FDA Could Have Warned Patients Sooner

The FDA Could Have Warned Patients Sooner About the Defective ASR

When DePuy Orthopaedics recalled the ASR XL Acetabular System and ASR Hip Resurfacing System last August, it did so voluntarily, without any warnings from the Food and Drug Administration. By this time, there was ample amount of data and reports, accumulated through a few years, which showed the unusually high revision rate associated with the ASR hip implant. The New York Times article published after the announcement of the recall, titled “Johnson & Johnson Recalls Hips Implants,” noted that by the time of the issued recall, the FDA had received 400 complaints about the ASR since the beginning of 2008.

In the fall of 2009, DePuy announced it was discontinuing the production of the ASR, with plans to phase out sales of the device by the end of 2010. The reason for the discontinuation of production was declining sales–and not safety concerns. In December of the same year, DePuy pulled the ASR from the Australian market all together, yet continued to sell it in other countries. Then in March of 2010, the company issued a Field Safety Notice regarding the high revision rates for both versions of the ASR when used with head sizes smaller than 50 mm in diameter. The notice referenced the revision rates reported in the Australian National Joint Replacement Registry, and emphasized adhering to surgical technique, selecting the appropriate patients for the surgery and the importance of cup placement.

During this chain of events, beginning from when the FDA first began to receive complaints up to the recall in August, the Food and Drug Administration issued no warnings about the high revision rates for the ASR implant, despite available data and reports.

The Medicines and Healthcare Products Regulatory Agency, England’s version of the FDA, is responsible for the regulation of medicines and medical devices. Several weeks after DePuy’s Field Safety Notice, the MHRA released a medical device alert regarding all metal-on-metal hip implants and recommended surgeons to follow up on patients with these types of hip implants and conduct testing for cobalt and chromium ion levels in the blood. A month later, on May 25th, the agency released another Medical Device Alert specific to the DePuy ASR, reiterating the recommendation DePuy made in its March Field Safety Notice regarding cup inclination angle and following up on patients and conducting metal ion level tests and MRI or ultrasound scans.

The FDA however, made no recommendations, notices or alerts concerning the high revision rate and reports of patients with metallosis due to the defective design of the ASR. A new section on the FDA website informs patients about hip replacement surgeries and the various types of devices that are available, including warnings of the risk of metal-on-metal hip devices. Metal-on-metal implants inevitably shed metal debris due to the contact of the ball with the cup; the amount of debris though is dependent on the design of the device and how well the surgeon implants the device.

Half of the world’s joint replacements surgeries are performed in the U.S. and it is very unfortunate that the FDA did not issue a warning about the risks of the DePuy ASR hip implant earlier. The company could have recalled the device earlier, but instead continuously refused to address data from joint registries, studies, and concerns expressed by surgeons regarding the high revision rate for the ASR. In the circumstance in which a company shows negligence towards the under-performance of one of its products, the FDA is expected to step in and take appropriate actions when a device is not functioning properly. A careful overview of all the available data would have led the FDA to make a more prompt decision about the risks of the DePuy ASR hip implant