Five medical device makers that manufacture transvaginal mesh implants that allegedly injured thousands of women are said to be in talks to settle scores of lawsuits.
Bloomberg News reports that people familiar with the matter say lawyers for C.R. Bard, Endo Health Solutions, Boston Scientific Corp., Coloplast, and Cook Medical have begun talks to settle lawsuits over the mesh implants, which are designed to treat pelvic organ prolapse and incontinence. Because they are not authorized to speak publicly, the people familiar with the matter have asked not to be identified. Johnson & Johnson, also facing lawsuits over mesh implants made by its Ethicon division, is not involved in the talks.
Plaintiffs’ lawyers reportedly want U.S. District Judge Joseph Goodwin in Charleston, West Virginia, who is overseeing federal suits over the implants, to appoint a settlement committee. More than 30,000 implant suits have been consolidated before Goodwin for pre-trial information exchanges. Bloomberg News reports the number of suits could increase to more than 50,000 as additional claimants seek to join the potential settlement.
In 2011, the U.S. Food and Drug Administration (FDA) noted a number of complications associated with transvaginal mesh implants: mesh erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. Many women have needed additional surgery to remove the implants or repair organ damage. Because of a significant number of adverse events reports the FDA received, the agency asked 33 mesh implant manufacturers to conduct post-market safety studies to investigate the effects of transvaginal mesh implants and the health concerns (www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm).
Bard has already settled some transvaginal mesh cases after losing two trials over the devices. The company pulled the Avaulta implant off the market last year after the FDA ordered the studies, according to Bloomberg News.