AMS Mesh Lawsuit Update
American Medical Systems Inc. settled over 100 injury suits in August 2015, that were part of consolidated multidistrict litigation (MDL) over medical complications alleged to have been caused by their pelvic and transvaginal mesh implants. This follows another larger settlement in April 2014, wherein $830 million funded close to 20,000 claims over the alleged mesh injuries. Plaintiffs in the suits have claimed that the vaginal mesh devices are defective and have caused chronic pain, fistulas, organ perforation, incontinence and other serious injuries.
The lawsuits included pelvic mesh implants, Apogee, Perigee, and MiniArc, Sparc, Monarc Slings, IntePro Y Sling and others.
In April 2014, the U.S. Food and Drug Administration (FDA) issued two proposed orders that would reclassify surgical mesh for transvaginal repair of pelvic organ prolapse as a high-risk device and require manufacturers to apply for premarket approval with the agency.
In 2019, most of the AMS mesh products had been removed from the market and were no longer being implanted in women. However, thousands of women have the AMS products indwelling. Many may experience complications and their surgeons advise to have the implant surgically removed or revised.
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