Approval process for devices and mesh for surgical treatment of pelvic organ prolapse and urinary incontinence - Abstract

Most marketed devices in the United States, including most used to treat prolapse and incontinence, are marketed without FDA approval; instead, they gain "clearance" as a class II device through premarket notification [also known as the 510(k) process].

Under this process, the manufacturer states that the device is substantially equivalent to one already on the market. Thus, mesh kits for prolapse and incontinence were not required to undergo clinical testing before reaching the market. In January 2012, the FDA announced that it would require postmarket surveillance studies to address safety and effectiveness of mesh kits for prolapse and for single-incision slings.

Written by:
Nygaard I.   Are you the author?
Department of Obstetrics and Gynecology, Division of Urogynecology and Reconstructive Pelvic Surgery, University of Utah School of Medicine, Salt Lake City, Utah.

Reference: Clin Obstet Gynecol. 2013 Jun;56(2):229-31.
doi: 10.1097/GRF.0b013e318282f2d7

PubMed Abstract
PMID: 23632639 Trauma & Reconstruction Section