What can an intragastric balloon do, and what happens afterwards?

Intragastric balloons are temporary devices used alongside weight-management care. Medsil and Stella are fluid-filled balloons placed and removed endoscopically; Allurion (formerly Elipse) is swallowed, filled through a catheter and designed to deflate and pass at about four months. Their pathways and evidence differ; results below are study averages, not personal predictions.

What a gastric balloon does and how outcomes are measured

A balloon occupies stomach space and may promote fullness while dietary/behavioural support is provided. It is temporary, not a guarantee of maintained loss. FDA describes liquid-filled balloons as taking up stomach space.[7] %TBWL is loss relative to starting weight; %EWL is loss relative to weight above a reference BMI, commonly 25 kg/m². Because denominators differ, %EWL is typically larger and not directly comparable. BMI change is kg/m². A between-group effect compares with control; within-group change does not.

Device, selection, support and follow-up affect findings. A four-month result with a balloon in place differs from a measure after removal or passage.

Endoscopic Medsil and Stella: placement and removal

These fluid-filled models are positioned/filled and later removed by endoscopy. Stella was studied over six months with the device, followed to month seven.

A retrospective Saudi cohort followed 301 patients treated with Medsil for six months, with a further assessment six months after balloon removal. Mean weight reduction was 13.08 kg at removal and 14.30 kg at the later visit; mean BMI reductions were 4.75 and 5.20 kg/m². These uncontrolled before-and-after averages do not isolate device effect from other care or later changes. The report described two pancreatitis cases, two intestinal obstructions after displacement and one arrhythmia; authors reported recovery after immediate removal. One centre cannot establish rates elsewhere.[4]

A prospective non-randomised Stella study enrolled 69 people at six Spanish hospitals; 66 had adequate placement/device integrity for main assessment. At month six, mean %TBWL was 15.39% (95% CI 13.77–17.00); safety follow-up continued to month seven. Five people (7.2%) had intolerance. Three device issues (deployment difficulty, rupture associated with fungal colonisation, partial deflation) had no reported clinical consequences. The full text reports 211 events in 57 people, predominantly mild or moderate, and no serious device-related event; it also notes one pregnancy had been misclassified as a serious event. This reporting nuance and the small sample/no control mean rare harms cannot be ruled out.[5]

These are not head-to-head findings. For a Medsil or Stella balloon package, clarify model, removal, follow-up and included services. The gastric balloon cost in Turkey is informational, not clinical evidence.

Randomised trials and pooled effects

Kotinda and colleagues’ random-effects meta-analysis included 13 randomised trials with 1,523 adults (859 balloon and 664 comparison participants). Most trials used one fluid-filled balloon; models and comparators varied, and follow-up ranged from three to eight months. The pooled between-group difference was 4.40 percentage points in %TWL (95% CI 1.37 to 7.43) and 17.98 percentage points in %EWL (95% CI 8.37 to 27.58). The 4.40-point estimate is an average advantage in the proportion of starting body weight lost, not a 4.40% prediction for every person. The review also estimated 6.12 kg greater absolute weight loss (95% CI 3.80 to 8.44) and 2.13 kg/m² greater BMI reduction (95% CI 0.57 to 3.68). These pooled estimates do not predict results for a named device. The original paper notes heterogeneity; intervals express uncertainty in pooled means, not an individual outcome range.[1]

This supports short-term effects across mixed models, not a product-specific forecast or proof of maintenance. Confidence intervals describe uncertainty in pooled estimates, not individual ranges. Silva et al. separately pooled 11 observational Allurion studies (2,107 people): around four months %TBWL 12.47% (95% CI 11.17–13.77), %EWL 48.04% (45.48–50.61), BMI reduction 4.75 kg/m² (4.47–5.02), serious adverse-event rate 0.90%. No randomised comparator means no causal advantage is established; do not compare directly with the endoscopic RCT synthesis.[6]

Swallowable Allurion: four-month outcomes and maintenance

Ienca et al. reported a prospective, open-label, non-randomised registry of 1,770 Elipse (now Allurion) patients at 19 centres. The study enrolled people aged 18–65 years with BMI above 27 kg/m² who had previously tried dietary treatment; these were study criteria, not universal eligibility rules. The programme also provided an app, connected scale, nutrition support and monthly visits. At four months, participants had a mean weight change of 13.5 kg (SD 5.8), mean %TBWL of 14.2% (SD 5.0), and mean BMI reduction of 4.9 kg/m² (SD 2.0).[2]

Because the registry had no control group, its outcomes describe the balloon-and-support programme and cannot isolate the balloon’s contribution. The report recorded endoscopic removal for intolerance in 52 participants (2.9%), early deflation in 11 (0.6%), small-bowel obstruction in three (0.17%), and gastric perforation in one (0.06%) requiring laparoscopic repair. Obstructions occurred in 2016 with an earlier device generation. No deaths or thromboembolic events were reported; rare risk is not excluded.

A later retrospective, single-arm study at nine centres analysed 522 people with one-year follow-up from a source database of 3,716 records. The followed subset was only a fraction of the source database; attrition and selection may affect who is represented, and the abstract does not establish that all database patients completed the year. Among those analysed, mean weight loss was 14.4 kg (SD 7.7) at month four and 13.9 kg (SD 11.6) one year after passage. Mean %TBWL was 13.9% (SD 6.3) and 13.2% (SD 9.9), respectively. The authors described 95% maintenance of month-four %TBWL within this analysed cohort. This is an observed group comparison, not a guarantee of maintenance for everyone treated.[3]

When comparing a swallowable Allurion balloon package, ask how placement is checked, who responds to symptoms, what happens if passage is delayed, and whether clinical support continues afterwards.

