As we have reported in a earlier issue, the FDA has issued an updated safety communication warning doctors, health care professionals and patients that the placement of surgical mesh through the vagina to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) may present greater risk for the patient than other non-mesh procedures. This is also called transvaginal mesh.
The FDA recently wrote to C.R. Bard, Johnson & Johnson and 31 other manufacturers asking them to conduct safety trials regarding these products which should last three years. Last year, the FDA issued a report which showed a five-fold increase in deaths and other serious injuries as a result of these products. The FDA has asked each manufacturer to gather data from these procedures to help determine whether these devices provided a benefit over older methods.
According to the FDA, complications from the transvaginal placement of the mesh include erosion of the mesh into the vaginal tissue, organ perforation, pain, infection, painful intercourse and urinary and fecal incontinence. Quite often, women require surgery to remove the mesh and oftentimes it’s impossible to remove all of the mesh involved. Currently, we are investigating cases involving mesh manufactured by American Medical Systems, Bard, Boston Scientific, Caldera, and Johnson & Johnson. If you need more information, contact Chad Cook or Leigh O’Dell, lawyers in our firm’s Mass Torts Section, at 800-898-2034 or at by email at Chad.Cook@beasleyallen.com or Leigh.Odell@beasleyallen.com.
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