Specifically, the studies will focus on pelvic organ prolapse (POP) and stress urinary incontinence (SUI), conditions that affect about 50 percent of women in the United States at some point in their lifetimes. The Bard Avaulta mesh implant is one of the products commonly used in the minimally invasive surgery to treat and repair POP and SUI.
As reported by The Wall Street Journal on January 5, the requirement for post-market testing—which will see women treated with Bard mesh and other products in that class followed for three years—is, for now, about as far as the FDA is prepared to go on the issue.
Criticism is coming from both sides. Manufacturers are grudgingly accepting the post-market studies, but continue to balk at any suggestion that mesh products should not be allowed onto the market without rigorous pre-market testing, currently not required under the FDA's 510(k) guidelines.
On the other side are health advocates such as Public Citizen, which has petitioned the FDA to ban transvaginal mesh (TVM mesh) entirely, including Bard mesh.
Nonetheless, the requirement for post-market testing is the first salvo in a war that will likely see tighter restrictions on TVM mesh. How tight those restrictions are, remains to be seen.
Surgical mesh has been around since the 1950's for the treatment of hernias. However, doctors and manufacturers eventually saw the mesh as the basis for a minimally invasive procedure that uses vaginal insertion—rather than surgically opening the abdomen—to install a mesh product such as Bard Avaulta.
Thanks to the FDA 510(k) guidelines, manufacturers are allowed to dispense with the need for lengthy and costly pre-market testing due to the mesh already in existence. When manufacturers bring products to market that are substantially similar to those already on the market, pre-market testing is not required.
The regulatory loophole was meant to eliminate the time and expense associated with pre-market testing, and to speed the process when it comes time for a manufacturer to update an existing product.
However, the regulatory fast track has provided the foundation for needless pain and suffering on the part of thousands of patients. In July of last year, the Institute of Medicine called for a complete overhaul of the FDA's approval process for medical devices, in order to achieve more oversight.
In a move to perhaps appease critics, the FDA has proposed a requirement that some mesh products undergo pre-market testing, but has yet to make a decision. Over the interim, in letters sent to 33 mesh manufacturers—including Avaulta pelvic mesh during the first week of January—the FDA suggested that post-market studies be structured in such as way as to mirror, in some fashion, the outcomes of a pre-market study on mesh used to repair POP.
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While manufacturers of TVM mesh maintain the benefits outweigh the risks, the FDA stated in a July 2011 safety communication that use of TVM mesh "poses risks," in the agency's view, and suggested that old-fashioned abdomen surgery was more effective. Others have opined that TVM should be relegated to "experimental use" only.
Even so, advocates such as Public Citizen would like nothing better than a complete Avaulta mesh recall, along with similar products issued by some 30 other manufacturers. Many women have been forced to stop having intercourse with their partners, due to the pain. In some cases, problematic mesh akin to that allegedly found in the Avaulta mesh system cannot be safely removed.