Patients naturally assume that when a sophisticated metal implant like a hip replacement is surgically placed into their bodies, it must have been thoroughly tested before wide use. The now-recalled DePuy ASR hip replacement shows how wrong that assumption is.
A medical device manufacturer in the United States can cobble together new components into an old, already-approved device, and the new hybrid device is essentially grandfathered into government approval since it in theory closely resembles the old device.
As explained by New York Times reporter Barry Meier in a long outtake:
Unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients.
That way, manufacturers can rapidly make small changes to a device to improve it. But those simpler procedures have also effectively created a loophole, experts say, that lets producers bundle a component from an unapproved implant into an existing design and sell a device with minimal testing. With the A.S.R., that process unfolded with devastating results.
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