DePuy Bails from the Metal on Metal Hip Replacement Market by Withdrawing its Pinnacle Metal-on-Metal Line
In the past, DePuy vigorously supported the continued use of metal-on-metal hip implants, even when mounting evidence through the registries and surgeons’ experiences showed that these types of hip implants had catastrophic results as compared to other safer alternative designs such as metal on polyethylene hip implants. DePuy will likely continue to deny that the Pinnacle Metal on Metal products are defective because they are fearful of the negative implications this would have with the massive number of patients who have filed lawsuits against DePuy, alleging that their metal on metal hip implants are defective. However, amidst mounting pressure from the FDA, surgeons’ negative experiences, and increased patient revision rates, DePuy has finally thrown in the towel and stopped its aggressive support of the metal-on-metal hip industry by announcing that it will be discontinuing sales of its Pinnacle metal-on-metal hip implants.
At the end of 2009, DePuy announced to US surgeons that it would be discontinuing sales of its DePuy ASR XL by the end of 2010. DePuy cited a decrease in sales as its motivator for discontinuing sales of the ASR XL, and DePuy vigorously denied that there were any safety issues with the DePuy ASR at that time. During this time period, US surgeons using the DePuy ASR were pitched on switching from the DePuy ASR XL to the Pinnacle metal-on-metal products and DePuy continued to support the use of metal-on-metal hip implants despite growing concerns of increased failure rates caused by cobalt and chromium metal toxicity.
In June 2012, the FDA held a panel discussion consisting of presentations from implanting surgeons, manufacturer representatives and patient advocates. Dr. Kwon discussed in detail his own observations of revising patients with metal-on-metal hip implants that needed to be removed due to high concentrations of cobalt and chromium being shed from the hip implants. He stated that numerous patients had necrotic metal stained tissue, joint fluid build-up, bone destruction and even pseudotumors that developed as a result of toxic concentrations of metal particles being shed from the hip implant.
In January 2013, the FDA issued a Med Watch safety alert to patients with metal-on-metal hip implants or those who were considering having a metal on metal hip replacement implanted (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm340655.htm). The FDA also gave the ultimatum to companies to either discontinue selling metal-on-metal hip implants or provide clinical studies which adequately addressed the risks and benefits of implanting metal-on-metal hip implants. Rather than provide the required clinical trial support that the FDA sought for these Pinnacle metal-on-metal implants that DePuy had already been selling for nearly a decade, DePuy made the decision to simply discontinue sales of these Pinnacle metal-on-metal hip implants by August 2013.