Sham surgery trials have shown us that some of our most popular surgeries are themselves shams.
Is Gastric Balloon Surgery Safe and Effective for Weight Loss?
4.6/5 - (41 votes)
Below is an approximation of this video’s audio content. To see any graphs, charts, graphics, images, and quotes to which Dr. Greger may be referring, watch the above video.
“Intragastric balloons” arrived with much fanfare in the 1980s––balloons that could be implanted into the stomach and inflated with air or water to fill up much of the space. Sadly, surgical devices are often brought to the market before there is adequate evidence of safety and effectiveness, and the balloons were no exception.
The “Gastric Bubble” had its bubble burst when a study at the Mayo Clinic found that 8 out of 10 balloons spontaneously deflated (which is potentially dangerous, as they could pass into the intestines and cause an obstruction), but not before causing gastric erosions in half the patients, damaging the stomach lining. The kicker is that in terms of inducing weight loss, it didn’t even work. Eventually, it was pulled from the market, but now, balloons are back.
After a 33-year hiatus, the FDA started approving a new slew of intragastric balloons in 2015, immediately resulting in more than 5,000 placements. By then, the Sunshine Act passed, which forced drug companies and the surgical and medical device industry to disclose any payments they were making to physicians to shine a disinfecting light on industry enticements. By now, most people know about the overly cozy financial relationships doctors can have with Big Pharma, but fewer may realize that surgeons can also get payments from the companies for the devices they use. The 100 top recipients of industry payments received an unbelievable 12 million dollars from device companies in a single year. Yet outrageously, when they published papers, only a minority disclosed the blatant conflict of interest.
The benefit of balloons over most types of bariatric surgery is that they’re reversible, but that doesn’t mean they’re benign. The FDA has released a series of advisories about the risks that include patient deaths. Wait. How could someone suffer a stomach perforation with a smooth rounded object? By causing the patient to puke so much they rupture their stomach and die. That’s how. Nausea and vomiting are unsurprisingly very common side effects, affecting the majority of those who have balloons placed inside of them. Persistent vomiting likely also explains cases of life-threatening nutrient deficiencies after balloon implantation.
Some complications, such as bowel obstruction, are due to the balloon deflating, but others, oddly enough, are due to the balloons suddenly overinflating, causing pain, vomiting, and abdominal distention. This was first noticed in breast implants, as documented in reports such as “The phenomenon of the spontaneously auto-inflating breast implant.” Out of nowhere, the implants just start growing, increasing breast volume by an average of more than 50 percent. “[I]t remains,” one review noted, “an underreported and poorly understood phenomenon.” (Interestingly, breast implants were actually used as some of the first failed experimental intragastric balloons.)
As with any medical decision, though, it’s all about risks versus benefits. Industry-funded trials display notable weight loss, but it’s hard to tease out the effect of the balloon alone from the accompanying supervised diet and lifestyle changes prescribed along with them in the studies. In drug trials, you can randomize subjects to sugar pills, but how do you eliminate the placebo effect of undergoing a procedure? Perform sham surgery.
In 2002, a courageous study was published in the New England Journal of Medicine. The most common orthopedic surgery—arthroscopic surgery of the knee—was put to the test. Billions of dollars are spent sticking scopes into knee joints, and cutting away damaged tissue in osteoarthritis and knee injuries. But does it actually work? Knee pain sufferers were randomized to get the actual surgery versus a sham surgery in which they actually sliced into people’s knees and pretended to perform the procedure, complete with splashing saline, but never actually did anything within the joint.
The trial caused an uproar. How could you randomize people to get cut open for fake surgery? Professional medical associations questioned the ethics of the surgeons as well as the sanity of the patients who agreed to be part of the trial. But guess…what…happened? Sure, the surgical patients got better, but so did the placebo patients. The surgeries had no actual effect. Currently, rotator cuff shoulder surgery is facing the same crisis of confidence.
When intragastric balloons were put to the test, sham-controlled trials show both older…and newer devices sometimes fail to offer any weight loss benefit. Even when they do work, the weight loss may be temporary because balloons are only allowed to stay in for six months (at which point the deflation risk gets too great). Why can’t you keep putting new ones in? That’s been tried, and failed to improve long-term weight outcomes. A sham-controlled trial showed that any effects of the balloon on appetite and satiety may vanish with time, perhaps as your body gets used to the new normal.
