FDA Orders Artificial Hip Makers to Perform Study
According to the May 11. 2011 article in the New York times, The FDA has ordered the manufacturers of the De Puy artificial hip and all producers of metal on metal artificial hips to undertake studies of the implants, which have been linked to high early failure rates and severe health effects in some patients.
Click here to read the entire New York Times article: Hip Makers Told to Study More Data
Metal-on-metal hips, in which the ball-and-socket components are made from metals like cobalt and chromium, accounted until relatively recently for about one-third of the estimated 250,000 hip replacement procedures performed annually in the United States. In March 2011, the British Orthopaedic Association, a professional medical group, reported that the De Puy ASR was projected to fail in one-half of the patients who received it within six years after implant.
Dr. William H. Maisel, the deputy director for science at the F.D.A.’s Center for Devices and Radiological Health, said the order marks the broadest use of the agency’s authority to conduct studies of devices after approval for sale. Dr. Maisel said companies would be expected to collect information from patients who received the devices, including taking blood samples to determine the levels of metallic ion in their systems. Invoking FDA procedures calling for post market testing and studies, Dr. Maisel said that the F.D.A. wanted information about the entire category of implants, not just the De Puy. Manufacturers will have 30 days to file a proposed plan with the F.D.A. Hopefully this will provide De Puy ASR and Pinnacle users as well as people with other implants important data as to what De Puy and others knew and enable physicians to make informed choices as to future care needs.
Depuy ASR Hip Replacement Linked To Metal Toxicity and Additional Surgery
This office is currently representing numerous consumers with significant problems from the De Puy ASR and Pinnacle devices. Click here to learn more about the Brandi Law Firm Hip Attorneys