Posted on Mar 11, 2019
Dangerous Devices Lead to Secret Program
According to officials with FDA at the time, “alternative summary reporting” began two decades ago to cut down on redundant paperwork. Former FDA official David Kessler said the program took shape after scandals over under-reporting of device problems spurred changes that allowed criminal penalties against medical device companies.
Thousands of injury and malfunction reports began coming to the agency each month. Kessler said some 15 staff members reviewed them. He said many reports were so similar that reviewing them individually was “mind-numbing.” Kessler went to the FDA’s legal department and to device makers for a solution. Medical device makers then wrote their own ticket; they would be able to seek a special “exemption” to avoid reporting certain complications to the public database. The manufacturers would instead send the FDA a spreadsheet of injury or malfunctions each quarter, half-year, or year. Nobody but the FDA would be able to put the actual injury numbers together after that, or the total number of adverse events. The agency would no longer share those real numbers with the public, with patients and medical providers.
Kessler said reviewers could then quickly look for new problems or spikes in known issues. (They would no longer be bogged down by actual reports, real numbers, total adverse events and injuries that were “redundant.” ) When the program launched in 2000, the list of exempted devices was made public and only a few devices were involved, according to Kessler.
Few people even within the FDA knew about the program then or now, and that list Kessler mentions as being public then is no longer public. We do know, however, that transvaginal mesh makers are now part of it, able to hide the actual number of women injured by the controversial plastic mesh used for pelvic organ prolapse and stress urinary incontinence.
Starting in September, KHN filed Freedom of Information Act requests for “exemption” agreements and reports for several medical devices. Health and Human Services officials denied an appeal to provide some of the records quickly, concluding there was no “compelling need” for haste. For one request, the records were estimated to arrive in 22 months.
The FDA did provide some top-level data. It shows that from 2014 through 2017, the overall number of alternative summary reports filed by device makers rose from 431,000 to 481,000.
The Kaiser Health News story suggests the FDA’s reporting deception was not uncovered until a surgeon performed his due diligence after a device he had used failed.
Dr. Douglas Kwazneski experienced a stapler malfunction during a liver surgery. He then researched other possible adverse events involving the stapler. He checked the FDA’s MAUDE database. He found “there was nothing.” But then he surveyed leading surgeons. Two-thirds of them told him they had also experienced stapler malfunctions, or they knew a peer who had.
Dr. Kwazneski then discovered that the FDA had granted the makers of surgical staplers a special “exemption.” This arcane arrangement allowed the device maker to file reports of malfunctions in a database hidden from both doctors and the public.
FDA Covers up 1.1 Million Events
“[I]t seemed like a coverup,” said Dr. Kwazneski, who practiced at the time in Pasco County, Florida.
Worse, the KHN investigation shows FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions. At least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository since 2016. They all but disappear there, instead of being described individually in the publically accessible MAUDE database.
The hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA. Many of those were implanted in patients or used in thousands of surgeries. The adverse event reports for surgical devices have included surgical staplers, balloon pumps for blood circulation, and mechanical breathing machines.
An FDA official said that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices. “Voluntary?”
KHN notes that the FDA’s secret reporting program has been so obscure that many of the doctors and engineers dedicated to improving device safety don’t even know about it. Even a former FDA commissioner said he knew nothing about it.
Give the Kaiser Health News team all the credit. They dug through abstruse piles of public records to find “oblique references to reporting exemptions.” They had to ask the FDA questions for months before the erstwhile “public” agency finally confirmed that it supervised “reporting-exemption” programs and helped hide thousands of never-before-acknowledged instances of malfunctions or harm.
FDA Information Blackout Harms People
FDA records show that amid the agency’s blackout on information regarding device risks, patients have been injured, in some cases hundreds of times.
A former FDA official. Dr. Lori S. Brown, who accessed the data for her research, said doctors who relied solely on the FDA’s incomplete public reports could easily reach the wrong conclusion about a device’s safety record.
KHN wrote, “The FDA has also opened additional – and equally obscure – pathways for device makers to report thousands of injuries brought to light by lawsuits or even deaths that appear in private registries that medical societies use to track patients. Those exemptions apply to risky and controversial products, including pelvic mesh and devices implanted in the heart.”
FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” she said in an email.
That’s hardly the stuff to build consumer confidence about medical device safety.
480,000 Hidden Reports in 2017
FDA records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.
FDA spokeswoman Alison Hunt said the majority of device makers’ “exemptions” were revoked that year as a program took shape that requires a “placeholder” report to be filed publicly.
1 Million+ Reports Hidden by FDA
More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA. But with the agency’s alleged new “transparency” push,” anyone unlucky enough to need a medical device (there are always alternatives) might be able to find a public report and submit a Freedom of Information Act request to get information about incidents. A response can take up to two years.
Ms. Hunt said in an email to KHN that the exemption program “has allowed the FDA to more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive.”
The “quality” of the FDA’s review of any medical device is so obviously compromised with the unveiling of the agency’s secret reporting program that such explanations would be laughable if the situation it has created weren’t so dangerous and irresponsible.
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