On April 26, 2013, a Texas resident filed a vaginal mesh lawsuit against American Medical Systems. The complaint accuses AMS of “failing to exercise reasonable care in manufacturing, selling and designing” the vaginal mesh implant.
Vaginal mesh is a device that is implanted in women who are suffering from pelvic organ prolapse (POP) and urinary stress incontinence. The condition is caused after menopause or childbirth. However, many of the vaginal mesh implants have resulted in lawsuits against the various manufacturers of these devices. In fact, on July 13, 2011, in a safety memo, the FDA issued a warning that stated that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” That adverse events report pointed out that the side effects linked to vaginal mesh implants include “transvaginal mesh erosion, mesh protrusion into other tissues, infections, painful intercourse, urinary tract problems, bleeding and damage to other organs.”
During this lawsuit, the plaintiff stated that she was given the American Medical System’s Monarc Subfascial Hammock, which didn’t work properly or cure her conditions. She even stated that the device caused her unbearable pain. AMS isn’t the only company to be sued over vaginal mesh complications. Other companies being sued in different lawsuits include devices made by Boston Scientific, Coloplast, American Medical Systems, C.R. Bard and Johnson & Johnson subsidiary Ethicon. To date, only two of the cases that have actually gone to trial resulted in an award for the plaintiff. The case against Ethicon (over the Gynecare Prolift vaginal mesh) resulted in an $11.1 million award for the plaintiff, and the case against Bard Avaulta resulted in a $5.5 million award. Many other awards or settlements are expected in the future as the vaginal mesh devices have all been deemed unsafe. Corrective surgery can be costly in some places and unavailable in others.