FDA warns against surgical mesh to repair pelvic problems, Boston Globe, July 13, 2011

Jul 13th, 2011 | By | Category: FDA, Media Reports, Medical News

The Boston Globe reports Wednesday, July 13, that women who have vaginal surgery to fix pelvic organ prolapse may suffer more risk than benefit. Quoting the Food and Drug Administration, the article reports patients and surgeons should consider other options.

Natick-based Boston Scientific Corp. along with several other companies will be present September 8 and 9th to meet with an expert panel convened by the FDA to determine whether to ban the mesh altogether.

With more than 100,000 women undergoing surgery every year with plastic mesh to treat a common problem, pelvic organ prolapse, the article quotes the FDA saying most can be successfully treated without mesh.

Here is the rest of the article.

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.