A lawsuit has been filed by an Arizona woman who claims that she suffered injuries from two transvaginal mesh products. The Mini Arc Sling, manufactured by American Medical Systems, and the Pinnacle Pelvic Floor Repair Kit, manufactured by Boston Scientific, were both allegedly used by the plaintiff filing the suit. The lawsuit was filed on May 30th in the U.S. District Court for the Southern District of West Virginia in a multidistrict litigation.
The plaintiff alleges that she suffered the injuries after receiving an implant of the defective Mini Arc Sling and Pinnacle Pelvic Floor Repair Kit devices. According to the lawsuit, both of the defendants knew of the serious risks associated with the products, but failed to disclose those risks to the plaintiff and other consumers.
“These products were marketed as safe and effective alternatives to traditional surgery, yet the manufacturers failed to warn of the dangerous risks associated with transvaginal mesh, which they have known about for years,” said Robert Price, a transvaginal mesh attorney at Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A.
Transvaginal mesh was approved using the Food and Drug Administration’s (FDA) 510(k) process, a fast-track approval system that requires very little safety review before products are put on the market. Transvaginal mesh devices were approved in the 1990s as a permanent treatment for urinary incontinence and pelvic organ prolapse in women.
In 2004, the industry began manufacturing “pelvic organ prolapse kits”, also known as “POP” kits, and began marketing the products as the best solution to treat pelvic organ prolapse. Doctors have since been using the pelvic mesh over traditional surgery under the false impression that the product is safe, when in fact, the product carries serious health risks.
Several health complications can arise after the implantation of the mesh, including organ erosion and perforation, where the mesh erodes and cuts surrounding organs and tissue. Other serious complications from the mesh include urinary incontinence, bleeding, infection and pain.
Krysta is a writer and researcher with Ring of Fire.