pay close attention to POP-Q measurements, especially vaginal length, to ensure that the reconstruction restores the same length without foreshortening. This approach entails leaving the cervix in most patients who have a shorter vagina, and making sure that the mesh is secured above the ischial spine in younger, sexually active patients who have demonstrated a higher risk of postoperative deep, penetrating dyspareunia, compared with older, less sexually active patients.

Also paramount is to ensure that you have manually displaced the vagina inwardly as much as possible before deploying or setting the mesh. If you simply try to suture secure the mesh with the vagina incised open, without the ability to deploy the mesh with a closed, displaced vagina (to mimic deep penetration), it is difficult, if not impossible, to properly set the mesh for optimal comfort.

In the early days of midurethral pubovaginal slings using polypropylene, the adage was “looser is better than tighter.” This is even truer for transvaginal mesh.

DR. KARRAM: Dr. Walters, please describe your current surgical procedure of choice without mesh and explain why you haven’t adopted mesh for routine repairs.

DR. WALTERS: About 20% of my prolapse surgeries—usually for posthysterectomy or recurrent vaginal vault prolapse—involve ASC with placement of polypropylene mesh. I perform most of these cases through a Pfannenstiel incision, but I’ve also done them laparoscopically. Several of my partners perform ASC laparoscopically and robotically.

For the other 80% of my patients who have prolapse, I perform repairs transvaginally, usually using high bilateral uterosacralligament vaginal-vault suspension. We have learned to suture higher and slightly more medial on the uterosacral ligaments to attain greater vaginal depth and minimize ureteral obstruction. We use two or three sutures on each uterosacral ligament, usually a combination of permanent and delayed absorbable sutures.

I am also performing more sacrospinous ligament suspensions because this operation is being studied by the Pelvic Floor Disorders Network. Properly performed, it is an excellent surgery for apical prolapse. But, as with most of our surgeries for prolapse, recurrent anterior wall prolapse remains a problem.

Like you, Dr. Karram, we’ve studied our group’s anatomic and functional outcomes very carefully for more than 10 years and are mostly satisfied with our cure and complication rates. Although our anatomic outcomes with these surgeries are not always perfect, our reoperation rate for prolapse is only about 5%, with a high level of satisfaction in 88% to 92% of patients.

DR. RAZ: Unaugmented reconstruction fails in more than 30% of cases. Some patients who have significant prolapse and attenuated tissue think that this tissue will become healthier or stronger after reconstructive surgery, but that isn’t the case. In these situations, excision and plication make no clinical sense.

The problem is that we have yet to identify the ideal surrogate for poor-quality tissue. Most of us use polypropylene mesh in different variations. We need a better material that will be nonimmunogenic, well tolerated, and easily incorporated without erosion. Xenograft-like derivatives of dermis, or allografts such as cadaveric fascia, have failed over the long term because the body reabsorbs the graft without forming any new connective tissue.

FIGURE 3 Mesh can be cut in the OR to custom-fit a patient

Hand-cut mesh and points of placement.
PHOTO: SHLOMO RAZ, MD

Is a kit a valuable aid?

DR. KARRAM: If a surgeon wants to augment a repair, what are the advantages of a packaged mesh kit, compared with simply cutting the mesh and performing surgery without a kit?

DR. WALTERS: The advantages of a packaged mesh kit are the convenience involved and the ability to consistently perform the same operation with the same product. That facilitates learning, teaching, and research. It also helps us understand the published literature a little better because “custom” prolapse repairs are operator-dependent and difficult to apply generally to a population of surgeons.

These advantages are most clearly apparent with midurethral sling mesh kits, which have almost revolutionized surgery for stress incontinence. I don’t believe mesh kits for prolapse are there yet, but they certainly have potential.

DR. RAZ: I’m opposed to the use of kits. They are industry-driven. One company has made $1 billion selling them. Imagine a patient who undergoes placement of a sling kit ($1,000), cystocele kit ($1,500), and posterior mesh kit ($1,500). How can our healthcare system sustain this burden, especially when there is no real evidence that a kit improves the operation, and given the incredible complication rate that we see?

