FDA Classifies Transvaginal Pelvic Mesh As “High Risk” Medical Device

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The U.S. Food and Drug Administration issued two final orders on Monday, January 4, 2016 to strengthen the data requirements for transvaginal surgical mesh devices that repair pelvic organ prolapse (POP). First, the agency reclassified mesh products designed and marketed for transvaginal treatment of POP as Class III “High Risk Devices.” Second, the FDA will now require manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

The new orders may be in response to suits filed by women injured by transvaginally placed polypropelene mesh products against mesh manufacturers, including Johnson & Johnson, Boston Scientific and Endo International. Under the new orders, the agency will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation. Particularly, the PMA process will require manufacturers of transvaginally placed POP mesh to prove their products are both safe and effective for use in the public. For devices that are already in the market, manufacturers will have thirty months to submit a PMA as required by federal law. For new surgical mesh devices, manufacturers must submit a PMA before those devices can be approved for marketing. Through the PMA process the FDA will determine if these products should be removed from the market. Even if the products are allowed to remain in the market, the FDA could require stricter warning labels.

Previously, the FDA issued safety warnings to doctors and patients about the use of surgical mesh for transvaginal POP repair in 2008 and 2011. The agency also convened an advisory panel to determine actions to take regarding transvaginal surgical mesh in 2011, and ordered manufacturers to conduct postmarket surveillance studies to address specific safety and effectiveness concerns related to transvaginal surgical mesh devices in 2012. In 2014, the FDA had even issued two proposed orders to reclassify the devices from class II to class III in order to require manufacturers to submit a PMA application instead of submitting to the less stringent 510k) approval process.

According to the orders, the announced FDA actions only apply to mesh devices marketed for the transvaginal repair of POP. Surgical mesh devices for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP, are excluded from these orders.

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