Number of federal transvaginal mesh cases could top 50,000

posted on:
October 4, 2013

author:
Kurt Niland

Sources close to the massive body of transvaginal mesh lawsuits combined for trial in a West Virginia federal court told Bloomberg News that the litigation could swell to more than 50,000 cases as increasing numbers of women living with mesh injuries step forward with complaints.

Six different manufacturers facing personal-injury transvaginal mesh claims have had their cases combined into as many multi-district cases (MDLs) under Judge Joseph Goodwin in U.S. District Court in Charlestown, W.V. Currently the claims pending in federal court number about 30,000, but the number could easily grow by 40 percent as women file lawsuits before the statute of limitations runs out.

The companies facing MDLs in federal court are Boston Scientific Corp., which faces more than 12,000 cases; C.R. Bard Inc., more than 12,000; Coloplast A/S and Cook Medical Inc., face about 1,000 combined; Endo (American Medical Systems Inc.), 13,500; and Johnson & Johnson (Ethicon), more than 12,250. All of the companies also face numerous claims in state courts throughout the U.S.

In July 2011, the U.S. Food and Drug Administration (FDA) reported a fivefold increase in the number of malfunctions, injuries, and even deaths linked to transvaginal mesh products. Federal regulators then ordered 33 manufacturers of the mesh products to conduct three years of safety and efficacy trials – testing that wasn’t conducted before the FDA granted them approval through its 510k fast-track process because they were deemed similar enough to mesh devices already approved and on the market.

Transvaginal mesh devices, used to correct pelvic organ prolapse (POP) and stress urinary incontinence (SUI), can shift from their intended position, break apart, and erode through the vaginal wall, which may result in intense pain and a range of complications including organ perforation, major bleeding events and infection. Complications can be so severe that they result in an inability to work or engage in sexual intercourse.

Moreover, because transvaginal mesh is designed to meld with surrounding muscle and tissue, removing it often requires multiple surgeries. In some cases, the device can’t be removed completely, leaving patients in a state of permanent, constant discomfort and pain.

Source: Bloomberg News

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