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It’s been about two years since I wrote here about the coverup that puts flawed and dangerous medical devices into the hands of doctors without their knowledge.
We’re talking about knee and hip replacements, pacemakers… you name it.
They end up in YOUR body, only to fail later and cause pain, inconvenience, even death.
Things have been kind of quiet lately, but a recent report has uncovered something disturbing.
Not only are those flawed medical devices being placed in your body, but when they do cause death, that death is often not reported.
Device manufacturers are succeeding more and more at hiding these reports of death in a system designed to protect them, instead of YOU.
A brief history of a coverup
While it’s mandatory that companies report deaths associated with their devices, reporting any other negative outcomes is strictly voluntary.
And just how many device manufacturers do you suppose are anxious to have it known that their product is unsafe?
Between 2016 and 2019 alone, more than 1.1 million incidents have fallen through a loophole that protects device manufacturers but makes these reports inaccessible to either doctors or their patients.
Reporting deaths, however, is mandatory. So that makes us all feel better and safer… right?
Not by a long shot.
Now, death is being hidden
The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database is where adverse events involving medical devices are reported and categorized.
Physicians and manufacturers who report adverse events must choose whether to classify the event as a malfunction, injury, death, or “other.”
Per FDA rules, even if the device may have played a part in the death, they must categorize the event as a “death”.
The correct categorization of adverse events is vital since those categorized as “deaths” must be reviewed by the FDA, and because frequent reports of death involving a particular device could prompt an investigation into the device’s safety.
But, as Dr. Christina Lalani of the Department of Medicine at University of California San Francisco says, “It may not be in their interest to facilitate identification of serious problems with their own devices in a timely manner.”
In other words, there’s a coverup going on, only this time it involves covering up deaths.
In a study last year, Dr. Lalani and her colleagues found that nearly a quarter of reports involving a death (23 percent) were not placed in the “death” category.
About 31,552 reports filed from December 31,1991 to April 30, 2020 were miscategorized in this way.
That’s a lot of medical devices that perhaps should have been investigated that weren’t.
How to protect yourself
It’s clear that the coverup goes even deeper than we knew. Still, there are proactive steps you can and should take before you or a loved one has surgery that might involve the placement of a medical device of any sort:
Talk to your doctor. Find out what he or she knows about the device.
Be informed. Make sure you know about all the possible adverse reactions to your device, as well as any restrictions or cautions you should be aware of while using it.
Keep track of how you feel. If you are carrying a medical device in your body or have had one used on you during surgery or other procedures, keep careful track of how you felt before, during and after the procedure.
Talk to people. Do you know anyone who’s had a similar procedure with your device? Talk to them and find out what they’ve experienced. Online groups can also offer insight into other people’s experiences.
Avoid elective surgeries. Unless you will be terribly unhappy through life, elective surgeries, especially cosmetic procedures, could expose you to more risk than they are worth.
Consider non-surgical options. Talk to your doctor about other options. Some conditions can be relieved through other means including physical therapy, medication and lifestyle. In 2019 a major $100-million dollar study found that in people with stable coronary artery disease, procedures including stents and bypass surgery were no more effective than medications and adherence to a healthy lifestyle.
If surgery is unavoidable, check your surgeon’s qualifications and evaluate the facility where the surgery will take place as well.
The more proactive you are, the less chance that you or a loved one will fall victim to this coverup.
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More Medical Device Deaths Than We Previously Thought? — Medpage Today
Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices — Kaiser Health News