As the first federal trial about the liability tied to transvaginal mesh begins today, one manufacturer announced it settled a number of mesh lawsuits.

American Medical Systems agreed to pay $54.5 million to an unknown number of plaintiffs who filed state and federal lawsuits related to the company’s mesh implants, according to a recent Securities and Exchange Commission (SEC) filing. The mesh products named in the claims included Perigee, Elevate and Apogee.

AMS, a unit of Endo Health Solutions Inc., reported that it faces about 6,000 mesh-related federal lawsuits and an unknown number of state claims. Another SEC filing from March 2012 shows AMS estimated its potential liability for all its current and future transvaginal mesh lawsuits at more than $160 million.

Transvaginal mesh is a synthetic material used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Nearly every mesh product has complications, including but not limited to organ perforation, infection and vaginal erosion.

The first federal trial against AMS is scheduled for December 2013.

AMS’s settlement agreement was announced just prior to the start of the first federal mesh-related trial of a manufacturer. A federal lawsuit involving C.R. Bard begins today in Charleston, W.Va.

Details of AMS’s SEC Filing

AMS’s SEC filing states that the settlement between AMS and the unknown plaintiffs “is not in any way an admission of liability or fault by the Company or AMS.” Executives at AMS “intend to continue to vigorously defend themselves in the remaining mesh product liability cases and in any new cases that may arise.”

Endo agreed to fund the $54.5 million settlement on or before July 15, and AMS must obtain full releases from at least 95 percent of the plaintiffs by Oct. 12, according to the filing. If AMS cannot obtain the releases, it may retract the settlement program.

Details of the settled cases are not public, but in its SEC filing Endo reported “plaintiffs in these suits allege various personal injuries including chronic pain, incontinence and inability to control bowel function, and permanent deformities.”

David Matthews of Houston-based Matthews & Associates, which represents the majority of the women in the AMS settlement, was not available for comment.

Mesh Manufacturers Under Fire

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It’s unclear if AMS and Endo will attempt to settle other claims in which it is involved. A separate SEC filing states there were an estimated 7,700 mesh-related pending lawsuits against AMS, Endo and specific subsidiaries as of April 26, according to Reuters.

It’s also unclear whether the AMS settlement agreement sets the stage for more settlements or if it will encourage other transvaginal mesh manufacturers to fight a growing number of claims. Bloomberg reported that 29,000 federal transvaginal mesh cases are consolidated in U.S. District Court in West Virginia, including those against AMS.

Overall, mesh manufacturers also face an unknown number of state lawsuits across the country. Trials against the other mesh manufacturers will follow in the coming months and years.

Additional companies targeted by the remaining federal claims:

  • C.R. Bard
  • Boston Scientific
  • Ethicon (a subsidiary of Johnson & Johnson)
  • Coloplast
  • Cook Medical

Henry Garrard, an attorney at Blasingame, Burch, Garrard & Ashley P.C. and co-lead counsel for plaintiffs Donna and Dan Cisson — whose case against C.R. Bard begins today — said his clients have a strong case.

“It’s just a multitude of problems with the transvaginal placement,” he told Drugwatch in regard to mesh. “I don’t think transvaginal placement products should be on the market.”

Plaintiff Victories

In July 2012, Christine Scott won $5.5 million. Scott experienced extensive pain, fecal incontinence and vaginal scarring, and underwent nine reparative surgeries rising from complications with C.R. Bard’s Avaulta Plus implant.

Another plaintiff, Linda Gross, received $11.11 million in February 2013 from Johnson & Johnson’s Ethicon unit. She claimed the Gynecare Prolift vaginal mesh implant eroded through her organ walls, causing her constant pain, an inability to sit comfortably and painful sexual intercourse. She underwent 22 surgeries in an attempt to have the mesh removed, but pieces of it still remain in her body.

“I want to help other women to not go through what I’ve gone through,” Gross said in a March 2013 PBS television special. “It saddens me because they took innocent women and used us as guinea pigs.”