Title: Gastric Balloon Removed Early: Rates From 2% to 19% Author: Arthur Harmash Published: 2026-10-29 Source: https://lymyvoyage.com/articles/gastric-balloon-removed-early-rates Citations: - https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140008B.pdf - https://pubmed.ncbi.nlm.nih.gov/28017964/ - https://blogs.the-hospitalist.org/content/orbera-intragastric-balloon-approved-weight-loss-obese-adults - https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190012B.pdf - https://pubmed.ncbi.nlm.nih.gov/39947163/ - https://link.springer.com/article/10.1007/s11695-020-04522-3 - https://allurion.com/en/blog/efficacy-and-safety-procedureless-gastric-balloon-weight-loss-systematic-review-and-meta-analysis - https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250023B.pdf - https://pubmed.ncbi.nlm.nih.gov/38038905/ - https://annals.edu.sg/?p=33166 - https://us-uk.bookimed.com/clinics/procedure=gastric-balloon/ - https://www.mediclinic.ae/en/corporate/stay/international-patients/mediclinic-international-patients-packages/bariatrics-and-weight-loss-packages.html --- Gastric balloons are meant to stay in the stomach for four to twelve months, depending on the type.[^1][^4][^8][^9] Some come out within days. How often that happens depends on which balloon, which study, and what the study counted as an early removal. The published rates run from about 2% to about 19%. They are not measuring the same thing. This article puts them on one table, explains why they differ, and asks who pays when a balloon fitted abroad has to come out ahead of schedule. ## Early removal rates, by balloon and study | Balloon | Study | Patients | Removed early | Main reasons | |---|---|---|---|---| | Orbera (6 months) | US pivotal trial, FDA summary | 160 | 18.8% (30)[^1] | 8 intolerance, 7 other adverse events, 15 patient request[^1] | | Spatz3 (adjustable, 8 months) | US pivotal trial, FDA summary | 187 | 16.6% (31)[^4] | 29 adverse events, 1 pregnancy, 1 relocation[^4] | | Adjustable balloons, mostly Spatz | 12 studies pooled | 4,981 | 5.7% within 3 months[^5] | Intolerance and early removal counted together[^5] | | Orbera365 (12 months) | UK clinic database | 1,149 | 50 for intolerance, about 4.4%[^9] | Intolerance[^9] | | Orbera365, Elipse, Spatz3 | Singapore hospital, looking back | 54 | 13.0% (7)[^10] | Intolerance[^10] | | Elipse, now Allurion (swallowed) | 6 studies pooled | 2,013 | 2.3%[^6] | Pooled rate; 3 vomited up, 9 deflated early[^6] | | Allurion | US pivotal trial, FDA summary | 264 | No rate given in the text[^8] | 185 of 261 went on to a second balloon[^8] | ## One trial, two numbers Orbera's US approval rests on one randomized trial. The US Food and Drug Administration (FDA) summary of that trial says 30 of 160 balloon patients, or 18.8%, had the balloon removed before six months.[^1] The trial's peer-reviewed report gives the same 18.8%.[^2] A news report of the same trial, written up from the presentation at a gastroenterology conference, gives 22%.[^3] It quotes the trial's presenter: "15 for symptoms and 13 at subject request." That is 28 removals. The gap is the denominator. The FDA's 160 includes 35 practice cases, where doctors were trained on the device.[^1] Divide 28 by the 125 randomized patients alone and you get 22.4%. Both numbers describe the same trial. They just count different people. Half of Orbera's early removals were not for a medical problem the investigator diagnosed. The FDA summary lists 15 of the 30 as "due to subject request", with "no additional information" on why.[^1] ## The adjustable balloon cut its own rate The FDA summary of Spatz3's US trial reports 31 of 187 balloons removed early, or 16.6%.[^4] The FDA called this a "high removal rate" that "may impact patient's ability to fully benefit from use of the device."[^4] The number would have been higher without the adjustment, which is the feature that sets this balloon apart. Fifty patients asked for removal because of side effects. Twenty-eight of them had the balloon's volume turned down instead, and 21 of those finished the full eight months.[^4] A 2025 review pooled 12 studies of adjustable balloons, with 4,981 patients. It put intolerance and early removal within three months at 5.7%.[^5] That is about a third of the trial figure. It is not a like-for-like comparison, because pooled clinic studies and a tightly monitored FDA trial do not count removals the same way. ## Why the swallowed balloon's number is lower Allurion's balloon is swallowed as a capsule. After about four months it empties and passes on its own.[^8] So "early removal" means something different here, because there is no planned removal procedure to bring forward. Allurion promotes a 2.3% early removal rate on its website.[^7] The figure comes from a 2020 review of six studies with 2,013 patients, published in Obesity Surgery.[^6] The same review recorded three balloons vomited up early and nine that deflated early.[^6] The FDA's own summary of Allurion's US trial, published in March 2026, does not state an early removal rate in its text.[^8] It reports something nearby: of 261 patients who started, 185 went on to receive the planned second balloon. That is 70.9%.[^8] The summary does not say why the rest did not. ## Real clinics, smaller numbers Outside FDA trials, the reported rates come in lower, though most of them count intolerance only. A UK clinic group followed 1,149 patients with a 12-month Orbera balloon between 2017 and 2021. Fifty needed removal because of intolerance,[^9] which works out to about 4.4%. A Singapore hospital looked back at 54 patients treated between 2017 and 2022. Seven, or 13.0%, had the balloon taken out early for intolerance.[^10] Patients with anxiety or depression were more likely to be among them. The authors call the study small and "hypothesis-generating".[^10] The timing matters for anyone travelling. In the Singapore group, early removals came a mean of seven days after placement.