Gastric balloon
A diagram of a gastric balloon.
Other namesStomach balloon, intragastric balloon

A gastric balloon, also known as an intragastric balloon (IGB) or a stomach balloon, is an inflatable medical device that is temporarily placed into the stomach to help reduce weight. It is designed to help provide weight loss when diet and exercise have failed and surgery is not wanted or not recommended for the patient.

Medical uses

Intragastric balloons are an alternative to bariatric surgery (or weight loss surgery), which is not generally offered to patients with a body mass index of less than 35. Gastric balloons are also designed for patients who require weight-loss support but who do not want to commit to surgical interventions.[1]

Intragastric balloons help induce weight loss by increasing satiety, delaying gastric emptying, and reducing the amount of food eaten at each meal.[1] Gastric balloons take up space in the stomach, which limits the amount of food that can be held. This creates an early feeling of fullness and satiety. A reduced intake of food then results in weight loss.

Endoscopic Intragastric Balloons

Most balloons require endoscopy for removal or placement. They are usually placed for up to six months, though some devices are placed for twelve months. The device is then removed, again using endoscopy. Longer placement 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 gastric balloon for weight loss differs from the Sengstaken-Blakemore balloon used to stop esophageal and gastric bleeding.

Non-Endoscopic Intragastric Balloons

Gastric balloon uptake has until recently been limited due to the need for endoscopy for placement or removal.[2]

Procedureless, or non-endoscopic, intragastric balloons offer a promising alternative to historic endoscopic balloons. Non-endoscopic balloons are also a less invasive alternative to weight-loss surgery.[2]

In 2015, Allurion's Elipse gastric balloon became the world's first non-endoscopic swallowable gastric balloon when it gained approval in Europe.[3][4] Except under exceptional circumstances, it does not require endoscopy or surgery for placement or removal.[2] The non-endoscopic gastric balloon capsule is swallowed for placement and, once in the stomach is filled with saline liquid. After 16 weeks, the non-endoscopic gastric balloon then automatically deflates and passes naturally at the end of placement. A recent meta analysis of 6 studies found the balloon was a safe device offering effective weight loss. Total pooled weight loss at the completion of treatment (4–6 months) was 12.8% and at 12 months was 10.9%.[4]

Adjustable Intragastric Balloons

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 [5][6][7] and (2) intolerance necessitating early balloon extraction.[8][9] 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.[10][11] 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.

Results

The device is intended to be used by people with a body mass index of more than 27 kg/m2.[12] or between 30 and 40 kg/m2[13] 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.[13]

A 2016 meta analysis of studies showed short term weight loss without any mortality.[14] 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.[14]

Results are influenced by the adherence to nutritional and dietary programs. Long-term studies show promise for patients who combine balloon treatment with exercise and a healthy diet. In a study on the 'Long-Term Efficacy of the Elipse Gastric Balloon System: An International Multicenter Study, Dr. Roberta Ienca and colleagues' report on 509 patients who received the non-endoscopic Elipse balloon and were followed for one year. After 4 months of treatment, patients achieved weight loss of 14.4 kg or 13.9% of total body weight. At one-year follow-up, 95% of this weight loss was maintained by patients included in the study.[2]

Safety and side effects

Gastric balloons are generally considered to be safe and effective in the short.[15] Existing clinical data shows an acceptable safety profile. One of the largest intragastric balloon studies ever performed, which included 1770 patients, demonstrated an excellent safety profile.[2]

There can be procedure-related side effects due to endoscopy and anesthesia on balloons that require medical intervention for placement or removal.[13] On very rare occasions, the endoscopic placement of a balloon has led to death.[16][17]

Several studies have demonstrated that the data on both the efficacy and safety for the non-endoscopic Allurion Elipse gastric balloon compares favorably with balloons that require endoscopy.[2] It showed an acceptable safety profile with 0.2% of serious adverse events, which is comparable to the Orbera balloon, which requires endoscopy.[4]

Post-placement side effects of gastric balloons are common and may include nausea, vomiting, reflux and stomach cramps.[18] Other side effects include indigestion, bloating, flatulence and diarrhea.[14] Rare side effects include esophagitis, gastric ulcer formation or gastric perforation.[19] The device can become deflated and slip into the lower intestines. Migration of a balloon can lead to bowel obstruction.[19]

Mechanism

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. One further balloon, Allurion's Ellipse, has European CE approval and does not require endoscopy for placement or removal.[1][4]

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.[15] Studies have suggested that fluid is superior to air for distending gastric balloons.[14] 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.

