Transvaginal Mesh Makers Reportedly Engaging in Settlement TalksOct 1, 2013
C.R. Bard Inc. and four other makers of transvaginal mesh implants accused of injuring thousands of women are said to be in talks to settle the lawsuits, according to people familiar with the discussions.
Bloomberg News reports that lawyers for 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 by supporting pelvic muscles. The people familiar with the matter are not authorized to speak publicly and 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, according to Bloomberg News. 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, including 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 it has received involving surgical mesh, the FDA asked 33 manufacturers to conduct post-market safety studies in order to investigate the effects of transvaginal mesh implants and the health concerns
Bard has settled some transvaginal mesh cases after losing two trials over the devices. The company pulled the Avaulta implants off the market last year after the FDA ordered the studies, Bloomberg News reports.