FDA Proposes Transvaginal Mesh Device Reclassification

The FDA has issued two proposed orders regarding surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) and health risks associated with this product. The orders propose reclassifying surgical mesh for transvaginal POP from a class II (moderate-risk) device to a class III (high-risk) device that would require a premarketing approval (PMA) application from manufacturers for safety and efficacy analysis.

The medical device surgical mesh is used to treat POP by providing additional support to weakened or damaged tissue due to pelvic organs dropping from their normal position and prolapsing into the vagina. The FDA issued an updated safety alert in July 2011 addressing potential serious complications associated with surgical mesh placed transvaginally to treat POP, along with a review of urogynecological surgical mesh safety and efficacy. In September 2011, an FDA advisory panel recommended that surgical mesh for transvaginal POP become a class III device and in January 2012, postmarket safety and efficacy surveillance studies were mandated for urogynecologic surgical mesh device manufacturers.

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Comments on the proposed order will be accepted for 90 days.

For more information call (888) 463-6332 or visit FDA.gov.