FDA Asks for Monitoring Help

Posted by Buck Daniels

July 5, 2012 – The Food and Drug Administration has suggested that metal on metal hip implants need closer, more consistent monitoring in order to cut down on high failure rates. Because the metal devices have been linked to almost 16,800 adverse events in the U.S. from 2000-2011, FDA regulators are concerned that sufficient imaging and ion testing, to observe the metal’s effects on surrounding tissue, is not being performed.

Due to the higher rate of failure in metal on metal implants, as compared to other versions, regulators know that increased monitoring is necessary to observe the unique problems presented by these metal devices.