Opening of Formerly Secret FDA Database Exposes Medical Device Failures, Spurring Lawsuits

Yves here. I am appalled by the anodyne tone of this Kaiser Health News article. I know their house style is “just the facts, ma’am,” but they are averting their eyes from an outrage. Who at the FDA allowed certain medical device-makers to shunt reports of product defects into a database hidden from the public and researchers? How could this bad practice go on so long and be ended only now? Why were the reports not complete in terms of describing patient harm?

Why aren’t these critical questions front and center in this article? How can it be deemed to be adequate as reporting? The author is clearly seasoned enough to know better.

Bear in mind that the medical device approval regime in the US is far less stringent than that for drugs, so the reporting of malfunctions is a critically important check.

Maybe KHN plans to dig deeper, but you’d think they’d exhibit more inquisitiveness with this account.

By Christina Jewett, Senior Correspondent with the KHN enterprise team, who spent seven years with The Center for Investigative Reporting, where she worked with on a series that uncovered widespread graft in Medicaid-funded drug rehab centers, spurring the closure of scores of centers and 11 arrests. She and colleagues won a George Polk Award for medical reporting, writing about a hospital chain that billed for an outsized rate of rare and lucrative ailments. She previously worked at ProPublica and the Sacramento Bee. Originally published at Kaiser Health News

Lorraine Bonner’s lawsuit alleges that a Covidien stapler caused her bowel leak. Bonner says that Covidien hid “the true risks of using the device from surgeons and patients.” (Heidi de Marco/KHN)

Lorraine Bonner felt as though she was the only one. The surgical staples used to seal her colon after surgery had leaked, she has alleged in a lawsuit, spurring additional surgeries and a long, difficult recovery.

And then, just over a year after the ordeal, she read a Kaiser Health News investigation that described worse cases. KHN revealed that the Food and Drug Administration had allowed stapler maker Covidien to quietly file tens of thousands of reports of stapler malfunctions into a then-hidden database.

Alarmed that others had been harmed and reports had been hidden, Bonner, a retired Oakland, Calif., doctor, decided to go forward with a lawsuit against the stapler maker.

“If the information had been out there, then maybe Covidien would have changed the design of the staplers and made them safer,” she said, “and that would have obviated the problem in the first place.”

Bonner’s lawsuit is one example of how a vast cache of records that were released this summer are taking on a life of their own.

For almost 20 years, malfunctions and injuries linked to 108 medical devices, including dental implants and pacemaker leads, were funneled into an FDA database that few patients, doctors or even FDA officials knew existed.

In 2016, for example, Covidien reported 84 injuries or malfunctions in the public database known as MAUDE, while nearly 10,000 incidents flowed into the hidden database, KHN reported in March. A few MAUDE reports mentioned the existence of an “alternative summary reporting” program, but until this summer, the FDA made that internal data available only through the Freedom of Information process, which can take up to two years.

KHN’s investigation prompted then-FDA commissioner Scott Gottlieb to pledge in a tweet to open the hidden data to the public. The agency released all 5.7 million records in June.

Since then, researchers, lawyers and the FDA’s own officials have taken a closer look at the data to learn more about which devices malfunctioned, and how often.

Libbe Englander, the founder and CEO of Pharm3r, a medical data consulting firm, discovered that the devices in the hidden database were much riskier than other devices tracked by the FDA.

Her firm concluded that the hidden reports were “more likely to be associated with life-threatening devices and to contain potentially serious problems.”

For example, just 10% of the devices tracked in the MAUDE database are implanted in the body. But 44% of those in the hidden data are lodged in a patient’s body, including pacemakers and heart valves.

The Pharm3r report also found that the devices in the hidden data were more likely to be subject to a Class 1 recall, initiated when a device problem could cause serious injury or death. The report also underscored how vast the now-open data is ― accounting for about 40% of the total device-problem reports lodged with the FDA over the past two decades.

The once-hidden reports also figured into the ECRI Institute’s annual list of health technology hazards, a list circulated to hospitals and health systems.

ECRI found that this year’s No. 1 hazard was misuse of the surgical stapler ― which has been linked to 412 deaths, more than 11,000 serious injuries and nearly 100,000 malfunctions since 2011, according to the FDA.

“Most of these [stapler] reports had not previously been accessible to the public,” the ECRI report notes. ECRI has advised doctors to have a backup plan in place in case a stapler malfunctions during surgery.

