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Background <p>Overweight and obesity are major global health challenges. Minimally invasive and reversible therapies such as the Allurion® gastric balloon (AGB) have emerged as alternatives for selected patients.</p> Objectives <p>To evaluate the efficacy and safety of the AGB in a real-world Ecuadorian cohort.</p> Methods <p>A retrospective cohort study including consecutive patients aged ≥ 13 years with BMI ≥ 25&#xa0;kg/m² who underwent AGB placement between September 2021 and September 2024. The primary endpoint was total weight loss percentage (TWL%) at 3, 6, and 12 months. Secondary endpoints included adverse events, early removal, readmission, and reintervention rates. Missing data were handled using Last Observation Carried Forward (LOCF).</p> Results <p>A total of 300 patients (68% female; median BMI 29.2&#xa0;kg/m²) were included. Mean TWL% was 8.3% at 3 months, 9.7% at 6 months, and 14.4% at 12 months. Follow-up rates were 91%, 70%, and 38%, respectively. Most adverse events were mild. Severe adverse events occurred in 2.0%. The reintervention rate was 1.3% (<i>n</i> = 4), all corresponding to endoscopic balloon removal for intolerance. Early removal occurred in 2%.</p> Conclusions <p>The AGB demonstrated an acceptable safety profile and clinically meaningful weight loss. Findings should be interpreted considering the retrospective design and attrition.</p>

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Evaluation of the Efficacy and Safety of the Allurion® Gastric Balloon in 300 Patients from a Single Metabolic Center in Ecuador

  • 期刊论文

  • 发表日期：

    2026年5月16日

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  • Tabata Tinoco Ortiz,
  • Maximo Torres Guaicha,
  • Ariadna Tobar,
  • Santiago Muñoz-Palomeque

摘要

Background

Overweight and obesity are major global health challenges. Minimally invasive and reversible therapies such as the Allurion® gastric balloon (AGB) have emerged as alternatives for selected patients.

Objectives

To evaluate the efficacy and safety of the AGB in a real-world Ecuadorian cohort.

Methods

A retrospective cohort study including consecutive patients aged ≥ 13 years with BMI ≥ 25 kg/m² who underwent AGB placement between September 2021 and September 2024. The primary endpoint was total weight loss percentage (TWL%) at 3, 6, and 12 months. Secondary endpoints included adverse events, early removal, readmission, and reintervention rates. Missing data were handled using Last Observation Carried Forward (LOCF).

Results

A total of 300 patients (68% female; median BMI 29.2 kg/m²) were included. Mean TWL% was 8.3% at 3 months, 9.7% at 6 months, and 14.4% at 12 months. Follow-up rates were 91%, 70%, and 38%, respectively. Most adverse events were mild. Severe adverse events occurred in 2.0%. The reintervention rate was 1.3% (n = 4), all corresponding to endoscopic balloon removal for intolerance. Early removal occurred in 2%.

Conclusions

The AGB demonstrated an acceptable safety profile and clinically meaningful weight loss. Findings should be interpreted considering the retrospective design and attrition.