Device maker Covidien has agreed to a settlement of more than 11,000 claims involving its transvaginal mesh devices, alleged to have caused severe and painful side effects.
A court filing on Tuesday in West Virginia federal court did not disclose the settlement amount or exactly how many cases would be resolved under the confidential agreement, but as of June 1, Covidien mesh products were involved in about 11,300 filed and unfiled claims, Reuters reports.
In 2014, Covidien was acquired by Medtronic for $42.9 billion in cash and stock. A regulatory filing with the Securities and Exchange Commission (SEC) reported the figure of more than 11,300 filed and unfiled claims involving Covidien mesh products. In addition, two Covidien subsidiaries supplied mesh products to another medical-device manufacturer, and Covidien is indemnifying that company in some cases, according to the filing. Covidien also said it believed that company was responsible for indemnifying it for claims over the devices’ promotion and marketing. The SEC filing did not name the manufacturer, but C.R. Bard has disclosed that two Covidien units supplied it with mesh products. Bard believes Covidien is responsible for defending or indemnifying it in approximately half of the more than 14,000 claims it faces, according to Reuters.
Transvaginal mesh devices are implanted to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), by providing additional support to weakened or damaged tissue. But tens of thousands of women have sued mesh makers over injuries and complications they have suffered. These include mesh erosion through the vagina (also called exposure, extrusion, or protrusion), infections, pain, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. Many women have undergone additional surgery to remove the mesh or repair organ damage. A number of the lawsuits were organized into seven multidistrict litigations (MDLs) overseen by U.S. District Judge Joseph R. Goodwin. Centralizing lawsuits before one judge makes pre-trial proceedings more efficient for all parties.
An estimated 100,000 lawsuits have been filed in state and federal courts against transvaginal mesh device makers, alleging that poor design and substandard materials led to the complications and serious and permanent injuries women have suffered.
The Food and Drug Administration (FDA) has advised women that complications linked to transvaginal mesh implants are “not rare.” The agency warned that the devices may actually be more harmful than alternative methods for treating pelvic organ prolapse. In April 2014 the FDA announced it was considering reclassifying transvaginal mesh devices from a moderate-risk device (class II) to a high-risk device (class III) and requiring manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.
Endo’s American Medical Systems was the first major transvaginal mesh device manufacturer to resolve mesh litigation claims. In 2014, the company set aside $1.6 billion to settle about 40,000 claims, Reuters reports.