FDA Plans Meeting on Metal-on-Metal Hip Implants
Posted 29 March 2012 | By
The US Food and Drug Administration (FDA) announced it is looking to hold a two-day meeting on implantable metal-on-metal (MoM) hip implants, saying it wants public input on whether to make the devices subject to more rigorous testing.
"Numerous recent publications, studies and registry reports have raised safety concerns for MoM total hip replacements," said FDA in the Federal Register posting, including reports from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the American Academy of Orthopedic Surgeons.
Said FDA: "The committee will be asked to discuss the following as it pertains to these devices in the U.S. population: Device mechanisms of failure, metal ion testing, imaging methods, local and systemic complications, preoperative and postoperative patient risk factors, as well as clinical follow-up considerations for patients with MoM hip systems (total and resurfacing)."
FDA- FDA to discuss risks and benefits of metal-on-metal hip replacements
Meetings: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory CommitteeRead all Regulatory Focus Articles on Hip Implants