The U.S. Food and Drug Administration (FDA) ordered metal hip implant makers to study the dangers of metal-on-metal hip implants on May 6, 2011. There is evidence that metal-on-metal implants can release tiny metal particles into patients’ bloodstreams, but the FDA seeks more information about the potential health risks.
The FDA says it is working on assessing the safety of metal-on-metal implants. Part of the assessment includes the order to 21 companies that make metal-on-metal hip implants to conduct individual studies on patients that have received a metal hip.
The agency has also stated that it plans to continue to review published literature, adverse event reports and data collected and published in orthopaedic device registries in an effort to better understand the possible health risks associated with an increase of metal debris in the bloodstream, particularly cobalt and chromium.
The FDA sent 145 orders to the 21 manufacturers, requiring that they turn in a research protocol to the FDA addressing specific safety issues.
