Johnson & Johnson's DePuy Pinnacle Hip Implant Troubles MountingJul 13, 2012 | Parker Waichman LLP
More than 10 percent of people relying on the DePuy Orthopaedics Pinnacle metal-on-metal hip implant will likely suffer a complication or the device will fail in the next two or three years, new estimates suggest.
It appears the metal-on-metal version of DePuy Orthopaedics Pinnacle hip implant is destined to take the similar route that led to the eventual recall of the Johnson & Johnson subsidiary’s ASR all-metal hip. According to a Reuters report, more than 1,600 lawsuits against the company have already been filed against the medical device company over defects and complications with the Pinnacle hip implant. Doctors following patients who rely on this specific hip implant model believe about 1 in 10 people are destined to suffer some degree of injury caused by their defective implant.
The problems associated with the Pinnacle implant mirror those that led to the August 2010 recall of the company’s ASR model metal-on-metal hip implant. It’s believed tens of thousands will suffer an early failure of that device caused by any number of problems that appear to plague the entire class of medical devices.
Metal-on-metal hip implants have only been on the market for less than a decade and were rushed through the Food and Drug Administration’s 510(k) “fast-track” approval system which requires little or no pre-market safety testing. This unknowingly put tens of thousands of recipients of these devices from more than 30 manufacturers into a test market and now regulators and the industry is working to correct the failures of the devices and the process through which they reached the market.
In addition to overall failures of the devices, such as snapping unexpectedly, metal-on-metal hips have caused pain and inflammation at the site of the implant to thousands. This leads to unexpected revision surgeries and possible replacement surgeries, placing the high costs of these procedures and subsequent physical therapy on the patient.
The hallmark problem with metal-on-metal hip implants is the toxic accumulation of the metals cobalt and chromium. Small metal particles are worn off the devices through normal wear-and-tear and build-up in the bloodstream or in surrounding muscle, tissue, and organs. This, if left unchecked, can cause metallosis (metal poisoning) and possible tissue and organ damage.
It was not until 2010 that the FDA warned of the risks associated with metal-on-metal hip implants and by that time, at least 16 percent of U.S. surgeons were using the devices on a regular basis for hip replacement procedures. Only about 10 percent of surgeons still use the devices, the report indicates, citing statistics from the American Academy of Orthopaedic Surgeons. More than a half-million Americans have received an all-metal hip implant.
In the last year, the FDA has ordered 33 manufacturers of metal-on-metal hip implants to conduct full post-market safety studies while the fate of this class of devices is considered. The agency also recently conducted a two-day hearing to determine the best treatment options for people who currently rely on all-metal hip implants.
Failures of other models outside the Pinnacle and ASR models from DePuy Orthopaedics suggest the problem is likely not product specific, as some manufacturers have argued.