The point of the study is to find out how fast and how many will fail, what is the failure rate. We have Johnson and Johnson largely at the head of this investigation for their DePuy failure rates and recalls, and of course they no longer make the product. As you can see below at the bottom there are others named in the request and there could be more requests generated as the FDA may look into the entire area of implants before they are done. BD
In an unusual move, the Food and Drug Administration has ordered all producers of a popular category of artificial hip to undertake studies of the implants, which have been linked to high early failure rates and severe health effects in some patients.
In a telephone interview on Tuesday, 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. He also said that the F.D.A. wanted information about the entire category of implants, not any single manufacturer’s device.
“This is the largest group of studies that we have asked for,” for an approved class of devices, said Dr. Maisel.
Along with the DePuy division of Johnson & Johnson, other major producers of hip implants include Zimmer, Stryker, Biomet and Wright Medical.
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