Transvaginal Mesh Help Center

Transvaginal Mesh Help Center The FDA has announced stronger regulations on transvaginal mesh and has reclassified the device as

January 2016: The FDA has announced stronger regulations on transvaginal mesh and has reclassified the device as “high risk.” Manufacturers are now required to submit a premarket approval (PMA) application that supports the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

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