The bigger concern is the realization that a hidden database established by the FDA years ago exists. The database essentially allowed adverse events, including deaths, to go unnoticed by doctors and patients alike for years. Since 2016, 1.1 million adverse events, either injuries, deaths, or malfunctions, have been reported to the hidden, internal database instead of being publicly acknowledged. Even former FDA deputy commissioner, Dr. Robert Califf, was unaware of the existence of such a database.
If only evaluating adverse events reported to the public Manufacturer and User Facility Device Experience (MAUDE), surgical staplers would appear safe to use, even efficient, for external and internal usage. But, the hidden database depicts otherwise. Along with hidden adverse reports related to the surgical stapler, the hidden database includes “about 100” other medical devices with similar reporting exemptions.
According to Larry Kessler, a former FDA official, the database was created to avoid under-reporting and alleviate the time it took to review reports of similar context. Device manufacturers would apply for “exemption” status to avoid reporting certain events to MAUDE. As part of that exemption status, the manufacturers would keep track of any injuries or deaths and on a regular basis, either each quarter, half-year, or year, report the events to the FDA via spreadsheet.
The program, launched in 2000, originally only included a few devices and was made public, but it has since grown in both size and secrecy.
As part of the Kaiser Health News report, Freedom of Information Act requests were filed in September 2018, but none have been fulfilled yet. The FDA cited the lack of urgency for delaying the response. Requests can take up to two years to fulfill.
Since the damaging report was released, the FDA has announced it is ending the program that hid reports of medical device malfunctions and injuries from the public. In addition to the ending of the program, the FDA will be releasing past reports to the public within weeks.
Manufacturers that have exemption status are largely unknown, but the FDA did confirm exemptions have been used for mechanical breathing machines, balloon pumps, pacemaker electrodes, pelvic mesh, MitraCLip, and implantable defibrillators.
The lack of transparency has likely put many individuals at risk. Without a clear picture of the number of injuries and deaths a device has caused, doctors unwittingly conclude that a particular device is safe for consumer use. Unbeknownst to the doctor and patient, the risk is much, much higher than predicted.
In terms of the surgical stapler, the FDA will evaluate its safety, but for the millions of people affected by the internal, hidden database, justice will not be achieved until all of the devices are evaluated for safety.
Dr. Michael Carome, director of the Public Citizen Health Research Group said, “It’s just another example of a flawed oversight system,” he said, “bent toward making it easier for industry rather than making protection of public health the primary goal.”