All-Metal Implants and FDA Restrictions

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Metal-on-metal implants have been a topic of interest lately, with several orthopedic implant manufacturers experiencing recalls issued by the FDA. More than 500,000 individuals in the US received hip implants between 2003 and 2010 that had the metal-on-metal design. The metal-on-metal implants were originally designed with the hypothesis that they would be more durable than their counterparts made with ceramic and polyethylene. While the old implants typically lasted about 15 years before failure, there is evidence now that shows the failure rate of the metal-on-metal implants up to about 50% at six years.

The primary cause of the adverse effects in patients has been due to ion toxicity. As the implant parts articulate with one another, metal particles enter the patient’s serum. The primary materials used have been chromium and cobalt. The result in patients has been metal debris left behind, causing severe tissue and bone damage with much pain. The question is, why did the products receive such quick approval without proper clinical trials?

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