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C.R. Bard, a manufacturer of transvaginal mesh, has agreed to settle more than 500 of the Avulta transvaginal mesh lawsuits pending against it for an undisclosed amount. C.R. Bard faces thousands of lawsuits, most of which are consolidated as part of a federal multidistrict litigation before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia. There are more than 9,000 cases filed against C.R. Bard and there are nearly 60,000 federally filed multidistrict litigation cases involving transvaginal mesh.
The lawsuits brought against C.R. Bard as well as actions brought against other mesh manufacturers allege significant injuries following surgery using vaginal mesh to stress urinary incontinence or pelvic organ prolapsed. The lawsuits allege that the devices are defective and provide an unnecessary risk of injury
The U.S. Food and Drug Administration ordered C.R. Bard Inc., and 43 other vaginal implant device makers to review the rates of organ damage and other complications in 2012, following mounting lawsuits. A Bloomberg Businessweek report from April 2013, reports that the devices are typically woven through incisions made in the vagina and are meant to strengthen weak pelvic muscles. In 2010 alone, more than 70,000 devices were placed in women in the United States.
In July 2011, the FDA reported that the most common complications with transvaginal mesh include pain, infection, organ perforation, mesh erosion through the vagina and urinary problems. The FDA warned that these complications were not rare and that such devices may cause more harm compared to other alternative forms of treatment.