By Sydney Lupkin, Data Correspondent, covers drug prices and specializes in data reporting for the KHN enterprise team. Originally published at Kaiser Health News.
[UPDATED at 1:30 p.m. ET]
After two decades of keeping the public in the dark about millions of medical device malfunctions and injuries, the Food and Drug Administration has published the once hidden database online, revealing 5.7 million incidents publicly for the first time.
The newfound transparency follows a Kaiser Health News investigation that revealed device manufacturers, for the past two decades, had been sending reports of injuries or malfunctions to the little-known database, bypassing the public FDA database that’s pored over by doctors, researchers and patients. Millions of reports, related to everything from breast implants to surgical staplers, were sent to the agency as “alternative summary” reports instead.
Here’s what we found in those newly public reports:
1. Blood glucose meters for patients with diabetes had more unique incidents than any other device in the database, logging 2.4 million reports over the past 20 years.
Almost all the products were made by LifeScan, which had been a Johnson & Johnson company until it was sold to a private equity firm in 2018. Common problems included displaying incorrect messages, losing power or being damaged before customers started using them, according to the database.
“When you’re trying to manage a chronic disease, and especially if your numbers are dangerously high, that’s life-threatening,” said Linda Radach, who chairs the medical device committee for the Patient Safety Action Network.
LifeScan did not return requests for comment.
The FDA said the number of glucose meter problems in the alternative summary reporting database shouldn’t be a surprise.
“Approximately 10% of the U.S. population has diabetes and most rely on these devices several times a day,” said FDA spokesman Michael Felberbaum. The agency also sees a “high volume” of adverse events for glucose meters in its longtime public database, called MAUDE, he said.
He reiterated that the alternative summary reporting program was intended for “well-understood” adverse events “so that we could focus more resources on identifying and taking action on new safety signals and less understood risks.”
2. There were 2.1 million reports for bad dental implants. And 114,200 were reported last year.
This kind of implant goes into the bone to support an artificial tooth or implant. Many of the reports were for problems with connections between the device and the bone.
“A lot of people have gone out and gotten these and probably don’t know about these risks,” said Madris Tomes, a former FDA manager who now runs a website to make the notoriously clunky MAUDE easier to work with.
Dental implants were among the last device types to lose permission to report harm via alternative summary reports instead of the public database. Although the device harm data doesn’t include what happened to patients, Tomes said that if a dental implant has to be removed, it often can’t be replaced because the underlying bone is so damaged.
Felberbaum said that the high number of reports for dental implants is expected because these are commonly used devices, and that more companies have brought new products to market in the past two decades.
3. There were 176 deaths reported through the alternative summary reporting system.
Alternative summary reports are not supposed to include deaths, except for cardiac arrest potentially caused by certain kinds of heart valves that were implanted at least five years beforehand. Those accounted for two-thirds of the deaths in the hidden database, KHN found.
The most recent death was reported last fall by Medtronic, and it was related to a MiniMed Paradigm insulin pump that was hard to program or calibrate. Deaths reported to the once-hidden database also included fatalities associated with two kinds of pacemakers, a breast implant, an intra-aortic balloon pump and a ventilator.
When asked why these were there, the FDA said its “standard practice” was to reach out to the manufacturer for more information when it detected an “ineligible event” in the alternative summary reports. Sometimes, a death was reported in error. Sometimes, the FDA required the manufacturer to report an incident to the public database as well.
KHN found that of the 59 ineligible deaths, only eight appeared to be revised in updated alternative summary reports.
“In some cases, the FDA revoked ASR exemptions following continued reporting of ineligible events in ASRs,” said Felberbaum, adding that ineligible deaths represented “0.001% of all reports received through the ASR program.”
The FDA contacted Medtronic “a number of weeks ago” about the 2018 insulin pump death, said company spokeswoman Pamela Reese. The death was not reported to MAUDE because the “alleged” device malfunction “did not cause or contribute to the patient death,” she said, adding that it was actually caused by “stroke and pneumonia.” She said that the company was in compliance with reporting rules and that the FDA has not asked Medtronic any additional questions about it.