[^10] In the Orbera trial, intolerance serious enough to count as a serious adverse event started a median of one day after placement.[^1] ## Who pays for the extra procedure None of the trials price an early removal. Clinic listings rarely do either. A medical-travel booking site lists one Turkish clinic's balloon package at $1,620. It notes that "a second visit for removal after 6 months incurs a separate fee of €400-500."[^11] That is the planned removal. The listing says nothing about an unplanned one. If the clinic that fitted the balloon is a flight away, removal may happen somewhere else. One Dubai hospital group lists a removal-only package, for a balloon "already externally placed in your stomach (in different facility)", at 4,682 United Arab Emirates dirhams.[^12] ## What the headline numbers leave out - **They count different things.** Some rates include patient requests, some only intolerance, some only the first three months. The 18.8% and the 2.3% are not a fair head-to-head. - **Trial patients are watched closely.** A higher trial rate may partly reflect more reporting, not a worse balloon. The data here cannot separate the two. - **Volume changes hide removals.** Spatz3 avoided 21 removals by turning the balloon down,[^4] and every adjustment is another endoscopy. - **The swallowed balloon has no published trial rate.** Allurion's 2.3% comes from pooled studies, not from the FDA summary of its US trial.[^6][^8] ## How to use these numbers Ask the clinic which balloon it uses, then ask what happens if it has to come out in the first week, and get the answer in writing. It should say who does the removal, where, and whether the package price covers it. If you will fly home within days of placement, ask how long the clinic wants you nearby. In the studies here, problems tended to show up in the first days. In US approval trials, 18.8% of Orbera balloons and 16.6% of Spatz3 balloons came out early. Allurion advertises 2.3%. Is the swallowed one really that much easier? Those numbers count different things. Orbera's 18.8% includes 15 patients who asked for removal with no reason recorded. Allurion's 2.3% pools six studies of a balloon that leaves on its own. Even one trial gives two answers. A news report of Orbera's trial said 22%. The FDA said 18.8%. The difference is whether 35 practice cases are counted. Outside trials, reported rates are lower, though most count intolerance only. A UK clinic group removed about 4.4% of 1,149 balloons for intolerance. A Singapore hospital removed 13.0% of 54, a mean of seven days in. What the data cannot prove: that one balloon is better tolerated. No study here compares them head to head, and the FDA summary of Allurion's US trial gives no early removal rate. Ask what happens if your balloon has to come out in the first week, who removes it, and whether that is in the price. Save this before you book. [^1]: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140008B.pdf — US Food and Drug Administration, "Summary of Safety and Effectiveness Data: ORBERA Intragastric Balloon System, PMA P140008" (approved Aug 2015). Accessed Oct 29, 2026. [^2]: https://pubmed.ncbi.nlm.nih.gov/28017964/ — Courcoulas A. et al., "Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial", International Journal of Obesity (published Dec 2016). Accessed Oct 29, 2026. [^3]: https://blogs.the-hospitalist.org/content/orbera-intragastric-balloon-approved-weight-loss-obese-adults — MDedge / The Hospitalist, "Orbera intragastric balloon approved for weight loss in obese adults", reporting the trial presentation at Digestive Disease Week. Accessed Oct 29, 2026. [^4]: https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190012B.pdf — US Food and Drug Administration, "Summary of Safety and Effectiveness Data: Spatz3 Adjustable Balloon System, PMA P190012" (approved Oct 2021). Accessed Oct 29, 2026. [^5]: https://pubmed.ncbi.nlm.nih.gov/39947163/ — Xia C. et al., "The Efficacy and Safety of Adjustable Intragastric Balloon for Weight Loss: A Systematic Review and Meta-Analysis", Obesity Facts (published Feb 2025). Accessed Oct 29, 2026. [^6]: https://link.springer.com/article/10.1007/s11695-020-04522-3 — Vantanasiri K. et al., "The Efficacy and Safety of a Procedureless Gastric Balloon for Weight Loss: a Systematic Review and Meta-Analysis", Obesity Surgery (published Sep 2020). Accessed Oct 29, 2026. [^7]: https://allurion.com/en/blog/efficacy-and-safety-procedureless-gastric-balloon-weight-loss-systematic-review-and-meta-analysis — Allurion, "Efficacy and safety of a procedureless gastric balloon for weight loss: systematic review and meta-analysis" (manufacturer's blog relaying the 2020 review). Accessed Oct 29, 2026. [^8]: https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250023B.pdf — US Food and Drug Administration, "Summary of Safety and Effectiveness Data: Allurion Gastric Balloon System, PMA P250023" (notice of approval Mar 2026). Accessed Oct 29, 2026. [^9]: https://pubmed.ncbi.nlm.nih.gov/38038905/ — Wiggins T. et al., "Safety and Efficacy of 12-Month Intra-gastric Balloon: Series of over 1100 Patients", Obesity Surgery (published Dec 2023). Accessed Oct 29, 2026. [^10]: https://annals.edu.sg/?p=33166 — Choo A. et al., "Predictors of early removal of intragastric balloon due to intolerance: Insights from a multiethnic Asian cohort", Annals, Academy of Medicine, Singapore (published Sep 2024). Accessed Oct 29, 2026. [^11]: https://us-uk.bookimed.com/clinics/procedure=gastric-balloon/ — Bookimed, "Gastric balloon clinics" (medical-travel booking listing). Accessed Oct 29, 2026. [^12]: https://www.mediclinic.ae/en/corporate/stay/international-patients/mediclinic-international-patients-packages/bariatrics-and-weight-loss-packages.html — Mediclinic Middle East, "Bariatrics and weight loss packages" (international patient price list). Accessed Oct 29, 2026.