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Metal-on-Metal Hips Need Work More Quickly (CME/CE)

MedPageToday, 2012

Finally, Smith and colleagues indicated that ceramic bearings would be most appropriate for patients needing large-head implants.
In an accompanying commentary, Art Sedrakyan, MD, PhD, of Weill Cornell Medical College in New York City, argued that the metal-on-metal implant story had revealed the inadequacy of medical device regulation in the U.S.
Sedrakyan called the FDA's 510(k) pathway "outdated and low-threshold" and suggested that it and its European counterparts "have created an environment that makes regulators vulnerable to errors."
He criticized the lack of rigorous requirements for pre- and postmarketing studies of most devices, including most hip implants, which meant that many thousands of metal-on-metal devices were placed before their propensity to fail became apparent.
An additional problem in the U.S., Sedrakyan suggested, is a political climate that pressures the FDA "not to stifle innovation."
it would not be surprising if metal-on-metal hip prostheses were just the tip of a device-safety iceberg yet to be revealed."
can look forward to "the burden of further surgical treatment as well as billions of dollars in costs to taxpayers."
Smith A, et al "Failure rates of stemmed metal-on-metal hip replacements: analysis of data from the National Joint Registry of England and Wales" Lancet 2012; DOI: 10.1016/S0140-6736(12)60353-5.
Sedrakyan A "Metal-on-metal failures -- in science, regulation, and policy" Lancet 2012; DOI: 10.1016/S0140-6736(12)60372-9.
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