Sham surgery experiments have shown that some of our most popular surgeries are themselves shams.
Gastric balloons “came into vogue in the 1980s,” as they could be inserted into the stomach and filled with air or water to fill a large area. Unfortunately, surgical devices are often brought to market before there is sufficient evidence of efficacy and safety, and balloons are no exception.
“Stomach foam” bubbled and burst when a study at the Mayo Clinic found that 8 out of 10 balloons “dissolve spontaneously,” which can be dangerous because they can travel to the intestines and cause complications, as you can see below and at 0:40 in my video. Is Gastric Balloon Surgery Safe and Effective for Weight Loss?.
However, before the balloons dissolved, they appeared to cause gastric erosions in some patients, damaging the lining of their stomachs. The kicker is that, in terms of weight loss, they didn’t work compared to diet and other behavior modification techniques. Eventually, intragastric balloons were taken off the market. But now, the balloons are back.
After a 33-year hiatus, the US Food and Drug Administration began approving a large number of intragastric balloons in 2015, which quickly led to the placement of more than 5,000 devices. At that time, the Sunshine Law had passed. It has forced drug companies and the surgical and medical device industry to disclose any payments made to doctors, shining a light on germs in the caverns of industry. By now, most people are aware of the cozy financial relationships that doctors can have with Big Pharma, but few realize that surgeons can receive payments from the device companies they use. The top 100 recipients of industry payouts earned an incredible 12 million dollars from device companies in one year. Yet annoyingly, when they published the papers, only a few disclosed the obvious conflict of interest.
The advantage of balloons over most types of bariatric surgery is that they are reversible, but that doesn’t mean they are dangerous. The FDA has issued a series of advisories about risks, including death. But how can a person get their stomach pierced with a smooth and round object? With that smooth, round thing that causes the patient to vomit so much that he bursts his stomach and dies. Nausea and excessive vomiting are “common side effects,” affecting most of those who have had balloons inserted inside them. Persistent vomiting likely explains life-threatening nutrient deficiencies after balloon insertion.
Some problems, such as intestinal obstruction, are caused by balloons that burst, but others, ironically, are caused by balloons that simply overinflate, causing pain, vomiting, and abdominal swelling, as you can see below and at 2:45 in mine. video.
This problem was first noticed in breast implants, as documented in reports such as “The Phenomenon of the Spontaneously Autoinflating Breast Implant.” In no time, tumors can begin to grow, increasing the volume of the breasts by more than 50%. “It remains an underreported and poorly understood condition,” noted one review. (Interestingly, breast implants were actually used as the first experimental intragastric balloons that failed.)
As with any medical decision, however, it’s all about risks and benefits. Industry-sponsored trials show “significant weight loss,” but it’s hard to reverse the ballooning effect itself from the “supervised diet and lifestyle changes” described in the studies. In drug trials, you can make research participants not choose sugar pills, but how do you eliminate the placebo effect of doing the procedure? Perform sham surgery.
In 2002, a study was published in liver e New England Journal of Medicine. A common orthopedic surgery—arthroscopic knee surgery—was evaluated. Billions of dollars are spent on attaching scopes to knee joints and severing damaged tissue from osteoarthritis and knee injuries, but does it really work? People suffering from knee pain were randomized to receive real surgery versus sham surgery, in which surgeons cut into people’s knees and pretended to perform the procedure—even injecting saline—without treating the joint.
The trial caused quite a stir. How is it possible for anyone to randomize people to be open to fake surgery? Professional medical organizations questioned the ethics of the surgeons and the “purity” of the patients who agreed to be part of the trial. Guess what happened? The surgery patients improved, but so did the placebo patients, as you can see below and at 4:42 in mine. video.
The operation had no real effect. Currently, rotator cuff shoulder surgery faces a similar confidence issue.
When intragastric balloons were tested, randomized controlled trials showed that both the old and new devices sometimes failed to provide any weight loss benefit. Even when they work, the weight loss may be temporary because the balloons are only allowed to stay up for six months (at which point the risk of inflation becomes greater). Why can’t you keep adding new ones? That has been tried; failed to improve long-term weight loss outcomes. A sham-controlled trial has shown that any ballooning effects on hunger and satiety may wear off over time, perhaps as your body adjusts to the new normal.
What our fake surgery test has shown us is that some of our most popular surgeries are themselves scams. Doctors like to pride themselves on being men and women of science. For example, we rightfully vilify the anti-vaccination movement. Many of us in medicine have been troubled by the political trend where people “choose their own truths.” But when I read that some of these popular surgeries are not only useless but can actually make things worse (for example, increasing the risk of going to a knee replacement), I can’t help but think that we are not immune to our versions of fake news and other facts.
Doctor’s Note
Next in this two-part series Extreme Weight Loss Devices.
To find out more about bariatric surgery, see the related posts below.
My book How not to eat focuses only on sustainable weight loss. Borrow it from your local library or pick up a copy from your favorite bookseller. (All proceeds from my books are donated to charities.)
