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].
The FDA has called for stricter regulations against unsafe products approved by the 510K, substantially equivalent process, in light of thousands of lawsuits filed by patients implanted with metal on metal hip, knee and vaginal mesh devices, as reported by Bloomberg Health News.
Johnson & Johnson wrote internal emails in 2009, one year before recalling the device that the FDA refused to approve it after noting it was failing prematurely in “significant” numbers, requiring repeat surgeries to replace it [reported by the New York Times @ www.nytimes.com].