The Food and Drug Administration recently ordered artificial hip manufacturers to undertake studies of their implants, and manufacturers of metal-on-metal hip devices will have to conduct studies of patients who received the device to determine whether the implants are shedding too much metallic debris, according to a story in the New York Times.
William H. Maisel, MD, deputy director for sciences at the FDA's Center for Devices and Radiological Health, said the studies were meant to collect additional data about hip implants as a whole, not a single device.
Approximately 20 device manufacturers received a letter from the FDA informing them that it would require post-market studies when the implant's failure could have serious consequences, such as metal-on-metal hip implants. Under the rule, companies have 30 days to propose a plan with the FDA to conduct the studies, which are expected to collect information from patients implanted with the device.
Many companies were also asked to determine the frequency of device failures.
Read the report about the FDA ordering additional studies of hip implants.
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5 Reasons Why Controversy Surrounds Metal-on-Metal Hip Replacements
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William H. Maisel, MD, deputy director for sciences at the FDA's Center for Devices and Radiological Health, said the studies were meant to collect additional data about hip implants as a whole, not a single device.
Approximately 20 device manufacturers received a letter from the FDA informing them that it would require post-market studies when the implant's failure could have serious consequences, such as metal-on-metal hip implants. Under the rule, companies have 30 days to propose a plan with the FDA to conduct the studies, which are expected to collect information from patients implanted with the device.
Many companies were also asked to determine the frequency of device failures.
Read the report about the FDA ordering additional studies of hip implants.
Related Articles on Hip Implants:
5 Reasons Why Controversy Surrounds Metal-on-Metal Hip Replacements
Dr. Craig Della Valle: Squeaky Hip Replacements Not Harmful to Patients
DePuy Launches New Hip Systems