Moreover, the kits contain a single-use needle and passer and a precut segment of polypropylene mesh. But every patient is different and requires a unique size or shape of mesh. I don’t believe that a surgeon who knows pelvic anatomy needs a kit to perform mesh-augmented reconstruction. We can buy the same segment of mesh for $200 to $400, cut it as needed, and perform the same operation advertised by industry.

For surgeons who prefer a kit, the tools that are included should be made reusable.

DR. LUCENTE: In my opinion, the primary advantage of a commercially available transvaginal mesh delivery system—notice, I avoided the word “kit,” because I think there are plenty of negative connotations associated with it—is the ability to deliver the mesh in a “tension”-free manner.

One alternative that many people pursue is cutting the mesh to size and using sutures to hold it in place while tissue ingrowth occurs. However, the hernia literature suggests that suturing mesh in place increases the risk of postoperative discomfort at the site of implantation. The true cause of the discomfort remains unclear, but it is thought to arise from nerve tethering or traction at the pre-committed points of attachment before the host tissue and mesh interface have adjusted or settled with tissue ingrowth.

All neuropathic complications of mesh implantation have been shown in the current hernia literature to be increased with the use of sutures.⁷ Also, as previously mentioned, it is extremely difficult to set or adjust the mesh with the vaginal incision remaining “open,” which is a downside to suture techniques.

What training is necessary to use a kit?

DR. KARRAM: Mesh kits are aggressively promoted by industry, with close to half a dozen different kits to be available soon. What is the minimum amount of training one should have before utilizing these kits?

DR. WALTERS: The surgeon should at least know how to perform traditional sutured prolapse repairs and SUI surgery and be able to perform cystoscopy. Ideally, the surgeon should undergo training on a cadaver with a skilled and experienced user of the mesh kit. The surgeon also should carefully review the risks and benefits of mesh kits with the patient and inform the patient that he or she is in the early learning curve of a particular surgery. The informed patient should have a right to refuse mesh-augmented prolapse surgery after the consent process.

DR. LUCENTE: I’m glad you asked this question. I strongly believe that surgical expertise and proficiency within gynecology need to be more effectively addressed by us all. We have a situation in our field in which techniques and technology are widening the gap between what is possible and what the surgeon is comfortable doing safely.

It’s incumbent on all of us, especially those who are in a leadership position as a chairperson or chief of a division, to work with our physician staff and faculty to optimize surgical skill and patient outcomes, including safety, with new technologies.

As for the minimal amount of training needed, that’s extremely variable. It depends on the current skill set of the physician and his or her ability to pick up the mechanics of the surgery as it is taught through a cadaver lab or preceptorship. It’s regrettable that some physicians lack the objectivity and insight to judge their own skill set. This, again, is the time for a chairperson or chief of a division to step up to the plate and ensure proper credentialing and demonstration of proficiency.

It is unrealistic to expect industry to decide who should or should not utilize this truly breakthrough technology. That is our responsibility as physicians.

DR. KARRAM: At a minimum, I think any surgeon utilizing a kit should have a firm understanding of pelvic floor anatomy and experience performing traditional repairs:

• intraperitoneal procedures such as Mc-Call culdoplasty and uterosacral suspension
• sacrospinous suspension
• retropubic procedures and anti-incontinence operations such as pubovaginal slings.

This three-dimensional understanding of the pelvic floor is mandatory if one is to assume that blind passage of trocars through potentially dangerous spaces is the wave of the future.

DR. RAZ: You need to be a pelvic surgeon, know your anatomy, and know how to manage complications if you are going to use one of these kits. You should stick to the surgery that works best in your hands. Industry cannot teach you to be a good pelvic surgeon; it takes lifelong experience.

