What’s the Latest News on Transvaginal Surgical Mesh?
You may be hearing a lot of news about transvaginal or synthetic surgical mesh used in women. The U.S. Food and Drug Administration (FDA) has not recalled the defective product, but it has come as close as it can to doing so. Synthetic mesh is made by nine companies, but most of the news and lawsuits revolve around four manufacturers, C. R. Bard, Ethicon (Johnson & Johnson), American Medical Systems (AMS), and Boston Scientific.
The FDA does not require these companies to do clinical trials before the mesh is marketed to doctors and the public, unlike the more stringent review required of drugmakers. Instead, mesh is grandfathered in under a process called 510(k), which is an FDA approval for marketing only – no assurances for safety are required. It’s basically an exchange of paper with the manufacturer claiming the medical device is substantially similar to one already on the market. The problem is one of the first meshes used as a “predicate,” the ProteGen, was taken off the market for being defective. You would think that would spark an internal FDA investigation to see if the defect was present in the meshes that followed. That never occurred.
Most recently, the FDA asked 35 manufacturers of mesh for pelvic organ prolapse and stress urinary incontinence to conduct three-year follow-up studies on women who receive the permanent implant. With all of the news about transvaginal mesh side effects and complications, it may be difficult to find a patient population to follow for three years. And with thousands of complications already reported, it seems that these women are walking into a potentially life-altering situation to have permanently implanted mesh when it is nearly impossible to remove if there are complications.
Even the FDA said in its July 13, 2011 Public Notification that complications are “not rare” and that the benefit of synthetic may not be outweighed by the risks it poses.
Complications include a return of incontinence and prolapse, debilitating pelvic pain, nerve and organ intrusion, mesh erosion, migration and shrinkage, repeated infections, and in some cases, death. The lawsuits representing thousands of injured women will begin being heard at some point in 2012, but meanwhile, the FDA has given manufacturers an additional three years to study the effects. Most of the public assumes that was done before the mesh was put on the market, not after. Meanwhile upward of 300,000 women will have mesh implanted as a treatment and many will not be aware of the controversy surrounding the defective product.
The Florida transvaginal mesh failure lawyers at Farah & Farah is talking to women who are suffering the complications of this defective product. Call us at (800) 533-3555 so we can offer you a complimentary consultation on your situation. The sooner you act, the sooner you might be able to find relief and compensation for your injury.