A new report reveals that federal health regulators are considering tough new regulations for surgical mesh used to treat pelvic organ prolapse (POP), which has been linked to thousands of serious injuries and complications.
RECOMMENDATIONS FOR HEALTH CARE PROVIDERS
The FDA encourages health care providers to:
CONSIDERATION OF REGULATORY CHANGES
The FDA is considering regulatory changes that may improve our understanding of the safety and effectiveness of this device. Considerations include:
On September 8-9, 2011, the FDA will convene a meeting of the Obstetrics-Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss the safety and effectiveness of transvaginal placement of mesh for POP and SUI procedures.