In 2011, a British implant registry published projected failure rates for Johnson & Johnson hip implants known as Articular Surface Replacement, or A.S.R. joints. They estimated that the joints were failing one-third of the time among patients who had had the implants the longest. Johnson & Johnson’s DePuy Orthopaedics division, the makers of the A.S.R. implant, publicly downplayed the findings. At the same time, they were conducting an internal study that eventually concluded that the metal devices would fail within 5 years for 40 percent of the patients who received them. These internal findings were not released to the public.
More than 30,000 patients in the United States received DePuy hip implants. A typical hip implant is intended to last roughly 15 years before it needs to be replaced. The percentage that requires replacement early is generally 1 percent per year. In other words, the expected replacement rate of a hip implant after 5 years is 5 percent. That is a far cry from the 40 percent estimated by Johnson & Johnson for the A.S.R. implant.
In 2009, the Food and Drug Administration asked J & J to provide additional safety data about the hip implants. Complaints were already being raised about the safety of the devices. The company decided to sell off the rest of its inventory and then phase out the product. It did not issue an official recall of the defective devices until mid-2010. By then, it was too late to prevent thousands of patients from having the dangerous devices implanted in their bodies.
More than 10,000 lawsuits have been filed regarding the DePuy hip implants. Many more are expected as additional patients are harmed by early failure. How much the company knew and when it knew it will be important issues in determining the proper outcome in those cases.
Source: The New York Times, “Maker Aware of 40% Failure in Hip Implant,” by Barry Meier, 22 January 2013