Availability and costs

Gastric balloon devices have been approved in many countries, among them Australia, Canada, Mexico, India, Guatemala and several European and South American countries.[20] They became available in the United States in 2015 when two different balloon devices were approved by the FDA.[21][13]

  • 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.[22]
  • Orbera consists of a single balloon device. It has been shown to reduce weight when combined with exercise and diet over six months.[12]
  • The Obalon balloon system may consist of one, two or three balloon devices. This balloon is swallowed for placement but requires endoscopy for removal.[23]
  • Europe has given the CE mark to Allurion Elipse gastric balloon, which is the only gastric balloon that does not need an endoscopic procedure for either placement or removal. It is swallowed for placement and passes naturally after around 16 weeks. It is offered as part of a combined package with a healthy lifestyle plan that includes nutritional advice.[3][4]

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. Average cost in Europe is around €3,000. Insurance coverage is usually not provided in the US.[24] 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).

History

The first person to use 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.[25] Free floating intragastric balloons were used by Nieben and Harboe in 1982.[26] Percival presented a “balloon diet” in 1984 when he placed inflated mammary implants as gastric balloons.[27] Elipse mide Balonu 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.[28] Analysis of its problems led to recommendations for safer designs.[12] 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.[28] In October 2017, ReShape Medical, which makes gastric balloons, was acquired by EnteroMedics in $38m cash-and-stock deal.[29][30]

