@article{79f206c3fa4843b28f6f35117881a2a9,
title = "Intragastric Balloon Treatment for Obesity: FDA Safety Updates",
abstract = "Over the past year, the FDA has issued two letters to healthcare providers alerting them to adverse events associated with ORBERA and ReShape intragastric balloons (IGBs), including several deaths. Both IGB devices were FDA-approved for use in the US in the summer of 2015. Although the adverse events cited in the two letters occurred following FDA approval, there was already evidence prior to FDA approval that the safety and efficacy of ReShape and ORBERA were highly questionable. Since January 1, 2006, ORBERA and Reshape IGB have been implicated in 33 deaths. Given the cited evidence, we recommend FDA withdrawal of these two devices.",
keywords = "Bariatric surgery, Endoscopy, Gastric capacity, Gastric distension, Obesity, Obesity treatment, Qsymia, Weight loss",
author = "Tate, {Chinara M.} and Allan Geliebter",
note = "Funding Information: This commentary was supported in part by the National Institute of Health, Bethesda, MD, USA; Grants R01 DK080153 (A.G.). No funding or sponsorship was received for the publication of this article. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. Publisher Copyright: {\textcopyright} 2017, Springer Healthcare Ltd., part of Springer Nature.",
year = "2018",
month = jan,
day = "1",
doi = "10.1007/s12325-017-0647-z",
language = "English",
volume = "35",
journal = "Advances in Therapy",
issn = "0741-238X",
publisher = "Springer International Publishing AG",
number = "1",
}