Five Vaginal Mesh Manufacturers Considering Settling Thousands of Suits

Five medical device makers - C.R. Bard, Boston Scientific, Endo Health Solutions, Coloplast, and Cook Medical - are considering settling thousands of lawsuits accusing them of releasing defective mesh implants, which are used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), into the market.

These surgeries are not guaranteed to resolve the problem entirely.

Lawyers for the plaintiffs are requesting that U.S. District Judge Joseph Goodwin of West Virginia, who is overseeing the litigation, appoint a settlement committee to help resolve the 30,000 suits already filed. It is believed that with talks of a settlement, the number of suits could grow to more than 50,000, according to Bloomberg.com.

Endo Health Solutions faces the most suits - 13,500 when combining federal and state cases - followed by Bard and Boston Scientific, which each face over 12,000 suits. Coloplast and Cook face a combined 1,000 claims. Although Coloplast faces one of the smallest portions of claims – roughly 600 – the company is the furthest along with regard to settlement talks and is aiming to resolve all litigation by the end of the year. Johnson & Johnson, despite facing 12,250 claims, have declined to participate in settlement talks. In February of this year, the company was held liable for $11.1 million in damages to a woman who claimed J&J’s Gynecare Prolift caused her injuries.

Between 2005 and 2007, the Food and Drug Administration received more than 1,000 adverse reports regarding vaginal mesh products, and within the next two years that number grew by nearly 3,000. The FDA published a press release in 2011 reporting that vaginal mesh was found to cause serious complications due to mesh erosion and contraction. As a result, patients experienced infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems. The press release warned that the insertion of vaginal mesh is permanent, and attempts to repair the mesh can require several surgeries; however, these surgeries are not guaranteed to resolve the problem entirely, the agency said.

Vaginal mesh companies Bard and Endo have already settled some suits over their allegedly defective implants. Endo agreed to pay $54.5 million to settle an unspecified number of cases this year, while Bard has lost two trials over their Avaulta Plus vaginal mesh. First, in a California state court last year, Bard was held liable for $3.6 million in damages for a woman who claimed she was injured by an implant manufactured by the company. Second, in August during its first federal trial over Avaulta, Bard was held liable for $2 million in damages to a woman who claimed the implant damaged her organs. More than 8,000 federal claims await Bard over its Avaulta implant and make similar accusations. Last year, Bard pulled the Avaulta implants off the market after the FDA ordered vaginal mesh makers to study rates of certain side effects linked to the implants, including organ damage, infection, and pain during sexual intercourse.

Plaintiffs’ lawyers are reportedly finding difficulty in the litigation settlement: not only are they taking on more than 50 different implants from six different companies, but some companies continue to implant devices, while others have pulled their products from the market. It has been reported that American Medical Systems’ inserts will be first on their list of priorities.