Panel calls for FDA to issue safety advice for metal-on-metal hip replacements2012; 345 doi: http://dx.doi.org/10.1136/bmj.e4542 (Published 03 July 2012) Cite this as: 2012;345:e4542
- Bob Roehr
- 1Washington, DC
An FDA advisory committee inquiry into metal-on-metal hip replacements was unable to determine whether all such implants were at risk of becoming damaged and shedding cobalt and chromium ions with effect on surrounding muscle tissue.
The committee spent two days wrestling with issues surrounding the 750 000 metal-on-metal hip replacements that have been done in the US. The agency was trying to sort out often conflicting data and interpretations of those data in updating its policy on the devices.
Two recent investigations by the BMJ have raised serious concerns about the regulation of medical devices and problems with metal-on-metal implants caused by metal ions leaking into the body.1 2 After publication of the articles, the UK’s Medicines and Healthcare Products Regulatory Agency recommended that all patients with metal-on-metal hip implants with a femoral diameter of ≥36 mm have annual blood tests to check metal ion …
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