According to the lawsuit, the Defendants were well aware of the risks associated with their allegedly defective products but continued to sell them to thousands of women across the country.
New York, NY (PRWEB) December 14, 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 transvaginal mesh devices caused physical injury in a New York woman. The suit was filed on December 10th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-08699). It has been filed into the multidistrict litigation known as In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2327). Ethicon, Inc., Ethicon, LLC, and Johnson & Johnson have been named as Defendants.
According to the Complaint, the Plaintiff was implanted with the Prolift and the Gynemesh PS transvaginal mesh. She received the implants to correct her stress urinary incontinence and pelvic organ prolapse, conditions for which the devices were approved, marketed and sold. The lawsuit, however, alleges that the mesh is defective and presents an unreasonable risk of injury to women. Among other things, the lawsuit alleges that the material used in the mesh is not inert, meaning it can react with the body’s own tissues.
The U.S. Food and Drug Administration (FDA) reports that the most common complications associated with transvaginal mesh include:
- Mesh erosion through the vagina (also called exposure, extrusion, protrusion)
- Pain during sexual intercourse (dyapareunia)
- Organ perforation
- Urinary problems
The agency has stated that adverse events linked to transvaginal mesh implants are “not rare” and warned that use of such devices may actually be more harmful compared to alternative methods for treating pelvic organ prolapse. The FDA has also asked 33 manufacturers, including Johnson & Johnson, to conduct post-market safety studies in order to investigate the effect of vaginal mesh on organ damage and other health concerns.
According to the lawsuit, the Defendants were well aware of the risks associated with their allegedly defective products but continued to sell them to thousands of women across the country. The lawsuit also points out that the devices were approved without any clinical testing due to a regulatory loophole known as 510(k). As a direct result of their wrongful and unethical conduct, the Plaintiff has allegedly suffered from physical injury, emotional distress and economic losses.
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