The U.S. Food and Drug Administration has strengthened rules regarding the use of vaginal mesh implants to treat pelvic organ prolapse in women.
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.
Pelvic organ prolapse involves a weakening or stretching of internal structures that support organs such as the bladder, bowel and uterus. It can happen in women after childbirth, a hysterectomy or menopause. It can cause pelvic pain, constipation and urinary leakage, and often affects sexual activity.
Surgeons have long used the mesh implants to reinforce weakened pelvic floor muscles and repair pelvic organ prolapse. But, problems afterwards such as pain, infection, bleeding, urinary problems and pain during intercourse are common, the agency said.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” Dr. William Maisel, deputy director of science and chief scientist at the FDA Center for Devices and Radiological Health, said in an agency 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,” he added.
The updated requirements apply to surgical placement of the mesh implants through the vagina (transvaginal) 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 they can be approved for sale in the United States, the FDA said.
The American Urogynecologic Society has more about pelvic organ prolapse.