The Food and Drug Administration on October 20th, 2008 issued a strong warning to consumers and health practitioners concerning a series of dangerous problems associated with the implant of the transvaginal mesh used to treat urinary incontinence and pelvic organ prolapse. Over the past several years the FDA has received approximately one thousand (1000) complaints from women who used the transvaginal mesh patch. The problems most commonly associated with the transvaginal mesh are 1) Infection; 2) Urinary problems; 3) Erosion through the vaginal wall; 4) Adhesion to other organs if the mesh path breaks through; 5) Recurrence of prolapse; 6) Other associated health complications. Here is a portion of the warning from the FDA:
“The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh,” William Maisel, MD, MPH, , deputy director of FDA’s center for devices and radiological health, said in a statement. “Mesh is a permanent implant – complete removal may not be possible and may not result in complete resolution of complications.”
The FDA studied the literature on the vaginal mesh patches from 1990 to 2010 and discovered that patients who used the transvaginal mesh patch did not obtain any better health benefits than the women who had repair with just stiches. The principle benefit from the transvaginal mesh path repair seems to be cosmetic and the serious health benefits are the health problems and the possibility that the mesh will adhere to other body organs and be impossible to remove. This most current warning by the FDA concerns only the transvaginal mesh path. Interestingly, for several years there have been recalls of other types of mesh patches such as those used to treat hernias. Coxwell & Associates recently helped aid a woman who had a hernia mesh path implant receive compensation due to the complications after the patch adhered to her internal organs.
A number a civil actions (lawsuits) have already been filed by women who are suffering severe complications due to the implant of the transvaginal mesh patch. Our criteria for vaginal mesh claims are that the implant was initially performed in 2001 or later. The manufacturers of the mesh patch that we are investigating are Bard, Boston Scientific, Ethicon and AMS. If you have one of the transvaginal mesh implants described in this article and you are experiencing serious complications, call Coxwell & Associates, PLLC for a free consultation and meeting with one of our attorneys. If we can help you, we will not charge you unless we are able to recover money for the harms and losses you may have suffered due to the implant product.