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intragastric balloon system (Orbera Intragastric Balloon System, ReShape Integrated Dual Balloon System)

Indications: - treatment of obesity Laboratory: - AGA recommends against screening for nutritional deficiencies [3] Complications: - balloons can erode gastric mucosa [3] - reports of at least 5 deaths within days or weeks of the procedure [1,2] Management: - lifestyle changes should accompany intragastric balloon therapy - proton-pump inhibitors should be given prophylactically [3] Notes: - Allurion intragastric balloon (formerly the Elipse, Allurion Technologies) is swallowed, requiring no surgery or endoscopic placement, shows high efficacy in achieving weight loss & an improved metabolic profile, with fewer adverse events than reported with other available gastric balloons [4]

General

device (medical device) bariatric surgery

References

  1. FDA Safety Alert. Aug 10, 2017 Liquid-filled Intragastric Balloon Systems: Letter to Healthcare Providers - Potential Risks. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570916.htm
  2. FDA Safety Alert. June 4, 2018 Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm609761.htm
  3. Muniraj T, Day LW, Teigen LM et al AGA Clinical Practice Guidelines on Intragastric Balloons in the Management of Obesity. Gastroenterology. 2021 160(5):1799-1898. April 1 PMID: 33832655 https://www.gastrojournal.org/article/S0016-5085(21)00477-7/fulltext
  4. Melville NA Swallowable Intragastric Balloon Shows Significant Weight Loss. Medscape. Jan 12, 2022 https://www.medscape.com/viewarticle/966489