What sham surgery trials have shown us is that some of our most popular surgeries are themselves shams. Doctors like to pride themselves on being men and women of science. We rightly rail, for example, against the anti-vaccination movement. Many of us in medicine have been troubled by the political trend of people “choosing their own facts.” But when I read that some of these still-popular surgeries are not only useless but may actually make things worse (for example, increasing the risk of progression to a total knee replacement), I can’t help but think we are hardly immune to our own versions of fake news and alternative facts.
Please consider volunteering to help out on the site.
- Vittal H, Raju GS. Endoscopic bubble: Can it bust the obesity bubble? Gastroenterology. 2005;129(3):1130-2.
- Ross S, Robert M, Harvey M-A, et al. Ethical issues associated with the introduction of new surgical devices, or just because we can, doesn’t mean we should. J Obstet Gynaecol Can. 2008;30(6):508-13.
- Lindor KD, Hughes RW, Ilstrup DM, Jensen MD. Intragastric balloons in comparison with standard therapy for obesity--a randomized, double-blind trial. Mayo Clin Proc. 1987;62(11):992-6.
- Twardzik M, Wiewiora M, Glück M, Piecuch J. Mechanical intestinal obstruction caused by displacement of a stomach balloon - case report. Wideochir Inne Tech Maloinwazyjne. 2018;13(2):278-81.
- Benjamin SB, Maher KA, Cattau EL, et al. Double-blind controlled trial of the Garren-Edwards gastric bubble: an adjunctive treatment for exogenous obesity. Gastroenterology. 1988;95(3):581-8.
- Tate CM, Geliebter A. Intragastric balloon treatment for obesity: review of recent studies. Adv Ther. 2017;34(8):1859-75.
- English WJ, DeMaria EJ, Brethauer SA, Mattar SG, Rosenthal RJ, Morton JM. American Society for Metabolic and Bariatric Surgery estimation of metabolic and bariatric procedures performed in the United States in 2016. Surg Obes Relat Dis. 2018;14(3):259-63.
- Garstka ME, Monlezun D, DuCoin C, Killackey M, Kandil E. The sunshine act and surgeons: a nation-wide analysis of industry payments to physicians. J Surg Res. 2019;233:41-9.
- Camp MW, Mattingly DA, Gross AE, Nousiainen MT, Alman BA, McKneally MF. Patients’ views on surgeons’ financial conflicts of interest. J Bone Joint Surg Am. 2013;95(2):e9.1-8.
- Ziai K, Pigazzi A, Smith BR, et al. Association of compensation from the surgical and medical device industry to physicians and self-declared conflict of interest. JAMA Surg. 2018;153(11):997-1002.
- UPDATE: Potential risks with liquid-filled intragastric balloons - Letter to Health Care Providers. FDA. August 10, 2017.
- Ashrafian H, Monnich M, Braby TS, Smellie J, Bonanomi G, Efthimiou E. Intragastric balloon outcomes in super-obesity: a 16-year city center hospital series. Surg Obes Relat Dis. 2018;14(11):1691-9.
- Trang J, Lee SS, Miller A, et al. Incidence of nausea and vomiting after intragastric balloon placement in bariatric patients - A systematic review and meta-analysis. Int J Surg. 2018;57:22-9.
- Saunders KH, Igel LI, Saumoy M, Sharaiha RZ, Aronne LJ. Devices and endoscopic bariatric therapies for obesity. Curr Obes Rep. 2018;7(2):162-71.
- de Quadros LG, Dos Passos Galvão Neto M, Grecco E, et al. Intragastric balloon hyperinsufflation as a cause of acute obstructive abdomen. ACG Case Rep J. 2018;5:e69.
- Landon J, DiGregorio V. The Phenomenon of the Spontaneously Autoinflating Breast Implant. NESPS 31st Annual Meeting. 2014.
- Robinson OG, Benos DJ, Mazzochi C. Spontaneous autoinflation of saline mammary implants: further studies. Aesthet Surg J. 2005;25(6):582-6.
- Hogan RB, Johnston JH, Long BW, et al. A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity. Gastrointest Endosc. 1989;35(5):381-5.
- Ali MR, Moustarah F, Kim JJ, American Society for Metabolic and Bariatric Surgery Clinical Issues Committee. American society for metabolic and bariatric surgery position statement on intragastric balloon therapy endorsed by the society of american gastrointestinal and endoscopic surgeons. Surg Obes Relat Dis. 2016;12(3):462-7.
