The FDA now reclassifies pelvic mesh as high risk. On January 4, 2016, the FDA announced that transvaginal or pelvic mesh used to treat pelvic organ prolapse (POP) will be reclassified as a high risk or class III device. The mesh previously held “moderate risk” or class II status. (See the FDA Release.)
The FDA is granting any makers of POP pelvic meshes that remain on the market (several have been withdrawn) 30 months to gather and submit proof that the devices they make are safe and effective. The FDA normally requires Premarket Approval (PMA) for class III medical devices, so this move is somewhat unprecedented.
Any new POP meshes will require their maker to submit a PMA before receiving FDA approval. All meshes, for both POP and stress urinary incontinence (SUI), were unleashed on the market under the aegis of the agency’s 510(k) approval process, which requires only that a device be ruled substantially similar to a predicate product already on the market.
Will mesh makers be able to demonstrate safety and efficacy through clinical trials? The bar is high. Clinical trials cost millions and typically take years to perform. A short cut for mesh makers may come from the FDA’s January 2012 ruling. At that time, the agency required mesh makers to conduct 522 post approval studies to test the safety and efficacy of mesh; those studies might be used as evidence by mesh makers.
POP vs. SUI Mesh
The order covers the larger pelvic meshes used for POP and not those used to treat stress urinary incontinence (SUI).
Pelvic mesh products used to treat stress urinary incontinence – often called mesh slings – remain classified at “moderate risk” or Class II status. Mesh makers can continue to introduce SUI meshes into the market under the 510(k) approval process if the makers claim their product is a “substantial equivalent” to another mesh already marketed.
FDA reclassifies pelvic Mesh as High Risk
William Maisel, MD, MPH, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, praised the new classification in a news release: “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse.”
Maisel added that the FDA intends to continue monitoring women implanted with mesh devices.
Thousands of Mesh Complaints not rare
FDA reports that it has received thousands of complaints regarding complications associated with pelvic mesh. Complications include mesh migration, erosion into other organs, chronic pain and infection, autoimmune reactions to the plastic mesh.
The reclassification follows two other pelvic mesh decisions from FDA. The agency declared in 2008 that complications from all meshes were “rare” and ruled that benefits likely outweighed risks. But then in July 2011, FDA reversed itself, announcing that complications from mesh implanted to treat POP were “not rare.” The agency ruled then, after receiving thousands of mesh complaints, that risks likely outweighed benefits.
The FDA order includes only those meshes which are implanted through the vagina, not those which are abdominally implanted.
Pelvic Mesh Deaths
Seven deaths from POP mesh surgery were reported from 2008-2010. According to the FDA’s web site, four deaths were due to post-operative medical complications.
Jane Akre of Mesh News desk reports that there were approximately 300,000 POP repairs in the U.S. in 2010 with about 70,000 using polypropylene (plastic) POP mesh. there are currently more than 80,000 pelvic mesh lawsuits filed in the multi district litigation court set in West Virginia.