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# FDA Orders Stronger Data Requirements for Surgical Mesh
- URL: https://www.fdaweb.com/fda-orders-stronger-data-requirements-for-surgical-mesh/
- Published: 2016-01-04T12:00:00.000Z
- Updated: 2026-09-15T02:24:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134298

> FDA has reclassified from Class 2 to Class 3 surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The agency is also requiring these product manufacturers to now submit a PMA to support their device’s safety and effectiveness. “The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness,” an [agency notice](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says. The actions do not apply to surgical mesh for other indications, like stress urinary incontinence or abdominal repair of POP, it says.  
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> FDA says surgical mesh makers will have 30 months to submit a PMA for devices that are already on the market. Manufacturers of new devices must submit a PMA before those devices can be approved for marketing.  
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> The new requirements address an increase over the past several years in adverse events associated with the use of surgical mesh for transvaginal POP repair. They follow recommendations made by a 2011 advisory panel that called for more data to establish the safety of such devices.