A New York woman has become the latest plaintiff to file a lawsuit against American Medical Systems for serious injuries allegedly sustained as a result of transvaginal mesh. According to a complaint filed by the national law firm of Parker Waichman LLP, the plaintiff suffered life-changing injuries following implantation of American Medical Systems’ IntePro Large Pore Polypropelene Y-Sling.
According to the complaint, the woman, a resident from Monroe, New York, received the American Medical Systems transvaginal mesh device during surgery in 2008 to treat stress urinary incontinence and pelvic organ prolapse. The lawsuit alleges that she suffered a number of health consequences as a direct result of the device, including significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity and loss of her bodily organ system. The lawsuit further claims that the IntePro Large Pore Polypropelene Y-Sling is defective, and increases the risk of vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess.
The lawsuit was filed in U.S. District Court for the Southern District of West Virginia, Charleston Division, where dozens of similar transvaginal mesh lawsuits are pending in the American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2325).
The U.S. Food & Drug Administration (FDA) has been conducting a safety review of transvaginal mesh devices since 2008. In January, it asked more than 30 companies that manufacture the products, including American Medical Systems, to conduct post-market safety studies of their devices. In July 2011, the agency revealed that it had received 2,874 reports of complications involving transvaginal mesh from 2008 to 2010. At the time, the FDA cautioned that transvaginal mesh may carry additional health risks while having little benefit over non-mesh methods used to repair stress urinary incontinence and pelvic organ prolapse.