FDA directs urogynecologic mesh companies to study safety and effectiveness; recommendations for clinicians unchanged.
For release: January 5, 2012, 12:00 PM
On January 4, 2012, the U.S. Food and Drug Administration (FDA) announced a new action requiring manufacturers of urogynecologic surgical mesh devices to complete postmarket surveillance studies to assess the safety and effectiveness of these products. The FDA issued 88 postmarket study orders to 33 manufacturers of urogynecologic surgical mesh for pelvic organ prolapse and 11 postmarket study orders to seven manufacturers of single-incision mini-slings for stress urinary incontinence. The FDA action can be accessed here.
Section 522 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360l, authorizes FDA to require a manufacturer to conduct postmarket surveillance of a class II or class III device that meets any of the following criteria: (1) its failure would be reasonably likely to have serious adverse health consequences; (2) it is expected to have significant use in pediatric populations' (3) it is intended to be implanted in the body for more than one year; or (4) it is intended to be a life-sustaining or life-supporting device used outside a device user facility. Urogynecologic mesh was found to meet criteria 1 and 3.
Recommendations for clinicians have NOT changed. The current recommendations for providers can be accessed here. The College’s Committee Opinion No. 513, “Vaginal Placement of Synthetic Mesh for Pelvic Organ Prolapse,” (December 2011) can be found here.
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. If mesh is reclassified to Class III, FDA would require manufacturers to file a premarket approval application (PMA) with clinical data on safety and effectiveness. The College will continue to monitor this issue for any additional announcements from the FDA.