The Next Medical Device Controversy: Vaginal Mesh, Business Week, September 15, 2011

Sep 26th, 2011 | By | Category: Media Reports

Business Week reports on The Next Medical Device Controversy: Vaginal Mesh

Marci Sutin Levin, a 65-year-old New York marketing executive says she can’t sleep, work, or have sex because of endless pain she’s experienced ever since she had surgical mesh implanted in 2007. Hers is one of 600 lawsuits that have been filed against mesh makers Johnson & Johnson, C.R. Bard, Boston Scientific, and American Medical Systems, acquired in June by Endo Pharmaceutical Holdings. Levin’s is one of 270 lawsuits filed against JNJ alone.

On July 13, 2011, the FDA warned of a five-fold increase in complications following the implantation of vaginal mesh for treatment of pelvic organ prolapse and urinary incontinence. An FDA expert panel agreed with a staff report the agency should reclassify synthetic mesh to a high risk medical device which would require premarket approval, currently not required.

About 300,000 women in the U.S. had pelvic organ prolapse surgeries last year, including more than 70,000 who received vaginal meshes.

So far, none of the cases have gone to trial, and women must prove their claims that mesh makers knew of safety risks and failed to disclose them and that the products were defective.

The reporters talk to Mike Matson, an analyst at Mizuho Securities USA says JNJ is the leader followed by American Medical Systems, Boston Scientific, and Bard. Mesh products represent no more than 2% of any manufacturer’s sales. #

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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.