The Food and Drug Administration (FDA) recently ordered all producers of metal-on-metal hip devices to undertake studies of the implants, which have been linked to high early failure rates and severe health effects in some patients, says an article by The New York Times.
The FDA sent 145 orders to 21 manufacturers requiring them to submit a research protocol to the agency that addresses specific safety issues related to these devices. Data from the studies conducted will enable FDA to better understand these devices and their safety profiles.
Metal-on-metal hips, accounted until relatively recently for about one-third of the estimated 250,000 hip replacement procedures performed annually in the United States. But over the last 2 years, the use of the implants has fallen off in part amid reports that they were prone to early failure and that some patients had developed serious health problems related to particles of metallic debris that are shed by the devices as they wear, the Times says.
The agency’s action could also prompt increased scrutiny of regulatory policies that allow implants like metal-on-metal hips to be approved for sale with little, if any, clinical testing in patients, says the article. In addition, the FDA’s oversight of hip implants has lagged behind other countries where registries follow the failure rate of orthopedic implants in patients.