New York, New York (PRWEB) November 12, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit alleging that two transvaginal mesh products caused serious injuries in one woman. The suit alleges that the Defendants, Ethicon, Inc., Ethicon, LLC and Johnson & Johnson, failed to warn about the dangers of using the Gynecare Prolift + M™ and the TVT Secur™. The suit was filed on November 9th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-7555). It has been filed alongside many similar cases in the multidistrict litigation entitled In Re: Ethicon Inc., Pelvic Repair System Products Liability Litigation (MDL No.2327).
According to the complaint, the Plaintiff was implanted with the Prolift + M™ and the TVT Secur™ in November 2009. The devices were implanted to treat her stress urinary incontinence and pelvic organ prolapse, the two conditions for which they were approved, marketed and sold. Stress urinary incontinence and pelvic organ prolapse are conditions that stem from the weakening of the pelvic muscles, often after childbirth. Transvaginal mesh attempts to correct these conditions by strengthening the pelvic walls. The lawsuit alleges, however, that the devices are defective and present an unreasonable risk of harm. Among other things, the suit alleges that the mesh can react with the tissues of the body because the material used is not inert. Allegedly, the Defendants knew about the dangers associated with the use of transvaginal mesh but failed to warn the public.
The U.S. Food and Drug Administration (FDA) has warned that complications associated with transvaginal mesh, such as mesh erosion, pain, infection, bleeding and pain during intercourse are “not rare.” The agency has also asked a number of manufacturers, including Johnson & Johnson, to perform safety studies to help determine whether the devices cause organ damage or other relevant health concerns.
Earlier this year, Ethicon stated that they would no longer be selling four types of transvaginal mesh, including the Prolift + M™ , TVT Secur, Prolift and Prosima. At the time, the company also asked the FDA to postpone the postmarket safety studies.
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 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