The mesh allegedly poses unreasonable risks to women because, among other things, the material used is not inert and can react with the tissues in the body.
(PRWEB) November 20, 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 the TVT transvaginal mesh caused significant damage and bodily harm in a Colorado woman. The suit was filed on November 9th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case 2:12-cv-07553). There, it is one of many cases 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 TVT transvaginal mesh in November 2010. Transvaginal mesh is approved and sold to treat stress urinary incontinence and pelvic organ prolapse. However, the lawsuit alleges that the devices are unsafe, inherently defective and caused serious injuries to the Plaintiff. The suit points out that the devices were approved through the 510 (k) process, meaning that transvaginal mesh manufacturers only needed to conduct minimal tests before having the device approved.
The mesh allegedly poses unreasonable risks to women because, among other things, the material used is not inert and can react with the tissues in the body. Transvaginal mesh allegedly has a risk of erosion, where the mesh moves through the tissues. In some cases, the device can become embedded in inappropriate areas and require multiple surgeries in order to remove it. The lawsuit alleges that the Defendants knew this information, but failed to warn consumers.
Last July, the U.S. Food and Drug Administration (FDA) warned that, contrary to previous notions, complications associated with transvaginal mesh are “not rare”. The agency also stated that there’s no substantial evidence to show that transvaginal mesh offers significant benefits over non-mesh methods for treating pelvic organ prolapse; on the contrary, it may pose more risks. The agency has asked 33 manufacturers, including Johnson & Johnson, to conduct post market safety studies to assess the risk of transvaginal mesh on organ damage and other health issues. According to the FDA’s Safety Communication, the most commonly reported complications associated with transvaginal mesh include:
- Mesh erosion through the vagina (exposure, extrusion, protrusion)
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
Earlier this year, Johnson & Johnson stated that they would no longer sell the Prolift, Prolift + M, TVT Secur and Prosima 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)
Contact: Parker Waichman LLP
Gary Falkowitz, Managing Attorney