It is still uncertain why and how many American Medical Systems (AMS) transvaginal mesh victims are affected, but Endo Health Solutions Inc, which bought the company, has agreed to settle a small number of AMS cases.
Endo has agreed to pay $54.5 million to settle product liability or defective product lawsuits filed by women implanted with Perigee, Apogee and Elevate transvaginal mesh used used to treat pelvic organ prolapse. They are made of a plastic called polypropylene and are implanted in a woman’s pelvic region and are intended to be permanent. When they go horribly wrong with symptoms such as erosion, migration, infection and disintegration, among other problems, it is very difficult, if not impossible to remove them entirely. Our clients are permanently disabled and many will never be the same.
In a filing with the Securities and Exchange Commission, AMS says it plans to vigorously defend itself in the remaining mesh product liability cases and in any new cases that may arise.
Still pending are 7,385 cases filed against AMS in multidistrict litigation consolidated in federal court in Charleston, West Virginia. That does not include the 16,000 cases filed by women naming five other manufacturers – C.R. Bard, Boston Scientific, Ethicon, Coloplast and Cook, as well as thousands of cases filed in state courts around the country.
In July 2011, the Food and Drug Administration issued a public health advisory that, “… in most cases, POP (pelvic organ prolapse) can be treated successfully without mesh thus avoiding the risk of mesh-related complications.”
That does not stop the continuing use of transvaginal mesh today. The FDA also stated that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
So far two trials have represented losses to the mesh medical device industry. C.R. Bard lost a case filed in a California last June over the Avaulta mesh and was ordered to pay the plaintiff $3.6 million. Her doctor was ordered to pay $1.5 million for medical malpractice.
Then last February, Ethicon, the unit of Johnson & Johnson was handed an $11.1 million loss after jurors listened to weeks of testimony about the damages experienced by a South Dakota nurse. She will never work again as a hospice nurse and spends most of her day in the home and lying in bed.
Sadly, that is the life left after multiple attempts to remove transvaginal surgical mesh. There are many more of these sad stories to be told and it will be up to the manufacturers to decide when enough is enough and offer a settlement to these women too.