When a patient is injured by a medical device, there is an FDA system through which they can report the problem. The Vaccine Adverse Event Reporting System (VAERS) exists so data regarding medical devices that harm can be studied for any patterns. Both the FDA and the public have access to this data so regulators and patients can make decisions.
The FDA’s Secret Reporting System
Information recently emerged about a secret system that the FDA had that shielded many of the adverse reports from the public. In total, this resulted in over two million event reports that the public could not see. This existed because of exemptions to the reporting rules that kept these reports private. While the FDA could still see these reports, the general public had no idea that they even existed. After this program came to light earlier in 2019, the FDA ended it and required public disclosure of adverse events. This was considered to be a victory for transparency as tens of thousands of people are injured each year by defective medical devices. The FDA took numerous steps in favor of requiring full reporting and making it accessible to the public after media reports shattered the secrecy shrouding some VAERS reports that were kept on an alternate system.
Unfortunately, this transparency does not fully extend to all medical devices. The FDA still has a similar registry exemption program that encompasses several devices. The end result is that adverse event reports for these devices are still kept out of public view. Prominent on this list are devices that treat heart valve issues. Thousands of reports relating to these devices exist but are not available to the public.
While the Secret System Is Gone, There Are Still Unreported Incidents
In fact, there have been accounts of reports of deaths resulting from numerous devices that still go unreleased to the public. As a result, patients end up getting an incomplete picture of the risks associated with certain medical devices and are not able to make informed health decisions.
In particular, there have been nearly 6,000 deaths that have been associated with a particular heart valve device that is manufactured by Medtronic. The device is called CoreValve and it is intended to prolong the life of patients who are not well enough to undergo open-heart surgery. Medtronic did file a summary spreadsheet with the FDA that referenced multiple deaths but did not file standalone reports for many of the deaths. Another competing product had 2,400 deaths associated with it but only 400 standalone reports. This product was the subject of a recall in August 2019. Although the companies claim that the amount of deaths is a small proportion of the patients who receive the devices, there is still a lack of information in the public realm about the most severe complication.
The FDA has another reporting system called MAUDE. This system only has limited functionality and it is viewed as outdated. However, the FDA has a registry exemption for six devices that still allows reports of adverse events to remain shielded from the public.
Heart Valve Deaths Are Hidden
Specifically, information from about half a dozen medical devices for the heart is not available. This includes reports of dozens of deaths that are associated with these medical devices. Consequently, the public has to wait roughly two years to see these reports after being able to access them due to open records laws. In the meantime, they do not know the risks that they are facing if they receive these medical devices and neither do their physicians. Usually, the public is able to see death data from medical devices, but these particular devices are an exception to the rule that hides key information.
This exemption has been in place since 2010 and it was not repealed at the same time as the FDA decided to allow for public exposure of all of the rest of the hidden data. Instead, the information flows between the device makers, the FDA and private parties who administer the database without sharing the death information with the general public that needs it. The device makers compile summary reports of the deaths, but they are kept behind a firewall. The FDA claims that it permits this because it needs the summary reports in order to be able to act quickly and flexibly to respond to reports of deaths.
For its part, the FDA blames the fact that the data is shielded from the public on the limited functionality of the MAUDE system. The agency claims that it is not its intention to keep this data hidden. There are plans to technologically update the system. Congress recently appropriated money to the FDA, and the agency has plans to modernize the system to allow for the release of more information to the public.
In general, physicians have claimed that the number of deaths associated with a heart device implanted in very sick patients should not be alarming. Nonetheless, what is alarming is a lack of information regarding the circumstances of those deaths and the role that the medical device played in it.
Greater Transparency May Be Coming
There have been numerous issues with FDA reporting, including instances in which device makers mislabeled patient deaths as injuries. The FDA appears to be moving towards greater transparency in the wake of the previous controversy about the secret registry so the hope is that hidden death reports will become a thing of the past entirely. In addition, better funding for the FDA could mean improved technology so the regulator can better monitor reports made to it and hold device makers accountable.