The US Drug Watchdog, an independent consumer monitor, said that “Because many individuals who received a DePuy ASR hip implant do not want to go through revision surgery, they do not complain.”  It was reported in various news reports that the DePuy recall has affected its former spokeswoman, who has filed complaints against the product and who stand different from the several others who opted for inaction.In August 2010, the DePuy ASR hip replacement system was recalled by Johnson & Johnson subsidiary DePuy Orthopedics after it was discovered that the device have a high failure rate. Released in 2003 under the 510(k) approval process of the US Food and Drug Administration, the device was rapidly adopted by surgeons despite the absence of a premarket trial. Approximately 93,000 devices were implanted in patients worldwide.

The Australia and UK joint registry detected a failure rate of more than 50% of the average rate of all-metal hip implants.  Reportedly, recipients of the device experienced complications from hip replacement.  Included in the symptoms of a failing hip implant are lack of flexibility, general discomfort, swelling of the hip, pain in the hip region, and difficulty in walking.The metal-on-metal device may expose patients to metal poisoning or metallosis, as debris of the device flake off and enter the bloodstream. Metallosis can cause soft tissue damage, inflammatory reactions and bone loss.
On the NBC Nightly News, the US Drug Watchdog was quoted as saying "There is a huge problem with metal-on-metal artificial hip implant devices.”  "We could have tens of thousands of DePuy hip implant victims in the US, and because of age, or not wanting to go through a hip replacement revision surgery, they say nothing,” added by the group.

 In the United States, the US Drug Watchdog is a premier pharmaceutical watchdog.  US consumers’ right to a safety prescription medicine and medical devices is upheld by the group.

Various sectors of the US and other countries, like Australia and UK, are advocating for patient safety and a tighter regulation on the release of medical devices. The company, DePuy Orthopedics, is also taking actions concerning their device through a hip replacement recall.   In addition, patients and surgeon must be mindful of the hip implants and report promptly any symptoms of failure.

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