Mesh kits for repairing prolapse are proliferating like crazy, just as they did for midurethral sling procedures. But mesh augmentation of prolapse surgeries requires more than a prepackaged assortment of tools and materials. In this article, moderator Mickey M. Karram, MD, and a panel of nationally recognized urogynecologists and urologists describe the literature on mesh augmentation and discuss indications, contraindications, techniques, applicable cases, and the considerable training required.

In Part 2, which will appear in the February issue of OBG Management, the panel tackles the thorny topic of complications, including erosion, extrusion, foreshortening of the vagina, dyspareunia, and pain. Their discussion focuses on ways to avoid these problems, and methods for correcting them.

Do we have enough data?

DR. KARRAM: To start, let’s quickly review the peer-reviewed literature on the use of mesh augmentation during surgery for pelvic organ prolapse.

DR. WALTERS: Until recently, most data concerned open abdominal sacrocolpopexy (ASC) using polypropylene or Merseline mesh. There is significant clinical experience with this operation, and multiple cohort studies show long-term cure rates of 78% to 100% for apical prolapse.¹

At least two randomized controlled trials have compared open ASC with sutured vaginal colpopexy procedures, and ASC is certainly equal to—perhaps better than—all transvaginal sutured repairs.^2,3

With ASC, most recurrences affect the distal half of the vagina and involve one or more of the following:

• anterior or posterior vaginal wall prolapse (or both)
• stress urinary incontinence (SUI)
• distal rectocele.^1,3

Mesh erosion occurs in 3.4% of cases and is usually easily managed.¹ Other complications, including bowel injury, tend to be related to access, regardless of whether the operation is performed via laparotomy or laparoscopy.

Robotic sacrocolpopexy has become popular in recent years, and we will probably see data on this approach as we gain experience.

When it comes to vaginal mesh kits, the peer-reviewed literature is just beginning to expand, with many studies being presented at international meetings. For anterior and, possibly, apical vaginal prolapse, the cure rate after use of a mesh kit appears to be as high as, or higher than, the rate for sutured repairs.⁴ This high rate of anatomic cure is balanced somewhat by additional cost and complications involving mesh and the kits.

For posterior vaginal wall prolapse and rectocele, I firmly believe, based on our research and that of others, that sutured repairs are superior to graft-augmented surgery.⁵

When is mesh appropriate?

DR. KARRAM: What are the indications and contraindications for mesh augmentation of prolapse repair ( FIGURES 1 and 2 )?

DR. LUCENTE: I believe mesh is indicated in any patient in need of surgical repair of pelvic organ prolapse who is seeking optimal durability and is willing to accept the known risks of the surgery.

The issue becomes more complex when it comes to contraindications. Absolute contraindications are fairly obvious; they include medically unstable patients and those who may have an inactive infectious process within the pelvis or even undiagnosed abnormal uterine bleeding.

At our center, because the potential for dyspareunia and pelvic discomfort is our biggest concern, we have developed a profile of the patient who is more likely to develop these complaints. The profile includes any patient who has a chronic pain disorder of any type, but especially chronic pelvic pain disorders such as endometriosis and vulvodynia. Other risk factors appear to be a history of pelvic surgery involving any permanent material, suture or mesh, and young age.

So if we have a patient in her late 30s who has undergone reconstructive surgery using permanent sutures and who has an element of chronic pelvic pain, we would counsel her strongly to consider surgical options other than the use of synthetic mesh.

DR. WALTERS: The main indications for mesh-augmented prolapse repair are recurrent posthysterectomy vaginal vault prolapse, for which I usually perform ASC, and recurrent cystocele or anteriorapical prolapse, for which I use one of the anterior mesh kits.

I still think sutured repairs—by that, I mean uterosacral ligament or sacrospinous colpopexy with sutured rectocele repair—work best for recurrent posterior wall and posteriorapical prolapse. I don’t use mesh augmentation for rectocele.

The main contraindication to mesh augmentation, as I see it, is a history of mesh complications. If I am repairing a mesh complication such as erosion or pain, I do not place another mesh.

