Endo Health Solutions Inc. will pay about $830 million to resolve most lawsuits alleging its vaginal mesh implants eroded in some women and left them incontinent and in pain.
Endo’s American Medical Systems Inc. unit said it’s settling about 20,000 suits over the devices, which include the Perigee, Apogee and Elevate implants. Dublin-based Endo still faces at least 5,000 claims against AMS, including some that have been consolidated for pretrial proceedings in West Virginia, according to court records.
The settlement comes a day after the U.S. Food and Drug Administration said vaginal mesh inserts should be subject to stricter safety requirements since they amount to high-risk devices. Thousands of women contend the implants cause organ damage and make sex painful.
“The settlements, once final, will resolve a substantial majority of the AMS vaginal mesh-related claims,” Endo officials said in a statement.
The FDA had previously ordered Endo, Johnson & Johnson, C.R. Bard Inc. and 31 other vaginal implant makers to study rates of organ damage and complications linked to the implants after manufacturers faced a wave of suits over the devices.
Doctors inserted more than 70,000 mesh devices in the U.S. in 2010 alone, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence, according to court filings.
Johnson & Johnson pulled four of its lines of vaginal implants off the worldwide market last year in the face of rising numbers of suits.
Under Endo’s settlement, women who contend they were injured by the implants will receive an average of $40,000 per case.
The settlement is designed to allow women to seek more for their claims if the devices caused severe injuries and forced them to undergo multiple surgeries to have the inserts removed, said Joseph Rice, a South Carolina-based plaintiffs’ attorney who helped negotiate the deal.
Other insert makers, including Bard, Boston Scientific Corp. and Coloplast A/S, also are engaging in settlement talks, people familiar with the discussions have said.
Vaginal mesh makers may have more incentive to settle after the FDA’s announcement that regulators are considering tightening safety standards for the devices.