Medical Device Recalls and the FDA Approval Process

Katie Korgaokar had her hip replaced in 2006, which freed her to hike, ski and ride horses without pain. Then in 2010, she received a letter that her hip was being "voluntarily recalled." She remembers thinking that it seemed like a cruel joke - an action that was reserved for car parts, not for parts you put in a person. The recall is however a reality, for Korgaokar and nearly 93,000 worldwide who received the ASR Hip Resurfacing System or ASR XL Acetabular System, both manufactured by DePuy Orthopedics, Inc.

The CBS Evening News recently reported that in 2006, approved medical devices were linked to more than 2,800 deaths and close to 120 injuries.

Archives of Internal Medicine Study

A recent Archives of Internal Medicine study examined medical device recalls. The study, authored by Diana M. Zuckerman, Paul Brown and Steven Nissen, found that there were 113 recalls from 2005 through 2009 that the Food and Drug Administration (FDA) determined were life-threatening or very serious hazards. Of those, 80 devices had been reviewed under the 510(k) process, which requires only that the device be similar to a device already marketed; under the 510(k) process, devices are often approved within 90 days. Eight devices were exempt from any FDA regulation.

Co-author Dr. Steven Nissen says that "[s]ome 80 percent or so of devices being recalled were actually never fully clinically tested in people." He believes that the regulatory system is failing. "There's a serious problem here when 112 million devices were recalled in less than five years," he says.

Recalls and Remedies

Among the nine device recalls in 2011 identified by the FDA are:

  • Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Pocket fills may result in patient harm, serious injury or death due to drug overdose or underdose
  • Merit Medical Systems Prelude Short Sheath Catheter Introducer: Introducer tips or tip material may detach and cause arterial injury, hemorrhaging, blood clots (thrombosis) or other serious events
  • AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon CatheterOTW 0.018" Platform (multiple sizes): May lead to significant arterial injury which may lead to death or need for additional surgical intervention

The authors of the study concluded that their findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices. An invited commentary accompanying the study says that analysis shows millions may be at risk for device-related injuries or recalls from high-risk devices that obtained FDA approval without any supporting clinical data. Any patient who has been implanted with or affected by a medical device recall should contact an attorney about their ability to seek compensation and about how to protect their interests.