Medical issues that might increase mesh complications, such as diabetes, steroid use, or severe vaginal atrophy, would, at the very least, make me consider carefully whether mesh augmentation is appropriate. The literature is not clear on this, so mesh could still be used if the surgeon thinks it is necessary.

DR. KARRAM: I haven’t found a definitive indication for mesh augmentation. We have used biologic meshes empirically, but I am not convinced that they really add long-term durability, regardless of whether they are used in the anterior or posterior vaginal segment.

Our published durability rate for traditional suture-type repairs is in the range of 85% at 5 years out.⁶ Even if I assumed that mesh would give me 100% 5-year durability, this rate would have to be at the expense of some erosion, pain, and other complications unique to mesh. I do not think that the potential improvement in durability is worth these potential complications.

FIGURE 1 When the pelvic support system is intact, prolapse is rare

In the normal pelvis, organs are supported by a complex web of muscles, fascia, and connective tissue.

FIGURE 2 Mesh augmentation seeks to enhance the durability of repair

One type of mesh in final position. Mesh-augmented repair restores the vaginal apex and lends support to the walls of the vagina.

Which technique is best?

DR. KARRAM: If you are doing a lot of mesh repairs, you are obviously content with the results and feel that the few complications you are seeing are outweighed by the advantages mesh confers. How do you avoid extrusion and avert creation of a painful vagina?

DR. RAZ: Most of our cases are recurrent prolapse after failed vaginal or abdominal repair. I am indeed using a significant amount of soft polypropylene mesh for reconstructive procedures. As with the use of any other synthetic material, low-grade infection can develop after a few weeks or months. I use copious irrigation with antibiotic solution during reconstruction.

To avoid extrusion, I perform deep, rather than superficial, dissection of the vaginal wall to allow for better coverage of the mesh. For posterior mesh reconstruction, I cover the mesh with pararectal fascia to prevent erosion.

For mesh-augmented procedures, I cut the mesh myself in the operating room ( FIGURE 3 ). For a sling, I use a 10 cm × 1 cm soft polypropylene mesh. For a grade 3 or 4 cystocele, I use a trapezoid of soft polypropylene mesh with several points of fixation:

• at the sacrouterine ligament
• lateral to the obturator fascia
• distal to the bladder neck.

I always repair the vault at the same time.

For vault prolapse, I use a segment of soft polypropylene mesh in the shape of an apron with two arms (1 cm × 4 cm) and a central segment (4 cm × 7 cm). I support the vault using number 1-0 delayed absorbable suture and mesh. From outside the vaginal wall, in the posterolateral deep vaginal wall (inside the peritoneum), I incorporate the origin of the sacrouterine ligament and one arm of the mesh in the groove between the colon and levator ani, 15 cm from the introitus. I bring the suture 1 cm from the original entrance. A separate set of sutures brings the perirectal fascia together with the sacrouterine ligaments and perivesical fascia to close the peritoneal cavity. I tie the vault-suspension sutures, providing support to the cuff in a high posterior position (12 to 15 cm from the introitus).

In selected cases of significant recurrent rectocele, I use a rectangle of soft polypropylene mesh anchored to the origin of the sacrouterine ligament and distal to the perineal membrane. The mesh is covered by the pararectal fascia.

We have not seen vaginal, urethral, or bladder erosion in 1,800 cases of our distal urethral Prolene sling procedure using 10 cm × 1 cm soft mesh. In patients who have significant cystocele, vault prolapse, and recurrent rectocele, our vaginal erosion rate is 3%. We have never encountered rectal, bladder, or bowel perforation using our technique.

DR. LUCENTE: We often use mesh and are more than simply content with our results—we are extremely pleased, and so are our patients. Having said that, our techniques have definitely evolved over the past few years, as we’ve focused on how to decrease exposure and, more recently, optimize sexual function and vaginal comfort.

First, to avoid exposure, the most critical step is precise hydrodissection and distention of the true vesicovaginal space. This step can only be achieved through careful tactile guidance of the needle tip into the space, where it should remain while hydrodissection is performed. Always remember, sharp dissection “follows” hydrodissection. If you place the needle bevel within the vaginal wall, you will “split” the vaginal wall—as during standard colporrhaphy—which will lead to a high exposure rate.

