American Radio Show Questions Likelihood of a Future Vaginal Mesh Recall
With the health issue now grabbing the attention of influential public figures like Robert F. Kennedy Jr., can an industry-wide transvaginal mesh recall be too far behind?
On Oct. 8, his affiliates at the radio program, Ring of Fire, posed the question, “One Year after the FDA’s Meeting on Transvaginal Mesh: Where Are We Now?” via its website.
The blog post called to mind one transvaginal mesh product in particular: the Perigee System, marketed by American Medical Systems. As the author describes the device created in 2004, he likens its curved “trocars” to “the metal hooks used by butchers in the meat industry.”
The author then proceeds to mention that the Perigee System was never explicitly approved by the U.S. Food and Drug Administration (FDA). Like many medical devices on the market today, it was allowed to enter the marketplace by way of the agency’s 510(k) process, which permits a product to do so as long as the manufacturer can prove it is considerably equivalent to one that has already been approved.
A year before this article was published, the FDA’s Obstetrics & Gynecology Devices Advisory Committee met to discuss the safety and efficiency of transvaginal mesh products. By the end of the September 2011 meeting, the panel agreed that more clinical testing needed to be put into place before the devices can be cleared by the FDA. The experts also said transvaginal mesh products should be re-classified as Class III, which would require that all companies get pre-market approval for their products before they can be sold to the public.
According to Ring of Fire, the side effects associated with these controversial products have led to more than 5,000 transvaginal mesh lawsuits filed in U.S. courts. To help handle proceedings, the following transvaginal mesh manufacturers are now involved in multidistrict litigations (MDL) around the country: C.R. Bard Inc., American Medical Systems, Boston Scientific Corp. and Ethicon.