Thursday, November 18, 2010

Does the Food and Drug Administration share some of the blame for allowing the ASR to go to market without clinical trials being conducted?

(exerpts from web postings I found of interest.)

DePuy sought approval of the ASR system in March 2004 when it filed for 510(k) approval with the FDA. Under this process the company only had to show that the ASR was “substantially similar” to other implants on the market. DePuy compared the ASR to its own prior hip product, the DePuy Pinnacle to the FDA so the new product would be fast tracked into the consumer market.

The FDA apparently did not determine there were differences  between the two devices. The Pinnacle needs external screws anchored to the bone while the ASR uses the surrounding bone to grow into the implant. This seems to be a big a big difference but the FDA granted 510(k) approval to the ASR with no clinical trials or other tests that might have detected defects in its design.

I wonder how difficult the surgery will be to remove a devise and replace it (aka revision surgery) once the bone has grown into the implant.  Surley requires questions to your surgeon.


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