“One has to wonder what other information wasn’t made public if something that clear-cut [the instruction not to include deaths in the ASR] was included and hidden from the public,” said Diana Zuckerman, president of the nonprofit National Center for Health Research. “Did FDA notice?”
4. Surgical stapler-related malfunctions accounted for more than 66,000 previously hidden incidents since 2001.
The KHN investigation spotlighted problems with staplers, which tend to be used in minimally invasive surgery to cut and seal tissue and vessels quickly. Although the FDA received only 84 reports for stapler-related harm in the public database, it acknowledged earlier this year that it had received nearly 10,000 reports through alternative summary reporting.
The most common problems were staplers that failed to fire or fired malformed staples. Nearly 4,700 stapler problems were reported through the hidden database in 2017 alone. If a stapler fails to seal tissue properly during surgery, it can lead to serious bleeding or infection.
An FDA advisory panel last month recommended the agency switch staplers to a higher-risk classification with more safety requirements.
5. Breast implant injuries and malfunctions accounted for nearly half a million unique reports over two decades, including implants that leaked, deflated or migrated.
More than 6,600 incidents have been reported in 2019 by three companies: Allergan, Mentor and Sientra. The most common problem was rupture.
Tomes was especially concerned about cancer attributed to breast implants, which was the subject of an investigation by the International Consortium of Investigative Journalists last fall. But without publicly available data tracking patient problems, which exists in adverse events data for drugs but not devices, it’s impossible to say.
“How is the public supposed to make sense of this if they’ve redacted patient safety codes?” she asked.
Plus: Thousands of medical device types are still eligible for reporting outside the FDA’s public database.
There are still ways that device makers can avoid submitting individual injuries and malfunctions to the MAUDE database.
To replace the ASR program, the FDA has launched the Voluntary Summary Reporting Program. More than 5,600 device types — or 87% of them — are eligible for summary reporting of device malfunctions, according to FDA records.
Patient advocates say they fear that these will be just as difficult to tally and track as ASRs. For example, a summary report for 156 injuries would appear to be a single MAUDE report with a note that it represents 156 injuries, not one.
“Why would you end one [hidden data program] just to start another?” Radach asked.
Methodology
To avoid double-counting adverse events, KHN counted each event identified with a unique report ID only once, unless otherwise noted.
Although this isn’t the norm, some companies appear to have recycled report IDs, using them for more than one event. As a result, our counts may be underestimated.
Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
12 comments
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the faa’s body count pales in comparison to the fda’s.
>>>“Why would you end one [hidden data program] just to start another?” Radach asked.<<<
The truth can be embarrassing.
All this reminds me of the “missing” 50% of unreported police homicides that were discovered after the Ferguson Protests prompted various bloggers and reporters to dig in to the FBI crime statistics.
The unending crime lab scandals and the decades long decline in the clearance rate for murders, and lesser felonies by America law enforcement.
The decline in both quality and quantity of autopsies for several decades because money.
The FAA and Boeing.
The economic data from the Feds that does not seem wrong so much but somehow slanted. I can not say why, but over the past thirty years what the Feds say about the economy seems increasingly fantastical.
The hidden deaths, injuries, rapes often caused by the guards in jails and prisons. My personal belief that the problem is worse than the rampant police corruption, abuse, and murders, but who knows? At least the police now report to the FBI statistics that resemble reality. As far as I know, there is no central database for the carceral state. I have no way to check if I am right or just wearing tinfoil. It is like all those sealed court cases that was reported here.
Then there is the NSA’s non stop lying about everything really to everyone including Congress, as well as the FBI and especially the CIA as well as the near global drone assassination program on whoever might, maybe be possibly terrorists. Sometimes using parameters that would net Deer hunters in California, Michigan, and elsewhere.
And all this is justoff the top of my head. No googling needed.
