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PMA Mandate Set For Pelvic Organ Prolapse Transvaginal Mesh

FDA issued final orders up-classifying surgical mesh for transvaginal repair of pelvic organ prolapse from class II to class III and calling for PMA standards, including clinical trial, animal studies, and materials testing data from new and existing manufacturers.

Existing manufacturers of transvaginal surgical mesh for pelvic organ prolapse procedures, including Boston Scientific Corp., ACell Inc., Coloplast AS, and American Medical Systems Holdings Inc., will have to file for PMAs in 30 months to keep their mesh products on the market, says FDA in a Jan. 4 final order

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