The United States Food and Drug Administration (FDA) has recently issued a press release dealing with new changes to regulations regarding the use of transvaginal mesh (TVM) implants.
Surgical mesh has been around for decades. In the 1950s, surgeons used the material to repair hernias. Two decades later, surgeons began experimenting with the use of surgical mesh to treat a serious medical condition in women known as pelvic organ prolapse (POP). However, at that time, surgeons would make an incision in the patient’s abdomen to implant the mesh, and this led to a longer and more painful recovery than many patients would have liked.
In the 1990s, surgeons experimented with the use of mesh to perform a transvaginal repair of POP. However, this was not an FDA approved use of the mesh. It was still perfectly acceptable as an off-label use for the medical device under FDA guidelines. Meanwhile, medical device companies were conducting clinical trials with transvaginal mesh implants and hoping for FDA approval.
After about ten years of testing and off-label use, FDA approved the first transvaginal mesh product as a class II device. Under FDA regulations, a class II device is classified as a moderate-risk medical device. Presently, there are five medical device companies that produce transvaginal mesh.
As more women began to undergo implantation of transvaginal mesh, patients were reporting more adverse events (side effects) than FDA was expecting. It turned out the device was causing erosion of vaginal tissue and pelvic floor and stress urinary incontinence (SUI). Specifically, POP involves the muscles of the pelvic floor and connective tissue becoming torn or significantly stretched. When this occurs, the pelvic floor becomes to weak to support the bladder, bowel, and uterus. At this point, the organs essentially drop from where they are supposed to be into the patient’s vagina. This causes pain as well as many serious and also embarrassing medical complications.
These complications have been the basis for the many transvaginal mesh implant lawsuits in Boston and across the country. While these side effects have been know for quite some time, and the FDA issued an advisory in 2012, the agency is now strengthening the requirements for companies wishing to sell these products. Under the new regulations, the Premarket Approval (PMA) pathway will require significantly more safety testing and document disclosure before the FDA will approve a new product.
This now applies to new TVM products, since manufacturers of medical devices already on the market will have 30 months to complete the PMA testing and produce compliance documents. A second new regulation will affect those already on the market as well as new products. FDA is reclassifying TVM from a class II medical device (moderate risk) to class III medical device (high-risk). With a product being classified as a high risk medical device, medical device manufacturers will be required to conduct more long-term safety testing and provide more documents to the FDA to insure compliance with the new regulations. This will also require more disclosure to patients about the risk of getting a transvaginal mesh implant, due to it being classified as a higher risk procedure.
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FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks, January 4, 2016, FDA News Release
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