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Vaginal Mesh Controversy Targets Manufacturers and FDA Approval Process

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One of the nearly 270 lawsuits filed against Johnson & Johnson, and the 600 filed against J&J as well as C.R. Bard, Boston Scientific, and American Medical Systems regarding transvaginal mesh devices, says that U.S. regulators failed consumers by not requiring extensive testing before allowing the manufacturers to put the surgical mesh implanted in the nearly 70,000 American women last year on the market.

The mesh has prompted 1503 reports of injury or malfunction from 2008 to 2010 in women who had the mesh implanted to correct pelvic organ prolapse.

Marci Sutin Levin says that after her 2007 implantation of the mesh she is unable to sleep through the night, have sex with her husband, or work because of the endless pain.

Last week, an advisory panel agreed with the FDA that the mesh should be reclassified as a high risk device, which would prompt testing to show efficacy and safety.

Attorneys are expecting a large surge in transvaginal mesh lawsuits because of the FDA notification. These lawsuits represent the growing concern regarding the FDA fast-track program that allows medical devices to streamline through the approval process if they show they are ‘substantially equivalent’ to existing products.



through their marketing and advertising campaigns, urged women to use Yaz/Yasmin instead of birth control pills that present a safer alternative,” the suit states.

The plaintiffs say in the lawsuit that if they had known about the dangers of Yaz, they would not have taken it. The lawsuit seeks actual and compensatory damages, plus costs, pre-and post-judgment interest, attorneys’ fees, punitive damages more than twice the compensatory damages and other relief the court deems just, the Madison Record reported. disclaimer: This article: Vaginal Mesh Controversy Targets Manufacturers and FDA Approval Process was posted on Friday, September 16th, 2011 at 7:31 pm at and is filed under Medical Device Lawsuits.

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