A New York woman who alleges that she suffered serious injuries from her Coloplast Aris-Transobturator Sling System transvaginal mesh implant intended to correct pelvic organ prolapse (POP) and stress urinary incontinence (SUI) has filed a lawsuit against Coloplast, the device’s manufacturer.
The plaintiff in this case was implanted with the Coloplast Aris-Transobturator Sling System in February 2008. She later suffered numerous complications, which, her lawsuit alleges, result from design defects in the device. She further claims that the defendants knew about the risks of using the mesh but did not adequately warn her, her doctor, or the public. She is suing for pain and suffering, emotional distress, and economic loss.
The Coloplast Aris-Transobturator Sling System transvaginal mesh implant is approved to treat POP and SUI. These conditions, which are more common after childbirth, are typically caused by weakening of the pelvic walls and muscles. Transvaginal mesh is supposed to correct these conditions by providing additional support to the pelvic walls, but the lawsuit alleges that these devices, in fact, cause worse problems, including mesh erosion, in which the mesh cuts through other tissues of the body and becomes deeply embedded in them. The U.S. Food and Drug Administration (FDA) issued a Safety Communication in 2011 about the device’s adverse effects and the agency has asked a number of transvaginal mesh manufacturers to conduct post-market safety studies to assess whether transvaginal mesh causes organ damage and other health issues.
The New York woman’s lawsuit, filed on January 28th by Parker Waichman LLP in the U.S. District Court for the Southern District of West Virginia, Charleston Division, is one of a number of similar suits consolidated into a multidistrict litigation (MDL) entitled In Re: Coloplast Corp., Pelvic Support System Products Liability Litigation (MDL No. 2387). In an MDL, a number of lawsuits containing common questions of fact are centralized in one court before one judge. The purpose of an MDL is to make pre-trial proceedings more efficient and to avoid duplicate findings.