The U.S. Food and Drug Administration (FDA) has reportedly written to Johnson & Johnson, C.R. Bard Inc., and 31 other manufacturers of vaginal mesh implants, telling them to conduct three years of trials on safety and effectiveness on the products. In other words, the manufacturers must study rates of organ damage and complications linked to vaginal mesh implants, especially since a July 2011 FDA report found a fivefold jump in deaths, injuries or malfunctions tied to the products.
The letters ask each vaginal mesh implant manufacturer to collect data on the results and potential complications of transvaginal procedures, i.e. procedures where the hammock-like meshes are threaded in place through an incision in the vagina. According to the FDA, almost 300,000 of these synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or shore up pelvic muscles. The alleged failures of some of these devices have resulted in more than 650 lawsuits against manufacturers, and caused heightened scrutiny of the FDA program that cleared the products for sale (in the first place) without human testing.
The companies in question have 30 days within which to comply with the FDA mandate.
Thu, Jan 5, 2012
General