Coloplast Agrees to Settle 400 Mesh Implant Cases for $16M

Denmark-based Coloplast a/s has agreed to pay about $16 million to settle about 400 cases involving its transvaginal mesh implants, according to a report on Bloomberg. In a move that may establish a precedent for the tens of thousands of cases still pending, the settlement means that the women will each receive about $40,000. Previously, one woman reportedly received over $11 million in a jury award from Johnson & Johnson.

Quoting people who asked not to be identified because they aren't authorized to speak for the company, the March 4 articleby Jef Feeley explains that "Coloplast executives have declined to seek a blanket settlement of cases over the company's implants and instead are settling inventories of cases collected by individual plaintiffs' lawyers."

Feely says that Ulla Lundhus, a spokesperson for Coloplast, declined to comment on the report of a settlement.

According to consumerinjurylawyers.com, attorneys have filed more than 40,000 lawsuits against makers of the devices in separate multidistrict litigations established in the U.S. District Court, Southern District of West Virginia, before Judge Joseph Goodwin in Charleston, WV.

Transvaginal mesh implants are used in the treatment of pelvic organ prolapse, pelvic floor repair and stress urinary incontinence. There are many potential causes for these conditions, including childbirth, hysterectomy, obesity, and normal aging. In order to treat them, a transvaginal mesh is surgically attached to or implanted, using the vaginal wall as an anchor point.  However, this implantation can expose the patient to complications including erosion of internal tissues and organs, painful sexual intercourse, infection, and urinary problems. 

Jennifer Mesko, writing for drugwatch.com, says, "Erosion of the mesh through the vagina is the most common and consistently reported problem, which can require multiple surgeries to repair. The other common problem is mesh contraction, which is associated with vaginal shortening, tightening and pain."

FDA approval of the devices was an expanded indication based on their prior use in other parts of the body, such as in the repair of hernia.  However, consumerinjurylawyers.com says, the vaginal mesh products were never tested for safety for use in transvaginal procedures. 

Feely's sources told him that officials at Bard, Endo and Boston Scientific are continuing discussions about resolving the lawsuits as part of a global settlement of cases. However, he said, a spokesman for Johnson & Johnson told him the company doesn't comment on legal strategy.

Stephen Levy is a contributor to Qmed and MPMN.