FDA Issues Recall On Trans-Vaginal Mesh
December 6, 2011
The Food and Drug Administration (FDA) issued a warning several months ago regarding the dangers of surgical mesh being used to support organs in women suffering from pelvic prolapse, a condition in which 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. Most often, the 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 conducted 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 are still working to decide which patients could benefit from its use.
The Texas Vaginal Mesh Failure Lawyers with Ferrer, Poirot and Wansbrough have years of experience helping victims who have been injured because of a doctor’s mistake in surgery. Contact us today by filling out a free initial consultation form if you have been hurt.