As the Australian Therapeutic Goods Administration (TGA) came under fire for its delayed response to the hip replacement recall issue, thousands of men and women who were given artificial hip implants are pondering their fates as painful revision procedures appeared to be their only relief option, media reports say. In fact, a former gymnastand DePuy advocate filed a lawsuit against the company. 

Surgeons and consumer groups across Australia criticized the TGA—Australia’s equivalent of the US Food and Drug Administration—for the three-year delay it took to act on the defective implants produced and marketed in the country by different manufacturers, says the daily newspaper The Age.

Scores of defective hip replacement owners are reportedly in the process of undergoing revision surgery before the yearend because of the high failure rates of the original devices they were implanted with, says The Age in a front-page report.

The patients who last year were fitted with artificial hips have reported high failure rates over 10%, which was more than twice the normal rate of 4%. The defects exposed them to twice the risk of undergoing painful and costly repeat surgery, the paper says, adding that those defective implants were spread across 24 brands of artificial hip prostheses, including the DePuy ASR system of Johnson & Johnson

Federal government-supervised National Joint Replacement Registry has tracked down around 2,700 elderly Australians who are suffering from problematic hip replacement procedures in 2010, the daily newspaper The Age says.

Australia’s politicians have designated committee to look into the failure statistics as the Senate prepares to release its report about the hip replacement recall dilemma.

As early as 2006 the National Joint Registry detected a 50% failure rate in metal-on-metal implants given to elderly citizens, describing the incidence as “higher than normal,” reports Australia’s leading daily newspaper Sydney Morning Herald..

More than half the implants sought for revisions involved products that were already known two years ago as problem-prone, says paper, citing figures made available by the National Joint Replacement Registry.

While the average orthopedic failure rate in hips run up between 4% and 5%, the TGA says, defective DePuy hip replacement had it at 10%. Around 80,000 artificial hips and knees are implanted to Australians each year. The DePuy hip replacement recall episode has sparked nationwide demands for stringent surveillance from health insurance providers and consumer lobby groups.

As a metal-on-metal device, various hip replacement system models can go through the typical wear and tear of daily use. But there is an attendant risk of recipients developing metal toxicity from particles flaking off as the metal components rub each other, says a report from the New York Times. Hip replacement recall on two of Johnson & Johnson’s products has remained in force worldwide in the last three years

Sources: 20111009-1lfx5.html


07/17/2012 23:16

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