Taking on the manufacturers of Vaginal Mesh
A medical device that is registered with the FDA as “Urogynecologic Surgical Mesh Implant” has been much in the news lately, for all the wrong reasons as far as the manufacturers are concerned. There have been a growing number of reports of adverse reactions to the procedure.
Surgical mesh has been used as a treatment device for over 30 years. Initially developed to treat hernias where the stomach lining needs strengthening, recently it has been successfully used to assist in the repair of the urinary tract (Sudden Urinary Incontinence or SUI and latterly in the treatment of Pelvic Organ Prolapse (POP). In 2010 it is estimated that 75,000 women in the United States had Vaginal Mesh implants.
Back in October 2008 the FDA had promulgated a warning alert that there had been several problems with vaginal mesh implants. At that stage, though, the numbers of reports were just over 1000 in 3 years and the problems were rated as rare. Since that time there has been acceleration in reports to the FDA such that in 2009 and 2010 1500 reports were submitted of complications resulting from vaginal mesh implants in POP cases and a further 1000 in the treatment of SUI.
As a result on 13 July 2011 the FDA issued a safety warning in which it stated that these cases were no longer to be considered rare and that there was cause for serious concern. The Vaginal Mesh FDA Warning makes a number of observations and recommendations amongst others being that patients be very fully informed of the risks they are taking in having the mesh implant and that they see no clear evidence of the advantages of mesh over the traditional stitching up surgical repairs that were the previous normal procedure.
A second consequence has been the launching of a number (over 500 reported) of Vaginal Mesh Lawsuits against the manufacturers for “mass tort” in that they had a civic duty to their users not to sell them a medical device that would cause them harm.
The breakdown of the device, as reported by the FDA is principally erosion. The device is embedded inside the vaginal wall and is meant to let the tissue grow through it as a permanent fitment. Instead in these instances the tissue has worn away and the mesh starts protruding into the vaginal passage. Other symptoms may include pain, bleeding, vaginal infections or shrinkage, urinary problems and irritation during intercourse.
A further difficulty is that the placement of the mesh is permanent. Shortly after insertion the body’s tissues naturally grow through the mesh and incorporate it as part of the healing process. Removal of the device is fraught with difficulties, as there are a lot of very sensitive organs such as incorporate the bladder, the uterus, the rectum, the front of the vagina (vaginal apex) after a hysterectomy, and the bowel. Removal also may well not cure the problems.
All women who have had this procedure and are experiencing no problems are nevertheless urged to maintain a routine annual check up. If they are experiencing any difficulties whatever they are advised to consult their care giver and after that contact the Vaginal Mesh Attorney.