The FDA has issued an updated safety communication warning doctors, health care professionals and patients that the placement of it can create greater risk for the patient. There is a 5 fold increase in deaths and serious injuries as a result of the product. Complications involve erosion of the mesh into vaginal tissue, organ perforation, pain, infection, urinary and fecal incontinence. Often, women need surgery to remove the mesh and sometimes all of it cannot be removed. We are reviewing cases involving American Medical Systems, Bard, Boston Scientific, Caldera, and Johnson & Johnson.
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