Tennessee Woman Implanted with Gynecare Prolift Files Lawsuit Alleging the Transvaginal Mesh Implant Caused Permanent Injuries, Physical Deformity

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Parker Waichman LLP has filed a lawsuit on behalf of a Blount County, Tennessee woman who was implanted with Johnson & Johnson’s Gynecare Prolift Total Pelvic Floor Repair System to correct her pelvic organ prolapse (POP) and stress urinary incontinence (SUI). According to this lawsuit, the risks of this device far outweigh any potential benefits.

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Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit on behalf of a woman who alleges that her injuries were a direct result of a transvaginal mesh implant manufactured by Ethicon, a Johnson & Johnson subsidiary. The suit was filed on July 12th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-03129) where it is one of many cases pending in the multidistrict litigation entitled In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2327). Ethicon, Inc., Ethicon Women’s Health and Urology, Gynecare and Johnson & Johnson have been named as Defendants.

According to the Complaint, the Plaintiff received the Gynecare Prolift Total Pelvic Floor Repair System in December 2008. The mesh implant is intended to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). According to the lawsuit, however, the mesh only creates an unreasonable risk of vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess. Allegedly, the mesh is defective because the material used is not inert, meaning that it can react with the tissues in the body.

The lawsuit holds the Defendants liable for the Plaintiff’s injuries because the manufacturers were allegedly aware of the dangers associated with the device, but did not adequately warn consumers. Among other injuries, the suit is claiming significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity and the loss of the Plaintiff’s bodily organ system.

The U.S. Food and Drug Administration addressed the risks associated with transvaginal mesh in October 2008. At that time, the agency said that complications were serious, but rare. Last July, the FDA updated this information by announcing that complications are “not rare” and that there is little evidence showing the benefits of transvaginal mesh over non-mesh methods of treating POP. The agency has asked Johnson & Johnson and 32 other manufacturers to conduct post market safety studies analyzing the impact of transvaginal mesh on organ damage and other relevant health concerns.

In June, J&J told Chief Judge Joseph R. Goodwin, who is overseeing the multidistrict litigation, that it would stop selling the Prolift, Prolift + M, TVT Secur and Prosima transvaginal mesh systems. In its letter to the judge, the company said that it had asked the FDA for the three-year post market safety studies to be postponed.

According to Bloomberg News, the Prolift was originally sold and marketed in 2005 without any approval from the FDA. Contrary to FDA sentiments, J&J reasoned that no formal approval was needed for the Prolift because it was similar enough to a previously approved device. When the agency found out about the Prolift in 2007, it told J&J to stop selling the product until proper approval was obtained. But according to recently unveiled court documents, the company sold the Prolift another nine months after the FDA gave direct orders to halt sales.

Parker Waichman LLP continues to offer free lawsuit consultations to victims of transvaginal mesh injuries. If you or a loved one experienced complications following POP and SUI surgery with transvaginal mesh, please visit the firm's transvaginal mesh injury page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

Contact: Parker Waichman LLP
             Gary Falkowitz, Managing Attorney
             (800) LAW-INFO
             (800) 529-4636

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Gary Falkowitz, Managing Attorney
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