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, although the manufacturer said the two events were unrelated.
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, called the "ASR Hip System," which had been surgically buried inside some 93,000 patients. It's unclear how many patients received the implant that year.
DePuy spokeswoman Mindy Tinsley said the decision to phase out the device and sell off remaining stocks was based on product sales, not safety.
"Up until August 2010, the totality of the data available to DePuy - including data from national joint registries, published literature, company-sponsored clinical trials, internal complaints data and external clinical research reports - indicated that the revision rate of the ASR Hip System was similar to that reported for other large diameter metal-on-metal monoblock and resurfacing hip devices," she said in a statement. Data obtained in August 2010 showing that 13 percent of implants failed within five years, a far cry from their touted 15-year lifespan, prompted the voluntary recall, Tinsley said.
Katie Korgaokar, 43, 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.
"We understand that the August 2010 ASR Hip System recall is concerning for patients, their family members and surgeons," Tinsely said. "Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need."
Although the 2009 letter from the FDA cited concerns about metal ions, Tinsley said the effects of those ions are still unclear.
"Regarding metal ions generally, metal-on-metal wear can result in the release of ions that can be measured through medical tests," she said. "These particles have not caused problems for most patients, but a small number of patients have been reported to have an adverse reaction to them."
According to the FDA, possible adverse reactions include "cardiomyopathy, thyroid dysfunction, and neurological changes including sensory, auditory, and visual impairments. Based on the limited number of case reports in published literature, the true incidence or prevalence of adverse systemic effects from [metal on metal] hip implants is not known at this time, but is believed to be rare."