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# FDA Halts Sales of Transvaginal Mesh Repair Products
- URL: https://www.fdaweb.com/fda-halts-sales-of-transvaginal-mesh-repair-products/
- Published: 2019-04-16T12:00:00.000Z
- Updated: 2026-09-15T01:20:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143875

FDA has ordered manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to immediately stop selling and distributing the products in the U.S. An agency [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM636114.htm?utm%5Fcampaign=04162019%5FPR%5FFDA%20takes%20action%20on%20tranvaginal%20mesh%20for%20POP%20repair&utm%5Fmedium=email&utm%5Fsource=Eloqua) says it has determined that the products’ manufacturers—Boston Scientific and Coloplast—have not demonstrated a reasonable assurance of safety and effectiveness for the devices, which is the premarket review standard that has applied to them since their 2016 reclassification to Class 3.

As part of the reclassification, the statement says, manufacturers were required to submit and obtain approval of PMA applications to continue marketing the devices in the U.S. The companies were given 10 days to submit a plan to withdraw the products from the market.

“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,” says CDRH director **Jeffrey Shuren**. “That evidence was lacking in these premarket applications and we couldn’t assure women that these devices were safe and effective long-term.”

The statement contains a chronology of FDA actions on the issue from its 7/2011 safety communication through a 2/12 advisory committee meeting.