Scary news for men with heart pumps, implants, and other medical devices
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Is the FDA hiding medical device failures?
I was researching the process for how medical devices get approved and I stumbled across some appalling information.
And I knew I had to share it with you right away.
It turns out that the processes you think medical devices might go through for approval are largely non-existent…
And reports that doctors make about failures are mostly hidden.
This is absolutely bonkers.
We assume medical devices are safe.
Most people assume that the medical devices that are implanted into or used on their bodies are safe.
This could be mesh for a hernia, rods and pins for a broken leg, and or even a stapler used in surgery.
But there are some mind-blowing problems in the United States with how medical devices are approved and how problems with them are reported.
“Substantially equivalent” devices are fast-tracked.
The first problem with the way medical devices are dealt with in the US is that most of them are “fast tracked”…
That means they don’t get any clinical trials.
Until the 1970s, there were no regulations at all on medical devices.
But some bad outcomes changed that.
“For most of the last century, medical devices were not regulated in the US. But a series of high-profile safety problems in the 1970s – including deaths, miscarriages, and injuries caused by a contraceptive implant – pushed Congress to intervene.”
“The laws that resulted are both more complex and less demanding than those governing drugs.”
However, the laws aren’t particularly adequate because most medical devices can get approved without objective data that they actually work.
“To win FDA approval, for example, most new prescription drugs undergo two large, rigorous clinical studies proving they benefit patients. But most new medical devices enter the market with no clinical trial testing.”
Only “high risk” devices such as heart pumps have to demonstrate safety and effectiveness in humans.
Everything else relies on being “substantially equivalent” to a product already on the market for approval.
That means most medical devices have very minimal testing in the US – even if they are designed to go into human bodies.
So that mesh for your hernia repair? It might have never seen a human trial before being deployed in surgery.
But wait… It gets even worse.
When things go wrong – hidden databases…
And if that isn’t bad enough… When medical device problems are reported, the info goes into HIDDEN databases.
And these are not accessible to most doctors.
One doctor discovered this when he was looking for information on a surgical stapler that failed during one of his surgeries.
“Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.”
“Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and ‘there was nothing,’ he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.”
It turns out that nearly any manufacturer of medical devices can ask for reports to go into “alternative summary reporting” – and those aren’t public.
“The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. Since 2016, at least 1.1 million incidents have flowed into the internal ‘alternative summary reporting’ repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.”
That means that the devices used in surgery and in our bodies often have less real review data behind them than a water bottle you buy on Amazon.
When it comes to medical devices, it’s buyer beware.
This is absolutely stunning information. Unfortunately, it’s also true.
Before you allow something to be implanted in your body, do your best research on the product.
Personally, I would even look for online forums to find out what is being said, since so many official bad reports can stay hidden from public view.
Are they permanently silencing health researchers for finding cures?
Well-known health researchers who have discovered cures to cancer, autism, and other terrible diseases are showing up dead under very mysterious circumstances…
These doctors’ families are claiming foul play… and there are many unanswered questions…
Is Big Pharma really this desperate to keep their profits up and their influence high?
… enough to censor these doctors and health researchers, PERMANENTLY?