Consumer Alert: FDA 510(k) Clearance Does Not Guarantee Safety

HOUSTON—In the eyes of the average American consumer, U.S. Food and Drug Administration (FDA) approval signifies that a medical device has been thoroughly tested and has been found to be safe and effective. The average consumer, however, is typically unaware of the various methods of obtaining FDA approval, one of which does not require formal product testing of any sort.

Standard protocol for receiving FDA approval is the premarket approval process (PMA), which involves an extensive review of the product in question, including rigorous clinical trials. The process often takes nearly two years to complete and can cost the manufacturer upwards of $250, 000. It seems understandable then, that companies might seek a less involved option if one were available.

Enter premarket notification, or 510(k) Clearance, which requires manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. If, during that period of time, the FDA determines that the “new” product is substantially similar to one that is already on the market, it will be approved without having to go through the normally required clinical trials.

Shockingly, only about 10 percent of 510(k) applications are referred back to the manufacturer for further testing; which means that roughly 90 percent of devices made available through this process have scarcely been studied, and may never have undergone a single clinical trial.

One such product that has recently come under fire for gross failure is the DePuy Orthodics, Inc. hip implant system, which includes the ASR XL Acetabular System and ASR Hip Resurfacing System. Approved through 501(k) Clearance in 2005, the device has since been implanted in more than 93,000 patients across the globe, and was originally anticipated to last for 15 years.

The ASR implant, a metal-on-metal ball-and-socket device used in hip replacement surgery, was touted by manufacturer Johnson & Johnson as a “high performance” replacement system that had significant advantages over other brands. However, the FDA began receiving complaints from patients and doctors regarding problems associated with the device as far back as 2008, and finally ordered a recall of the product in August 2010. A British study has since confirmed that nearly 12 percent of those who received the implants required corrective procedures, called revision surgeries, within five years.

While DePuy considered the metal-on-metal feature of the ASR device a notable attribute, some experts believe that it is to blame. The metal-on-metal contact of the ball and socket creates microscopic metal debris that damages nearby muscles and soft tissues. Some experts also believe that the design of the ASR hip replacement cup was too shallow making the system more difficult to position during surgery.

The premature failure of a hip implant can result in considerable physical, emotional, and financial hardship, none of which should become the patient’s responsibility. The fact that DePuy’s products were approved via an expedited FDA process means that defects the company may have been aware of were easily swept under the rug.