Gastric balloon

The balloon limits the amount of food the stomach can hold and thereby creates an early feeling of fullness and satiety. Less intake of food will result in weight loss. After up to six months (or up to twelve months with some newer devices), the device is removed using endoscopy again. Longer stay of a balloon is not advised because of the danger of damage to the tissue wall and degradation of the balloon. The use of the balloon is complemented with counseling and nutritional support or advice.

Endoscopic placement of the balloon is temporary and reversible without surgical incisions. The (intra)gastric balloon for weight loss differs from the Sengstaken-Blakemore balloon used to stop esophageal and gastric bleeding.

Adjustable Gastric Balloons are able to increase or decrease their volume. While non-adjustable gastric balloons have been successfully used for weight loss for the last 30 years, the adjustability function was developed to address the following issues: (1) variability of response and reduced efficacy after 3 months [1] [2] [3] and (2) intolerance necessitating early balloon extraction. [4] [5] Alleviating intolerance with a downward adjustment and renewing weight loss after balloon upward adjustment, are responsible for higher success rates compared with non-adjustable balloons.[6] [7] The Spatz3 Adjustable Gastric Balloon is the first intragastric balloon approved for 1-year implantation (outside of the US), while featuring an adjustability function that provides balloon volume changes as needed.

The device is intended to be used in people with a body mass index of more than 27 kg/m².[8] or between 30 and 40 kg/m²[9] and have weight-related co-morbidity. It should not be applied to patients with certain intestinal problems such as inflammatory bowel disease or delayed gastric emptying, who are pregnant, or who are taking blood thinner medications such as Coumadin. Low dose aspirin (100 mg) is permitted.[9]

A 2016 meta analysis of studies showed short term weight loss without any mortality.[10] It was calculated that the weight loss was 1.59 and 1.34 kg/m² for overall and 3-month body mass index (BMI) loss, respectively, and 4.6 and 4.77 kg for overall and 3-month weight loss, respectively.[10]

Results are short term and influenced by the adherence to nutritional and dietary programs. Long term studies are lacking.

Gastric balloons are generally considered to be safe and effective in the short run.[11] There can be procedure-related side effects due to endoscopy and anesthesia.[9] On a rare occasion the endoscopic placement of a balloon can lead to death.[12][13]

Initial side effects of the balloon are common and may consist of nausea, vomiting, reflux and stomach cramps.[14] Other effects could be indigestion, bloating, flatulence and diarrhea.[10] Rare side effects include esophagitis, gastric ulcer formation or gastric perforation.[15] The device can become deflated and slip into the lower intestines. Migration of a balloon can lead to bowel obstruction, a surgical emergency.[15]

Currently there are three FDA approved balloons in the USA. These approved devices are placed via the esophagus using endoscopy. This can be done in an outpatient setting under sedation. Once in place the balloon is filled with saline and remains as a free-floating object in the stomach cavity, too big to pass through the pylorus. In addition to saline, the balloon that is made from silicone may contain some radio-opaque material as a radiographic marker and a dye such as methylene blue to alert the patient if the balloon leaks.[11] Studies have suggested that fluid is superior to air for distending gastric balloons.[10] Inflated balloons reduce the operative volume capacity of the stomach. While the typical gastric volume is about 900 ml, an inflated balloon may take up most of the space, about 700 (+/-100) ml.

Gastric balloon devices have been approved in many countries, among them Australia, Canada, Mexico, India, Guatemala and several European and South American countries.[16] They became available in the United States in 2015 when two different balloon devices were approved by the FDA.[17][9]

• ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is a double balloon device. The double balloon system is supposed to provide a level of safety: when one balloon leaks or ruptures, blue dye in the urine will alert the patient that there is a problem.[18][19]
• Orbera consists of a single balloon device. The Orbera system also reduced weight significantly when combined with exercise and diet over a six months span.[8]
• The Obalon balloon system may consist of one, two or three balloon devices. To date, these are the only swallowable, gas filled gastric balloons available.[20]

Costs for the gastric balloon are surgeon-specific and vary by region. Average cost in the US is $8,150 USD, and generally less in other countries. Insurance coverage is usually not provided in the US.[21] There are three cost categories for the intragastric balloon: pre-operative (e.g. professional fees, lab work and testing), the procedure itself (e.g. surgeon, surgical assistant, anesthesia and hospital fees) and post-operative (e.g. follow-up physician office visits, vitamins and supplements).

The first who used a gastric balloon for the treatment of obesity was A Henning 1979. (Inn. Med.6(1979),149)He and his wife used it in a self-experiment.

The use of gastric filling devices to induce weight loss is not new. DeBakey’s review in 1938 showed that bezoars led to weight loss.[22] Free floating intragastric balloons were used by Nieben and Harboe in 1982.[23] Percival presented a “balloon diet” in 1984 when he placed inflated mammary implants as gastric balloons.[24] In 1985 the Garren-Edwards Bubble was introduced as the first FDA-approved device, but the approval was withdrawn seven years later because of complications.[25] Analysis of its problems led to recommendations for safer designs.[8] While a number of further developed devices were used outside of the US, mostly in Europe and South America, the FDA did not approve any new devices until 2015.[25] In October 2017, ReShape Medical, which makes gastric balloons, was acquired by EnteroMedics in $38m cash-and-stock deal.[26][27]

Bonazzi P, Petrelli MD, Lorenzini I, et al. Gastric emptying and intragastric balloon in obese patients. Eur Rev Med Pharmacol Sci. 2005;9(5 Suppl 1):15–21.
Totté, E.; Hendrickx, L.; Pauwels, M.; Van Hee, R. (2001-08-01). "Weight Reduction by Means of Intragastric Device: Experience with the Bioenterics Intragastric Balloon". Obesity Surgery. 11 (4): 519–523. doi:10.1381/096089201321209459. ISSN 1708-0428.
Courcoulas, A; Abu Dayyeh, B K; Eaton, L; Robinson, J; Woodman, G; Fusco, M; Shayani, V; Billy, H; Pambianco, D (2016-12-23). "Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial". International Journal of Obesity. 41 (3): 427–433. doi:10.1038/ijo.2016.229. ISSN 0307-0565. PMID 28017964.
Mathus-Vliegen EM. Intragastric balloon treatment for obesity: what does it really offer? Dig Dis. 2008;26(1):40–4. Review
Imaz I, Martínez-Cervell C, García-Alvarez EE, et al. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg. 2008;18(7):841–6. Review
Usuy, Eduardo; Brooks, Jeffrey (2017-10-31). "Response Rates with the Spatz3 Adjustable Balloon". Obesity Surgery. 28 (5): 1271–1276. doi:10.1007/s11695-017-2994-x. ISSN 0960-8923. PMID 29090379.
De Almeida, Leonard Salles (2018-09-04). "Spatz3 Adjustable Balloon: Weight Loss and Response Rates in Brazil". Integrative Gastroenterology and Hepatology: 38–41. doi:10.18314/igh.v1i1.1193. ISSN 2637-6954.

• Media related to Gastric balloons at Wikimedia Commons