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.

Reference:

earlsview.com/2011/10/07/us-drug-watchdog-says-its-urgent-they-identify-all-recalled-depuy-asr-hip-implant-recipients/

usdrugwatchdog.com/index.htm

news.yahoo.com/us-drug-watchdog-says-urgent-identify-recalled-depuy-183018774.html
www.arthritistoday.org/news/asr-depuy-hip-replacement-recall078.php
 
 
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:
http://www.theage.com.au/national/suspect-artificial-hips-implanted-in-thousands- 20111009-1lfx5.html


 
 
The DePuy Orthopaedics Inc.’s strategy of funneling ASR hip recall cases through what is called Multi-District Litigation (MDL) took a stumble after two US district judges allowed four plaintiffs to keep their cases out of the MDL last July.  Just weeks after a Wisconsin judge ruled to put the case of Malkmus v. DePuy Orthopaedics, Inc., et al, in the U.S. District Court for the Eastern District of Wisconsin out of the MDL, a judge in the U.S. District Court in Nevada made a similar ruling for three plaintiffs to keep their cases out of a complicated and slow moving federal court process known as an “MDL”. The DePuy hip replacement recall spawns thousands of complaints even with the growing number of lawsuits filed against the medical device manufacturer.

 Attorneys of the DePuy ASR Hip Recall Law Firm Alliance consider both judges’ rulings as a legal victory for ASR hip replacement implant victims.   Proceedings in an MDL are complicated and typically take much longer than litigation in state court, said the Alliance.   Brian Franciskato of the DePuy ASR Hip Recall Law Firm Alliance said that the DePuy’s dogged efforts to keep these cases in the MDL shows that DePuy feels that they have a better legal standing in the MDL venue than in state court.     
 
A worldwide recall of two of its hip replacement systems, the ASR XL Acetabular System and the DePuy ASR Hip Resurfacing Platform, was announced by DePuy, a division of Johnson & Johnson, approximately a year ago.  A data was released from a study by the National Joint Registry (NJR) of England and Wales that indicated the five-year failure rate of the ASR was approximately 13 percent, or one in every eight patients receiving the hip implant, according to DePuy’s website, before the recall was announced.   In early December, many of the lawsuits that followed the recall were consolidated into an MDL, a legal procedure that will streamline a messy set of circumstances.
 
 DePuy expressly denies that the ASR devices are faulty in any manner according to their response to a Neveda lawsuit despite a worldwide recall of the ASR hip replacement.  “These victims have clearly gone through tremendous pain as a direct result of the defective ASR hip implants, and prolonging the litigation by herding their cases into the MDL only prolongs their pain,” according to Franciskato, adding that “Our clients would have to strongly disagree with that claim.”
 
DePuy’s hip replacement recall has not stopped complaints from rolling in with more than 350 cases filed in an Ohio court this month alone, all of them directly tied to a case undergoing pre-trial proceedings in the Northern District of Ohio.  The complaints received by the US Food and Drug Administration (FDA) on hip replacement have numbered to 5,000 for this year alone and DePuy accounts for 75 percent of those complaints.    


 
 
Following the hip replacement recall of the ASR XL Acetabular and ASR Hip Resurfacing System by Johnson and Johnson subsidiary DePuy, reports have indicated that the said orthopedic manufacturer have already known the 5 -year failure rate of the devices. A New York Times article written in March 2010 disclosed that months before DePuy issued a recall of the hip replacements, they were aware that the ASRs were failing at a dramatic rate.

In recent interviews, orthopedic experts expressed their disappointment over the fact that DePuy haven't withdrawn the ASRs as soon as data were gathered. More so, data collected in Australia, where the hip replacements were sold more extensively than in the United States, have been accumulating for quite some time now. The company have been sitting on the data a long time before issuing the hip recall.

Australian director of an implant database, Dr. Stephen Graves, asserted that the company's plans to phase out the devices before 2010 ends were too late to curb alarming damages. Unfavorable data have already started to pile up in Australia, where the hip replacements were sold more extensively than in the United States. It showed for quite some time that the devices fail earlier than their competitors. Prior to the worldwide hip recall, DePuy have withdrawn the ASRs from the Australian market.

As early as 2008, the U.S. Foods and Drugs Administration has started to receive around 300 complaints against the DePuy hip replacements. An ASR 'cup', which is a device component sold separately, did not undergo clinical trials for approval. A company representative claimed that problems with the ASRs were because surgeons were installing them improperly. Shortly after that however, DePuy started sending out letters to doctors saying the hip replacements were less effective among women, persons with small stature and those who have weak bones.

A faulty DePuy hip replacement were said to cause substanital damage to a patient. Metal ions from the device are scraped off and affect muscles, tissues and bloodstream. At the very worst, an expensive second hip replacement surgery is required.

It is clear that DePuy could have taken appropriate action had they wanted to do so. If you are a recipient of a DePuy hip replacement ASR, you need to consult your doctor to undergo a medical evaluation. An appointment with a hip recall lawyer is important for them to protect your best interests.
 
 
When one consents to a hip replacement procedure, he or she expects to have a better overall health experience due to an improved hip condition. Lawsuits numbering in the hundreds were filed against DePuy when the company issued a voluntary recall of two of their hip implants namely, ASR XL Acetabular System and the ASR Hip Resurfacing System. Twelve to thirteen percent of the total 93,000 recipients are expected to be needing a total hip replacement surgery due to the fact that the devices fail within five years of implantation. This would mean that additional expenses need to be made and a longer period of time is required for recovery and rehabilitation. The hip replacement recall has made headlines in the medical and legal field.

It is essential that you find out if you have been implanted with a defective DePuy ASR device especially if you have been operated on between now and 2003. Symptoms of a failed hip replacement include pain, stiffness in the hip area, dislocation, difficulty walking and cobalt and chromium poisoning. If you have not experienced any of these, that still does not mean that you get off scott-free from the complications the defective implants cause.

But if you find out that what you have is not a DePuy hip replacement but you still experience the symptoms of a failed implant, you may still have grounds to file a lawsuit against the manufacturer of your hip prosthesis. If you are not sure, your surgeon or your primary health physician could give you the name of your hip device.

Other than DePuy ASRs, the Zimmer Durom cup has also been recalled. Whatever it is you have been implanted with, you should seek the legal expertise of a lawyer who would define and describe to you the options you can take regarding the recall. Speaking with an attorney would greatly improve your chances of recovering compensation.

To learn more about the DePuy hip replacement recall or if you wish to take legal expertise, feel free to visit the hip replacement website.
 
 
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