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 ...
