Gastric balloon

A gastric balloon, also known as stomach balloon, is an inflatable medical device that is temporarily placed into the stomach to reduce weight. It is marketed to provide weight loss when diet and exercise have failed and surgery is not wanted or not recommended.

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

Medical uses

The balloon limits the amount of food the stomach can hold and creates thereby 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.

Results

The device is intended to be used in patients with a body mass index of more than 27 kg/m2.[1] or between 30 and 40 kg/m2[2] 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.[2]

A 2016 meta analysis of studies showed short term weight loss without any mortality.[3] 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/m2 for overall and 3-month weight loss, respectively.[3]

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

Side effects

Gastric balloons are generally considered to be safe and effective in the short run.[4] There can be procedure-related side effects due to endoscopy and anesthesia.[2] On a rare occasion the endoscopic placement of a balloon can lead to death.[5][6]

Initial side effects of the balloon are common and may consist of nausea, vomiting, reflux and stomach cramps.[7] Other effects could be indigestion, bloating, flatulence and diarrhea.[3] Rare side effects include esophagitis, gastric ulcer formation or gastric perforation.[8] The device can become deflated and slip into the lower intestines. Migration of a balloon can lead to bowel obstruction, a surgical emergency.[8]

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. 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.[4] Studies have suggested that fluid is superior to air for distending gastric balloons.[3] 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.[9] They became available in the United States in 2015 when two different balloon devices were approved by the FDA.[2][10][2]

  • 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.[11][12]
  • 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.[1]
  • Spatz 3 Adjustable Intragastric Balloons (Dynamic - IGBs) are intragastric balloons are able to increase or decrease their volume. The Spatz adjustable balloon was introduced in 2010 as the first IGB approved for 1-year implantation (outside of the US), while featuring an adjustability function that afforded balloon volume changes as needed. The adjustability function was developed to address the issues related to IGBs: (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. The Spatz balloon is currently under PMA review by the FDA- all endpoints were reached.
  • 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.[13]

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.[14] 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 use of gastric filling devices to induce weight loss is not new. DeBakey’s review in 1938 showed that bezoars led to weight loss.[15] Free floating intragastric balloons were used by Nieben and Harboe in 1982.[16] Percival presented a “balloon diet” in 1984 when he placed inflated mammary implants as gastric balloons.[17] 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.[18] Analysis of its problems led to recommendations for safer designs.[1] 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.[18] In October 2017, ReShape Medical, which makes gastric balloons, was acquired by EnteroMedics in $38m cash-and-stock deal.[19][20]

References
  1. 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.
  2. "FDA approves non-surgical temporary balloon device to treat obesity". U.S. Food and Drug Administration. July 30, 2015. Retrieved September 22, 2015.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. "Gastric Balloon - FAQ". The BMI Clinic. Retrieved November 18, 2016.
  8. 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.
  9. Rosenthal, Elisabeth (January 3, 2006). "Europeans Find Extra Options for Staying Slim". The New York Times. Retrieved November 18, 2016.
  10. "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.
  11. "New Weight Loss 'Balloon': Is It Right for You?". Newsmax Health. July 29, 2015. Retrieved November 18, 2016.
  12. 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 Trail 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.
  13. 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/
  14. Gastric Balloon Surgery: Complete Patient Guide (Annual Gastric Balloon Cost Survey), Bariatric Surgery Source, retrieved November 19, 2016
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. "EnteroMedics: Soars after co acquires gastric balloon maker - Times of India". The Times of India. Retrieved 2017-10-16.
  20. "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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