FDA Rules To Reclassify POP Vaginal Mesh as High Risk!
January 4, 2016 ~ An expert panel convened by the U.S. Food and Drug Administration (FDA) decided in September 2011 that mesh used to treat pelvic organ prolapse (POP) should be reclassified as high risk from its moderate risk (Class II) status.
Today, the FDA announced POP mesh would finally be reclassified as a high risk device.
The makers of POP pelvic meshes still on the market will have 30 months to submit proof their devices are safe and effective as proven by clinical trials or other evidence. The FDA requires PMA or Premarket Approval of drugs and class III medical devices. It is considered a more stringent requirement to assure patient safety.
New POP meshes will require the manufacturer to submit a PMA before they receive FDA approval.
Whether manufacturers will be able to demonstrate safety and effectiveness through existing clinical trials remains to be seen since that was not previously a requirement for entering the market. Clinical trials to assure safety can run into the millions of dollars and are required of drug makers.
*Update* -An FDA spokeswoman tells MND the evidence coming into the 522 post approval monitoring studies the FDA required of manufacturers in January 2012, may suffice as evidence of a device’s safety.
The order covers the larger pelvic meshes used for POP and not those used to treat stress urinary incontinence SUI.
Often called “hammocks” or “ribbons,” referring to their smaller amount of polypropylene mesh, SUI mesh remains in a Class II status or “moderate risk.” SUI mesh can continue to be introduced into the market once the manufacturer claims to the FDA it is the” substantial equivalent” of another mesh already being sold. The FDA’s 510(k) approval process, as it is known, relies on the integrity of the manufacturer to assure patient safety and does not require clinical trials to back up that assurance.
When MND reviewed FDA data in March 2013, SUI injury reports to the agency were up 36 percent. Reclassifying SUI mesh has not be proposed by the FDA. See the background story here.
POP MESH INJURIES
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, MD, MPH, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, in a news release.
“We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures.”
The FDA says it has received thousands of reports of complications associated with pelvic mesh including mesh migration, erosion into other organs, chronic pain and infection, and autoimmune reactions to the polypropylene mesh.
This order does not include POP meshes implanted abdominally, just those that are implanted through the vagina or transvaginally.
The move to reclassify follows on the heels of two other FDA decisions regarding pelvic mesh.
In 2008, the agency said complications from all meshes were “rare” and that the benefits likely outweighed the risks. By July 2011, the FDA did an about face and announced POP complications with mesh were “not rare” and that the risks likely outweighed the benefits. That after the agency noted a five-fold increase in the number of reports of complications coming into the FDA representing thousands of complaints.
Between 2008 and 2010 there were seven reported deaths associated with pelvic organ prolapse mesh repairs. Two included towel perforations and one hemorrhage. Four deaths were due to post-operative medical complications, according to the FDA’s website.
There were approximately 300,000 POP repairs in the U.S. in 2010 with about 70,000 using polypropylene POP mesh. Additionally, thousands of POP repairs occur internationally. Many meshes taken off the market in the U.S., continue to be sold globally.
Pelvic organ prolapse meshes are generally larger and have arms that anchor them into deep tissues, muscles and ligaments. Mesh removal experts consider them particularly difficult to remove.
POP meshes include the Perigee, introduced by American Medical Systems in 2004; Prolift was introduced by Ethicon in 2005; the Elevate by AMS in 2008 and the Pinnacle/Uphold was introduced by Boston Scientific in 2007 and 2008.
Elevate and Apogee (AMS) are still on the market. Restorelle by Coloplast is still used for POP repair. Prolift was quietly removed by Ethicon (J&J) in June 2012. C.R. Bard took its Avaulta mesh off the market in 2012.
Manufacturers moved to remove their POP meshes from the market after a January 2012 mandate by the FDA that required three years of post-approval monitoring of the health of women implanted with POP mesh. By removing the mesh from the market, the manufacturers were relieved of the monitoring requirement, though the mesh remains in the women’s bodies.
*Update**– On February 26, 2016, the agency will convene an expert panel to review the safety of trocars, used to place the mesh transvaginally. The are stainless steel hooks and instruments used to place the mesh during the blind pelvic procedure. #
FDA News Release, Jan 4, 2016
July 2011 FDA White Paper on Pelvic Mesh
MND, Jan. 2012, Mesh Makers who Received 522 PostMarket Surveillance Orders
MND, March 2013, SUI Injury Reports to FDA up 36 Percent
FDA Federal Register, Final Order, January 5, 2016