Transvaginal Mesh Lawsuit - Call Today 1.877.779.1414





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Published on Dec 20, 2011

Transvaginal Mesh Lawsuit - Free Case Evaluation: 1.877.779.1414

Visit our website for more information: http://consumerinjurylawyers.com/vagi...

Call today for a Free and Confidential Case Evaluation: 1.877.779.1414

Transvaginal Mesh, also referred to as TVM or pelvic mesh, was touted as a solution for thousands of women suffering from Pelvic Organ Prolapse or Stress Urinary Incontinence.

Unfortunately, thousands of these women are now suffering complications from these products that are far more painful and problematic than the original conditions for which they sought treatment.

So, what went wrong and how were these defective devices brought to market in the first place?

• Beginning in 1996 and continuing through 2008, several manufacturers of surgical mesh received clearance from the Food and Drug Administration (the FDA) to market and sell their mesh products for use in pelvic floor repair, pelvic organ prolapse, and stress urinary incontinence surgical procedures.

These products were approved based on their prior history of use in other parts of the body (e.g., to repair hernias) but were never adequately tested for safety for use in transvaginal surgeries.

• In 1999: Boston Scientific recalled approximately 20,000 ProtoGen mesh units after receiving reports of medical complications, including pain during intercourse and erosion of vaginal tissue. Notwithstanding the recall, the FDA continued to clear virtually identical mesh products for use in transvaginal surgeries.

• Between 2005 and 2008: The FDA received more than 1,000 reports from nine manufacturers of complications stemming from surgical mesh devices used to treat pelvic organ prolapse.

• By 2008: The FDA issued a health alert cautioning doctors about the risks associated with transvaginal mesh. At this time, the FDA stated that mesh complications were "rare."

• Subsequently, between 2008 and 2010: The FDA received over 2,800 reports of complications associated with transvaginal mesh procedures.

• In August 2010: The Journal of the American College of Obstetricians and Gynecologists published a study concluding that there is a high vaginal mesh erosion rate associated with Prolifit, a mesh product manufactured by Ethicon, a Johnson & Johnson company.

• About a year later, in July 2011: The FDA issued a warning regarding the high incidence of complications associated with transvaginal mesh when used for the treatment of pelvic organ prolapse. The FDA warning specified that the complications are not linked to a single brand of mesh.

• Shortly thereafter in September 2011: The Obstetrics and Gynecology Devices advisory panel to the FDA recommened that transvaginal mesh be reclassified so that manufacturers will have to undergo rigorous clinical testing in order to receive FDA approval for their products. The panel supported the FDA's plans to require more pre-market approval studies for new transvaginal mesh devices.

• Today, transvaginal mesh manufacturers are currently defending thousands of lawsuits nationwide filed by individuals who were injured as a result of surgical mesh implants. These lawsuits involve a variety of mesh products, including but not limited to products manufactured by AMS, Boston Scientific, C.R. Bard and Johnson & Johnson:

o American Medical Systems: Sold under the names Elevate, Perigee and Apogee.
o Boston Scientific: Sold under the names Pinnacle and Uphold.
o C.R. Bard, Inc.: Sold under the names Avaulta, Pelvisoft BioMesh, Pelivicol Acellular Collagen Matrix, Pelvitext, and Pelvilace.
o Johnson & Johnson/Ethicon: Sold under the names Gynecare, Gynemesh, Gynecare Prolift, Gynecare Prolift+M, Gynecare Prosima and Gynecare TVT.

If you've been implanted with a transvaginal mesh product and are experiencing complications, call the lawyers at Bernstein Liebhard LLP today for a free and confidential consultation concerning your legal rights. We've spoken to hundreds of women and understand the sensitive and difficult issues involved. We are actively involved in litigating these cases and would be happy to answer any questions you may have.



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