I think that a form of lying is also generalized in the names that corporate entities attach to themselves these days. Just from the above I highlight: LifeScan, MiniMed, Medtronic, Allergan, Mentor, and Sientra. Such punning compounds and neologisms were devised to obscure the specific nature of businesses and to remove all hints of personal responsibility, as once could be traced back from company names like “Johnson & Johnson” or “Boeing.” None of them means anything; the difference between a Sientra and a Sentra, a Mentor and a Mentos, could easily be lost on anyone – which is the point. Since they continue to proliferate (Alphabet, Altria, Uber, etc.) , such meaningless names must be working as designed, to suppress public awareness of what the firms behind them are up to, and who/what is behind the firms. Much the same purpose as that of a secret FDA database, it seems to me.
on anodyne, unmemorable naming conventions:
we’re dealing with that phenomenon with medical billing. from the “floor doctor” to the surgeons, and the surgical staff, to the imaging people to the various labs…etc.
nobody works for the hospital….rather, 40 different companies, none with memorable names, all sending bills.
it’s a mess, and not something that sick folks should have to wade through.
it’s not about “efficiency”, fer sure…but about confusing you into paying things you might not even owe. we don’t know who about half of these bill senders are, nor what they did for us.
one of the surgeons who worked on my wife(whom i liked a lot) talked about this openly…how the “business office” was an unsavory part of it all, full of mean, uncaring people who only cared about money…and how he wished the focus could be on the practice of medicine===helping humans===rather than all this money grubbing(bernie in the primary, hillary in the general).
the bill we’ve determined to be linked with his office has a letterhead that is different than what is on the door of his office, as if that has been outsourced, adding another layer of beak-wetting, as well as plausible deniability, of sorts….
we had to show him the bill…”yep, that’s us…”
“rational actors, using perfect information”,lol…
it’s crazy…and again…the names of the entities sending the bills impart no actionable or clarifying information…it’s obfuscatory, by design.
regarding the article…even if there was no secret database of failed devices(who’s brilliant idea was that, and how do they justify it?), and all that was out in the open…how would it benefit the patient?
it’s not like they give you a menu in the ER or the OR. you get what the facility has on hand. I presume that the orthopedic doctors’ corp who put my hip in did a little due diligence about the hardware beforehand…but i don’t know. do they have an inhouse vetting person who researches this stuff? or do they have the equivalent of a farm bureau/ag extension agent telling them to use the latest corporate offering?
is my artificial hip model* in this “secret database”? if the orthopedic doctor corp knows that it is, is it in their interest to tell me, given that i no longer even have medicaid, and haven’t the wherewithal to sue?
* they gave me the promotional glossy booklet with “my hip” circled in magic marker…i have it somewhere…but all this tells me is that they chose this one for some unknown criteria balancing cost and quality.
if it turns out my hip is in the secret file, what can i do about it?
tort reform and rampant opacity and the effects of hyperinequality(i couldn’t hire a lawyer if i wanted to) would likely prevent adequate recourse.
we can do better.
===I presume that the orthopedic doctors’ corp who put my hip in did a little due diligence about the hardware beforehand…do they have an in house vetting person who researches this stuff? or do they have the equivalent of a farm bureau/ag extension agent telling them to use the latest corporate offering?===
You probably do not want to know. Many years ago I worked as a plastics engineer for Baxter Healthcare. Like everything else, it is about cost. Back then Baxter used to make the best IV bags in the business but for hospital systems to buy Baxter IV bags, Baxter would make them “bundle” other Baxter medical devices and hospital products. In other words if you want our IV bags you have to use us as a single source supplier of all our hospital products and medical devices.
One caveat. I worked at Baxter Healthcare in the late 1980’s and back then they put a lot of time and money into R&D (not sure about now). Like everything else with outsourcing, globalization, etc. things have changed. Back in the 80’s Baxter used to do their own in house injection molding of medical devices but I am pretty sure it is all outsourced now.
