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
August 16, 2021: Final Results of the Boston Scientific Transvaginal Mesh for Pelvic Organ Prolapse (POP) 522 studies
The Boston Scientific and Coloplast devices for transvaginal repair of pelvic organ prolapse are no longer commercially available. However, the FDA required the manufacturers to continue follow-up of the subjects 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.
The Coloplast 522 study final report is expected in February 2022.
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 their 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 to include more information for patients about stress urinary incontinence (SUI). This update provided the FDA's current thinking about the use of surgical mesh for repair of SUI and is based on an analysis of adverse events reported to the FDA, findings reported in the scientific literature and input received from the Sept. 9, 2011 meeting of the Obstetrics and Gynecology Devices Panel of the Medical Device Advisory Committee. Additionally, the FDA is following through on 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 will enable the agency to better understand the safety and effectiveness profiles of these devices. 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 - Frequently Asked Questions (FAQs).
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 is considering 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).
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.
- Federal Register: Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair
- Federal Register: Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair
- 513(e) Proposed Order for Reclassification of Surgical Mesh for Transvaginal POP Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation
- 513(b) Proposed Order for Premarket Approval for Surgical Mesh for Transvaginal POP Repair
- Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse (PDF - 252KB)
- 2011 Meeting Materials of the Obstetrics and Gynecology Devices Panel