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Transvaginal mesh hysteropexy for symptomatic uterovaginal prolapse may not significantly reduce treatment failure after 3 years, compared with vaginal hysterectomy with uterosacral ligament suspension, according to randomized trial results.
Nevertheless, “the point estimate favored hysteropexy,” the study authors wrote in JAMA. The 36-month cumulative treatment failure outcomes – defined as retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms – were 33% for patients who underwent hysteropexy, compared with 42% for patients who underwent hysterectomy. In addition, mean operative time was 45 minutes less for patients who underwent hysteropexy.
The publication follows the Food and Drug Administration’s ruling in April 2019 that manufacturers must cease marketing transvaginal mesh kits for repair of anterior or apical compartment prolapse. The investigators plan to continue evaluating patient outcomes to 5 years, and they noted that longer follow-up may lead to different conclusions.
From a class II device to class III
Surgical repair of uterovaginal prolapse is common. Although vaginal hysterectomy is the procedure of choice for many surgeons, “uterine-sparing suspension techniques ... are increasing in usage,” wrote Charles W. Nager, MD, chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, and coauthors. However, few high-quality, long-term studies have compared apical transvaginal mesh with native tissue procedures.
The FDA first approved a mesh device for transvaginal repair of prolapse in 2002. In 2008, the agency notified clinicians and patients about an increase in adverse event reports related to vaginal mesh. It later advised that mesh for the treatment of pelvic organ prolapse does not conclusively improve clinical outcomes and that serious adverse events are not rare.
In 2016, the FDA reclassified surgical mesh to repair pelvic organ prolapse transvaginally as high risk, citing safety concerns such as severe pelvic pain and organ perforation. And in April 2019, the FDA ordered companies to stop selling transvaginal mesh intended for pelvic organ prolapse repair. “Even though these products can no longer be used in patients moving forward, [manufacturers] are required to continue follow-up” of patients in post–market surveillance studies, the FDA said in a statement.
An FDA panel had concluded that 3-year outcomes for prolapse repair with mesh should be better than the outcomes for repair with native tissue, and that the procedures should have comparable safety profiles.
The SUPeR trial
To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy, Dr. Nager and colleagues conducted the Study of Uterine Prolapse Procedures Randomized (SUPeR) trial.
Researchers enrolled 183 postmenopausal women with symptomatic uterovaginal prolapse undergoing surgical intervention at nine sites between April 2013 and February 2015. Investigators randomized 93 women to undergo vaginal mesh hysteropexy and 90 to undergo vaginal hysterectomy with uterosacral ligament suspension. Hysteropexy used the UpholdLITE transvaginal mesh support system (Boston Scientific). Uterosacral ligament suspension required one permanent and one delayed absorbable suture on each side. The primary analysis included data from 175 patients.
Compared with hysterectomy, hysteropexy resulted in an adjusted hazard ratio of treatment failure of 0.62 after 3 years, which was not statistically significant (P = .06). The 95% confidence interval of 0.38-1.02 “was wide and only slightly crossed the null value,” the researchers said. “The remaining uncertainty is too great” to establish or rule out the benefit of vaginal mesh hysteropexy.
Mean operative time was about 45 minutes shorter in the hysteropexy group versus the hysterectomy group (111.5 minutes vs. 156.7 minutes). Adverse events in the hysteropexy versus hysterectomy groups included mesh exposure (8% vs. 0%), ureteral kinking managed intraoperatively (0% vs. 7%), excessive granulation tissue after 12 weeks (1% vs. 11%), and suture exposure after 12 weeks (3% vs. 21%).
“Both groups reported improvements in sexual function, and dyspareunia and pain and de novo dyspareunia rates were low,” Dr. Nager and colleagues wrote. “All other complications with long-term sequelae were not different between groups.”
“Patients in the current study are being followed up for 60 months and the results and conclusions at 36 months could change with extended follow-up,” they added.
A role for mesh?
“The report ... by Nager and colleagues is particularly timely and important,” Cynthia A. Brincat, MD, PhD, wrote in an accompanying editorial. Dr. Brincat is affiliated with the division of female pelvic medicine and reconstructive surgery at Rush Medical College, Chicago.
