I’ve been warning you for years about the serious dangers associated with endoscopes—the medical devices used to perform procedures, like colonoscopies, that examine the inside of the gastro-intestinal (GI) tract.
We now know these devices can spread harmful bacteria from one patient to the next. In fact, even when staff follow proper sanitation procedures, endoscopes can still harbor bacteria. Some believe the devices’ flawed design makes them impossible to properly sterilize.
In 2015, the Food and Drug administration (FDA) ordered the makers of these devices to conduct post-market surveillance studies to crack down on the spread of bacteria.
But instead of this step resolving the problem, it’s only gotten worse!
So, I’ll tell you all about some much safer, effective options for monitoring your GI health in a moment. But first, let’s back up and examine the endoscope problems more closely…
Like a bad penny, problems keep turning up
An endoscope is the general term for a tube-like medical device that’s inserted into the GI tract. Colonoscopies use a type of endoscope called a colonoscope, which enters the body through the anus to screen for colon cancer, polyps, and other problems in the lower GI tract.
Of all the endoscopes used in clinical practice, colonoscopes pose the greatest danger (population attributable risk) because they’re used in 15 million “routine” colonoscopies each year in the U.S.
Yet, there’s much more in the national news about problems with duodenoscopes—a less-commonly used type of endoscope that’s threaded down the throat, through the stomach, and into the small intestine. They’re sometimes used to remove gallstones, heal pancreatitis, and drain bile ducts, among other things.
But problems with these devices keep turning up…
Contamination rate increasing, not decreasing
As I mentioned a moment ago, in 2015, the FDA ordered Japanese manufacturers Fuji, Olympus, and Pentax to begin conducting post-marketing studies following the purchase and use of their duodenoscopes.
The FDA’s initial report on these post-marketing studies, released in December 2018, showed their duodenoscopes had a contamination rate of 3 percent for high-concern, antibiotic-resistant microbes, such as E. coli and Staphylococcus.
Then a second report in March 2019 showed a contamination rate of 5.4 percent for these high-concern microbes. Plus, an additional 3.6 percent of samples tested for the presence of microbes considered to be “low-to-moderate concern.” So, the total contamination rate was 9 percent.
Meanwhile, the FDA was expecting to see a total contamination rate as close to zero as possible…and no higher than 1 percent. Clearly we are nowhere near seeing a contamination rate close to zero. And the contamination rate is going in the wrong direction!
In response to these reports, the FDA sent letters to all three manufacturers warning of their failure to achieve this goal. The agency is also working with the manufacturers to redesign the endoscopes to reduce contamination risk, including developing devices that can be fully sterilized, instead of just cleaned and “processed.” They’re also looking at the possible development of disposable scopes.
FDA fails to approve safer options
In my view, the FDA’s actions still fall short. They should have pulled these dangerous devices off the market long ago!
Not to mention, these post-marketing surveillance studies are focused on duodenoscopes. When, in my view, the “scope” of the problem could be much larger, especially if the FDA were to start looking more closely at contaminated colonoscopes.
Plus, with all these growing problems with endoscopes, why hasn’t the agency approved the routine use of the “camera pill,” a much safer device that’s swallowed and looks at the entire GI tract?
The FDA has only approved the camera pill for use after an endoscopic examination has revealed a finding…quite possibly making it the only instance on record where the FDA and doctors don’t want you to just swallow another pill!
Of course, there’s no telling if or when the FDA will approve the camera pill for routine use. But there are still many other affordable, safe, and effective alternatives to screening for colon cancer, including the non-invasive colon cancer screening test called Cologuard.
This safe, effective test has some real, practical advantages over dangerous and costly colonoscopies. (I should also mention all the studies showing that ancient botanical remedies are effective against the dangerous types of bacteria, which cause contamination, even when antibiotics fail, as I often report.)
In fact, the U.S. Preventive Services Task Force now recommends that people older than 70 years no longer get a “routine” colonoscopy. Which makes a lot of sense when you consider it takes 15 years on average for colon cancer to develop, even if a “pre-cancerous” polyp is found in a routine colonoscopy.
Plus, there’s now growing concern that invasive colonoscopies (and the stringent and disruptive GI “preparation”) disturb the health of your GI microbiome—the environment in your GI tract where trillions of healthy bacteria thrive. The GI microbiome plays an important role in supporting your brain and cognition, digestion, metabolism, immune system, and neurological system.
In the end, I suggest you avoid these problematic endoscopes whenever possible. I remember a time when the words “Made in Japan” caused concern when they appeared on a product. Consumers knew to exercise due caution.
And in the case of these potentially “lethal” Japanese endoscopes, caution is most definitely still required. It can be a matter of life and death.
P.S. I discussed the fatal side effects of colonoscopies and five safe, effective alternatives in the April 2018 issue of my monthly newsletter, Insiders’ Cures (“URGENT UPDATE: Research reveals even MORE deadly risks and complications of colonoscopies”). Subscribers have access to this issue and all of my past issues. So if you haven’t already, click here to sign up today!
“Duodenoscope contamination rates still lethally high: FDA.” Medscape, 4/12/19. (medscape.com/viewarticle/911756)