FDA's Activities: Urogynecologic Surgical Mesh

The FDA continues to take steps to support women's health and access to safe and effective medical devices. The FDA's efforts on urogynecologic surgical mesh have focused on identifying benefit-risk concerns related to some of these devices, and strengthening the FDA's regulatory oversight to protect patients, while enabling those who need these devices to benefit from them.

FDA’s Ongoing Efforts on Urogynecologic Surgical Mesh

Reviewing and analyzing published literature, Medical Device Reports (adverse event reports), and postmarket information submitted to the FDA.
Conducting epidemiological research on the safety and effectiveness of surgical mesh, as a part of our effort to better understand possible adverse events associated with surgical mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
Collaborating with professional societies and other stakeholders to fully understand the postmarket performance of urogynecologic surgical mesh devices, and the occurrence of and signs and symptoms associated with specific adverse events including low frequency but life-altering adverse events that may occur following repairs with surgical mesh.

Summary of FDA Activities

April 11, 2024: Evaluation of Final Results of the 522 Studies for SUI Mini-Slings and the FDA’s Literature Review

The FDA’s evaluation of the final reports submitted for the completed 522 SUI Mini-Slings studies shows that SUI mini-slings are as effective as traditional mid-urethral slings over a 36-month timeframe. The SUI mini-slings also showed similar types and rates of adverse events and re-surgery compared to traditional mid-urethral slings through 36 months. More information about the 522 studies is available on the Stress Urinary Incontinence Surgical Mesh Considerations and Recommendations web page.

The FDA also completed a systematic literature review of 30 randomized controlled clinical trials published between 2013-2023 comparing the safety and effectiveness of SUI mini-slings with traditional mid-urethral slings. This review supports the conclusion that the clinical performance of SUI mini-slings is comparable to that of traditional mid-urethral slings. More information about the literature review is available on the Stress Urinary Incontinence Surgical Mesh Considerations and Recommendations web page.

The FDA will continue to consider postmarket surveillance studies (“522 studies”) for mini-slings with novel designs or technological characteristics as described in Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff.

October 17, 2022: Final Results of the Coloplast Transvaginal Mesh for Pelvic Organ Prolapse (POP) 522 study
The Coloplast devices for transvaginal repair of pelvic organ prolapse (Direct Fix A for anterior/apical repair and Direct Fix P for posterior/apical repair) are no longer commercially available. However, the FDA required the manufacturer to continue follow-up of the patients already enrolled in the Coloplast postmarket surveillance study (“522 study”), which looked at effectiveness and safety of transvaginal mesh for POP as compared to transvaginal native tissue repair (repairs without the use of mesh).

The Coloplast 522 study was completed, and the final report (36-month follow-up data) was reviewed by the FDA. The study results showed Coloplast transvaginal POP mesh had similar effectiveness and safety outcomes to native tissue repair at 36 months. The FDA continues to believe that devices of this type for transvaginal POP mesh repair present potential additional risks compared to native tissue repair, including mesh exposure and erosion. Therefore, the FDA maintains that these devices do not have a favorable benefit-risk profile.

With the completion of the Coloplast 522 study, the FDA has now reviewed all final results from the 522 orders issued for surgical mesh indicated for transvaginal repair of pelvic organ prolapse and communicated the study results publicly.

August 16, 2021: Final Results of the Boston Scientific Transvaginal Mesh for Pelvic Organ Prolapse (POP) 522 studies
The Boston Scientific devices for transvaginal repair of pelvic organ prolapse (Uphold Lite and Xenform for anterior/apical repair) are no longer commercially available. However, the FDA required the manufacturer to continue follow-up of the patients already enrolled in their postmarket surveillance studies (“522 studies”), which looked at effectiveness and safety of transvaginal mesh for POP as compared to transvaginal native tissue repair (repairs without the use of mesh).

The two Boston Scientific 522 studies were completed, and the final reports (36-month follow-up data) were reviewed by the FDA. The study results showed that Boston Scientific transvaginal POP mesh had similar effectiveness and safety outcomes to native tissue repair at 36 months. The FDA continues to believe that devices of this type for transvaginal POP mesh repair presents potential additional risks compared to native tissue repair, including mesh exposure and erosion. Therefore, the FDA maintains that these devices do not have a favorable benefit-risk profile.

April 16, 2019: Order to Stop Selling and Distributing Products
After the reclassification of surgical mesh for transvaginal repair of pelvic organ prolapse into class III, the FDA began its review of two Premarket Approval Applications (PMA) from Boston Scientific for its devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System, and a Premarket Approval Application from Coloplast for its device, Restorelle DirectFix Anterior.

The FDA decided not to approve these PMAs because the data submitted did not provide a reasonable assurance of safety and effectiveness. In particular, the data submitted were not consistent with the recommendations of the February 2019 advisory panel (see below). The FDA ordered the two manufacturers of the three mesh surgical products on the market for the transvaginal repair of pelvic organ prolapse to stop selling and distributing their products immediately. The companies subsequently withdrew their products from the market.

February 12, 2019: Obstetrics and Gynecology Devices Panel Meeting
The FDA convened an advisory committee meeting to solicit input from experts on how to evaluate the safety and effectiveness of surgical mesh for transvaginal repair of prolapse. The panel concluded that to support a favorable benefit/risk, surgical mesh for transvaginal repair of prolapse should be superior to native tissue repair at 36 months, and the safety outcomes for surgical mesh for transvaginal repair of prolapse should be comparable to native tissue repair.

