On June 21, the U.S. Food and Drug Administration (FDA) published millions of adverse event reports previously concealed within their hidden database. The adverse event reports included information on injuries caused by a variety of medical devices.
Six Million Hidden Injuries Caused by Medical Devices
On June 21, 2019, the FDA released about six million reports filed by manufacturers relating to medical devices. The reports were filed from 1999 through April, 2019. Device manufacturers have been able to use an alternative summary reporting pathway for certain injuries and other adverse events caused by their medical devices instead of publicly cataloging these adverse events in the FDA’s publicly available database, MAUDE (Manufacturer and User Facility Device Experience).
The six million newly-released reports represent at least six million patients over the last 20 years who suffered injury and whose experiences went unknown to the public and the medical community. Medical device manufacturers in these reports include:
These are only a sampling of the major medical device manufacturers who have flown under the radar for decades.
Medical Device Reporting Loophole
There is an adverse event reporting loophole that has existed for 20 years. The loophole allows medical device manufacturers to avoid publicly filing reports of patient injury by filing their adverse events as summaries instead. Spokespeople for the FDA have previously defended the long-standing system saying that it was originally designed to reduce redundant paperwork.
Grouping the reports should have allowed a record of the malfunctions of similar devices, but would not add anything new to the body of knowledge. Furthermore, it would not add to “well-known and well-understood” adverse events, according to the agency. And yet, no one from the FDA has yet to provide a suitable comment as to why this summary reporting lasted for so long or why precisely it needed to be private.
The practice of alternative summary reporting ended formally this month after a bombshell report from Kaiser Health News, as well as unflattering and outraged coverage from various other news outlets. To the FDA’s credit, the agency did take decisive action at once, beginning the gradual shutdown of the program.
More Summary Databases Come to Light
The FDA’s action to shut down the alternative summary reporting database also involves shutting down another database called the “retrospective summary reporting” database. This is a database in which the agency catalogs adverse events years after they occur.
One method of summary reporting will remain an option for medical device manufacturers, called the Voluntary Malfunction Summary Reporting Program. This program, which is a new method of summary reporting is not a private database. The adverse events reported via this summary reporting program will be available to the public. Also, the regulations for acceptable reports in this new program are far more strict than under the alternative summary reporting program.
The FDA says it is not appropriate for manufacturers to use this summary program when:
- A medical device malfunction involves a device similar to one that required remedial action.
- A malfunction involves the same or a similar device as one that is subject to an active FDA recall.
- The FDA determines that individual malfunction reports are necessary.
- The FDA determines a specific manufacturer is no longer eligible for summary reporting.
- The malfunction is a new type of malfunction never before reported to the FDA for that device.
Responses from the Manufacturers of Medical Devices
The responses from medical device manufacturers have largely been positive, almost blasé, about the revelation of the hidden database and summary reports. The same day the FDA released the six million adverse event reports Medtronic, the world’s largest medical device company, released a statement nonchalantly admitting that their company has utilized the various summary reporting programs in full compliance with FDA regulations. They said in their statement,
“We applaud the FDA for their ongoing efforts to drive transparency and openness around medical device performance, and we will continue to work with FDA on future, modern programs of reporting.”
AdvaMed agreed it is important for doctors and consumers to have access to the complete body of information about medical device performance. The group said they support the FDA’s efforts to publish the results of the alternative summary program.
What Can we Learn from the Newly Released Information?
Though some experts say the influx of millions of adverse events reports at once will not benefit the public in any way, the public outrage in learning about the hidden database clearly indicates that the American people value transparency in their federal agencies.
It is true that the six million reports will be very difficult to decipher. The reports contain numerical codes established by manufacturers that refer to specific types of injuries. Not to mention, the sheer volume of reports available to the public is daunting to anyone who is interested in discovering just what the hidden database has concealed.
Regardless of whether or not this information is useful in any measurable sense, at least the public can see what the FDA has seen over the years, which is the true number of times medical devices have harmed patients. There is no going back to repair the harm this secrecy has caused in the past, but moving forward consumers and healthcare providers will have access to accurate information that represents the risks of medical devices.
What Types of Medical Devices Are in the Reports?
Drug and Device Watch has previously reported on surgical staplers, internal defibrillators, and other medical devices. The true impact cannot be really known until the reports in the hidden database are sorted out. Devices included in the released documents include:
- Pacemaker electrodes
- Dental implants
- Breast implants
- Heart monitors
- Pediatric breathing machines
At Drug and Device Watch, we will be monitoring the information released by the FDA to update our readers about possible risks or recalls.
Learn More About Medical Devices
Are you battling an injury caused by a medical device? Learn more about your legal rights by contacting Drug and Device Watch. The device manufacturer may be liable for your suffering. Our legal professionals can help you determine the best course of action for your situation.
Regardless of whether the specific device that caused your injury was named in the newly released database, you have rights, and you have options. Contact Drug and Device Watch today to learn more. Call 888-458-6825 for a free consultation, or contact us online.