Although the mesh exposures, granulation tissue, or suture exposures during the trial did not require reoperation, “management of these adverse events was not described,” the editorialist noted. “Clinically important differences could exist between the management of these reported adverse events.”
Based on the findings, gynecologic surgeons “will need to reconsider several important questions regarding the repair of pelvic organ prolapse. For instance, is hysterectomy a necessary component for the repair? What is the role of mesh, and can its use reduce the use of otherwise unnecessary procedures (i.e., hysterectomy) without increasing risk to patients?” she wrote. Other questions center on what constitutes operative failure and how surgeons should augment prolapse repair.
“This study also provides a potential new and well-defined role for the use of mesh in pelvic prolapse surgery, with no significant difference, and perhaps some benefit (i.e., no hysterectomy), compared with a native tissue repair,” Dr. Brincat wrote. “The study also provides useful information for shared decision-making discussions between patients and gynecologic surgeons with respect to selection of procedures and use of mesh for treatment of women with symptomatic uterovaginal prolapse undergoing vaginal surgery.”
The trial was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Boston Scientific provided support through an unrestricted grant. One author reported stock ownership in a medical device company, and others reported grants from medical device companies outside the submitted work. Dr. Brincat reported no conflicts of interest.
SOURCES: Nager CW et al. JAMA. 2019 Sep 17;322(11):1054-65; Brincat CA. JAMA. 2019 Sep 17;322(11):1047-8.
Transvaginal mesh hysteropexy for symptomatic uterovaginal prolapse may not significantly reduce treatment failure after 3 years, compared with vaginal hysterectomy with uterosacral ligament suspension, according to randomized trial results.
Nevertheless, “the point estimate favored hysteropexy,” the study authors wrote in JAMA. The 36-month cumulative treatment failure outcomes – defined as retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms – were 33% for patients who underwent hysteropexy, compared with 42% for patients who underwent hysterectomy. In addition, mean operative time was 45 minutes less for patients who underwent hysteropexy.
The publication follows the Food and Drug Administration’s ruling in April 2019 that manufacturers must cease marketing transvaginal mesh kits for repair of anterior or apical compartment prolapse. The investigators plan to continue evaluating patient outcomes to 5 years, and they noted that longer follow-up may lead to different conclusions.
From a class II device to class III
Surgical repair of uterovaginal prolapse is common. Although vaginal hysterectomy is the procedure of choice for many surgeons, “uterine-sparing suspension techniques ... are increasing in usage,” wrote Charles W. Nager, MD, chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, and coauthors. However, few high-quality, long-term studies have compared apical transvaginal mesh with native tissue procedures.
The FDA first approved a mesh device for transvaginal repair of prolapse in 2002. In 2008, the agency notified clinicians and patients about an increase in adverse event reports related to vaginal mesh. It later advised that mesh for the treatment of pelvic organ prolapse does not conclusively improve clinical outcomes and that serious adverse events are not rare.
In 2016, the FDA reclassified surgical mesh to repair pelvic organ prolapse transvaginally as high risk, citing safety concerns such as severe pelvic pain and organ perforation. And in April 2019, the FDA ordered companies to stop selling transvaginal mesh intended for pelvic organ prolapse repair. “Even though these products can no longer be used in patients moving forward, [manufacturers] are required to continue follow-up” of patients in post–market surveillance studies, the FDA said in a statement.
An FDA panel had concluded that 3-year outcomes for prolapse repair with mesh should be better than the outcomes for repair with native tissue, and that the procedures should have comparable safety profiles.
The SUPeR trial
To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy, Dr. Nager and colleagues conducted the Study of Uterine Prolapse Procedures Randomized (SUPeR) trial.
Researchers enrolled 183 postmenopausal women with symptomatic uterovaginal prolapse undergoing surgical intervention at nine sites between April 2013 and February 2015. Investigators randomized 93 women to undergo vaginal mesh hysteropexy and 90 to undergo vaginal hysterectomy with uterosacral ligament suspension. Hysteropexy used the UpholdLITE transvaginal mesh support system (Boston Scientific). Uterosacral ligament suspension required one permanent and one delayed absorbable suture on each side. The primary analysis included data from 175 patients.
