An Oregon woman who alleges that she was severely injured by a defective Elevate transvaginal mesh implant has filed a lawsuit against American Medical Systems, Inc. (AMS) and Endo Pharmaceuticals, Inc.
The woman received the mesh implant in January 2011 and subsequently suffered severe physical pain and emotional distress because of her physical injuries. In addition, she incurred substantial medical expenses as a result of the defective device. The lawsuit alleges that the defendants knew about the risks of using transvaginal mesh but did not warn the plaintiff that, among other things, the material used in the implant is not inert. The mesh can react with the body’s tissues and the device can move through the body, causing pain, organ damage, and urinary problems.
The lawsuit was filed on the woman’s behalf by Parker Waichman LLP on January 18, 2013 in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:13-cv-01083). This suit is one of many lawsuits pending in a multidistrict litigation (MDL) involving claims against various manufacturers of transvaginal mesh devices. A number of adverse effects have been attributed to transvaginal mesh implants, including pain, infection, bleeding, organ perforation, mesh exposure or extrusion through the vagina, pain during sexual intercourse, and urinary problems.
The U.S. Food and Drug Administration (FDA) in a 2011 Safety Communication warned that complications from transvaginal mesh devices are “not rare” and that there was no clear evidence of the benefits of using transvaginal mesh over non-mesh methods of treating pelvic organ prolapse (POP).