DePuy Hip Replacement
What it is?
DePuy Orthopaedics withdrew its ASR XL Acetabular metal-on-metal DePuy ASR hip replacement on August 24, 2010 after around 300 complaints from people undergoing hip replacement. The ASR hip replacement is a metal-on-metal device that has to a flawed design that has resulted in many patients needing follow-up hip revision surgery to replace the device soon after implant. The ASR is considered by a number of orthopedic experts to be a defective product and DePuy hip replacement lawsuits are currently pending.
The DePuy hip replacement, known as the ASR, appears to have a high failure rate compared with other hip replacement devices. Many experts consider the hip replacement recall way to late, and should have taken place a long time ago. DePuy Orthopaedics pulled the ASR from Australia in December 2009 and from the US in March 2010, but the Johnson and Johnson hip replacement recall follows more than two years of complaints from patients who needed costly and painful hip revision surgery following the initial procedure.
In late 2009, DePuy Orthopedics, a division of Johnson & Johnson, announced its plan to phase out sales of the product worldwide by the end of 2010. About 250,000 people in the US receive hip replacement implants every year and about one-third of those receive metal-on-metal implants. Of those that receive the DePuy ASR hip replacement, twelve percent, or approximately 1 in 8 patients, will require hip revision surgery.
In March, 2010 Depuy sent a letter to doctors saying recently analyzed data from Australia indicated a higher-than-expected failure rate than traditional hip replacement on certain types of patients. As well, the data showed that the risk was highest for patients of small stature, suggesting both women and patients with weak bones are at greater risk.
DePuy Hip Failure
Although early reports indicated the Depuy hip replacement device was failing at a rate of between 12 and 13 percent, more recent reports suggest that even this failure rate was an understated. In March 2011, the British Orthopaedic Association and the British Hip Society said preliminary data, based on the reports of four surgeons, put the actual failure rate much higher. Data on the ASR XL Acetabular System shows that 21 percent of patients with that hip replacement system require revision surgery after four years and approximately 49 percent of patients require revision surgery after six years.
This means that based on the data, almost half the patients who received the DePuy ASR XL Acetabular System could require revision surgery after six years of the implant. Furthermore, although the 21 percent after four years includes patients who required revision surgery, it did not include patients who currently have pain in the implant area but have not yet required revision surgery. If all those patients required revision surgery, the organizations said, the revision rate could rise from 21 percent up to 35 percent after four years.
A study published in November 2011 in the British Medical Journal suggested that metal-on-metal hip replacement devices are no more effective than traditional hip replacement devices and may have higher revision rates. According to researchers, patients who receive a metal-on-metal hip replacement device could be at double the risk of undergoing hip revision surgery.
Meanwhile, a report by the National Joint Registry for England and Wales (09/11) found that the failure rate of all-metal hips is increasing, with the ASR failing at the highest rate. According to the report, the ASR failed in approximately one-third of patients who were followed for the longest period. The report noted that of people who received the ASR six years ago, approximately 30 percent had it replaced. Of those who had the ASR implanted five years ago, 17 percent had it replaced, although that percentage could increase in the next year.
An article in The New York Times suggests DePuy executives knew about the high failure rate a year before the recall was announced. According to the article, the FDA rejected a DePuy hip replacement device because of studies showing a high premature failure rate. That same device was later sold overseas, while a different device was used in the US.
DePuy ASR Defects
A number of orthopedic doctors believe the DePuy metal on metal implant has a design flaw that makes it difficult to implant properly, specifically that the component has a narrow window for proper placement. The design of the ASR cup is shallower than some similar devices, and believed to be the implant’s problems.
According to The New York Times, other problems associated with the DePuy metal on metal implant include the potential for generating large amounts of metal debris during normal wear and tear, which can negatively impact soft tissue and evolve into a health issue for some patients.
Product liability lawsuits allege negligent design and promotion of a defective product. According to the New York Times, DePuy Orthopedics introduced their metal-on-metal hip implant without adequately testing and researching the device. Although the ASR was approved for use by the FDA in 2005, it was cleared through a regulatory pathway that did not require it to undergo clinical trials.
Some patients who were implanted with the DePuy ASR have developed ALVAL (aseptic lymphocyte dominated vasculitis associated lesion), which is an adverse tissue reaction to metal particles and ions, and pseudotumor (a soft tissue mass that may be the result of a toxic reaction to an excess of particulate metal wear debris).
At Sheff Law, we are the Massachusetts law firm with the resources, experience, and national reputation to investigate injuries resulting from exposure to Depuy hip replacement. Patients across Massachusetts and America are starting to realize some of the potential harmful consequences of having the Depuy hip replacement surgically inserted. If you or a loved one has been injured as a result of Depuy hip replacement, contact an attorney at Sheff Law today by filling out a FREE consultation form, or call at (888) 423-4477 or 617-227-7000.
February 23rd, 2016 | Posted in Blog