SILVER SPRING, Md., Jan. 4 (UPI) -- The Food and Drug Administration reclassified surgical mesh used for transvaginal repair of pelvic organ prolapse as high-risk and is requiring manufacturers to collect more safety data as part of its application for approval, the agency announced Monday.
The agency's new regulations come after thousands of complaints filed in recent years about adverse events as the devices have increasingly been used. The FDA has issued safety communications to doctors and manufacturers, and convened a safety panel four years ago, before proposing the now-adopted rules in 2014.
"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," said Dr. William Maisel, deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health, in a press release. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures."
Pelvic organ prolapse happens when muscle and tissue in the pelvic floor stretch, tear or weaken, causing organs such as the bladder, bowel, or uterus to bulge into the vagina. Gynecologists in the 1970s started repairing the prolapse with surgical mesh, which was used at the time to repair abdominal hernias.
In the 1990s, doctors started using the mesh to repair prolapses transvaginally, though the FDA didn't clear it for that use until 2002 when it cleared it as a moderate-risk device.
The FDA warned doctors starting in 2008 about cases of extreme pain and the mesh dislodging from its original placement, convening an advisory panel in 2011 for recommendations on actions the agency should take. In 2012, the agency asked manufacturers to gather information on use as it investigated whether new rules were necessary.
At least 23,000 lawsuits have been settled by two of the devices' five manufacturers since 2014, the Wall Street Journal reported, the same year the FDA proposed reclassifying surgical mesh used to repair prolapse as a class 3 high-risk device and for manufacturers to submit a premarket approval application that includes data to support the safety and efficacy of the devices.
New devices will be subject to the new requirements immediately, while the manufacturers of previously approved devices have 30 months to submit PMAs for each.