In the wake of the DePuy fiasco, Johnson & Johnson has just announced that it will discontinue its metal-on-metal hip devices. This comes after years of defending thousands of claims concerning its DePuy ASR and DePuy Pinnacle implants. In a statement released by the company it said that demand for these devices has waned and that new, stricter approval processes required by the FDA also affected the decision.
Metal-on-metal hips were all the rage eight years ago and were the implants of choice for surgeons. Patients were promised that they would be able to resume all normal activities, including extreme sports, and that the hips would last at least 15 years. In 2007, sales of the device reached an all-time high, accounting for approximately 20% of all hip implants sold in the United States and Europe.
However, not long afterwards there were reports of patients experiencing unanticipated side effects and premature failure of the implants. Since then sales have plummeted as doctors questioned their safety and patients brought legal action. It has been reported by Johnson & Johnson’s DePuy unit that it has seen a 90% decline in metal-on-metal sales industry wide since 2007. Today, surgeons prefer new technology and next-generation materials for hip implants, including ceramic and polyethylene, which are safer alternatives.
The catastrophic effect some of these devices have had on patients has prompted the FDA to propose strict changes in the regulation of the entire class of metal-on-metal products. Companies will be required to complete new clinical trials, which must demonstrate the safety and effectiveness of the devices they manufacture if they want to continue selling them.
Johnson & Johnson has stated that this move does not represent a recall. In 2010, DePuy did recall the ASR system and in March 2013 a US claimant was awarded $8.3 million in damages in the first case to go to trial. With more than 500,000 patients having been fitted with a metal-on-metal hip, we can expect to see many more claims being brought.