“If a hazard is getting a lot of attention, hospitals want to have a plan to address that,” said Rob Schluth, a senior project officer with the institute.

For Bonner, the problems with a surgical stapler became apparent just over a week after she had colon surgery in November 2017. Retired from a career as a hospital physician, she knew the steps to take toward recovery. But she felt nauseated all the time and could barely hold down water.

“I was trying to get up and walk,” she said. “I was doing everything, but I just got worse and worse.”

Doctors went in for a second surgery on Dec. 6 and found infected pus filling her abdomen. They routed her colon’s contents to be collected outside her body. It took additional surgeries to restore her colon function and address hernias caused by the procedures.

Bonner’s lawsuit alleges that a Covidien stapler caused her bowel leak and that the company, by not reporting malfunctions to the public database for years, “have hidden the true risks of using the device from surgeons and patients.”

In court records filed in the ongoing case, Covidien denied all of Bonner’s claims but did say that the FDA invited the company in 2001 to submit stapler malfunctions with quarterly “alternative summary” reports.

Medtronic spokesman John Jordan said the company does not have a comment on the pending legal case.

Other devices are under scrutiny. The once-hidden data showed more than 2 million problems with dental implants.

During an October FDA webinar on dental devices, an FDA official said her office was “taking a deeper dive and trying to identify lessons learned” from dental implant incidents.

Dr. Malvina Eydelman, of the Division of Dental Devices in the agency’s device branch, acknowledged that the number of events was “very high” and said her team was trying to develop a plan to share information with the public.

Also under scrutiny are the textured breast implants made by Allergan. The company’s Biocell implants, recalled in July, have been linked to 12 deaths and 481 of the 573 worldwide cases of “breast implant-associated” lymphoma, according to the FDA. Breast implant injuries and malfunctions accounted for nearly half a million reports in the hidden database, including implants that leaked, deflated or migrated.

Patients in Missouri, California, New York and Illinois have filed federal class action lawsuits against Allergan in recent weeks, each decrying the company’s heavy use of the “alternative summary reporting” program to file injury reports ― which were analyzed by the International Consortium of Investigative Journalists.

Lorraine Bonner, a retired doctor and sculptor from Oakland, Calif., says she spent a year recovering after surgical staples were used to seal her colon. (Heidi de Marco/KHN)

A class action case filed in Florida notes FDA rules say that alternative summary reports cannot include severe or unexpected events, “yet it is believed that these incidents were kept hidden in ASRs,” including at least one lymphoma case.

An ongoing federal securities lawsuit also alleges that Allergan used “inappropriately nonpublic” alternative summary reports, disregarding the “risk that some [lymphoma] cases would go undetected by the FDA.”

Allergan has not yet responded to the class action cases or to calls for comment. It denied the “threadbare” allegation in the securities lawsuit, citing the KHN article, which “makes clear that the filing of ASRs was permissible and even encouraged by the FDA to reduce ‘redundant paperwork.’”

While the FDA has ended the alternative summary reporting program, it opened the door for makers of more than 5,000 device types to file quarterly summaries of reported malfunctions. In each case, the device maker must file a public report to the MAUDE database noting how many reports were filed directly with the agency.

An FDA spokeswoman said the agency has stopped accepting summary reports of injuries cited in pelvic mesh lawsuits. The agency does continue to accept hundreds of death report summaries under a special exemption for devices tracked in a “registry” held by a specialty medical society.

“We are in the process of reviewing the effects of these changes and will continue working to improve the usability and transparency of information in the MAUDE database — whether that information was submitted as a summary or individual report,” FDA spokeswoman Stephanie Caccomo said in an email.

The release has not been as informative as Madris Tomes had hoped, she said, given that the FDA did not disclose data on how the devices harmed patients. Tomes is a former FDA manager who runs the company Device Events, which analyzes FDA data.

For instance, she said a breast implant injury report might say there was a “biocompatibility” problem, but it’s unclear what happened to the patient.

“Did it result in lymphoma or the patient needing a device replacement?” asked Tomes. “Without that outcome, we’re still a little bit in the dark on what this data means.”

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16 comments

  1. Huey

    Wow. I expected some level of crap from instrument manufacturers but this is a bit much. It makes you wonder just as much about everything from IV brannulas to defibrillators. It’s not a very comforting picture at all, sadly.

