Bloomberg news announced that Endo International will pay about $830 million to resolve about 20,000 lawsuits related to vaginal-mesh implants which eroded in some women and left them in pain and with incontinence.
The settlement came a day after the U.S. Food and Drug Administration said vaginal-mesh inserts should be subject to stricter safety requirements because they are high-risk devices. Endo said in securities filings in February it was reserving $520 million to deal with vaginal-mesh litigation.
According to the article, Endo’s move to settle is a sign many vaginal-mesh makers are ready to end litigation over the devices, Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in the interview: “We could very well see a wave of similar settlements in coming months, the device makers haven’t won many cases in court and settlement is looking more attractive to them,” Tobias said.
The FDA had previously ordered Endo, Johnson & Johnson (JNJ), C.R. Bard Inc. and 31 other vaginal-implant makers to study rates of organ damage and complications linked to the devices after manufacturers faced a wave of lawsuits. J&J took four lines of vaginal implants off the global market last year.
Doctors inserted more than 70,000 mesh devices in the U.S. in 2010, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence, according to court documents.
The lawsuits pending against the manufacturers allege that the transvaginal mesh devices used in pelvic organ prolapse (POP) and stress urinary incontinence (SUI) repair surgeries caused women to suffer serious complications, including vaginal erosion, inflammation, infection, chronic pain and organ damage.