The U.S. Food and Drug Administration (FDA) has warned that complications associated with transvaginal mesh implants are “not rare.”
New York, New York (PRWEB) January 04, 2013
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 the TVT transvaginal mesh caused serious injuries in a New York woman. The suit was filed on December 27, 2012 in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case 2:12-cv-09722). It is one of the many cases filed in the transvaginal mesh multidistrict litigation as part of the 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.
Transvaginal mesh implants are medical devices approved to treat pelvic organ prolapse, a condition where the weakened pelvic muscles cause organs to slide out of place, and stress urinary incontinence. Transvaginal mesh is intended to correct these conditions by strengthening the walls of the pelvis. According to the lawsuit, however, transvaginal mesh products pose more risks than benefits.
According to the Complaint, the Plaintiff was implanted with the TVT transvaginal mesh in November 2008. Thereafter, she suffered a number of injuries, allegedly due to using the device. The lawsuit alleges that the mesh poses a dangerous and unreasonable risk to women because, among other things, the material used for the mesh is not inert and reacts with the tissues of the body. The suit further alleges that the Defendants knew about these risks but chose to sell the devices without warning the Plaintiff or the public.
The U.S. Food and Drug Administration (FDA) has warned that complications associated with transvaginal mesh implants are “not rare.” According to a Safety Communication issued last summer, the most common reported adverse events related to transvaginal mesh include:
- Mesh erosion through the vagina (also called exposure, extrusion, protrusion)
- Pain during sexual intercourse (dyapareunia)
- Organ perforation
- Urinary problems
The agency also stated that there is no clear evidence showing that transvaginal mesh is better than non-mesh methods for treating pelvic organ prolapse (POP). The FDA has asked 33 manufacturers, including Johnson & Johnson, to conduct post market studies evaluating the dangers of transvaginal mesh.
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).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney