Endo Pharmaceuticals, a unit of American Medical Systems Inc. (AMS), has agreed to pay $54.5 million to settle some of the thousands of lawsuits alleging the company’s transvaginal mesh device caused serious injury.
AMS estimated its liability from current and future transvaginal mesh lawsuits to be at least $160 million. It did not say how many of the lawsuits would be resolved by the settlement, and the company refused to admit liability or fault.
Several companies that manufacture transvaginal mesh are facing lawsuits in state and federal courts alleging the devices caused serious injuries or death. Transvaginal mesh is a type of surgical mesh used to treat pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. The mesh is implanted vaginally to shore up organs that have dropped, causing discomfort, pain and incontinence.
Since the devices became available more than a decade ago, the Food and Drug Administration (FDA) has warned that complications with the mesh were not uncommon. The mesh can erode into pelvic organs causing pain, disability, hemorrhaging and infections. In some cases, repeated surgeries were needed to remove the mesh.
As of April 26, there were an estimated 7,700 mesh lawsuits against AMS. The company says it expects that number to climb now that it has agreed to settle many of the cases.