Experts are calling the way the FDA oversees device makers “flawed.”
I call it a FRAUD!
The agency has been HIDING reports of adverse events for DOZENS of risky medical devices…
And they’re only saying anything at all now because they’ve been EXPOSED by a SHOCKING new report.
I thought I’d heard it all when it comes to the feds… but this one takes the cake.
The FDA has announced that it’s “concerned” about the safety of just one of the types of devices that it’s given a pass to.
But what about all the others?
It’s time for the SECRECY to end.
And if we put enough pressure on them, those tight-lipped feds are going to sing like a bird.
The scam that’s kept you and your doc in the DARK
If you’ve ever used an office stapler, you know how frustrating it can be when it locks up and the staples get jammed inside.
Now, imagine that same malfunction happening to a surgeon in the operating room.
Surgical staplers are meant to cut and seal tissue or vessels… but they can MISFIRE.
When they do, they can sever a vein… or worse.
You could bleed to death – or if you’re lucky, you could just get sepsis or experience a recurrence of cancer.
Hear about the risk ahead of time, and you could opt for an alternative procedure.
But even your doc might not know how bad the risk is.
The FDA has granted medical device companies a special “exemption”…
For the last TWO DECADES, the agency has allowed “about 100” of them to SKIP reporting injuries and malfunctions on MAUDE , the Manufacturer and User Facility Device Experience.
Both doctors and patients rely on the information contained in this public database to make CRITICAL decisions regarding surgical procedures.
Instead, those reports have been filed in a “dark database” that NO ONE has access to!
Medical device makers were only REQUIRED to file incidents of patient deaths in MAUDE.
Anything else bad that happened was conveniently hidden from public view, thanks to this “alternative reporting.”
But now, a Kaiser Health News investigation has blown the lid off the whole sham…
And the feds are finally OWNING UP to the fact that such reporting-exemption programs EXIST… and that thousands of instances of malfunctions or harm occurred amidst this “information blackout.”
The paltry amount of information that HAD been divulged to the public constitutes just 0.01%of the total amount of harm that’s been done by these devices.
More than 32,000 malfunctions and more than 9,000 serious injuries from surgical staplers were SECRETLY reported — in just seven years!
The scariest part is that ANY device manufacturer can request an exemption from its reporting requirements…
And you’ll be NONE THE WISER.
It’s as though the FDA has just GIVEN AWAY any authority it has over the device industry!
And the companies reaping the biggest benefits are those that make the most controversial and riskiest devices.
It’s not just staplers and their staples… but also pelvic mesh… surgical robots… heartvalves… stents… and pacemakers.
You could submit a Freedom of Information Act request to learn about past incidents… but it could take up to two years to get a response.
If you’re looking at going under the knife, you may not have the luxury of waiting two years.
We now know that SOME of the risk in surgical staplers comes from operator error…
So, ask your doc IF a stapler will be used, WHO will be using it, and whether they’ve been FULLY trained to use it.
But don’t let the FDA – or device makers – off the hook that easily.
When the agency issues a new draft guidance for manufacturers of surgical staplers and staples for internal use later this year, you’ll have the chance to comment as a member of the public.
Give them the business… and give it to them good.