- Moseley JB, O’Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002;347(2):81-8.
- Maffulli N. We are operating too much. J Orthop Traumatol. 2017;18(4):289-92.
- McCormack RG, Hutchinson MR. Rocking the shoulder surgeon’s world. Br J Sports Med. 2017;51(24):1727.
- Martinez-Brocca MA, Belda O, Parejo J, et al. Intragastric balloon-induced satiety is not mediated by modification in fasting or postprandial plasma ghrelin levels in morbid obesity. Obes Surg. 2007;17(5):649-57.
- Genco A, Cipriano M, Bacci V, et al. BioEnterics Intragastric Balloon (Bib): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients. Int J Obes (Lond). 2006;30(1):129-33.
- Dumonceau J-M, François E, Hittelet A, Mehdi AI, Barea M, Deviere J. Single vs repeated treatment with the intragastric balloon: a 5-year weight loss study. Obes Surg. 2010;20(6):692-7.
- Orchard J, Moen MH. Has reimbursement for knee osteoarthritis treatments now reached “postfact” status? Br J Sports Med. 2017;51(21):1510-1.
- Thorlund JB. Deconstructing a popular myth: why knee arthroscopy is no better than placebo surgery for degenerative meniscal tears. Br J Sports Med. 2017;51(22):1630-1.
- Rongen JJ, Rovers MM, van Tienen TG, Buma P, Hannink G. Increased risk for knee replacement surgery after arthroscopic surgery for degenerative meniscal tears: a multi-center longitudinal observational study using data from the osteoarthritis initiative. Osteoarthritis Cartilage. 2017;25(1):23-9.
- Milone M, Scarano V, Di Minno MN, Lupoli R, Milone F, Musella M. Rapid onset of Wernicke's syndrome after gastric balloon positioning. Eur J Clin Nutr. 2012;66(8):971.
Video production by Glass Entertainment
Motion graphics by Avo Media
Below is an approximation of this video’s audio content. To see any graphs, charts, graphics, images, and quotes to which Dr. Greger may be referring, watch the above video.
“Intragastric balloons” arrived with much fanfare in the 1980s––balloons that could be implanted into the stomach and inflated with air or water to fill up much of the space. Sadly, surgical devices are often brought to the market before there is adequate evidence of safety and effectiveness, and the balloons were no exception.
The “Gastric Bubble” had its bubble burst when a study at the Mayo Clinic found that 8 out of 10 balloons spontaneously deflated (which is potentially dangerous, as they could pass into the intestines and cause an obstruction), but not before causing gastric erosions in half the patients, damaging the stomach lining. The kicker is that in terms of inducing weight loss, it didn’t even work. Eventually, it was pulled from the market, but now, balloons are back.
After a 33-year hiatus, the FDA started approving a new slew of intragastric balloons in 2015, immediately resulting in more than 5,000 placements. By then, the Sunshine Act passed, which forced drug companies and the surgical and medical device industry to disclose any payments they were making to physicians to shine a disinfecting light on industry enticements. By now, most people know about the overly cozy financial relationships doctors can have with Big Pharma, but fewer may realize that surgeons can also get payments from the companies for the devices they use. The 100 top recipients of industry payments received an unbelievable 12 million dollars from device companies in a single year. Yet outrageously, when they published papers, only a minority disclosed the blatant conflict of interest.
The benefit of balloons over most types of bariatric surgery is that they’re reversible, but that doesn’t mean they’re benign. The FDA has released a series of advisories about the risks that include patient deaths. Wait. How could someone suffer a stomach perforation with a smooth rounded object? By causing the patient to puke so much they rupture their stomach and die. That’s how. Nausea and vomiting are unsurprisingly very common side effects, affecting the majority of those who have balloons placed inside of them. Persistent vomiting likely also explains cases of life-threatening nutrient deficiencies after balloon implantation.
Some complications, such as bowel obstruction, are due to the balloon deflating, but others, oddly enough, are due to the balloons suddenly overinflating, causing pain, vomiting, and abdominal distention. This was first noticed in breast implants, as documented in reports such as “The phenomenon of the spontaneously auto-inflating breast implant.” Out of nowhere, the implants just start growing, increasing breast volume by an average of more than 50 percent. “[I]t remains,” one review noted, “an underreported and poorly understood phenomenon.” (Interestingly, breast implants were actually used as some of the first failed experimental intragastric balloons.)
