Posted on 03/13/2019 10:43:22 AM PDT by E. Pluribus Unum
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.
Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.
“I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.
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.
Deaths must still be reported in MAUDE. But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to improve circulation and mechanical breathing machines.
An FDA official said that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in...
(Excerpt) Read more at khn.org ...
Like everything else in modern society — some folks are expected to follow the rules and pay the price when they screw up — and some people get a special deal and are allowed to screw up and never pay a price.
Well why not! I mean every other agency of our Federal Government is f*cked up!
You cannot trust any of it!
Hmmm, I am often amazed at how many surgeons I have witnessed blame their screw ups on other things. Not saying devices do not malfunction, they do. I am saying, however, that so do surgeons. The question becomes how does the FDA sort it out.
We need a public database of FDA and CDC failures, decisions made on fake science, suspected influence peddling, whistle blowers, revolving jobs, etc.
American Lobbyists can get anything done. Just pass along enough $$$ and Congress and Government agencies are worst than a crack prostitute.
“Well why not! I mean every other agency of our Federal Government is f*cked up!
You cannot trust any of it!”
Years ago in my naive 20s, I’d have labeled those statements as delusions of a paranoid.
Now, I cannot think of a single government agency that I actually respect. (The military excepted, but for how long?)
Need to feed this to as many Senators and Congressmen as possible.
Also, challenge MSM to dig in!
Not unexpected - when the government effectively nationalized healthcare with Obamacare the government because the effective manager of medical device manufacturers as well - as the government is now in bed with the manufacturers it has to protect their appearance.
Much as the FAA does with Boeing today but with an even tighter relationship.
This list was in use long before Obamacare.
My guess is that, if the data was public, the companies would not volunteer to report.
“Now, I cannot think of a single government agency that I actually respect. (The military excepted, but for how long?)”
But after just reading another post about the collisions of our Navy’s destroyers with commercial traffic, I would start the process of “vacating your military exception” post haste! And ALL OF IT has to be directed in the series of really worthless Presidents we’ve had since RR ( and unfortunately prior to his presidency as well). We really have had ONLY ONE PRESIDENT IN MY LIFETIME, and that man is DJT. And until he came along, I must admit, with a few exceptions, I didn’t think unkindly about most of them. They have all been “the man behind the curtain”!
FDA doesn’t sort out surgeons. That’s the job of State Medical Boards.
Right - but that was when the FDA was serving it’s purpose and tracking device defects - that’s why, AFTER Obamacare, there’s incentive to bury the defects.
“We need to know the good and the bad,” said Margolis, who treats patients in his urogynecology practice. “If you’re trying to hide complications from me, well that’s … wrong, my God, it’s heinous.”
This is why it's a good basic rule to stay away from meds and procedures as much as practical. If even the best and most diligent doctors have no idea of risks because they are denied knowledge within their own information loop, then their trusted advice is compromised from the outset.
The medical establishment is yet another system that needs to be busted down to the foundation and rebuilt from a new, transparent cornerstone.
Yes but this is even worse. This hides that the perpetrator of the injury is the manufacturer/government alliance and turns it into a legal battle between the two victims.
But vaccines are 100% foolproof and safe...
Huh? Even the biggest vaccine supporters never say that.
The FDA has a revolving door situation much like the DOD does. It is corrupt beyond reason.
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