A Tennessee woman has filed a transvaginal mesh injury lawsuit against American Medical Systems and Endo Pharmaceuticals, claiming that its AMS MiniARC sling implant caused her to suffer “catastrophic injury.” 

Plaintiff Debra S. says that on March 4, 2009, she underwent surgery to have the AMS MiniARC sling implanted in her body. Three months later, she was implanted with a second device. 

Debra’s AMS transvaginal mesh injury lawsuit says that the product’s “defective design” and the material used in it, has caused her and many other patients to have adverse reactions.

Allegedly, the sling is made with polypropylene and/or collagen. According to the lawsuit, the makers of the device claim that polypropylene is inert, but it is incompatible with human tissue as a result of  high levels of bacteria adhering to the mesh, “causing immune reactions and subsequent tissue breakdown and adverse reactions and injuries.”

The AMS lawsuit goes on to say that collagen in the defendant’s devices also causes serious inflammation, which can cause chronic pain and fibrotic reaction.

Additionally, the transvaginal mesh lawsuit claims that the collagen products disintegrate after being implanted in the pelvis, which then allegedly causes “adverse tissue reactions” connected to infection.

This adverse reaction occurs because the collagen, a foreign material made from animal tissue, is “harsh upon the female pelvic tissue,” according to the transvaginal mesh injury suit. Allegedly, the collagen in the AMS MiniARC vaginal sling can harden after it’s implanted.

Inserting a vaginal sling in the body “creates a non-anatomic condition in the pelvis leading to chronic pain and functional disabilities,” the transvaginal mesh injury lawsuit claims.

Allegedly, not enough review of the AMS MiniARC sling was conducted before the device was released put on the market. Debra says the AMS MiniARC sling implant sidestepped adequate testing because it was deemed “substantially equivalent” to other products already on the market.

In 2008, the U.S. Food and Drug Administration (FDA) announced that it had received more than 1,000 reports of complications from pelvic mesh. Allegedly, American Medical Systems and Endo Pharmaceuticals are identified in the FDA database as connected to the notification.

Debra’s lawsuit notes that in 2011, the FDA announced that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” These complications included vaginal pain, vaginal shortening, and vaginal tightness.

The FDA communication was followed by similar warnings and information. Based on this information, Debra says that American Medical Systems and Endo Pharmaceuticals knew, or should have known, that the device posed a risk to patients, but marketed them nonetheless.

In April, the FDA ordered all manufacturers of “surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately.” The agency cited concerns that the mesh may pose more risks than benefits.

The AMS MiniARC Sling Lawsuit is Case No. 3:19-cv-00399-JRG-HBG, in the U.S. District Court for the Eastern District Court for the Eastern District of Tennessee, Knoxville Division.