High Failure Rate Leads to DePuy Hip Implant Recall
According to The New York Times, nearly 250,000 hip replacement surgeries are performed in the United States every year. In about one-third of those cases, the devices used are “metal-on-metal” implants, where the ball and socket joints of the implants are made of metals like chromium and cobalt.
The Times report notes that these implants, designed to last up to 15 years, have been failing at an alarming rate. In some cases, the devices need to be replaced after only a couple of years.
While the wear and tear associated with the metal can lead to problems, specifically dislocation or fractures in hip replacements, there is also the risk that metal debris can be absorbed into the patient’s body, causing inflammation and infection.
Voluntary Recall of ASR Systems
In August, DePuy Orthopedics, a division of Johnson & Johnson, voluntarily recalled its ASR XL Acetabular Hip System and ASR Hip Resurfacing System. According to a company press release, these replacement systems first became available to patients in July of 2003 and the recall could potentially affect 93,000 people worldwide.
DePuy notes that after five years, 12 percent of patients who had the ASR resurfacing device implanted and 13 percent of those who received the ASR total hip replacement needed to have a revision surgery .
In March, The New York Times reported that DePuy was halting the sale of ASR hip replacement systems due to declining sales. It had, however, been reported for years that the device would fail after only a few years, requiring those patients to undergo another replacement operation.
Research Questioning Effectiveness of Metal-on-Metal Implants
Over the past decade, the use of metal-on-metal joints for replacement surgeries has been steadily increasing. But over the past few years, new research is questioning the safety and effectiveness of these devices.
The New York Times examined several studies from Oxford University and the University of British Columbia surrounding abnormal soft tissue masses or damage in different hip replacement systems. In 3.4 percent of the cases studied, patients developed abnormal soft tissue masses surrounding the DePuy implants. This problem did not occur in patients that had a similar device implanted manufactured by Birmingham.
Similarly, patients that received the Durom device, manufactured by Zimmer Holdings, experienced significantly higher blood serum levels of chromium and cobalt. In 2008, Zimmer suspended the sale of its Durom system.
More Trouble for Johnson & Johnson
For Johnson & Johnson, this is the latest in the round of embarrassing product recalls for the company. According to the Associated Press, the DePuy recall is the 11 th time in the past year that a Johnson & Johnson product has been recalled.
Prior to the ASR recall, DePuy received a warning letter from the Food and Drug Administration regarding the improper marketing of the TruMatch knee replacement system and a different hip replacement device. The FDA alleges that DePuy violated the law by failing to obtain the required preapproval before selling the device.
Working With an Attorney
Though it has not yet been certified as a class action, numerous lawsuits are expected to be filed surrounding the product. If you had hip replacement surgery after July 2003 or have been injured by any sort of defective product or act of medical malpractice, it is important to discuss your options with an experienced attorney.