The Medical Device Industry is the Wild West (And That Should Scare All of Us)
At the end of last year, the U.S. Government Accountability office… our federal watchdog… issued a scathing report about the medical device industry.
You didn’t see it. And, trust me, you weren’t supposed to see it.
It dropped around the holidays… when no one would be paying attention.
But it confirmed what many of us have feared all along…
The medical device industry in America has become the Wild West.
The Food and Drug Administration is incapable of policing it. It’s basically making its own rules.
Good people are being harmed… and even dying… as a result.
The results of the report are horrifying.
But you paid for this report and you deserve to know about it, so you can make the best health decisions for yourself and the people you care about.
“Charles” was a police dispatcher from Alabama who had been living with type 1 diabetes for years.
Then, in 2020, his insulin pump reportedly malfunctioned – delivering an extremely high dose that killed him.
“Gary” a firefighter from Connecticut, was given an artificial knee known to fail prematurely and fragment. After multiple surgeries and infections, he was left permanently disabled.
Now, I know what you’re thinking – we’re supposed to have a government oversight system that prevents these types of things from happening.
Well, apparently we haven’t for a long, long time. At least, that’s the main takeaway from this new GAO report.
The report found that the FDA has not demanded a single medical device be pulled from the market since 1992.
We’ve had seven presidential administrations since that time… and now 10 Winter Olympics.
But not a single FDA-mandated recall, even as the injuries and bodies piled up.
In fact, there were nearly 4,000 medical device recalls from 2020-2024, and every single one of them was initiated by the manufacturer.
Nobody makes them do it. They issue the recalls when and if they feel like it – and if they don’t, they know the FDA isn’t going to do anything.
That’s like having a police force that doesn’t arrest anyone – but relies on criminals to turn themselves in.
And when those recalls are announced, the FDA doesn’t really make sure they happened – not in a timely fashion, anyway.
After manufacturers tell the FDA they completed a recall, the FDA is supposed to double check within 90 days that it was done properly. Instead, it takes them, on average, two and a half years.
So, yes, you could fake a recall… or do a really shoddy job… and it might be years before anyone catches on.
Like I said, this is the Wild West. When you get a medical device, whether it’s an artificial knee, a pacemaker, or a C-PAP machine, you are riding into a town with no sheriff.
I’m certainly hoping the current presidential administration cleans this mess up. But, for now, it’s up to you to keep yourself safe.
For any medical device that a doctor wants to give to you or put in your body, do your homework. Ask for the specific brand name. Look online for lawsuits, groups where people are sharing their experiences, and anything else that will give you the lay of the land.
And keep reading your HSI eletter. Because when this industry gets up to no good, we’re going to expose the truth and hold everyone accountable.
In Your Corner,
Dr. Allan Spreen
In Case You Missed It
Sources:
- Mar E. (2025, July 10). Private firm uses bankruptcy to dodge lawsuits. MyMountainMover. https://mymountainmover.com/private-firm-uses-bankruptcy-to-dodge-lawsuits/
- ProPublica. (2025, January). FDA rarely forces companies to recall defective devices: GAO report. https://www.propublica.org/article/fda-defective-device-recalls-gao-report
- Schulte, F., & Hacker, H. K. (2023, December 21). Deep flaws in FDA oversight of medical devices, and patient harm, exposed in lawsuits and records. KFF Health News. https://kffhealthnews.org/news/article/medical-device-malfunction-fda-oversight-patient-harm/
- U.S. Government Accountability Office. (2025, December 8). Medical device recalls: HHS and FDA should address limitations in oversight of recall process (GAO-26-107619). https://files.gao.gov/reports/GAO-26-107619/index.html
