Endo Health Solutions, which bought American Medical Systems (AMS) Inc., in 2011, reached a settlement this week in cases of women suing over implanted transvaginal mesh, according to the Charleston Gazette. About 6,000 women will be affected by this settlement, which came to about $830 million.
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Reuters said that Endo and AMS are among several other medical-device manufacturers that have been plagued with tens of thousands of lawsuits over complications with mesh devices including pain during sex and bleeding, which are used as treatment for stress urinary incontinence and pelvic organ prolapse.
As of February 20, 2014, both Endo and AMS faced about 22,000 transvaginal mesh lawsuits, and just last year, Endo agreed to settle an undisclosed number of cases filed for $54.5 million, according to the source.
Additionally, Reuters noted that the agreement with Endo is subject to conditions including confirming the plaintiffs’ medical records, and the company said it had set aside $520 million to cover legal claims pertaining to mesh devices. A lawyer for the plaintiffs said the settlement would be implemented over the next year as a result of the “adversarial but respectful and professional negotiation” between all of the involved parties.
The U.S. Food and Drug Administration (FDA) initially warned manufacturers of transvaginal mesh of the possible complications back in 2008, and in 2012, the organization ordered manufacturers including AMS to conduct post-market safety studies and pay attention to how often complications were reported. On April 29, 2014, the FDA announced proposals to reclassify transvaginal mesh to a class III high-risk device.
Women who’ve suffered serious complications due to transvaginal mesh and are considering suing should contact a lawyer who specializes in these sort of cases to improve their chances of a positive outcome following the trial.