On May 16th, DePuy Orthopaedics announced that it would no longer sell the metal-on-metal version of the Pinnacle hip implant. Brian Devine, a former insider at an orthopedic company, believes DePuy’s action is really a “silent recall” of the Pinnacle implant.
In DePuy’s press statement, it claims that the decision to stop selling the metal-on-metal Pinnacle hip implant was based on declining surgeon demand and a recent ruling by the FDA affecting metal-on-metal hip implants. DePuy claims that its decision was “not related to safety or efficacy, and is not a recall.”
DePuy’s statement rings hollow in light of the 3,000 lawsuits that have been filed against the company that describe serious injuries that were caused by the Pinnacle hip implant. As we reported earlier, the number of adverse events associated with the metal-on-metal Pinnacle implant began skyrocketing in 2007.
DePuy used a regulatory “loophole” to bring the Pinnacle hip implant to market. This loophole allowed DePuy to sell the Pinnacle without ever having to establish that it was either safe or effective through the Premarket Approval process. Instead, DePuy only had to show that the Pinnacle was “substantially equivalent” to a hip implant already on the market through what is known as the “510(k) process.” This is the same loophole that DePuy used to sell the ASR hip implant, which was recalled in 2010.
But in January 2013, the FDA announced a proposal that would require DePuy to establish the safety and effectiveness of the metal-on-metal Pinnacle implant through the Premarket Approval process. DePuy, it seems, was afraid of a process that could have exposed that the Pinnacle metal-on-metal implant was neither safe nor effective. DePuy decided that rather than undergo this scrutiny, it would quietly stop selling the Pinnacle metal-on-metal hip implant.
Meanwhile, DePuy has left the thousands of victims of the metal-on-metal Pinnacle hip implant in the lurch. These patients have had to pay for their own surgeries to remove and replace the failed hip implant, and they are not receiving any assistance from DePuy. To add insult to injury, DePuy is fighting their claims in Court by arguing that the patients or their orthopedic surgeons are to blame for the failures.