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FDA Orders Transvaginal Mesh Manufacturers to Conduct Safety Trials
January 5, 2012
Yesterday, the Food and Drug Administration ordered manufacturers of surgical mesh, including Johnson & Johnson, C.R. Bard, and Boston Scientific, to conduct new studies on the effectiveness and safety of vaginal mesh when used to treat pelvic organ prolapse and stress urinary incontinence.
"The FDA's order reflects increasing reports of series injuries caused by certain vaginal mesh products, and the fact that the manufacturers have marketed these products heavily without conducting adequate human studies or providing adequate risk information," stated Lieff Cabraser attorney Lexi J. Hazam, who represents women nationwide in vaginal mesh side effects lawsuits.
Ms. Hazam added, "The data requested should help alert doctors and patients to the dangers of mesh, but will come too late for many women who have already suffered life-altering injuries from defective products they should never have received. We encourage women harmed by mesh to contact us about their legal rights."