Medical Device Maker Began to Phase Out Hip Implant Year Before Recall

Medical Device Maker Began to Phase Out Hip Implant Year Before RecallThe manufacturers of a hip implant that was recalled in 2010 for being faulty began to attempt to phase out the product as early as 2009, weeks after the U.S. Food and Drug Administration asked the company to provide safety data on the product, however the company claims the two events were not related, ABC News reports.

According to the media outlet, the FDA found that some of the metal ball-and-socket devices, manufactured by Johnson and Johnson's DePuy Orthopaedics, led patients to show a  "high concentration of metal ions" in the bloodstream. But the warning came a year before any recall was made for the "ASR Hip System," which has been implanted in about 93,000 patients.

Mindy Tinsley, a spokeswoman for DePuy, stated that the company decided to gradually phase out the product because of poor sales, not for any safety reasons.

"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 stated.

Now, patients are worried the hip implant they have been living with for years could be involved in the recall.

"I thought, 'That’s what happens to cars,'" said Denver resident Katie Korgaokar, 43. "It just really seemed like a joke. You don’t recall parts you put in a person."

After having the product in place for five years, Korgaokar had the implant removed in a second surgery.

According to the FDA, adverse reactions to metal-on-metal hip implants include several forms of changes to sensory, auditory and visual impairments. The side effects arise as the metal begins to wear down.