Lastly and analogy. My wife and recently went to Lowes for some home improvement items: countertops, carpeting, etc. After the fact, I am aware that like most big corporations when you buy something from Lowes you are really buying something from their layers of suppliers. Most business have suppliers or vendors but I think the larger the business the more layers of suppliers and supply chains. So if you want to talk to the actual maker, builder, manufacturer, etc. of the item you purchased, good luck. The small mom and pop businesses probably have a more personal connection with their vendors.
IMO the same thing applies to modern healthcare(and other industries) especially the large hospital systems. When a person is getting a new hip or any medical device or drug, for them to find out the actual manufacturer/source would take a detective.
The installer who put in our new countertops said that Lowes is not a home improvement store, it is a bank or financial services company. I thought that was a good analogy too.
there was a documentary on netflix called ,”the bleeding edge”
I chronicled different medical devices, and the metal on metal /cobalt steel surface of a hip joint; was one of them. The orthopedic surgeon who had for years put other peoples implants in, got one himself.
After years of deteriorating, he found it was the leeching cobalt into surrounding tissue, that could cause early onset dimentia symptoms… which went away after he had his taken out and replaced with a non cobalt type of device….
They had plenty of stories of patients whose lives were seriously effected by the medical device industry who enjoys the ability to get new products on the market by claiming that they are “equal or equivalent to” something that was already allowed. The product that was equal or equivalent to… one product; that itself may have been equal or equivalent to something, which itself may have been equal or equivalent to something….. that has since been removed for saftey reasons …still qualifies for the exception…
But the industry ,like all others, uses people as their guinea pigs .
This is a prime example of how industry makes an end run around regulations that are designed to protect the consumer.
I’m sorry but it seems as if we never should have given up our pitchforks.
I wish I had known about tooth implants that don’t work before I had one. The implant lasted for awhile but then the bone between two teeth began to dissolve. Unfortunately, my dentist then suffered a heart attack so I have had no follow-up information. Tooth implants: don’t get them. They are too costly and they ruin your jawbone.
One of my friends received an implant that his body rejected. Last I heard, he had it extracted and is now using a bridge.
My signifigant other has the allergan silicon breast implants that make up many reports. Only 6 months ago, a conference lead to the declaration that BII, breast implant illness, is a real condition.
Silicon is reactive in the body, and the implants leach out all sorts of chemicals. this leads to immune response that only gets more severe.
Symptoms range from insomnia, rashes, weakness, severe pain, brain fog, vertigo, to fevers and nearly anything you can think of that would ruin your life.
She hasn’t been able to work because she’s been so ill from the implant. There’s a 400,000 strong facebook group full of similar stories. Private insurance will refuse to cover excision, unless you’re a pit bull who can dedicate endless time and resources to fighting it.
This secret database is the source of massive amounts of harm to the population.
Both the FDA and the device makers need to be severely punished.
“the faa’s body count pales in comparison to the fda’s.”
kimyo wins the Internet prize for comment of the day.
There was once upon a time when the FDA had integrity and trustworthiness similar to that of the NIH. Over the past dozen years or so, I started to notice the directors of both FDA and CDC began offering a lot of opinions to the media, some not even supported by their own agency’s research much less other labs. But their remarks were welcomed by Big Health – esp. Big Pharma and Big Tobacco.
A great example is the rabid US opposition to eCigarettes, an annoying product the allows users to inhale a relatively harmless but highly addictive substance called Nicotine – the stuff that makes deadly tobacco cigarettes addictive. In several countries, the UK for example, doctors are encouraged to recommend to tobacco smoking patients that they switch to vaping because the overwhelming evidence is that they are 10 times safer.
FDA and CDC have attacked “vaping” using the Music Man character Professor Harold Hill argument – we need to protect our young ones after school this despite no credible evidence of harm to teen or adult vapers. As Big Tobacco dominates the vaping industry they win if eCigarettes dominate or tobacco does. There are still no regulations for the safety of the devices (some cheap models to leach toxins from components and even explode). Worse, there is no regulation restricting the potency of Nicotine in eCigarettes. Yet, that is FDA’s main mission!