According to a report published in The New York Times, based in information obtained under the Freedom of information Act, the decision on the hip implant phase out was made just weeks after the company received a letter from U.S. regulators seeking safety data on an ASR hip implant used in hip resurfacing procedures.
According to the Times, the FDA letter expressed concerns about elevated levels of metal ions seen in the blood of some DePuy ASR hip implant recipients. The letter, dated August 13, 2009, was a so-called nonapprovable letter in which the agency confidentially notified DePuy that it would not be permitted to sell the ASR Hip Resurfacing System in the U.S.
Both the ASR XL Acetabular Hip Implant and the ASR Hip Resurfacing System were finally recalled in August 2010, after data from a medical device registry in the U.K. indicated that they were failing in about 12% of patients within five years. According to the Times, it is not known how many patients received one of the devices during the year DePuy’s rationalization strategy was in effect. However, it is known that 93,000 patients worldwide received the model, about one-third of them in this country, according to the Times. According to data from British device registries, the ASR model sold in the U.S. is failing prematurely at even higher rates than the hip resurfacing device the FDA would not approve.