FDA Requires More Research on Artificial Hip Implants
by Karen Lachica in Health News on Jun 12, 2011
The Food and Drug Administration, in their atypical move, has ordered all the producers of a famous category of an artificial hip to undertake the studies of the hip implant. This is in connection to its association with the high early failure rates and severe health effects in some patients.
According to the FDA order, the so-called “metal-on-metal” hip producers “will have to conduct studies of the patients who received the device to determine whether the implants are shedding high levels of metabolic debris.” In an early result, some of the patients have encountered such problem. The patients also experienced the disabling soft tissue damage.
Dr. William H. Maisel, the deputy director for science at the FDA’s Center for Devices and Radiological Health stated, “The order marks the broadest use of the agency’s authority to conduct studies of devices after approval for sale.” He also added, “FDA wanted information about the entire category of implants, not any single manufacturer’s device.”
Maisel emphasized, “Our concern is the product, not about the manufacturer.”
There are about 20 manufacturers that the FDA sent the letter that was “invoking a rule requiring postmarket studies” especially in cases where the implant’s failure could cause complications and other consequences on the patient.
The agency’s move could also be the quick solution to the analysis of regulatory policies which allow implants such as “metal-on-metal” hips to be approved for sale with clinical testing in patients.
Related Posts:
