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Clinical Obstetrics & Gynecology:
doi: 10.1097/GRF.0b013e318282f2d7
Devices and Meshes for the Surgical Treatment of Prolapse and Incontinence

Approval Process for Devices and Mesh for Surgical Treatment of Pelvic Organ Prolapse and Urinary Incontinence

NYGAARD, INGRID MD, MS

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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.

© 2013, Lippincott Williams & Wilkins

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