FDA’s oversight of patient harm from FAULTY medical devices comes up short
Investigation BLOWS THE LID off FDA’s weak regulation of medical devices
“First, do no harm.”
We’ve all HEARD those words as it relates to our medical system…
But how often to the folks in charge… the hospital admins, the docs, and even the feds… actually FOLLOW that oath?
Makes me wonder if anybody is paying attention to this creed at all…
Because too many patients are getting HURT… way too often.
And as it turns out, it’s happening even MORE than we thought – because the cat’s finally out of the bag.
The medical mainstream may have wanted to keep incidences of patient harm as HUSH-HUSH as possible…
But the TRUE goings-on have been EXPOSED… thanks to court records and government docs that have been THRUST into the public spotlight.
I’ve shared with you before about the INCOMPETENCE surrounding docs and care settings… including the medical errors that are KILLING patients.
Well, the latest news has to do with medical devices – and how the feds are as USELESS as a chocolate teapot!
According to a STUNNING report from KFF Health News, everything from artificial joints to heart pumps are implicated in BOTCH JOBS left and right!
Knee replacements are wearing out prematurely…
Metal hip implants are breaking like twigs…
Ventilators are going on the fritz…
And dental devices are DESTROYING teeth and jawbones.
That could leave you in CRIPPLING agony… GASPING for air… or worse.
It’s happening SO MUCH… the FDA can’t even TRACK all of the failures, injuries, and deaths.
And according to this latest investigation, federal oversight is DEEPLY FLAWED.
We might not even have known the extent of the harm associated with these medical devices, were it not for the lawsuits on the books.
And you can imagine how many situations there are in which a patient doesn’t have the resources to lawyer up… or file a case with the courts.
Especially the dead patients.
Imagine getting hooked up to an insulin pump… and then suffering through a MALFUNCTION…
In which it delivers TOO MUCH insulin… or TOO LITTLE.
Either way, it’s a life-threatening situation… one you’d think would NEVER happen with the kind of approvals a medical device must have to go through before it hits the market.
But that’s EXACTLY the problem, friend…
Because there’s a little-known loophole that allows UNTESTED devices to slip PAST the regulatory process…
And take a SHORTCUT to get them STRAIGHT to patients.
All their maker has to do is prove that the gadget is substantially SIMILAR to one that’s already available.
That means a new device may have gone through ZERO clinical trials to prove that it works… and, more importantly, that it’s safe.
And that puts YOU in the position of guinea pig.
Once ENOUGH patients in the real world get hurt by the darn thing… the maker just might issue a recall.
But for some, it’ll be too little… too late…
Especially if the manufacturer KNOWS about a product malfunction… and WAITS to act on it.
Even the feds admit that they don’t know how many serious adverse events are actually happening out there… because not everybody reports them.
But based on the KFF Health News investigation… the even the underreported numbers are ALARMINGLY high…
And only getting higher… with the reports received by the FDA in 2022 inching towards 3 million… which is nearly TRIPLE the number of reports received in 2018.
If you’re about to receive any kind of implant… or use any other kind of medical device… do your research.
Find out the device’s model name and manufacturer… how long it’s been on the market… and whether it’s been subject to any prior recalls.
You can look up any reports of adverse events in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database…
But keep in mind that there’s usually a significant LAG between the time the harm occurs… and when the feds actually RECEIVE the report.
And if you’re the one who gets hurt by a device… and I pray you NEVER do… don’t let its maker get away with it.
File that report… hire a lawyer… and FULLY explore your legal options.
In pursuit of the truth,
Dr. Marc S. Micozzi, M.D., Ph.D.
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