References

  1. 1 2 3 Jamal, M.H., Almutairi, R., Elabd, R. et al. The Safety and Efficacy of Procedureless Gastric Balloon: a Study Examining the Effect of Elipse Intragastric Balloon Safety, Short and Medium Term Effects on Weight Loss with 1-Year Follow-Up Post-removal. OBES SURG 29, 1236–1241 (2019). https://doi.org/10.1007/s11695-018-03671-w
  2. 1 2 3 4 5 6 Ienca, R., Al Jarallah, M., Caballero, A. et al. The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients. OBES SURG 30, 3354–3362 (2020). https://doi.org/10.1007/s11695-020-04539-8.
  3. 1 2 “Allurion Technologies’ Elipse® Program Demonstrates Significant Weight Loss in Findings Presented at 24th World IFSO Congress”. Business Wire. Retrieved 2021-02-16.
  4. 1 2 3 4 5 Vantanasiri, K., Matar, R., Beran, A. et al. The Efficacy and Safety of a Procedureless Gastric Balloon for Weight Loss: a Systematic Review and Meta-Analysis. OBES SURG 30, 3341–3346 (2020). https://doi.org/10.1007/s11695-020-04522-3.
  5. ↑ 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.
  6. ↑ 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.
  7. ↑ 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.
  8. ↑ Mathus-Vliegen EM. Intragastric balloon treatment for obesity: what does it really offer? Dig Dis. 2008;26(1):40–4. Review
  9. ↑ 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
  10. ↑ 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.
  11. ↑ 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.
  12. 1 2 3 Gaur S, Levy S, Mathus-Vliegen L, Chuttani R (2015). "Balancing risk and reward: a critical review of the intragastric balloon for weight loss". Gastrointestinal Endoscopy. 81 (6): 1330–6. doi:10.1016/j.gie.2015.01.054. PMID 25887720.
  13. 1 2 3 4 "FDA approves non-surgical temporary balloon device to treat obesity". U.S. Food and Drug Administration. July 30, 2015. Retrieved September 22, 2015.
  14. 1 2 3 4 Saber AA, Shoar S, Almadani MW, Zundel N, Alkuwari MJ, Bashah MM, Rosenthal RJ (2017). "Efficacy of First-Time Intragastric Balloon in Weight Loss: A Systematic Review and Meta-analysis of Randomized Controlled Trials". Obesity Surgery. 27 (2): 277–287. doi:10.1007/s11695-016-2296-8. PMID 27465936. S2CID 22109833.
  15. 1 2 Fernandes FA, Carvalho GL, Lima DL, Rao P, Shadduck PP, Montandon ID, de Souza Barros J, Vieira Rodriguez IL (2016). "Intragastric Balloon for Overweight Patients". Journal of the Society of Laparoendoscopic Surgeons. 20 (1): e2015.00107. doi:10.4293/JSLS.2015.00107. PMC 4777670. PMID 26955259.
  16. ↑ Caglar E, Dobrucali A, Bal K (2013). "Gastric balloon to treat obesity: filled with air or fluid?". Digestive Endoscopy. 25 (5): 502–7. doi:10.1111/den.12021. PMID 23369002. S2CID 205059265.
  17. ↑ Commissioner, Office of the. "Safety Alerts for Human Medical Products - Liquid-filled Intragastric Balloon Systems: Letter to Healthcare Providers - Potential Risks". www.fda.gov. Retrieved 31 August 2017.
  18. ↑ "Gastric Balloon - FAQ". The BMI Clinic. Retrieved November 18, 2016.
  19. 1 2 Al Shammari NM, Alshammari AS, Alkndari MA, Abdulsalam AJ (2016). "Migration of an intragastric balloon: A case report". International Journal of Surgery Case Reports. 27: 10–12. doi:10.1016/j.ijscr.2016.08.006. PMC 4983633. PMID 27518432.
  20. ↑ Rosenthal, Elisabeth (January 3, 2006). "Europeans Find Extra Options for Staying Slim". The New York Times. Retrieved November 18, 2016.
  21. ↑ "ReShape and Orbera - Two Gastric Balloon Devices for Weight Loss". The Medical Letter on Drugs and Therapeutics. 57 (1476): 122–3. August 31, 2015. PMID 26305524. Retrieved November 18, 2016.
  22. ↑ Ponce J, Woodman G, Swain J, Wilson E, English W, Ikramuddin S, Bour E, Edmundowicz S, Snyder B, Soto F, Sullivan S, Holcomb R, Lahmann J, REDUCE Pivotal Trial Investigators (2015). "The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity". Surgery for Obesity and Related Diseases. 11 (4): 874–81. doi:10.1016/j.soard.2014.12.006. PMID 25868829.
  23. ↑ Dinesh Vyas D, Deshpande K, Pandya, Y (2017) Advances in endoscopic balloon therapy for weight loss and its limitations. World J Gastroenterol. 23(44): 7813–7817. doi: 10.3748/wjg.v23.i44.7813 PMID 5703910/
  24. ↑ Gastric Balloon Surgery: Complete Patient Guide (Annual Gastric Balloon Cost Survey), Bariatric Surgery Source, retrieved November 19, 2016
  25. ↑ DeBakey M, Ochsner A (1939). "Bezoars and concretions. A comprehensive review of the literature with an analysis of 303 collected cases and a presentation of 8 additional cases". Surgery. 5: 132–160.
  26. ↑ Nieben OG, Harboe H (1982). "Intragastric balloon as an artificial bezoar for treatment of obesity". Lancet. 319 (8265): 198–199. doi:10.1016/s0140-6736(82)90762-0. PMID 6119560. S2CID 38110793.
  27. ↑ Percival WL (1984). "'The balloon diet': non-invasive treatment invasive treatment for morbid obesity: preliminary report on 108 patients". Canadian Journal of Surgery. 27 (2): 135–136. PMID 6704815.
  28. 1 2 Gleysteen JJ (2016). "A history of intragastric balloons". Surgery for Obesity and Related Diseases. 12 (2): 430–5. doi:10.1016/j.soard.2015.10.074. PMID 26775045.
  29. ↑ "EnteroMedics: Soars after co acquires gastric balloon maker - Times of India". The Times of India. Retrieved 2017-10-16.
  30. ↑ "EnteroMedics acquires ReShape Medical in $38m cash-and-stock deal – MassDevice". www.massdevice.com. 2017-10-03. Retrieved 2017-10-16.
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