Data from the U.S. Food and Drug Administration (FDA) shows that there are over 100,000 medical devices on the market. Unfortunately, not all of them are safe. In fact, agency data indicates that between 13 and 75 devices are recalled in the United States every day. Motley Fool reports that a regulatory loophole, which allows devices to be sold and implanted into patients without clinical testing, may be a major contributing factor to these statistics.
Manufacturers can submit certain devices for 510(k) approval; this process can allow a device to be sold on the market without clinical testing for safety or efficacy so long as the FDA finds that the product is “substantially equivalent” to an older product. Only Class I and Class II devices are eligible for 510(k) clearance. Class III “high-risk” devices must go through the more stringent premarket approval.
Motley Fool reports that the testing loophole may to be blame for some of the unfortunate medical device catastrophes that have occurred. Johnson & Johnson’s DePuy ASR hip implant recall is a prime example. 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. While the device approved through 510(k) has some similarities to an older device, experts say its solid metal cup component was a faulty design. The metal materials can release metal debris when surfaces of the implant rub together, causing a host of problems.
It is not uncommon for device makers to make small changes to a device. However, 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.
J&J ultimately recalled the ASR hip implants in 2010, following reports of high failure rates and complications such as metallosis and pseudotumors. A failed implant is often replaced through revision surgery. By the time the recall was issued, the device had already been implanted in 37,000 people in the United States and 93,000 worldwide. More than 7,500 lawsuits were filed and the company paid billions to settle cases.
Metal hip implant safety concerns were not isolated to J&J; in fact, the devices as a whole have come under scrutiny. Stryker Corporation recalled two implants in 2012 due to metal corrosion and implant failure and many other device makers are facing lawsuits.