Amid Public Uproar, FDA Mulls Risk Upgrade For Controversial Pelvic Mesh

Published: Apr 30, 2014

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The FDA today issued a pair of proposed orders that would increase regulatory oversight of controversial pelvic mesh products, responding to a long-running public uproar about the implants' potential for harm to women.

If finalized, the orders would bump the surgical mesh, used for transvaginal repair of pelvic organ prolapse, from the lower-risk class II up to class III devices, requiring that manufacturers submit premarket approval applications for evaluation by the FDA. The agency today opened up a 90-day comment period on the proposal.

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