Second, to avoid dyspareunia, it’s essential to pay close attention to POP-Q measurements, especially vaginal length, to ensure that the reconstruction restores the same length without foreshortening. This approach entails leaving the cervix in most patients who have a shorter vagina, and making sure that the mesh is secured above the ischial spine in younger, sexually active patients who have demonstrated a higher risk of postoperative deep, penetrating dyspareunia, compared with older, less sexually active patients.

Also paramount is to ensure that you have manually displaced the vagina inwardly as much as possible before deploying or setting the mesh. If you simply try to suture secure the mesh with the vagina incised open, without the ability to deploy the mesh with a closed, displaced vagina (to mimic deep penetration), it is difficult, if not impossible, to properly set the mesh for optimal comfort.

In the early days of midurethral pubovaginal slings using polypropylene, the adage was “looser is better than tighter.” This is even truer for transvaginal mesh.

DR. KARRAM: Dr. Walters, please describe your current surgical procedure of choice without mesh and explain why you haven’t adopted mesh for routine repairs.

DR. WALTERS: About 20% of my prolapse surgeries—usually for posthysterectomy or recurrent vaginal vault prolapse—involve ASC with placement of polypropylene mesh. I perform most of these cases through a Pfannenstiel incision, but I’ve also done them laparoscopically. Several of my partners perform ASC laparoscopically and robotically.

For the other 80% of my patients who have prolapse, I perform repairs transvaginally, usually using high bilateral uterosacralligament vaginal-vault suspension. We have learned to suture higher and slightly more medial on the uterosacral ligaments to attain greater vaginal depth and minimize ureteral obstruction. We use two or three sutures on each uterosacral ligament, usually a combination of permanent and delayed absorbable sutures.

I am also performing more sacrospinous ligament suspensions because this operation is being studied by the Pelvic Floor Disorders Network. Properly performed, it is an excellent surgery for apical prolapse. But, as with most of our surgeries for prolapse, recurrent anterior wall prolapse remains a problem.

Like you, Dr. Karram, we’ve studied our group’s anatomic and functional outcomes very carefully for more than 10 years and are mostly satisfied with our cure and complication rates. Although our anatomic outcomes with these surgeries are not always perfect, our reoperation rate for prolapse is only about 5%, with a high level of satisfaction in 88% to 92% of patients.

DR. RAZ: Unaugmented reconstruction fails in more than 30% of cases. Some patients who have significant prolapse and attenuated tissue think that this tissue will become healthier or stronger after reconstructive surgery, but that isn’t the case. In these situations, excision and plication make no clinical sense.

The problem is that we have yet to identify the ideal surrogate for poor-quality tissue. Most of us use polypropylene mesh in different variations. We need a better material that will be nonimmunogenic, well tolerated, and easily incorporated without erosion. Xenograft-like derivatives of dermis, or allografts such as cadaveric fascia, have failed over the long term because the body reabsorbs the graft without forming any new connective tissue.

FIGURE 3 Mesh can be cut in the OR to custom-fit a patient

Hand-cut mesh and points of placement.
PHOTO: SHLOMO RAZ, MD

Is a kit a valuable aid?

DR. KARRAM: If a surgeon wants to augment a repair, what are the advantages of a packaged mesh kit, compared with simply cutting the mesh and performing surgery without a kit?

DR. WALTERS: The advantages of a packaged mesh kit are the convenience involved and the ability to consistently perform the same operation with the same product. That facilitates learning, teaching, and research. It also helps us understand the published literature a little better because “custom” prolapse repairs are operator-dependent and difficult to apply generally to a population of surgeons.

These advantages are most clearly apparent with midurethral sling mesh kits, which have almost revolutionized surgery for stress incontinence. I don’t believe mesh kits for prolapse are there yet, but they certainly have potential.

