Transvaginal Mesh Adverse Effects. Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit alleging Ethicon’s Gynecare Gynemesh PS caused permanent injuries, physical deformity and other adverse effects. 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-03162) where it is one of many cases pending in the multidistrict litigation as part of the 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 is a woman from Park County, Wyoming who had the Gynecare Gynemesh PS implanted in September 2005 to treat her pelvic organ prolapse and stress urinary incontinence. The suit alleges that the device caused significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity and loss of her bodily organ system. The lawsuit also alleges that the Defendants marketed and sold the mesh despite the fact that they were aware of the increased risk of vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess.
Complications Linked To Transvaginal Mesh
From 2005 through 2007, the U.S. Food and Drug Administration (FDA) received over 1,000 reports of complications linked to transvaginal mesh. The agency addressed the complaints in October 2008, stating that the side effects are serious, but rare. The FDA amended this information last July, after receiving an additional 2,874 reports. This time, the agency acknowledged that complications such as erosion, pain, infection, and organ perforation were “not rare” and noted that there may be no advantage to using transvaginal mesh over non-mesh methods.
Last month, Johnson & Johnson told Chief Judge Joseph R. Goodwin, who is overseeing the transvaginal mesh multidistrict litigation, that they would no longer be selling four types of transvaginal mesh products, including the Prolift, Prolift + M, TVT Secur and Prosima. The company also said that they had asked the FDA for permission to continue selling the Gynecare Gynemesh PS with revisions to product labeling.
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. Free case evaluations are also available by calling 1-800-YOURLAWYER (1-800-968-7529).