Not as many medical devices are approved by the FDA as you might think. While many people expect that all implantable medical devices are regulated by the federal government, the reality is that a significant number of these devices sidestep the FDA’s testing process.
Like any budget-conscious government agency, the FDA follows practices that allow it to focus its time and resources on what it views as the most high-risk activities within the scope of its oversight. One such practice is known as the 510(k) program. Unfortunately, the consequences are not always as intended.
FDA’s 510(k) Program Allows the Sale of Medical Devices without Clinical Testing
The 510(k) program allows medical device manufacturers to bypass the FDA’s clinical testing and review processes for any device that they can demonstrate is “substantially equivalent” to another device already on the market. The idea is that patients should not have to wait for government approval of a competitive product if a similar device has already passed FDA inspection.
In practice, however, some medical device manufacturers are using the 510(k) program to start selling devices that would otherwise fail to meet the FDA’s standards. In fact, 71 percent of medical devices cleared for sale under the 510(k) program over the five-year period from 2005 to 2009 have been recalled over safety issues.
Defective Medical Devices Cleared through the 510(k) Program
The following are examples of dangerous and defective medical devices that have made it to market through claims of substantial equivalency under the FDA’s 510(k) program:
DePuy Orthopaedics ASR and Pinnacle Devices
DePuy Orthopaedics (now known as DePuy Synthes) was well known for having devices cleared through the FDA’s 510(k) program. One such device, the Articular Surface Replacement (ASR) XL Acetabular system, caused complications for numerous patients and prompted a recall in 2010. Thousands of lawsuits followed.
DePuy’s Pinnacle hip replacement device was also widely known to cause problems, and brought another round of lawsuits in 2013.
Zimmer NexGen Knee Replacement Devices
Zimmer Holdings, another major medical device manufacturer, used the 510(k) process to get several of its NexGen knee replacement devices in the hands of doctors without comprehensive government testing. Over 68,000 patients received implants of devices that were later found to cause complications ranging from severe pain to bone fractures in the area surrounding the implant.
Stryker Rejuvenate and ABG II Hip Replacements
Perhaps the most well known example of dangerous devices clearing through the 510(k) process is the recent recall of Stryker Corp.’s Rejuvenate and ABG II hip replacement implants. Stryker settled claims relating to injuries caused by these devices for a record $1.4 billion in November 2014. Read more about the Stryker hip implant lawsuit settlement.
Contact Carey, Danis & Lowe | Attorneys for Victims of Defective Medical Devices
For more information about defective medical devices cleared through the FDA’s 510(k) program, contact Carey, Danis & Lowe today.