DR. RAZ: I’m opposed to the use of kits. They are industry-driven. One company has made $1 billion selling them. Imagine a patient who undergoes placement of a sling kit ($1,000), cystocele kit ($1,500), and posterior mesh kit ($1,500). How can our healthcare system sustain this burden, especially when there is no real evidence that a kit improves the operation, and given the incredible complication rate that we see?

Moreover, the kits contain a single-use needle and passer and a precut segment of polypropylene mesh. But every patient is different and requires a unique size or shape of mesh. I don’t believe that a surgeon who knows pelvic anatomy needs a kit to perform mesh-augmented reconstruction. We can buy the same segment of mesh for $200 to $400, cut it as needed, and perform the same operation advertised by industry.

For surgeons who prefer a kit, the tools that are included should be made reusable.

DR. LUCENTE: In my opinion, the primary advantage of a commercially available transvaginal mesh delivery system—notice, I avoided the word “kit,” because I think there are plenty of negative connotations associated with it—is the ability to deliver the mesh in a “tension”-free manner.

One alternative that many people pursue is cutting the mesh to size and using sutures to hold it in place while tissue ingrowth occurs. However, the hernia literature suggests that suturing mesh in place increases the risk of postoperative discomfort at the site of implantation. The true cause of the discomfort remains unclear, but it is thought to arise from nerve tethering or traction at the pre-committed points of attachment before the host tissue and mesh interface have adjusted or settled with tissue ingrowth.

All neuropathic complications of mesh implantation have been shown in the current hernia literature to be increased with the use of sutures.⁷ Also, as previously mentioned, it is extremely difficult to set or adjust the mesh with the vaginal incision remaining “open,” which is a downside to suture techniques.

What training is necessary to use a kit?

DR. KARRAM: Mesh kits are aggressively promoted by industry, with close to half a dozen different kits to be available soon. What is the minimum amount of training one should have before utilizing these kits?

DR. WALTERS: The surgeon should at least know how to perform traditional sutured prolapse repairs and SUI surgery and be able to perform cystoscopy. Ideally, the surgeon should undergo training on a cadaver with a skilled and experienced user of the mesh kit. The surgeon also should carefully review the risks and benefits of mesh kits with the patient and inform the patient that he or she is in the early learning curve of a particular surgery. The informed patient should have a right to refuse mesh-augmented prolapse surgery after the consent process.

DR. LUCENTE: I’m glad you asked this question. I strongly believe that surgical expertise and proficiency within gynecology need to be more effectively addressed by us all. We have a situation in our field in which techniques and technology are widening the gap between what is possible and what the surgeon is comfortable doing safely.

It’s incumbent on all of us, especially those who are in a leadership position as a chairperson or chief of a division, to work with our physician staff and faculty to optimize surgical skill and patient outcomes, including safety, with new technologies.

As for the minimal amount of training needed, that’s extremely variable. It depends on the current skill set of the physician and his or her ability to pick up the mechanics of the surgery as it is taught through a cadaver lab or preceptorship. It’s regrettable that some physicians lack the objectivity and insight to judge their own skill set. This, again, is the time for a chairperson or chief of a division to step up to the plate and ensure proper credentialing and demonstration of proficiency.

It is unrealistic to expect industry to decide who should or should not utilize this truly breakthrough technology. That is our responsibility as physicians.

DR. KARRAM: At a minimum, I think any surgeon utilizing a kit should have a firm understanding of pelvic floor anatomy and experience performing traditional repairs:

• intraperitoneal procedures such as Mc-Call culdoplasty and uterosacral suspension
• sacrospinous suspension
• retropubic procedures and anti-incontinence operations such as pubovaginal slings.

This three-dimensional understanding of the pelvic floor is mandatory if one is to assume that blind passage of trocars through potentially dangerous spaces is the wave of the future.

DR. RAZ: You need to be a pelvic surgeon, know your anatomy, and know how to manage complications if you are going to use one of these kits. You should stick to the surgery that works best in your hands. Industry cannot teach you to be a good pelvic surgeon; it takes lifelong experience.