Posts Tagged ‘ Organ perforation ’

Shortcomings of Vaginal Mesh Do Not Add Up – Are Docs Paying Attention?

Aug 9th, 2012 | By
Shortcomings of Vaginal Mesh Do Not Add Up – Are Docs Paying Attention?

August 9, 2012, by Amy Gezon ~ In the weeks preceding the first landmark settlement against the manufacturers of surgical mesh implants used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the New England Journal of Medicine (NEJM) (here) published an article promoting the prophylactic use of mesh slings at
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Hundreds of Utah Women File Lawsuits Alleging Complications for Pelvic Implants

Jul 8th, 2012 | By
Hundreds of Utah Women File Lawsuits Alleging Complications for Pelvic Implants

~Salt Lake Tribune, July 8, 2012 “Lee” had a pelvic mesh sling implanted six years ago to treat incontinence, which was an inconvenience. But after two surgeries and continuing health complications, Lee and about 50 other Utah women have filed lawsuits alleging they are suffering “severe and permanent  bodily injuries” from the pelvic mesh devices
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J&J Continued to Sell Vaginal Mesh Implant After FDA Ordered Halt

Jun 26th, 2012 | By
J&J Continued to Sell Vaginal Mesh Implant After FDA Ordered Halt

June 26, 2012 ~ Johnson & Johnson, the global healthcare company, has once again found itself in the spotlight for failing to follow the rules. J & J was ordered to stop selling a controversial vaginal mesh product, the Gynecare Prolift,  but kept selling it even after being warned by the U.S. Food and Drug
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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.