There are 100,000 medical devices on the market, according to data from the U.S. Food and Drug Administration, but unfortunately not all of them are safe. FDA data shows that every day, between 13 and 75 devices are recalled in the United States. Motley Fool reports that this problem may be largely attributed to a regulatory loophole that allows devices to be on the market without clinical testing.
The testing loophole refers to the 510(k) approval process; this route can clear devices if the product is “substantially equivalent” to a previously approved device, known as a predicate. The 510(k) process is usually only applied to Class I and Class II device, which are designated as low and moderate risk, respectively. Class III devices, which are considered high risk, usually must go through the stricter premarket approval that mandates clinical testing for safety and efficacy.
The lack of clinical testing in the 510(k) process may be to blame for some of the unfortunate medical device safety issues that have arisen over the years, such as Johnson & Johnson’s DePuy ASR hip implant recall. The metal-on-metal hip systems were on the market for a number of years before they were recalled due to a high failure rate and the risk of metallosis, or metal poisoning. DePuy was required to conduct clinical trials for the hip, but the meantime received 510(k) clearance for a version of the implant in 2005. These implants were Class III but were regulated through 510(k) because they were “preamendment devices”. Manufacturers often make small changes to a device, but if an increasing number of these small changes are made through this loophole, the end result can be a medical device that has not been adequately tested.
Even though the implant cleared through 510(k) has some similarities to an older device, experts say its solid metal cup component was its downfall. The metal materials can release metal debris when surfaces of the implant rub together, causing a host of problems.
In 2010, J&J recalled the ASR hip implants due to high failure rates and complications such as metallosis and pseudotumors. When an implant fails, revision surgery is performed to remove the device. The device had already been implanted in 37,000 people in the United States and 93,000 worldwide when the recall was issued. J&J faced more than 7,500 lawsuits and paid billions in settlements.
J&J was not the only manufacturer to struggle with safety issues related to metal-on-metal hip implants. The entire category of devices has actually come under scrutiny. In 2012, Stryker Corporation recalled two implants due to metal corrosion and implant failure and many other device makers are facing lawsuits. The FDA proposed in January 2013 that manufacturers of metal hips be required to submit their devices through premarket approval, and therefore conduct clinical testing.