Compared with hysterectomy, hysteropexy resulted in an adjusted hazard ratio of treatment failure of 0.62 after 3 years, which was not statistically significant (P = .06). The 95% confidence interval of 0.38-1.02 “was wide and only slightly crossed the null value,” the researchers said. “The remaining uncertainty is too great” to establish or rule out the benefit of vaginal mesh hysteropexy.
Mean operative time was about 45 minutes shorter in the hysteropexy group versus the hysterectomy group (111.5 minutes vs. 156.7 minutes). Adverse events in the hysteropexy versus hysterectomy groups included mesh exposure (8% vs. 0%), ureteral kinking managed intraoperatively (0% vs. 7%), excessive granulation tissue after 12 weeks (1% vs. 11%), and suture exposure after 12 weeks (3% vs. 21%).
“Both groups reported improvements in sexual function, and dyspareunia and pain and de novo dyspareunia rates were low,” Dr. Nager and colleagues wrote. “All other complications with long-term sequelae were not different between groups.”
“Patients in the current study are being followed up for 60 months and the results and conclusions at 36 months could change with extended follow-up,” they added.
A role for mesh?
“The report ... by Nager and colleagues is particularly timely and important,” Cynthia A. Brincat, MD, PhD, wrote in an accompanying editorial. Dr. Brincat is affiliated with the division of female pelvic medicine and reconstructive surgery at Rush Medical College, Chicago.
Although the mesh exposures, granulation tissue, or suture exposures during the trial did not require reoperation, “management of these adverse events was not described,” the editorialist noted. “Clinically important differences could exist between the management of these reported adverse events.”
Based on the findings, gynecologic surgeons “will need to reconsider several important questions regarding the repair of pelvic organ prolapse. For instance, is hysterectomy a necessary component for the repair? What is the role of mesh, and can its use reduce the use of otherwise unnecessary procedures (i.e., hysterectomy) without increasing risk to patients?” she wrote. Other questions center on what constitutes operative failure and how surgeons should augment prolapse repair.
“This study also provides a potential new and well-defined role for the use of mesh in pelvic prolapse surgery, with no significant difference, and perhaps some benefit (i.e., no hysterectomy), compared with a native tissue repair,” Dr. Brincat wrote. “The study also provides useful information for shared decision-making discussions between patients and gynecologic surgeons with respect to selection of procedures and use of mesh for treatment of women with symptomatic uterovaginal prolapse undergoing vaginal surgery.”
The trial was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Boston Scientific provided support through an unrestricted grant. One author reported stock ownership in a medical device company, and others reported grants from medical device companies outside the submitted work. Dr. Brincat reported no conflicts of interest.
SOURCES: Nager CW et al. JAMA. 2019 Sep 17;322(11):1054-65; Brincat CA. JAMA. 2019 Sep 17;322(11):1047-8.
Transvaginal mesh hysteropexy for symptomatic uterovaginal prolapse may not significantly reduce treatment failure after 3 years, compared with vaginal hysterectomy with uterosacral ligament suspension, according to randomized trial results.
Nevertheless, “the point estimate favored hysteropexy,” the study authors wrote in JAMA. The 36-month cumulative treatment failure outcomes – defined as retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms – were 33% for patients who underwent hysteropexy, compared with 42% for patients who underwent hysterectomy. In addition, mean operative time was 45 minutes less for patients who underwent hysteropexy.
The publication follows the Food and Drug Administration’s ruling in April 2019 that manufacturers must cease marketing transvaginal mesh kits for repair of anterior or apical compartment prolapse. The investigators plan to continue evaluating patient outcomes to 5 years, and they noted that longer follow-up may lead to different conclusions.
From a class II device to class III
Surgical repair of uterovaginal prolapse is common. Although vaginal hysterectomy is the procedure of choice for many surgeons, “uterine-sparing suspension techniques ... are increasing in usage,” wrote Charles W. Nager, MD, chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, and coauthors. However, few high-quality, long-term studies have compared apical transvaginal mesh with native tissue procedures.
The FDA first approved a mesh device for transvaginal repair of prolapse in 2002. In 2008, the agency notified clinicians and patients about an increase in adverse event reports related to vaginal mesh. It later advised that mesh for the treatment of pelvic organ prolapse does not conclusively improve clinical outcomes and that serious adverse events are not rare.
