Surgical Mesh Warning Issued by the FDA

by nph | July 15th, 2011

July 15, 2011

The Food and Drug Administration (FDA) issued a warning Wednesday regarding the dangers of surgical mesh used to support organs in women suffering from pelvic prolapse, a condition in which internal body parts, like the bladder and reproductive organs, slip down into the vagina. Doctors have also used the mesh to correct stress bladder incontinence in women.

The warning states that complications could arise from the use of the product, such as pain, bleeding, and infection. Over a two-year period, from 2008 to 2010, more than 1500 patients reported post surgery issues involving the mesh. In most cases, complications arose after the mesh failed to bond correctly to the body and came through the vaginal wall.

Even with the great risk of injury, the FDA is choosing not to pull the product completely because certain patients may still benefit from its use. For now, experts are recommending that doctors perform a more traditional prolapse surgery using only stitches instead of the mesh product.

The FDA will conduct a meeting in September to determine the fate of the surgical mesh by asking patients whether it should be considered a high-risk product and will determine what studies could show which patients could benefit from its use.

The Ohio Medical Malpractice Attorneys with Nurenberg, Paris, Heller & McCarthy may be able to assist victims of surgical malpractice by helping to hold surgeons and other hospital staff accountable for the mistakes made during your procedure.