A Florida woman, who alleges she was seriously injured by a defective transvaginal mesh implant, has filed a lawsuit against Coloplast Corporation, the device’s manufacturer.
The plaintiff received an Aris-Transobturator Sling System implant in September 2009. Her lawsuit alleges that the implant is defective and, further, is inadequately designed for use in the female pelvis. Among other things, the suit alleges that the material used to manufacture the mesh is not inert and therefore can react with the tissues of the body. The mesh can move in the pelvis and become deeply embedded, sometimes requiring numerous surgeries to remove the device. Transvaginal mesh recipients can suffer serious and permanent health problems, even after removal of the implant. The lawsuit alleges that, overall, the risks of the transvaginal mesh implant outweigh any benefits.
The lawsuit was filed by Parker Waichman LLP on January 28th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No.2:13-cv-01513). This case is one of a number of similar cases pending in the multidistrict litigation (MDL) known as In Re: Coloplast Corp., Pelvic Support System Products Liability Litigation (MDL No. 2387).
Transvaginal mesh was approved by the U.S. Food and Drug Administration (FDA) to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), conditions 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 Florida woman’s lawsuit alleges that these devices only cause more problems. The FDA has asked a number of transvaginal mesh manufacturers to conduct post-market safety studies of their devices to assess whether they cause organ damage and other health issues.