FDA Orders Bard, Others To Study Surgical Mesh Implants

Law360, New York (January 4, 2012, 7:23 PM EST) -- The U.S. Food and Drug Administration has ordered Boston Scientific Corp., C.R. Bard Inc. and 31 other companies to conduct post-market studies of surgical mesh used in vaginal surgeries amid concerns over complications such as fistulas, the agency said Wednesday.

The agency said that it had sent letters to the 33 manufacturers of urogynecologic surgical mesh devices on Tuesday ordering them to conduct 88 post-market surveillance studies, known as 522 studies, to help the FDA better understand adverse events associated with the devices.

Failure of these...
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