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FDA Panel to Tighten Up Approval Process for Transvaginal Mesh

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Washington, DCA Food and Drug Administration (FDA) advisory panel ruled Thursday to back plans by the FDA to establish pre-approval study protocols for new transvaginal mesh (TVM) products. Transvaginal surgical mesh is used to treat pelvic-organ prolapse and its manufacturers include Johnson & Johnson, C.R. Bard Inc., and Boston Scientific.

Currently, transvaginal mesh is approved – or not – without supporting data from new research. The advisory panel also backed plans by the FDA to change this situation, so that manufacturers would have to generate new research – pre approval studies – on the safety and efficacy of their products. As well, products that are currently approved and available on the market would require new research.

The FDA is taking renewed interest in transvaginal mesh following numerous reports of injury, and the Wall Street Journal reports, as many as seven deaths that may be linked to these products.


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