5 issues we discovered within the FDA’s hidden system database

After 20 years of holding the general public at the hours of darkness about tens of millions of medical system malfunctions and accidents, the Meals and Drug Administration has revealed the as soon as hidden database on-line, revealing 5.7 million incidents publicly for the primary time.

The newfound transparency follows a Kaiser Well being Information investigation that exposed system producers, for the previous 20 years, had been sending experiences of accidents or malfunctions to the little-known database, bypassing the general public FDA database that is pored over by medical doctors, researchers and sufferers. Tens of millions of experiences, associated to every part from breast implants to surgical staplers, have been despatched to the company as “various abstract” experiences as an alternative.

Here is what we present in these newly public experiences:

1. Blood glucose meters for sufferers with diabetes had extra distinctive incidents than some other system within the database, logging 2.four million experiences over the previous 20 years.

Nearly all of the merchandise have been made by LifeScan, which had been a Johnson & Johnson firm till it was offered to a personal fairness agency in 2018. Widespread issues included displaying incorrect messages, dropping energy or being broken earlier than clients began utilizing them, based on the database.

“While you’re making an attempt to handle a continual illness, and particularly in case your numbers are dangerously excessive, that is life-threatening,” mentioned Linda Radach, who chairs the medical system committee for the Affected person Security Motion Community.

LifeScan didn’t return requests for remark.

The FDA mentioned the variety of glucose meter issues within the various abstract reporting database should not be a shock.

“Roughly 10% of the U.S. inhabitants has diabetes and most depend on these gadgets a number of occasions a day,” mentioned FDA spokesman Michael Felberbaum. The company additionally sees a “excessive quantity” of antagonistic occasions for glucose meters in its longtime public database, referred to as MAUDE, he mentioned.

He reiterated that the choice abstract reporting program was meant for “well-understood” antagonistic occasions “in order that we might focus extra sources on figuring out and taking motion on new security indicators and fewer understood dangers.”

2. There have been 2.1 million experiences for dangerous dental implants. And 114,200 have been reported final 12 months.

This type of implant goes into the bone to assist a synthetic tooth or implant. Most of the experiences have been for issues with connections between the system and the bone.

“Lots of people have gone out and gotten these and possibly do not learn about these dangers,” mentioned Madris Tomes, a former FDA supervisor who now runs a web site to make the notoriously clunky MAUDE simpler to work with.

Dental implants have been among the many final system varieties to lose permission to report hurt through various abstract experiences as an alternative of the general public database. Though the system hurt knowledge would not embrace what occurred to sufferers, Tomes mentioned that if a dental implant must be eliminated, it usually cannot be changed as a result of the underlying bone is so broken.

Felberbaum mentioned that the excessive variety of experiences for dental implants is predicted as a result of these are generally used gadgets, and that extra firms have introduced new merchandise to market prior to now 20 years.

three. There have been 176 deaths reported by way of the choice abstract reporting system.

Various abstract experiences should not supposed to incorporate deaths, apart from cardiac arrest doubtlessly brought on by sure sorts of coronary heart valves that have been implanted at the least 5 years beforehand. These accounted for two-thirds of the deaths within the hidden database, KHN discovered.

The newest dying was reported final fall by Medtronic, and it was for a MiniMed Paradigm insulin pump that was arduous to program or calibrate. Deaths reported to the once-hidden database additionally included fatalities related to two totally different sorts of pacemakers, a breast implant, an intra-aortic balloon pump and a ventilator.

When requested why these have been there, the FDA mentioned its “normal observe” was to achieve out to the producer for extra data when it detected an “ineligible occasion” within the various abstract experiences. Generally, a dying was reported in error. Generally, the FDA required the producer to report an incident to the general public database as properly.

KHN discovered that of the 59 ineligible deaths, solely eight gave the impression to be revised in up to date various abstract experiences.

“In some instances, the FDA revoked ASR exemptions following continued reporting of ineligible occasions in ASRs,” mentioned Felberbaum, including that ineligible deaths represented “zero.001% of all experiences acquired by way of the ASR program.”

When requested whether or not the FDA had contacted the corporate in regards to the 2018 insulin pump dying, Medtronic was unavailable for remark.

“One has to marvel what different data wasn’t made public if one thing that clear-cut [the instruction not to include deaths in the ASR] was included and hidden from the general public,” mentioned Diana Zuckerman, president of the nonprofit Nationwide Heart for Well being Analysis. “Did FDA discover?”

four. Surgical stapler-related malfunctions accounted for greater than 66,000 beforehand hidden incidents since 2001.

The KHN investigation spotlighted issues with staplers, which are usually utilized in minimally invasive surgical procedure to chop and seal tissue and vessels rapidly. Though the FDA acquired solely 84 experiences for stapler-related hurt within the public database, it acknowledged earlier this 12 months that it had acquired practically 10,000 experiences by way of various abstract reporting.

The most typical issues have been staplers that failed to fireside or fired malformed staples. Almost four,700 stapler issues have been reported by way of the hidden database in 2017 alone. If a stapler fails to seal tissue correctly throughout surgical procedure, it could possibly result in critical bleeding or an infection.

An FDA advisory panel final month really useful the company change staplers to a higher-risk classification with extra security necessities.

5. Breast implant accidents and malfunctions accounted for practically half 1,000,000 distinctive experiences over 20 years, together with implants that leaked, deflated or migrated.

Greater than 6,600 incidents have been reported in 2019 by three firms: Allergan, Mentor and Sientra. The most typical drawback was rupture.

Tomes was particularly involved about most cancers attributed to breast implants, which was the topic of an ICIJ investigation final fall. However with out publicly accessible knowledge monitoring affected person issues, which exists in antagonistic occasions knowledge for medication however not gadgets, it is inconceivable to say.

“How is the general public imagined to make sense of this in the event that they’ve redacted affected person security codes?” she requested.

Plus: Hundreds of medical system varieties are nonetheless eligible for reporting outdoors the FDA’s public database.

There are nonetheless ways in which system makers can keep away from submitting particular person accidents and malfunctions to the MAUDE database.

To switch the ASR program, the FDA has launched the Voluntary Abstract Reporting Program. Greater than 5,600 system varieties — or 87% of them — are eligible for abstract reporting of system malfunctions, based on FDA data.

Affected person advocates say they worry that these will probably be simply as troublesome to tally and monitor as ASRs. For instance, a abstract report for 156 accidents would look like a single MAUDE report with a word that it represents 156 accidents, not one.

“Why would you finish one [hidden data program] simply to begin one other?” Radach requested.


To keep away from double-counting antagonistic occasions, KHN counted every occasion recognized with a novel report ID solely as soon as, until in any other case famous.

Though this is not the norm, some firms seem to have recycled report IDs, utilizing them for multiple occasion. Consequently, our counts could also be underestimated.

This text was reprinted from khn.org with permission from the Henry J. Kaiser Household Basis. Kaiser Well being Information, an editorially unbiased information service, is a program of the Kaiser Household Basis, a nonpartisan well being care coverage analysis group unaffiliated with Kaiser Permanente.