Gastric Balloon Results — Data From 200,000+ Patients Worldwide

The Allurion swallowable gastric balloon is backed by a broad safety and efficacy database, with more than 200,000 placements worldwide. In this article we cover 4 separate clinical studies (Ienca 2020, Caballero 2025, Dejeu 2024, and a 2025 multicenter series), Türkiye data, and the factors that influence individual results.

---

What 200,000+ Placements Mean

Real-world data of this magnitude is rare for a clinical device. This figure indicates:

• that the safety profile has been validated in a large population
• that efficacy has been evaluated across different ethnic groups, body types, and clinical settings
• that the FDA PMA application (February 2026) also rests on this body of evidence

---

Study 1: A Multicenter Series of 1,770 Patients

Ienca et al., Obesity Surgery 2020 PMID: 32279182 →

Parameter	Value
Number of patients	1,770
Number of centers	19
Design	Multicenter retrospective
Mean TBWL	14.9%
Serious adverse events	<0.2%

This study constitutes Allurion's most frequently cited real-world series.

---

Study 2: One-Year Long-Term — 522 Patients

Caballero et al., Obesity Surgery 2025 PMID: 40676353 →

Parameter	Value
Number of patients	522
Follow-up point	12 months after the balloon is passed
Weight maintenance	~95% 1
Design	International multicenter

The ~95% rate reported for weight maintenance one year after the balloon stems from key references on the long-term efficacy of the Allurion Program.

Individual results may vary. Individual outcomes may differ from the group average.

---

Study 3: The Digital-Tracking Difference — 571 Patients

Dejeu et al., Clinical Practice 2024 PMID: 38804393 →

Parameter	Value
Number of patients	571
Focus	The effect of Allurion Scale + App use
Findings	Positive correlation between frequency of digital-tool use and weight loss

This study explains why Allurion is not just a balloon but an integrated program: adherence to measurements and the app directly affects results.

---

Study 4: Real-World — Multicenter 2025

Obesity Surgery 2025 PMID: 41037243 →

A multicenter real-world study in which the Allurion Program was applied in everyday practice, outside the clinical-trial setting. It supports a similar safety and efficacy profile under non-trial conditions as well.

---

Türkiye Performance: Global Benchmark

Allurion's global database classifies clinics by tier. The Türkiye data are noteworthy:

Group	Mean TBWL
Published multicenter average (Ienca 2020, n=1,770)	~15% (14.9%)

In clinical studies, a mean total body weight loss of approximately 15% (14.9%) has been reported (PMID: 32279182). Individual results may vary.

---

Safety Summary

The safety profile derived from a database of 200,000+ placements:

• Serious adverse events: <0.2% (PMID: 32279182, Ienca et al. 2020)
• Deaths reported: none
• Requiring endoscopic intervention: very rare
• FDA PMA Class III approval (February 2026) — a regulatory approval class (PMA) that requires comprehensive clinical evidence for Class III devices

---

Individual Factors That Influence Results

Although the group average is strong, individual results are shaped by the following factors:

Factor	Effect
Starting BMI	Higher starting BMI → greater absolute kg loss
Program adherence	App + scale use = better results
Dietary change	Calorie restriction and adequate protein
Physical activity	Preserving muscle mass + supporting metabolism
Physician follow-up	Remote monitoring positively associated with adherence
Psychological readiness	Commitment to the program strengthens long-term maintenance

---

A Realistic Expectation

Clinical data show a group average of 14.9% TBWL. For someone starting at 80 kg, that means roughly 12 kg. However:

• Some patients achieve results well above this average
• Some patients may lose less weight
• The 95% weight-maintenance rate depends on the program's behavioral-change component

To support the benefit you expect from the program: fully engage with the program alongside the balloon.

---

Continue reading:

• How Much Weight Can You Lose With a Gastric Balloon? →
• The Allurion 6-Month Program Journey →
• Clinical Evidence →
• Calculate Your BMI →
• Find a Specialist →

---

This content is for informational purposes based on clinical study data. For a personal weight-loss estimate, consult your specialist physician.

An Authorized Clinic in a City Near You

You can access the Allurion Program at more than 60 authorized clinics across Türkiye. For clinics in major cities:

• Gastric balloon clinic in İstanbul →
• Gastric balloon clinic in Ankara →
• Gastric balloon clinic in İzmir →
• Gastric balloon clinic in Antalya →
• Find a specialist in all cities →

Footnotes

1. Weight-maintenance rate of ~95% at 12 months; Caballero et al., Obesity Surgery 2025 (PMID: 40676353). ↩