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.
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References
Tate CM, Geliebter A. Intragastric balloon treatment for obesity: review of recent studies. Adv Ther. 2017;34(8):1859–75.
MAUDE—manufacturer and user facility device experience. [Online]. Available: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. Accessed 13 Oct 2017.
Acknowledgements
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.
Disclosures
Chinara M. Tate has nothing to disclose. Allan Geliebter is a scientific advisor to Gelesis (Boston, MA), a company involved in developing obesity and diabetes treatments. He was a scientific advisor in 2003–5 to Fulfillium (Foster, CA), a company engaged in developing a gastric balloon, and received shares in the company, which is no longer active.
Compliance with Ethics Guidelines
This article is based on previously conducted studies and does not involve any new studies of human or animal subjects performed by any of the authors.
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Tate, C.M., Geliebter, A. Intragastric Balloon Treatment for Obesity: FDA Safety Updates. Adv Ther 35, 1–4 (2018). https://doi.org/10.1007/s12325-017-0647-z
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DOI: https://doi.org/10.1007/s12325-017-0647-z