As with any medical decision, though, it’s all about risks versus benefits. Industry-funded trials display notable weight loss, but it’s hard to tease out the effect of the balloon alone from the accompanying supervised diet and lifestyle changes prescribed along with them in the studies. In drug trials, you can randomize subjects to sugar pills, but how do you eliminate the placebo effect of undergoing a procedure? Perform sham surgery.
In 2002, a courageous study was published in the New England Journal of Medicine. The most common orthopedic surgery—arthroscopic surgery of the knee—was put to the test. Billions of dollars are spent sticking scopes into knee joints, and cutting away damaged tissue in osteoarthritis and knee injuries. But does it actually work? Knee pain sufferers were randomized to get the actual surgery versus a sham surgery in which they actually sliced into people’s knees and pretended to perform the procedure, complete with splashing saline, but never actually did anything within the joint.
The trial caused an uproar. How could you randomize people to get cut open for fake surgery? Professional medical associations questioned the ethics of the surgeons as well as the sanity of the patients who agreed to be part of the trial. But guess…what…happened? Sure, the surgical patients got better, but so did the placebo patients. The surgeries had no actual effect. Currently, rotator cuff shoulder surgery is facing the same crisis of confidence.
When intragastric balloons were put to the test, sham-controlled trials show both older…and newer devices sometimes fail to offer any weight loss benefit. Even when they do work, the weight loss may be temporary because balloons are only allowed to stay in for six months (at which point the deflation risk gets too great). Why can’t you keep putting new ones in? That’s been tried, and failed to improve long-term weight outcomes. A sham-controlled trial showed that any effects of the balloon on appetite and satiety may vanish with time, perhaps as your body gets used to the new normal.
What sham surgery trials have shown us is that some of our most popular surgeries are themselves shams. Doctors like to pride themselves on being men and women of science. We rightly rail, for example, against the anti-vaccination movement. Many of us in medicine have been troubled by the political trend of people “choosing their own facts.” But when I read that some of these still-popular surgeries are not only useless but may actually make things worse (for example, increasing the risk of progression to a total knee replacement), I can’t help but think we are hardly immune to our own versions of fake news and alternative facts.
Please consider volunteering to help out on the site.
- Vittal H, Raju GS. Endoscopic bubble: Can it bust the obesity bubble? Gastroenterology. 2005;129(3):1130-2.
- Ross S, Robert M, Harvey M-A, et al. Ethical issues associated with the introduction of new surgical devices, or just because we can, doesn’t mean we should. J Obstet Gynaecol Can. 2008;30(6):508-13.
- Lindor KD, Hughes RW, Ilstrup DM, Jensen MD. Intragastric balloons in comparison with standard therapy for obesity--a randomized, double-blind trial. Mayo Clin Proc. 1987;62(11):992-6.
- Twardzik M, Wiewiora M, Glück M, Piecuch J. Mechanical intestinal obstruction caused by displacement of a stomach balloon - case report. Wideochir Inne Tech Maloinwazyjne. 2018;13(2):278-81.
- Benjamin SB, Maher KA, Cattau EL, et al. Double-blind controlled trial of the Garren-Edwards gastric bubble: an adjunctive treatment for exogenous obesity. Gastroenterology. 1988;95(3):581-8.
- Tate CM, Geliebter A. Intragastric balloon treatment for obesity: review of recent studies. Adv Ther. 2017;34(8):1859-75.
- English WJ, DeMaria EJ, Brethauer SA, Mattar SG, Rosenthal RJ, Morton JM. American Society for Metabolic and Bariatric Surgery estimation of metabolic and bariatric procedures performed in the United States in 2016. Surg Obes Relat Dis. 2018;14(3):259-63.
- Garstka ME, Monlezun D, DuCoin C, Killackey M, Kandil E. The sunshine act and surgeons: a nation-wide analysis of industry payments to physicians. J Surg Res. 2019;233:41-9.
- Camp MW, Mattingly DA, Gross AE, Nousiainen MT, Alman BA, McKneally MF. Patients’ views on surgeons’ financial conflicts of interest. J Bone Joint Surg Am. 2013;95(2):e9.1-8.
- Ziai K, Pigazzi A, Smith BR, et al. Association of compensation from the surgical and medical device industry to physicians and self-declared conflict of interest. JAMA Surg. 2018;153(11):997-1002.