In 2016, the FDA reclassified surgical mesh to repair pelvic organ prolapse transvaginally as high risk, citing safety concerns such as severe pelvic pain and organ perforation. And in April 2019, the FDA ordered companies to stop selling transvaginal mesh intended for pelvic organ prolapse repair. “Even though these products can no longer be used in patients moving forward, [manufacturers] are required to continue follow-up” of patients in post–market surveillance studies, the FDA said in a statement.
An FDA panel had concluded that 3-year outcomes for prolapse repair with mesh should be better than the outcomes for repair with native tissue, and that the procedures should have comparable safety profiles.
The SUPeR trial
To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy, Dr. Nager and colleagues conducted the Study of Uterine Prolapse Procedures Randomized (SUPeR) trial.
Researchers enrolled 183 postmenopausal women with symptomatic uterovaginal prolapse undergoing surgical intervention at nine sites between April 2013 and February 2015. Investigators randomized 93 women to undergo vaginal mesh hysteropexy and 90 to undergo vaginal hysterectomy with uterosacral ligament suspension. Hysteropexy used the UpholdLITE transvaginal mesh support system (Boston Scientific). Uterosacral ligament suspension required one permanent and one delayed absorbable suture on each side. The primary analysis included data from 175 patients.
Compared with hysterectomy, hysteropexy resulted in an adjusted hazard ratio of treatment failure of 0.62 after 3 years, which was not statistically significant (P = .06). The 95% confidence interval of 0.38-1.02 “was wide and only slightly crossed the null value,” the researchers said. “The remaining uncertainty is too great” to establish or rule out the benefit of vaginal mesh hysteropexy.
Mean operative time was about 45 minutes shorter in the hysteropexy group versus the hysterectomy group (111.5 minutes vs. 156.7 minutes). Adverse events in the hysteropexy versus hysterectomy groups included mesh exposure (8% vs. 0%), ureteral kinking managed intraoperatively (0% vs. 7%), excessive granulation tissue after 12 weeks (1% vs. 11%), and suture exposure after 12 weeks (3% vs. 21%).
“Both groups reported improvements in sexual function, and dyspareunia and pain and de novo dyspareunia rates were low,” Dr. Nager and colleagues wrote. “All other complications with long-term sequelae were not different between groups.”
“Patients in the current study are being followed up for 60 months and the results and conclusions at 36 months could change with extended follow-up,” they added.
A role for mesh?
“The report ... by Nager and colleagues is particularly timely and important,” Cynthia A. Brincat, MD, PhD, wrote in an accompanying editorial. Dr. Brincat is affiliated with the division of female pelvic medicine and reconstructive surgery at Rush Medical College, Chicago.
Although the mesh exposures, granulation tissue, or suture exposures during the trial did not require reoperation, “management of these adverse events was not described,” the editorialist noted. “Clinically important differences could exist between the management of these reported adverse events.”
Based on the findings, gynecologic surgeons “will need to reconsider several important questions regarding the repair of pelvic organ prolapse. For instance, is hysterectomy a necessary component for the repair? What is the role of mesh, and can its use reduce the use of otherwise unnecessary procedures (i.e., hysterectomy) without increasing risk to patients?” she wrote. Other questions center on what constitutes operative failure and how surgeons should augment prolapse repair.
“This study also provides a potential new and well-defined role for the use of mesh in pelvic prolapse surgery, with no significant difference, and perhaps some benefit (i.e., no hysterectomy), compared with a native tissue repair,” Dr. Brincat wrote. “The study also provides useful information for shared decision-making discussions between patients and gynecologic surgeons with respect to selection of procedures and use of mesh for treatment of women with symptomatic uterovaginal prolapse undergoing vaginal surgery.”
The trial was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Boston Scientific provided support through an unrestricted grant. One author reported stock ownership in a medical device company, and others reported grants from medical device companies outside the submitted work. Dr. Brincat reported no conflicts of interest.
SOURCES: Nager CW et al. JAMA. 2019 Sep 17;322(11):1054-65; Brincat CA. JAMA. 2019 Sep 17;322(11):1047-8.
FROM JAMA