American Medical System has agreed to pay $54.5 million to settle an undisclosed number of transvaginal mesh lawsuits filed against the company. The lawsuits involved women who had sued American Medical System (AMS) in state and federal court after they suffered complications from one of the company’s transvaginal surgical mesh products, which include implants marketed under the brand names Perigee, Apogee, and Elevate.
Transvaginal surgical mesh products are used to treat patients with stress urinary incontinence or pelvic organ prolapse through surgery. In 2011, the Food and Drug Administration issued a warning about transvaginal mesh, stating that these products carried unique risks that were not found with traditional surgical repair techniques. Consumer advocacy groups have called on the FDA to recall these devices based on the risk of severe pain, organ perforation, and other side effects that have been reported with surgical mesh products used for transvaginal repair.
The settlement of these claims by AMS does not affect the remainder of the 5,000 other transvaginal mesh lawsuits still facing the company. Endo Pharmaceuticals—which acquired AMS in 2011—is one of four companies facing more than 29,000 surgical mesh cases that have been consolidated in a multi-district litigation (MDL) in West Virginia. The first of these lawsuits—filed against C.R. Bard—is scheduled to go to trial in July.
The two mesh lawsuits that have gone to trial so far have both resulted in verdicts in favor of plaintiffs who were injured by surgical mesh products. Last year, a California woman was awarded damages of $3.6 million against C.R. Bard over injuries caused by the company’s Avalta Plus implant. In February of this year, a New Jersey jury awarded $11 million to a woman who was injured by Ethicon’s Gynecare Prolift surgical mesh device.