- UPDATE: Potential risks with liquid-filled intragastric balloons - Letter to Health Care Providers. FDA. August 10, 2017.
- Ashrafian H, Monnich M, Braby TS, Smellie J, Bonanomi G, Efthimiou E. Intragastric balloon outcomes in super-obesity: a 16-year city center hospital series. Surg Obes Relat Dis. 2018;14(11):1691-9.
- Trang J, Lee SS, Miller A, et al. Incidence of nausea and vomiting after intragastric balloon placement in bariatric patients - A systematic review and meta-analysis. Int J Surg. 2018;57:22-9.
- Saunders KH, Igel LI, Saumoy M, Sharaiha RZ, Aronne LJ. Devices and endoscopic bariatric therapies for obesity. Curr Obes Rep. 2018;7(2):162-71.
- de Quadros LG, Dos Passos Galvão Neto M, Grecco E, et al. Intragastric balloon hyperinsufflation as a cause of acute obstructive abdomen. ACG Case Rep J. 2018;5:e69.
- Landon J, DiGregorio V. The Phenomenon of the Spontaneously Autoinflating Breast Implant. NESPS 31st Annual Meeting. 2014.
- Robinson OG, Benos DJ, Mazzochi C. Spontaneous autoinflation of saline mammary implants: further studies. Aesthet Surg J. 2005;25(6):582-6.
- Hogan RB, Johnston JH, Long BW, et al. A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity. Gastrointest Endosc. 1989;35(5):381-5.
- Ali MR, Moustarah F, Kim JJ, American Society for Metabolic and Bariatric Surgery Clinical Issues Committee. American society for metabolic and bariatric surgery position statement on intragastric balloon therapy endorsed by the society of american gastrointestinal and endoscopic surgeons. Surg Obes Relat Dis. 2016;12(3):462-7.
- Moseley JB, O’Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002;347(2):81-8.
- Maffulli N. We are operating too much. J Orthop Traumatol. 2017;18(4):289-92.
- McCormack RG, Hutchinson MR. Rocking the shoulder surgeon’s world. Br J Sports Med. 2017;51(24):1727.
- Martinez-Brocca MA, Belda O, Parejo J, et al. Intragastric balloon-induced satiety is not mediated by modification in fasting or postprandial plasma ghrelin levels in morbid obesity. Obes Surg. 2007;17(5):649-57.
- Genco A, Cipriano M, Bacci V, et al. BioEnterics Intragastric Balloon (Bib): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients. Int J Obes (Lond). 2006;30(1):129-33.
- Dumonceau J-M, François E, Hittelet A, Mehdi AI, Barea M, Deviere J. Single vs repeated treatment with the intragastric balloon: a 5-year weight loss study. Obes Surg. 2010;20(6):692-7.
- Orchard J, Moen MH. Has reimbursement for knee osteoarthritis treatments now reached “postfact” status? Br J Sports Med. 2017;51(21):1510-1.
- Thorlund JB. Deconstructing a popular myth: why knee arthroscopy is no better than placebo surgery for degenerative meniscal tears. Br J Sports Med. 2017;51(22):1630-1.
- Rongen JJ, Rovers MM, van Tienen TG, Buma P, Hannink G. Increased risk for knee replacement surgery after arthroscopic surgery for degenerative meniscal tears: a multi-center longitudinal observational study using data from the osteoarthritis initiative. Osteoarthritis Cartilage. 2017;25(1):23-9.
- Milone M, Scarano V, Di Minno MN, Lupoli R, Milone F, Musella M. Rapid onset of Wernicke's syndrome after gastric balloon positioning. Eur J Clin Nutr. 2012;66(8):971.
Video production by Glass Entertainment
Motion graphics by Avo Media
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Is Gastric Balloon Surgery Safe and Effective for Weight Loss?
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Content URLDoctor's Note
The next video in this two-part series is Extreme Weight-Loss Devices.
Have you seen my series on bariatric surgery? If not, check out:
- The Mortality Rate of Bariatric Weight-Loss Surgery
- The Complications of Bariatric Weight-Loss Surgery
- Bariatric Surgery vs. Diet to Reverse Diabetes
- How Sustainable Is the Weight Loss After Bariatric Surgery?
My book How Not to Diet is focused exclusively 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 charity.)
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