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Home/Large Joints and Extremities/Australian Agency Increases Implant Safety Warnings
Large Joints and Extremities

Australian Agency Increases Implant Safety Warnings

April 22, 2015 1 min read Premium comments

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Australian Agency Increases Implant Safety Warnings
Courtesy: Australian Government
Secondary

Australian doctors are seeing a rise in the number of safety warnings about parts commonly used in hip and knee replacements. In just the past three months the Therapeutic Goods Administration (TGA) has issued seven alerts warning of higher-than-expected failure rates.

By way of contrast, the agency issued only 13 warnings for implants and heir components between 2013 and 2014. Despite the increased umber of warnings officials of the TGA and the Australian Orthopaedic Association insist the rise in alerts does not mean there is a larger problem.

“I think it’s a very good thing, ” said Australia Orthopaedic Association spokesman Professor Stephen Graves. “The TGA has been working in more recent times to be more transparent and accountable with the decisions made and reviewing outcome.” The organization believes that the monitoring of components is now even more stringent than it had been before.

Nevertheless patients who are scheduled for joint replacements are nervous. One of them, Jill Heasly-Quintard, who recently had her second hip replaced said, “My reaction is—that’s pretty scary.”

Author

BW
Biloine W. Young
React:

Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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