    Thanks much for the heads up as always Yves.

    Reply
  2. butch

    Watch “The Bleeding Edge” on Netflix. Just another example of the myth that our ALPHABET agencies work for us, they are cloaking device agencies that exist to protect their donors, BIG WHATEVER………..WAKE UP!!

    Reply
  3. Carla

    “still a little bit in the dark” is exactly what we are after reading this KHN article. Thank you, Yves, for posting this AND for your right-on editorial comments that preface it. I had a dental implant a couple of months ago — a hideously expensive procedure. Sure hope it doesn’t “fail.”

    Reply
  4. The Rev Kev

    Did they seriously think that this database would never get released? That no-one would note the absence of data eventually? The worse aspect of this is that the FDA was guilty of aiding & abetting this as they had the database and not the individual companies themselves. There is going to be hell to pay for this as there were deaths involved and it seems that the FDA was quite happy to not only protect these companies but to take the rap for them as well. To be truthful though, in the unlikely event that FDA people are sacked because of this, do not be surprised to see them taking jobs the following week with these very same medical device-making companies.

    Reply
  5. KB

    Thanks Yves, and I hope even one of your excellent questions will be answered…

    This has been going on a long time. I got a metal on metal hip replacement in 2006…But, my symptoms still weren’t taken seriously until 2014 when a new Hip Surgeon of mine ordered a metal blood test. I had one of the highest blood levels of chromium and cobalt in my state and 2 pseudotumors of metal shavings that migrated to sciatic notch and elsewhere…
    With revision surgery I lost 3 pelvic muscles removing this poisonous product.

    My implant was late to be recalled because of this precise issue. Hidden alternative data…IIRC my attorney, the master of the tort claim, did discover the hip manufacturer knew this could/would happen
    My hip implant was supposed to be one of the “better” metal on metal ones….

    I sincerely hope this issue and Yves questions will be followed up by someone.

    Reply
  6. Off The Street

    How much trust are you willing to pay for?

    That seems to be the unstated question in the neo-liberal Hellscape, medical or otherwise. When there are no consequences, no watchers, nothing solid to grasp, then mission accomplished.

    Reply
  7. California Bob

    Wow. I had a molar replaced by an implant a couple years ago; it never occurred to me that this ‘routine’ surgery could have issues (I know, there is no such thing as ‘routine surgery;’ it’s an oxymoron). My oral surgeon was very conscientious, and I have had no issues with the implant, but in hindsight I should have informed myself better.

    Reply
    1. Yves Smith Post author

      Another charming fact: root canals about 25 years ago would typically involve inserting a screw in the root as part of the post they used to anchor the restoration.

      They have now found out that those screws crack roots, necessitating an extraction.

      Reply
  8. Adams

    Timely.

    The FDA approved DEXCOM’s G6 continuous glucose monitor (CGM) for use in making decisions about administration of insulin, and further approved DEXCOM’s contention that finger stick calibrations (much more accurate) are not necessary. My daughter’s G6 is frequently off by 30, 50 even 100%. Of course, we are very cautious about trusting the G6 for absolute blood glucose levels (BG) and tend to trust it mostly to indicate direction and rate of change.

    Consider a diabetic patient whose BG is 60 (somewhat low) but whose CGM displays a reading of 90 (within normal range). Now consider that this patient plans to eat a meal that contains 50 grams of carbohydrate. Using their usual carb to insulin ratio (1:5 in this case), they administer ten units of insulin and wait the usual 15 minutes before eating. During that time their BG goes down to 40 and is trending steeply downward (dangerously low). At that level judgement and physical functioning may be impaired and the person unable to take appropriate and immediate action to increase their BG and avoid passing out.

    Also, see in today’s NYT the article about the failure of DEXCOM to inform users of their system of a failure of an important alert function over the weekend. No redundancy in this critical system? Note the facile, mealymouthed “apology” from the CEO. Nothing to see here, just move along.

    Trusting the FDA or other gummint agencies to protect our health and safety is, of course, just as dumb as trusting the corporations that seek approval to sell their products. The G6 is a somewhat useful device that is, in our experience, not even close to what DEXCOM promises and the FDA approved.

