FDA Hides Millions of Adverse Reports

For the last 20 years, the FDA has been filing thousands of device failure reports from the public under an exemption program for manufacturers.

According to a report from Kaiser Health News, the US Food and Drug Administration has been hiding adverse events and malfunction reports from the public.

Over 1 million reports have been intentionally hidden from public view.

Instead of being sent to the Manufacturer and User Facility Device Experience (MAUDE) which is accessible to the public online, the reports have been sent to an internal system knowns as the “alternative summary reporting repository”.

Medical experts and members of the public are able to access MAUDE to critically analyze device failure, malfunction, or conduct general research. Deaths are also included in MAUDE reports.

In 2017, over 480,000 injuries or malfunctions were included in the inaccessible reporting system; while over 2 million reports have been filed in it since 2014.

Members of the public are allowed to submit Freedom of Information Act (FIA) requests to obtain access to the incidents. But this process can take up to two years to be finalized.

Surgical staplers the balloon pumps are among the roughly 100 medical device malfunctions in the alternative repository. But the FDA has declined to provide a comprehensive list of the devices that were granted exemptions.

For months, the FDA was questioned about the reporting exemptions. Finally, it confirmed the validity of a reporting system for device malfunction hidden from public view.

S. Lori Brown, a former FDA official, was able to access the reporting information for her research. “The public has a right to know about this,” she said. Many doctors rely on what is available to the public to better inform themselves and their patients.

Countless healthcare professionals are probably still unaware of this secondary reporting system. The fact that the FDA has hidden device malfunction from the public has only encouraged doctors and other healthcare professionals to rely solely on inconclusive data.

Former FDA manager, Madris Tomes, said the agency is undermining its responsibility to the public. “The FDA is basically giving away its authority over device manufacturers. If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of those devices,” he said.

Apparently the alternative summary reporting began nearly 20 years ago to cut down on paperwork. According to Larry Kessler, former FDA official and current health services provider at the University of Washington, the timing of this came shortly after device companies were being slapped with criminal penalties for underreporting device failures.

It was originally created for “well-known and well-documented” reports within the FDA. Meaning, devices that already had complaints and reports against them.

Kessler told Kaiser Health News a limited number of staff members to review injury and malfunction reports prompted the implementation of the program by creating exemptions for certain manufacturers.

Those exemptions came in the form of quarterly and bi-annual reports from manufacturers instead of the FDA reviewing each case on a monthly basis. The reports were to indicate related issues which would then allow reviewers to notice trends. This was meant a cut back on the arduous time it would take for reviewers to flag individual cases.

In 2011, many pelvic mesh devices were discontinued by manufacturers due to an increased public awareness of lawsuits over device failure and other major side effects. At this time, the FDA allowed manufacturers to continue making these concerning products under the “litigation complaint summary reporting” system.

This kind of reporting allowed for one single injury report for as many as 1,175 individual patient injury reports. The devices under this guise are quite prominent– anywhere from surgical mesh to robotic surgery systems for heart valves and implants, manufacturers have been allowed these exemptions.

For example, Intuitive Surgical was allowed an exemption for its da Vinci robotic-assisted, catheter-based instrument used for biopsy deep within the lungs. Approximately 1,400 injuries related to the device were confined into one single report. Now, the reports are filed in smaller batches between 100 and 130 injuries at a time.

Abbott has been able to use the exemption to hide reports from public view. The company has been allowed to report over 300 deaths or 1,000 injuries in a single report. The Honolulu Star Advertiser reported last year that medical device reports on breast implants had been kept artificially low via the summary reporting program.

According to former device firm manager and medical device consultant, Christine Posin told Kaiser Health News many companies have remained quiet about the exclusive exemption reporting program. This helps them leverage a better view in the public eye against competitors that may not be aware of the program.

The summary reporting pathway underwent reforms in 2017, and a new voluntary summary reporting program was implemented for up to 5,600 devices. Manufacturers will no longer have to notify the FDA of their filings in the MAUDE database, nor will they have to seek request for exemptions.

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