Transvaginal mesh has been used in surgery to treat women suffering from pelvic organ prolapse (POP) and Stress Urinary Incontinence. However, transvaginal placement of surgical mesh, previously believed to rarely cause complications, in fact does result in serious complications which might require multiple follow-up surgeries to resolve the complications, according to a recent FDA warning.
Since October 2008 over 1,000 incidents of transvaginal surgical mesh complications have been reported, according to the Food and Drug Administration.
These mesh complications have included the following concerns:
- Erosion through vaginal epithelium (the tissue inside the vagina)
- Urinary problems
- Recurrence of prolapse and/or incontinence
- Bowel, bladder, and blood vessel perforation during insertion
- Vaginal scarring
- Mesh erosion causing discomfort, pain, and/or dyspareunia (painful intercourse)
Women who have experienced serious complications such as mesh erosion, pain, organ perforation and urinary problems may be eligible for compensation through filing a lawsuit.
The U.S. Food & Drug Administration (FDA) has been conducting a safety review of transvaginal mesh since 2008. Last July, the agency said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh products made by Johnson & Johnson and other companies from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. According to the FDA, even when women undergo surgery, sometimes multiple surgeries, to have defective mesh removed, complications continue because it is almost always impossible to completely remove the device.
According to the Mass. Market report, the FDA originally placed transvaginal mesh products in its Class II device category, meaning they didn’t need thorough clinical human trials to prove their safety before they were put on the market. Manufacturers only needed to show a product was “substantially equivalent” to another already approved by the agency. In January, the FDA asked transvaginal mesh manufacturers to conduct post-market safety studies of their products. The agency is now considering moving transvaginal mesh for POP repair to a higher risk medical device category.
The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph R. Goodwin has scheduled the first trial for February 3, 2013.
If you or a loved one had pelvic organ prolapse and have undergone a transvaginal surgical mesh procedure, please contact us for help.