In a highly unusual move, the U.S. Food and Drug Administration (FDA) announced on Wednesday, January 4, it is considering upgrading the classification of surgical mesh used in woman to hold up pelvic organs or to treat incontinence. Synthetic transvaginal mesh is currently Class II. A Class III designation would mean clinical studies would have to be conducted for safety and efficacy before the product is introduced to the market.
What does that mean? You may have heard all of the controversy about the way the FDA allows some permanently implanted medical devices to be approved for marketing without any scientific assurances for safety and efficacy. There is a little known loophole within the FDA called the 510(k) process that allows just that. Manufacturers of medical devices love 510(k) because they can get a device into the hands of doctors and consumers faster and with less cost.
But the serious injuries and deaths that have resulted from synthetic transvaginal mesh failure have the FDA reevaluating whether the implanted and permanent devices should be approved without scientific studies. A reclassification from Class II to Class III would no longer allow it to pass only 510(k) scrutiny; manufacturers would now have to conduct clinical trials to prove mesh is safe for patients. Most consumers assume that this is already happening. They would be wrong.
This is just the latest in a long list of problems with synthetic surgical mesh.
On July 13, 2011, the FDA issued its strongest worded warning about the medical device, just short of issuing a recall, that said “serious complications associated with surgical mesh for transvaginal repair of POP (pelvic organ prolapse) are not rare.” The FDA also said it’s not clear whether synthetic mesh offers any advantages over traditional non-mesh repairs.
The Institute of Medicine concluded in a report issued the next month that the 510(k) process was “fatally flawed” in that it let thousands of defective medical devices onto the market without any assurances of safety.
Still thousands of these medical devices are implanted every year to unsuspecting women despite the fact that the FDA noted a five-fold increase in complications, such as mesh erosion into the vagina, pelvic pain, and nerve entrapment, among other problems.
The Florida transvaginal mesh lawyers of Farah & Farah are talking to women who may have had defective transvaginal mesh surgery and are now suffering the complications. The sooner you contact our office, the sooner we can help you retrieve your medical records to discover what type of mesh you had so a complication report can be lodged with the FDA and we can hold the manufacturers accountable for this defective product. You have a limited time within which to act, so call us at 1(800) 533-3555 at no cost to you unless we receive an award in your favor.
Source: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm
