Overall the lawsuit alleges that the risks of the transvaginal mesh implant outweighs any benefits and is inadequately designed for use in the female pelvis.
(PRWEB) February 11, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit on behalf of a Florida woman who alleges she was injured by her transvaginal mesh implant. The suit was filed on January 28th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No.2:13-cv-01513). There, it is one of many similar cases pending in the multidistrict litigation known as In Re: Coloplast Corp., Pelvic Support System Products Liability Litigation (MDL No. 2387). Mentor Worldwide LLC, Coloplast A/S, Coloplast Corp., Coloplast Manufacturing US, LLC and Porges S.A. have been named as Defendants.
According to the Complaint, the Plaintiff was implanted with the Aris-Transobturator Sling System in September 2009. The lawsuit alleges that the implant is defectively designed and caused severe injury in the Plaintiff. Among other things, the suit alleges that the material used to manufacture the mesh is not inert and can react with the tissues of the body. This can allegedly lead to mesh erosion, where the mesh moves through the body’s tissues; in some cases the mesh becomes deeply embedded and requires numerous surgeries to remove the device. Overall the lawsuit alleges that the risks of the transvaginal mesh implant outweighs any benefits and is inadequately designed for use in the female pelvis.
Transvaginal mesh is approved to treat pelvic organ prolapse and stress urinary incontinence, conditions that are typically caused by the weakening of the pelvic walls. Transvaginal mesh attempts to correct these conditions by providing additional support to the pelvic walls and muscles, but the lawsuit alleges that these devices only cause more problems. The U.S. Food and Drug Administration (FDA) has asked a number of transvaginal mesh manufacturers to conduct postmarket safety studies of the mesh to assess whether or not they cause organ damage and other health issues.
The FDA has also warned that complications associated with transvaginal mesh are “not rare.” According to a Safety Communication issued by the agency in July 2011, the most common adverse events associated with transvaginal mesh include:
- Mesh erosion through the vagina (also called exposure, extrusion, protrusion)
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
The FDA also stated that there is little evidence indicating that transvaginal mesh is more beneficial than non-mesh methods for treating pelvic organ prolapse.
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 stress urinary incontinence (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