Mesh Medical Device News Desk, September 30, 2014 ~ This afternoon Endo International announced a master settlement has been reached that will resolve the lawsuits facing the vaginal mesh maker and its subsidiary AMS (American Medical Systems).
The press release says the settlement in no way admits any liability or fault. In its most recent SEC report from July, AMS tells shareholders it is facing 25,000 defective mesh cases.
Endo CEO, Rajiv De Silva announced “We are very pleased to resolve substantially all of the remaining U.S. vaginal mesh litigation claims facing our AMS business.” The settlement will allow AMS to continue to grow and focus on its medical device division, he says in the news release here.
Initially the company estimated a pre-tax product liability reserve of about $1.2 billion but settling the additional cases, both present and in the future, increased the settlement amount to approximately $1.6 billion. Payments will be settled during this year and through 2017. So far Endo/AMS has paid out about $200 million in settlement claims.
Back in May the company announced it would pay out about $830 million to resolve 20,000 pelvic mesh lawsuits.
The Wall Street Journal reported last month that Endo has put AMS on the auction block even though it delivers 19 percent of Endo’s revenue. The company is valued at about $2 billion today. Three years ago Endo purchased AMS for $2.9 billion.
Endo's top priority is the safety and efficacy of its subsidiaries' products and supporting the patients and physicians who use them, says the company. Endo continues to support the FDA's recommendations that physicians be well trained and patients fully understand the risks associated with the use of mesh products.
The company says in its news release it remains committed to the safety and efficacy of AMS transvaginal mesh and plans to continue growing the women’s health division “so that women have appropriate access to innovative, safe and effective therapies.”
AMS is headquartered in Minnetonka, Minnesota. Endo International is based in Dublin, Ireland with U.S. headquarters in Malvern, PA.
Endo/AMS products include:
ElevateTM Anterior and Posterior Pelvic Floor Repair System. Our AMS segment offers the Elevate® transvaginal pelvic floor repair system, for the treatment of pelvic organ prolapse, which may be caused by pregnancy, labor, and childbirth. Using an anatomically designed needle and self-fixating tips, Elevate® allows for safe, simple and precise mesh placement through a single vaginal incision, avoiding an external incision. Elevate® revenue accounted for approximately 1% of our total revenues in both 2013 and 2012.
Monarc® Subfascial Hammock. The Monarc® subfascial hammock is our leading device to treat female stress urinary incontinence, which generally results from a weakening of the tissue surrounding the bladder and urethra which can be a result of pregnancy, childbirth and aging. It incorporates unique helical needles to place a self-fixating, sub-fascial hammock through the obturator foramin. Monarc® revenue accounted for approximately 1% of our total revenues in both 2013 and 2012.
In January, 2012, the Food and Drug Administration ordered AMS to conduct post-approval studies on women who had received the pelvic organ prolapse and mini-sling implants to monitor them for complications. AMS received 19 orders but has honed that down to sixteen “for various commercial reasons” says its filing.
AMS took its Apogee and Perigee pelvic organ transvaginal mesh (TVM) off the market and in doing so it relieved them of the FDA mandated post-market monitoring. #