American Medical Systems is an operating company of Endo International — a healthcare company with global headquarters in Dublin, Ireland. American Medical Systems focuses on finding treatments for pelvic health needs, and claim to be the “leading brand name among urologists, gynecologists and urogynecologists.” In recent years, however, they have been the subject of more than 25,000 federal and state lawsuits regarding their vaginal mesh implants.

Transvaginal Mesh Devices

Transvaginal mesh is a synthetic or biologic material permanently implanted in women to repair pelvic organ prolapse (POP) or to support the urethra as a treatment for stress urinary incontinence (SUI), conditions which arise when the vaginal wall and other supporting muscles have been weakened. This weakening often occurs as a consequence of pregnancy and childbirth, and may also arise from other factors, including aging.

In some cases, the treatment works as planned and women experience dramatically improved quality of life through a relatively mild surgery. However, in many cases, the mesh shrinks once inside the vagina, causing vaginal shortening, tightening, and intense pain. Another more serious possibility is that part of the mesh material does not get absorbed into the tissue as intended and instead remains free inside the pelvic area. The U.S. Food & Drug Administration (FDA) has determined that transvaginal mesh may cause complications such as the erosion of the product into surrounding areas of the pelvis and perforation of pelvic organs.

Recall

American Medical Systems has manufactured numerous vaginal mesh products for prolapse and incontinence repair. Two such products, Apogee Vaginal Value Prolapse Repair System and Perigee Train Vaginal Mesh, are no longer available in the United States.

Lawsuits

In 2013, American Medical Systems paid $54.5 million to an unknown number of plaintiffs who filed lawsuits involving the company’s mesh implants. In May 2014, they paid $830 million to settle approximately 20,000 lawsuits. Approximately 5,000 more federal cases against American Medical Systems are currently involved in the multidistrict litigation in the U.S. District Court for the Southern District of West Virginia.