FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse

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

Title: FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse

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FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse

04/29/2014 09:53 AM EDT

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

 

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