Announced today, FDA has issued two final orders regarding data requirements for manufacturers of surgical mesh used for transvaginal pelvic organ prolapse (POP) repair:
- Reclassify the surgical mesh from a Class II to a Class III device
- Manufacturers must submit a PMA backing up the safety and effectiveness of the mesh for transvaginal POP repair
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at CDRH 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.”
Manufacturers of the mesh must address safety issues, including severe pelvic pain and organ perforation. Companies will have 30 months to submit a PMA for surgical meshes that are already on the market. New devices will need to go through the standard PMA process.
The agency orders only apply to surgical mesh for transvaginal repair of POP. They do not affect mesh for stress urinary incontinence or abdominal repair of POP.
The full release on the FDA orders for POP surgical mesh can be viewed on FDA’s website.