Medical Devices

FDA’s Role and Activities

The FDA continues to assess the safety and effectiveness of urogynecologic surgical mesh devices. Specifically, the FDA has:

  • Reviewed and analyzed published literature, Medical Device Reports (adverse event reports) submitted to the FDA, and postmarket information submitted to the FDA.
  • Conducted 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.
  • Collaborated 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.

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 Jan. 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 Feb. 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 Sept. 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 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 provide additional information to the public as it becomes available.

Page Last Updated: 10/21/2013
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