Wednesday, January 26, 2011

Interview with Dr. Stephen Graves, Director of the Australian Joint Registry

While the reason for the market withdrawal quoted in Depuy’s hip recall press release was adverse data from the British National Joint registry[more recent data], Depuy had long been well aware of the problem with the problems surround the hip from the Australian Joint Registry.  The registry records a high percentage of joint replacements in Australia with the objective of watching how they perform to avoid unnecessary revision surgeries.  While the interview was longer,   I reported the questions and answers that were appropriate for the topics discussed in this blog.
Reporter:  Were you surprised by the [US] recall of the Depuy hip?
Dr. Graves:  No not surprised at all.
Reporter:  Why is that?
Dr. Graves:  The Australian joint registry has identified for a number of years that the ASR prosthesis had a high rate of revision.
Reporter:  How did the Depuy hip perform relative to other devices of a similar class?
 Dr. Graves:  In 2008, we knew that the resurfacing procedure and the ASR device both had higher rates of revision.  After 3 years, these devices were 4-5 x the revision rate compared to other devices.
Reporter:  But in the Depuy press release, they stated that according to other international joint replacement registries, the Depuy hip was performing in line with other devices of similar kind.
Dr. Graves:  Yes I noticed  that comment in the Depuy press release and I couldn’t quite understand it because that simply is not correct because Depuy was fully aware of the Australian registry data so I’m not quite sure why they said that because it is simply not true.
Reporter:  Then why did the surgeons in Australia continue to use it given the public data on the registry?
Dr. Graves:  In Australia, the surgeons didn’t continue to use it once the problem was identified and in fact, Depuy removed the device from the Australian market last year [2009].
Reporter:  So what’s the bigger story here?  Are there other hips that are nonperforming that should not be on the market?
Dr. Graves: If the risk of revision is 2x compared to other devices, this is not considered to be an acceptable standard.  The results are reported annually and normally when we do that, the surgeons reduce the use of the device considerably.  In 2009 we identified 50 devices that were not acceptable.  Many of the devices are no longer being used but a significant number are.  Publishing these rates enables the [regulators]  to review each of these devices and determines what should be done with them.
Reporter:  What has the joint registry done for Australia?
Dr. Graves:  The rate of revision surgeries has been dramatic over each year which is to say,  1500 less revisions have occured each year with high complication rates.

Connie

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