Metal-on-metal hip systems are regulated under the Food and Drug Administration (FDA) 510(k) premarket notification program and classified as Class III (higher risk) devices. In addition, the medical devices are not required to undergo premarket testing or clinical trials before they are used in patients. Under the 510(k) program, manufacturers simply have to state that their medical devices are similar to medical devices already on the market.
In May 2011, the FDA ordered 21 prosthesis manufacturers to conduct post-market studies on their metal-on-metal hip systems. A year later, an FDA panel concluded that there is little benefit for surgeons to continue using metal-on-metal hip implant systems. The FDA said “a decision on the proper classification of metal-on-metal hip systems is forthcoming.”
This fails to bring comfort to those seriously injured by these all-metal implant systems. People are stunned to learn Congress entrusted the FDA with protecting the general public. However, the FDA’s actions appear to be favorable to business, but offers little protection for those injured by metal-on-metal hip implants with the 510 (k) premarket approval.