Transvaginal mesh results in pain, injury and lawsuits

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Thousands of women receiving transvaginal mesh surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are now suffering from pain, bleeding, infection and other major complications. Many of the women injured by this product say that the conditions leading to their surgeries were nothing compared to the pain and suffering they experience after being treated with transvaginal mesh.

The implants are manufactured by a number of companies, including:

American Medical Systems: Sold under the names Elevate, Perigee and Apogee

Boston Scientific: Sold under the names Advantage Transvaginal Mid-Urethral Sling System, Pinnacle Posterior Pelvic Floor Repair Kit, Obtryx Transobturator Mid-Urethral Sling System, Polyform Synthetic Mesh, Prefyx Mid U Mesh Sling System, Prefyx PPS System, Uphold Vaginal Support System

C.R. Bard, Inc.: Sold under the names Avaulta, Pelvisoft BioMesh, Pelivicol Acellular Collagen Matrix, Pelvitext, and Pelvilace

Johnson & Johnson/Ethicon: Sold under the names Gynecare, Gynemesh, Gynecare Prolift, Gynecare Prolift+M, Gynecare Prosima and Gynecare TVT

The Food & Drug Administration allowed transvaginal mesh implants to be approved without the need of thorough clinical human trials to prove their safety prior to putting the product on the market. Manufacturers only needed to show a product was “substantially equivalent” to another product already approved by the agency. However, the FDA has been conducting a safety review of transvaginal mesh since 2008, after reports of complications linked to the products increased. This past January, the FDA asked manufacturers of the mesh to conduct post-market safety studies of their products. The agency is now considering moving transvaginal mesh for POP repair to a higher risk medical device category.

Since the FDA issued its first transvaginal mesh warning in 2008, suits have been filed against the makers of the devices alleging the products caused serious and painful injuries. Plaintiffs claim the device makers underreported problems and withheld information about the complications related to the pelvic mesh products.

If you or anyone you know has been injured due to transvaginal mesh surgical implants, call Harmon Smith & Vourvoulias today at 504-717-2093 for a free case evaluation. Our experienced medical malpractice attorneys are available to provide you with the help you need to protect your rights.

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By George Vourvoulias

George is a founding member and managing member of Harmon, Smith & Vourvoulias L.L.C., a New Orleans law firm. George concentrates his practice in maritime personal injury, construction litigation, personal injury, workers' compensation, medical malpractice, and DUI defense. George Vourvoulias's Google+ Profile