FDA Tightens Rules for Surgical Mesh in Pelvic Prolapse Repair
Agency aims to improve treatment of pelvic organ prolapse.
(HealthDay News) -- The US Food and Drug Administration has strengthened rules regarding the use of vaginal mesh implants to treat pelvic organ prolapse in women, according to a news release issued by the agency.
The devices were reclassified on Monday from a "moderate" to "high" risk category. Manufacturers must now submit pre-market approval applications to the FDA to help the agency better assess the implants' safety and effectiveness.
"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," William Maisel, MD, MPH, deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health, said in the 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 updated requirements apply to transvaginal placement of the mesh implants to treat pelvic organ prolapse. The new rules do not apply to other uses of surgical mesh. Makers of transvaginal mesh implants already on the market now have 30 months to submit pre-market approval applications, while makers of new devices must submit an application before their devices can be approved for sale in the United States, the FDA said.