July 13, 2018: Order to Stop Selling and Distributing Products
The FDA ordered the manufacturer of the last mesh surgical products on the market for the transvaginal repair of pelvic organ prolapse in the posterior compartment (rectocele) to stop selling and distributing their products. The company withdrew its product from the market.

January 5, 2016: Proposed Orders Finalized
The FDA finalized the proposed orders issued in 2014. As a result, the FDA reclassified surgical mesh for transvaginal repair of pelvic organ prolapse into class III, which require premarket approval (PMA) applications, the agency's most stringent device review pathway. The FDA mandated that premarket approval applications be filed by July 5, 2018 for any surgical mesh marketed for transvaginal pelvic organ prolapse repair. As a result of the FDA's actions, all manufacturers ceased marketing of surgical mesh intended for transvaginal repair of posterior compartment prolapse (rectocele).

April 29, 2014: Proposed Orders Issued
The FDA issued two proposed orders for surgical mesh for transvaginal pelvic organ prolapse (POP) repair that put forth changes to address the risks associated with these devices.

One order proposed to reclassify surgical for transvaginal repair of POP from class II to III.
The second order proposed to require PMA applications for these devices.

Once final, manufacturers will be required to provide clinical data in a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for transvaginal POP. Also, manufacturers of the tools specifically for implanting surgical mesh will be required to obtain premarket clearance (510(k)).

March 27, 2013: Stress Urinary Incontinence (SUI) Updates on FDA.gov
The FDA updated the Urogynecologic Surgical Mesh Implant pages on FDA.gov with additional information for patients about stress urinary incontinence (SUI). This update provided the FDA's thinking about the use of surgical mesh for repair of SUI and was based on an analysis of adverse events reported to the FDA, findings reported in the scientific literature at the time and input received from the September 9, 2011 meeting of the Obstetrics and Gynecology Devices Panel of the Medical Device Advisory Committee. This update reflected our commitment to inform the public about surgical mesh for stress urinary incontinence (SUI).

January 3, 2012: Postmarket Surveillance Studies Ordered
The FDA ordered postmarket surveillance studies ("522 studies") by manufacturers of urogynecologic surgical mesh devices to address specific safety and effectiveness concerns related to mini-sling devices for SUI and surgical mesh used for transvaginal repair of POP. For information on the status of the 522 Postmarket Surveillance Studies and the FDA's authority to order 522 studies, see 522 Postmarket Surveillance Studies Program.

As of February 17, 2013, the FDA issued:

95 postmarket study orders to 34 manufacturers of urogynecologic surgical mesh for POP; and
14 postmarket study orders to seven manufacturers of mini-slings for SUI.

Data from the studies were intended to enable the agency to better understand the safety and effectiveness profiles of these devices.

September 8-9, 2011: Obstetrics and Gynecology Devices Panel Meeting
The FDA convened the Obstetrics and Gynecology Devices Panel of the Medical Device Advisory Committee (the Panel) to discuss the safety and effectiveness of surgical mesh used to treat both SUI and POP.

Based on the Panel's deliberations, assessment of Medical Device Reports (adverse event reports) submitted to the FDA, and evaluation of the published literature, the FDA considered the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II (low- to moderate-risk devices) to Class III (high-risk devices).
The Panel also recommended that surgical mesh for SUI and surgical mesh for abdominal repair of POP remain in Class II (low- to moderate-risk devices).

In addition, the panel and the FDA’s review found:

The safety and effectiveness of multi-incision slings was well-established in clinical trials that followed patients for up to one-year. Longer follow-up data was available in the literature, but there were fewer of these long-term studies compared to studies with one-year follow-up.
The safety and effectiveness of mini-slings for female SUI had not been adequately demonstrated. At that time, it was unclear how mini-slings compare to multi-incision slings with respect to safety and effectiveness for treating SUI. Additional studies could help the agency to better understand the safety and effectiveness of these devices.
Mesh sling surgeries for SUI had been reported to be successful in approximately 70 to 80 percent of women at one year, based on women’s reports and physical exams. Similar effectiveness outcomes were reported following non-mesh SUI surgeries.
The use of mesh slings in transvaginal SUI repair was known to introduce a risk, mesh erosion (extrusion) not present in traditional non-mesh surgery for SUI repair.
At the time, erosion of mesh slings through the vagina was the most commonly reported mesh-specific complication from SUI surgeries with mesh. The average reported rate of mesh erosion at one year following SUI surgery with mesh was approximately 2 percent. Mesh erosion is sometimes treated successfully with vaginal cream or an office procedure where the exposed piece of mesh is cut. In some cases of mesh erosion, it may be necessary to return to the operating room to remove part or all of the mesh.
The long-term complications of surgical mesh sling repair for SUI reported in the literature were consistent with the adverse events reported to the FDA.
The complications associated with the use of surgical mesh slings marketed at the time for SUI repair were not linked to a single brand of mesh.

July 13, 2011: Safety Communication and Analysis Issued
The FDA provided an updated communication about serious complications associated with transvaginal placement of surgical mesh used to treat POP. For details, see UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.

The FDA also released an analysis titled Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse (PDF-252KB). The FDA previously communicated about serious complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and SUI in the October 20, 2008 FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence.

The FDA will continue to provide information to the public as it becomes available.

U.S. Food and Drug Administration

FDA's Activities: Urogynecologic Surgical Mesh

FDA’s Ongoing Efforts on Urogynecologic Surgical Mesh

Summary of FDA Activities

Additional Information