Safety, symptoms and intervention

Nausea, vomiting, abdominal discomfort and reflux may occur during adjustment; the Stella article did not count first-week accommodation symptoms as adverse events. Separately, the FDA’s 9 February 2017 communication discussed reports involving Orbera and ReShape liquid-filled balloons. It listed severe abdominal or back pain, abdominal distension, breathing difficulty and vomiting in connection with overinflation or pancreatitis and advised clinicians to consider these complications and assess patients promptly. It did not give incidence estimates for Medsil, Stella or Allurion and is not product-specific evidence for them.[7] Severe or worsening abdominal/back pain, marked abdominal swelling, breathing difficulty or persistent vomiting after balloon placement warrants prompt clinical assessment. Routine adjustment symptoms and warning symptoms are distinct. Study percentages are not personal risk scores because models and cohorts differ.

Follow-up is part of the intervention

Allurion registry care included preparation, nutrition support, tracking and monthly visits; Stella follow-up included one month after removal. These are study protocols, not universal schedules. Before proceeding, confirm who will be clinically responsible, when reviews will take place, what support is available, how to report symptoms, and how endoscopic removal or natural passage will be managed. Endoscopic models have planned removal; swallowable models are designed to pass, but intervention can still be needed.

Questions to discuss with the treating clinician

• Which model is proposed and how is it placed/removed?
• How do history, medicines or prior gastrointestinal surgery affect suitability?
• Which outcome measure and time point underpin expected results?
• What nutrition, behavioural and clinical support is provided?
• Which symptoms need urgent attention and where is emergency care available?
• How is removal booked or passage/delay managed?
• Which visits, medicines and emergency arrangements are included in the price?

These questions do not replace assessment. Just Clinic Istanbul is an independent marketing and lead-generation platform, not a healthcare provider or medical tourism intermediary. Enquiries may be shared with authorised healthcare partners with your consent.

How to interpret the evidence

Randomised mixed-model trials strengthen short-term comparisons but limit product-specific inference; uncontrolled cohorts cannot separate device effect from selection and support. The one-year study has substantial attrition. Several findings come from observational or single-arm evidence, and some source text was available only through indexed records; this limits certainty and direct comparison. The Stella authors disclosed fees from Mikromic Medical for procedures and follow-up, and one author’s role in inventing the device; the Ienca registry authors disclosed Allurion consultant/advisor relationships. These disclosures are relevant when weighing product-specific reports. The evidence includes mixed-device trials and observational programmes, so results should be interpreted within each device’s study design and follow-up period. Price and package links do not substantiate clinical claims.

References

1. Kotinda APST, de Moura DTH, Ribeiro IB, Singh S, da Ponte Neto AM, Proença IM, Flor MM, de Souza KL, Bernardo WM, de Moura EGH. Efficacy of Intragastric Balloons for Weight Loss in Overweight and Obese Adults: a Systematic Review and Meta-analysis of Randomized Controlled Trials. Obesity Surgery. 2020;30(7):2743–2753. Online 5 May 2020; issue July. doi: 10.1007/s11695-020-04558-5. PMID 32300945.
2. Ienca R, Al Jarallah M, Caballero A, et al. The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients. Obesity Surgery. 2020;30(9):3354–3362. Online 11 April 2020; issue September. doi: 10.1007/s11695-020-04539-8. PMID 32279182; PMCID PMC7458897. Conflict correction PMID 32869126.
3. Caballero A, Giardiello C, Schiano Di Cola R, et al. Weight Loss Maintenance 1 Year after the Swallowable Gastric Balloon: Results from an International Multicenter Study. Obesity Surgery. 2025;35(9):3591–3598. Online 17 July 2025; issue September. doi: 10.1007/s11695-025-08074-2. PMID 40676353; PMCID PMC12457444.
4. Almeghaiseeb ES, Ashraf MF, Alamro RA, Almasoud AO, Alrobayan AA. Efficacy of intragastric balloon on weight reduction: Saudi perspective. World Journal of Clinical Cases. 2017;5(4):140–147. 16 April 2017. doi: 10.12998/wjcc.v5.i4.140. PMID 28470006; PMCID PMC5395982.
5. Espinet-Coll E, Turró-Arau R, Nebreda-Durán J, Abad-Belando R, Núñez-Martínez Ó, Saenger F, Varas-Lorenzo M, Samaniego-Aquino FA, Díaz-Galán P, Ortega-Sabater A, Grau-Manrubia G, López-Roldán G, Alberdi-Alonso JM, Galvao Neto M. Prospective, Multicenter Clinical Trial to Evaluate the Safety of the Stella® Intragastric Balloon at 7 Months and the Balloon Delivery System. Obesity Surgery. 2025;35(10):4440–4451. Online 19 September 2025; issue October. doi: 10.1007/s11695-025-08264-y. PMID 40968297; PMCID PMC12540573. Correction record.
6. Silva AF, Bestetti AM, Kum AST, et al. Effectiveness and Safety of the Allurion Swallowable Intragastric Balloon for Short-term Weight Loss: A Systematic Review and Meta-analysis. Obesity Surgery. 2024;34(10):3735–3747. Online 23 August 2024; issue October. doi: 10.1007/s11695-024-07453-5. PMID 39174862.
7. US Food and Drug Administration. The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons. Safety communication, 9 February 2017. FDA communication.