FDA Will Review MoM Hip Safety (MedPageToday)
FDA seeks more advice on metal hip implants (FDA press release)
The FDA “is considering whether to make metal-on-metal hip systems subject to more rigorous testing and premarket review requirements,” the agency said.
An FDA advisory committee will meet June 27-28 to review data on failure rates, patient complications, and risk factors associated with metal-on-metal hip replacements.
Recent studies have indicated that metal-on-metal implants are more likely than other types to need short-term revision. Also, metal ions leaching from the implants have been linked to local and systemic reactions in a small number of patients.
British regulators recently told doctors to conduct yearly checkups on patients who have received metal-on-metal hip implants, including tests for metal ions in blood as well as clinical evaluations. In 2010, the U.K. Medicines and Healthcare Products Regulatory Agency warned physicians that metal-on-metal implants may be more likely to fail prematurely.
However, the FDA has been slower to respond. Last February, it created a special section in its website for information on the risks and benefits associated with the devices, and in May it ordered manufacturers to conduct new postmarketing safety studies.
Its review will cover both total hip replacements and resurfacing systems. Metal-on-metal is the only type of device available for resurfacing, whereas total replacement can include various combinations of polyethylene and ceramic as well as metal components.
At this point, however, many orthopedic surgeons have already stopped using metal-on-metal implants. Estimates now are that fewer than 5% of procedures use the devices, down from 30% at their peak of popularity.