The European equivalent of the US FDA, the Medicines and Healthcare Products Regulatory Agency [MHRA], recently updated their recommendations for physician management and follow up visits for patients with metal-on-metal implants. Patients should be followed yearly and monitored for complications [such as chromium toxicity and device failure]. Previously, they recommended follow up every 5 years. This change is a result of the EU’s diligent post marketing surveillance, finding many patients having severe pain and complications necessitating revision surgeries, which may have been minimized by more frequent follow up.
The MHRA was the first regulatory agency in the world to issue follow up recommendations for physicians in April 2010 for these patients. See the MHRA press release http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON143784
These devices have been shown to be leaching the elements chromium and cobalt; causing metalosis and tissue death in some patients. Hopefully, the US FDA will follow the EU’s lead and issue similar recommendations for physicians to follow in order to minimize the severe complications patients are experiencing.