FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

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FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

01/04/2016 09:44 AM EST

The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

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