Australian regulators criticized for waiting three years to recall DePuy ASR hip implant

Filed September 29th, 2011 Joshua Sophy

Some 5,000 Australians could have avoided a painful and costly revision surgery if Australian regulators had acted to recall the DePuy ASR hip implant when it first knew its defective design was responsible for a high early-failure rate.

According to a report from Sydney (Australia) Morning Herald, about 5,000 Australians had the now-recalled DePuy ASR metal-on-metal hip implanted after the country’s Therapeutic Goods Administration first learned of solid evidence linking the medical device to a high failure rate. Touted as having a lifespan of at least 15 years, many ASR implants are failing after just a few years.

Some reports indicate the DePuy ASR implant will fail early in up to 30 percent of patients receiving it. Apart from a defective design which can lead to squeaking, popping and implant breaks, the metal-on-metal design proves to be one of its biggest faults. Through normal wear-and-tear of the device, small metal fragments are dispersed through the body and bloodstream, leading to toxic build-ups of cobalt and chromium.

Thousands of people around the world have suffered from the defective design of the ASR hip implant, resulting in costly and painful revision surgeries.

Australia was the first country to recall the DePuy ASR implant in September 2009. Regulators there waited three years after reports surfaced of widespread problems with the implant to issue the recall. The link was confirmed to Australian regulators in 2007 but the agency still waited two more years to issue a recall. In the U.S., the implant was recalled in September of last year.

At least 3,500 Australians have been compensated more than $21 million through a Johnson & Johnson claims process. J&J is the parent company of DePuy Orthopaedics.

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