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FDA's Activities: Urogynecologic Surgical Mesh

FDA's Activities: Urogynecologic Surgical Mesh

The FDA continues to take steps to assure 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 including:

  • 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 SUI and 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 both SUI and POP repair with surgical mesh.

A summary of FDA activities to date include:

On April 16, 2019, the FDA ordered the two manufacturers of the three mesh surgical products on the market for the transvaginal repair of pelvic organ prolapse in the anterior/apical compartment (cystocele) to stop selling and distributing their products immediately. The companies must withdraw their products from the market.

On February 12, 2019, 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.

On July 13, 2018, 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.

On January 6, 2017, the FDA issued the final order reclassifying instrumentation for use with urogynecology surgical mesh from class II to III, requiring submission of 510(k)s for these devices.

On January 5, 2016, 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).

On April 29, 2014, 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, and 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)).

On March 27, 2013 the FDA updated the Urogynecologic Surgical Mesh Implant website to include more information for patients about stress urinary incontinence (SUI). This update provides 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).

On January 03, 2012, 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. This order was based on the FDA's evaluation of the published literature, analysis of adverse events reported to the FDA and feedback from the Obstetrics and Gynecology Devices Panel of the Medical Device Advisory Committee.

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, visit the 522 website.

On September 8-9, 2011, 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).

On July 13, 2011, the FDA provided an updated communication about serious complications associated with transvaginal placement of surgical mesh used to treat POP (FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.) At this time, the FDA also released an analysis titled "Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse." 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: 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.

Additional Information