Putting a Price on Pain: AMS Transvaginal Mesh

Bend, OREndo Pharmaceutical’s American Medical Systems (AMS) has agreed to pay almost $1.3 billion to resolve its AMS transvaginal meshlawsuits over the mesh implants. This amount may seem substantial but only averages $40,000 per case, which is nowhere near enough for women who have suffered and continue to suffer mesh erosion and other serious vaginal mesh side effects.

Laurie says that her mother recently received a letter stating she would be getting a settlement out of the $830 million AMS settlement. “My mother is a very tough woman and she has been dealing with this implant for years, but how much pain and suffering can one woman endure?” Laurie asks. “I want to ask AMS how is it fair for a woman to only receive around $48,000 for years of pain and suffering, and several more years to come when she believed this device was going to help her?”

This new deal from Endo will settle more than 10,000 AMS lawsuits. Earlier this year Endo agreed to pay approximately $830 million to settle an additional 20,000 AMS transvaginal mesh lawsuits, including Laurie’s mother’s claim. Interestingly, Endo struck the deal shortly after the FDA announced that transvaginal mesh devices should be subject to stricter safety requirements because they are in now in a high-risk device category.

“My mother is only 68 years old and if she doesn’t get all of this mesh removed - and from what I understand, it is almost impossible to get it all taken out - she must live out the rest of her life with a disability,” says Laurie.

Suzanne is still waiting to get her AMS letter in the mail. “I had the AMS transvaginal mesh removed in 2012 - it had eroded through my vaginal wall,” she says. “This mesh has caused almost 10 years of anguish, pain and suffering to the point that I feel like a prisoner in my own house.” Suzanne had the mesh implanted for urinary incontinence, but her symptoms have substantially worsened.

“I can’t go anywhere without wearing Depends, which is so embarrassing and debilitating,” Suzanne adds, crying in frustration. “Along with the drug company, the FDA is also responsible because they didn’t require this product to be tested. Instead, it just got fast-tracked to the marketplace and the drug companies sold doctors a bill of goods. Forty-thousand dollars doesn’t amount to much if it is spread out over 20 or so years of pain.”

According to Bloomberg (October 1, 2014), Endo, based in Dublin, said it settled “substantially all” the remaining U.S. suits against its American Medical Systems Holdings unit over the Perigee, Apogee and Elevate mesh implants. In a statement, Chief Executive Officer Rajiv De Silva said, “We believe these settlements will allow the AMS business to continue its return to growth and enhance focus on operations and profitability.”

However, attorneys are still accepting AMS mesh claims and Endo still faces about 5,000 more lawsuits over its AMS mesh devices. Some of those cases have now been consolidated before U.S. District Judge Joseph Goodwin, who is overseeing information exchanges and trials (In re American Medical Systems Inc. Pelvic Repair Systems Products Liability Litigation, 12-md-02325, U.S. District Court, Southern District of West Virginia [Charleston]).

Endo first paid out $54.4 million in June of 2013 to settle the first set of AMS claims. To date, Endo is the only major mesh manufacturer - and it is second to Ethicon in the number of claims - to announce a global settlement agreement on its outstanding claims. The other manufacturers, including Boston Scientific and C.R. Bard, are still fighting resolution.