Bard IVC Filter and the FDA’s 510(k) Clearance Process
How is it that the same issues associated with one Bard IVC filter appear to be passed on to the next model and then the next? One answer comes from the process by which the FDA approves medical devices.
Each Bard IVC filter has been cleared for marketing via the FDA’s 510(k) process. This process does not require clinical trials that test the safety and effectiveness of a device on human subjects—either before or after clearance. It only requires the maker to show that a device is “substantially equivalent” to a device that is already on the market, called the “predicate device.” If a device fails the 510(k) process, it must go through a premarket approval (PMA) process which is much more thorough and demanding and requires clinical trials. Devices that complete PMA requirements are called “approved medical devices.” Devices that go through the 510(k) process are said to be “cleared” devices.
The FDA’s 510(k) process appears to have led to the clearance of many medical devices that were later found to be dangerous and even deadly. A 2011 study in JAMA Internal Medicine, a journal published by the American Medical Association, found that from the year 2005 through 2009, 113 devices were recalled for being “life-threatening or very serious hazards,” Eighty (71%) were cleared through the 510(k) process.
The JAMA study applies directly to the 510(k) approval process that cleared every Bard IVC filter. In each case the predicate device used to gain clearance for a new Bard IVC filter—the device to which the filter was claimed to be substantially equivalent—was the previous Bard IVC filter. The Recovery was the predicate device for the G2, the G2 was the predicate device for the G2 Express and the G2 Express was the predicate device for the Eclipse. No clinical trials to test the safety and effectiveness of these devices were required. Each Bard IVC filter, including the Meridian and the Denali, was cleared based on an earlier Bard IVC filter.
It is easy to see how such an approval system could provide a gateway for design flaws to pass from one generation of Bard IVC filter to the next. A July 2011 report prepared for the FDA by the prestigious Institute of Medicine concluded, “510(k) clearance is not a determination that the cleared device is safe or eﬀective.”
“Since the §510(k) process is focused on equivalence, not safety, substantial equivalence determinations provide little protection to the public.”
S. Supreme Court decision in Medtronic, Inc. v. Lohr et vir. (1996)