January 4, 2012

FDA issues 522 orders for postmarket surveillance studies for transvaginal mesh devices for POP and single-incision mini-slings for SUI.

UPDATE:

• Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.

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

• Review and analysis of published literature, Medical Device Reports (adverse event reports) submitted to the agency, and post-approval study reports.
• Epidemiological research on 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.
• Collaborations with professional societies and other stakeholders to fully understand the postmarket performance of urogynecologic surgical mesh devices, as well as the occurrence of and signs and symptoms associated with specific adverse events.
• Collecting and reviewing all available information about currently marketed urogynecologic surgical mesh devices.
• Mandating postmarket surveillance studies (“522 studies”) by manufacturers of urogynecologic surgical mesh devices. On January 03, 2012, the FDA issued:
• 88 postmarket study orders to 33 manufacturers of urogynecologic surgical mesh for POP; and
• 11 postmarket study orders to seven manufacturers of single-incision mini-slings for SUI.

The manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for POP and single-incision mini-sling devices 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.

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

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm2025152.htm