    Reply
  9. JTMcPhee

    If my little window into one government agency (US EPA) is at all typical, we still have to be grateful that the agencies exist. There’s a constant war between the people who actually care about and try to protect human health and the environment, and the long parade of “conservative/neoliberal” Fifth Columnists that what, 50 years of corporatist political rulership has planted (via hiring and firing policies) in the Agency.

    I’m glad that at least some effort is being applied, by vastly frustrated and depressed and overworked actual civil servants, under constant threat of outplaying for being too dedicated to the nominal mission, to be sure that milk and eggs and bread and medications and such meet basic cleanliness and wholesomeness standards. Of course recognizing that enforcement Of law and regulation is hamstrung by the upper levels of management (political appointments and the people they bring in with them, infilling regional offices and laboratories) and the guidance documents and “enforcement strategies” worked out with the scumbag “conservative” lawyers in the so-called Justice Department and consultations with industry executives and corporate shills and lobbyists.

    We blog participants think and speak in big terms and categories, I guess looking for some magic elixir Or formula (other than the nepenthe of throwing up one’s hands in despair), while piling on to the showing of how woke we are to all the horrors that bedevil the mopery. There are people within the bureaucracy who at considerable personal cost are trying to do the right thing. I wonder what can be done to get more of the people who are trying to do the right thing to stand up and be counted. Interesting how little support there really is for the real whistleblowers who are signaling real actual crimes and horrors. There’s unfortunately what seems to be to be an inevitable application of Gresham’s Principle, of the bad driving out the good, though.

    Reply
  10. smoker

    Re: Maybe KHN plans to dig deeper, but you’d think they’d exhibit more inquisitiveness with this account.

    Yep, and also that they’d provide more of the useful patient and caretaker information on the issue. A perfect example being this linkless paragraph:

    Patients in Missouri, California, New York and Illinois have filed federal class action lawsuits against Allergan in recent weeks, each decrying the company’s heavy use of the “alternative summary reporting” program to file injury reports ― which were analyzed by the International Consortium of Investigative Journalists.

    That’s the only reference to the International Consortium of Investigative Journalists. [ICIJ], not even a link to the far more patient and caretaker helpful ICIJ Implant Files analysis site, (let alone a link for the released FDA files)??? Shame on Kaiser Health News [KHN] for not linking to ICIJ’s extensive investigations which look to have preceded, and perhaps prompted, KHN’s investigation.

    From an ICIJ piece dated June 24, 2019, by Ben Hallman, FDA Releases Vast Trove of Hidden Medical Device Injury and Malfunction Reports , numerous hyperlinks were removed for postability):

    On Friday, in a major advance for medical device transparency, the U.S. Food and Drug Administration released more than 6 million previously hidden medical device “incident” reports, filed in secret from 1999 through 2019 by device makers using a controversial and now-ended program known as “alternative summary reporting.”

    The release comes seven months after publication of the Implant Files, an investigation by the International Consortium of Investigative Journalists and media partners. Among other revelations, ICIJ showed that breast implant makers had concealed thousands of apparent injuries through use of summary reporting — a number that swelled to more than 350,000 after subsequent disclosures by the FDA.

    A March 7 report by Kaiser Health News revealed that more than 1.1 million incidents since 2016 had been kept from public view because of summary reporting.

    ICIJ had the courtesy to link to the initial, March 7, 2019 KHN expose™ but that initial Kaiser piece doesn’t even mention, let alone link to, the Implant Files website (linked at the top of this comment), which preceded the KHN expose™ by around four months.

    Reply
  11. HotFlash

    My dear Adams,

    I have to agree w/JTMcPhee. Gummint is far, far from perfect, but at least we are finding out now about this dangerous and disgraceful conduct. When do you think we would have found out about this stuff if the device mfgrs were ‘self-regulating’, which is their wet dream? The problem is not gummint per se, but regulatory capture of gummint, which weakens laws of, by, for, and to protect the people. That is to say, weakens gummint — which is us. When govt agencies are starved until drownable in a bathtub (and bribable with a revolving door), it is cruel and unreasonable to expect them to be the knights in shining armour on white horses that will protect us. They have been reduced, through budget cuts, staff cuts, and meretricious politicization, to emaciated cadavers in green plastic garbage bags riding broken skateboards. But, as JT says, some of them are still trying. Med Device makers most certainly are not.

    Just musing, y’all: what would Bernie do? Would be nice to have a new sheriff in town.

    Reply

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