The timing of DePuy Orthopaedics’ 2009 decision to phase-out its now-recalled ASR hip implant devices has come under suspicion. According to a report published in The New York Times, the decision on the DePuy ASR 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.
At the time, DePuy was already marketing another version of the device, the ASR XL Acetabular Hip Implant, in the U.S. That device had been approved in 2005 through the FDA’s 510(k) approval protocols, which do not require human testing if a product is shown to be substantially equivalent to other devices already on the market. Because hip resurfacing was a new procedure, the ASR Hip Resurfacing System was not eligible for 510(k) clearance.
The ASR hip resurfacing implant, however, was available for sale overseas. In the letter obtained by the Times, the FDA also wrote that reports from countries where the implant was then being used showed it was performing “somewhat more poorly” than data submitted by the company’s DePuy Orthopaedics unit indicated. The agency also asked DePuy for added safety data if it wanted to pursue its application, the Times said.
Within weeks of receiving the FDA’s letter, executives at Johnson & Johnson, DePuy’s parent, decide to phase out the ASR implants and sell off its inventories for use in patients both in the U.S. and abroad. In doing so, DePuy launched a so-called rationalization strategy to “end the model’s production and to sell off its existing stocks while persuading orthopedic surgeons to switch to other implants from the company,” the Times said. The ASR hip implant phase-out was announced in November 2009, with DePuy stating that sales of the ASR hip implant model would end in late 2010. But in Spring 2010, a DePuy executive reported in an email that ASR hip implant stocks were not yet depleted, and that the rationalization program would not end on a fixed date.
DePuy has long maintained that its decision to phase out the ASR model was motivated by lagging sales of the device, not safety concerns.
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.