(NEW YORK) — The makers of a faulty hip implant recalled in 2010 started phasing out the device in 2009, weeks after the U.S. Food and Drug Administration asked for safety data, the New York Times reported.
The FDA said some patients who got the metal ball-and-socket joint made by DePuy Orthopaedics, a division of Johnson & Johnson, showed a “high concentration of metal ions” in their blood, according to a confidential letter to the company obtained by the Times. But it was a year before the company issued a recall for the device, which had been surgically implanted inside some 93,000 patients. It’s unclear how many patients received the hip that year.
Calls to DePuy were not immediately returned, but a spokeswoman told the Times the decision to phase out the device and sell off remaining stocks was based on product sales, not safety. The company maintains the implant was working as well as those of competitors prior to the August 2010 recall. But 2009 data showed the device was failing just a few years after implantation, a far cry from its touted lifespan of 15 years, according to the Times.
Katie Korgaokar is one of thousands of patients to sue DePuy over the implant. The 43-year-old said she was shocked when she received a letter informing her that her hip had been recalled.
“I thought, ‘That’s what happens to cars,’” said Korgaokar, who lives in Denver. “It just really seemed like a joke. You don’t recall parts you put in a person.”
Five years after the painful procedure to implant the metal hip, Korgaokar underwent a second surgery to take it out. A spokeswoman for DePuy said the company “is committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary.”
When asked whether the 2009 letter from the FDA should have been released to doctors and patients, DePuy’s chief executive officer, Andrew Ekdahl, said any suggestion that the implant had safety issues was “simply untrue,” according to the Times.
The company claims the letter was asking for more safety and efficacy data, not raising safety concerns.
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