Endo International, parent company of American Medical Systems, Inc., has offered to pay out a sum of approximately $830 million to about 20,000 women who have filed vaginal mesh lawsuits after receiving vaginal mesh implants that resulted in serious complications.
This vaginal mesh lawsuit covers several different devices, including implants sold under the brand names of Elevate, Apogee and Perigee. If agreed to, the women will receive, on average, about $40,000 each, but the lawsuit is structured to allocate more money to women who suffered permanent disability and multiple surgeries. Endo International, which is based in Dublin, Ireland, won’t see an end to its legal woes with this latest settlement. They still have over 23,000 unsettled claims surrounding its vaginal mesh inserts.
The women have reportedly endured a range of different symptoms, including infection, chronic pain, incontinence, painful intercourse, internal bleeding and internal tissue damage resulting from vaginal mesh erosion. The latter condition occurs when the mesh panel, similar to the mesh used in hernia surgeries, rubs
against and erodes internal tissue structures and organs.
Pelvic mesh devices, also called transvaginal mesh for the way they’re inserted into the pelvic area through the vagina, are used to treat several conditions, including pelvic organ prolapse whereby the pelvic organs shift out of the natural position.
According to court filings, over 70,000 pelvic mesh devices were implanted worldwide in 2010 alone.
Another manufacturer of transvaginal mesh implants, Johnson & Johnson, recently stopped selling four different vaginal mesh implant devices. What’s more, settlement discussions are now underway with several other implant manufacturers, including Boston Scientific and CR Bard.
In March 2014, Coloplast agreed to settle a total of 400 claims for a combined total of around $16 million, with women receiving approximately $400,00 each. Notably, this Endo International settlement comes around the same time as a move by the U.S. Food and Drug Administration (FDA) to re-classify pelvic mesh as a high risk device, which would require pelvic mesh manufacturers to submit comprehensive clinical data to the FDA for review prior to approval.
The FDA has also ordered CR Bard, Johnson & Johnson, and American Medical ystems, among over 30 other manufacturers of pelvic mesh devices, to investigate the incidence of complications and organ damage. The FDA has since discovered that approximately 10 percent of women suffer complications and half required at least one follow-up operation.