One of the most frequently asked questions when deciding on a gastric balloon is this: "How safe is it?" In this article, we present the safety data published by clinical studies, the possible side effects, and the situations in which caution is needed.
Allurion and FDA Approval
The Allurion Program received FDA (U.S. Food and Drug Administration) PMA Class III approval in February 2026. This approval shows that the system meets the standards set by the U.S. regulator in terms of both efficacy and safety.
Common (Expected) Side Effects
The following are adaptation symptoms frequently seen with balloon treatments, and they are generally temporary:
| Side Effect | Frequency | Duration |
|---|---|---|
| Nausea | Common | First 3-7 days |
| Vomiting | Common | First 3-7 days |
| Stomach cramps | Common | First 1-2 weeks |
| Increased reflux | Moderate | Variable |
| Bad breath | Rare | Temporary |
These symptoms are the body's natural response to the balloon settling in. Your physician can provide medication support if needed.
Serious Complications: How Rare Are They?
In a multicenter study published in 2024 (n=571), the serious adverse event rate associated with the Allurion Balloon was reported to be **below 1%**¹. The reported serious complications are as follows:
- Early deflation of the balloon: The balloon deflates before 16 weeks; it is most often passed naturally
- Intestinal obstruction: Very rare; early deflation + the balloon becoming lodged in the small intestine
- Stomach ulcer: Risk of flare-up in a pre-existing ulcer
¹ PMID: 38804393 — Dejeu et al., 2024, n=571
Who Carries a Higher Risk?
- Those with an active stomach ulcer or gastritis
- Those whose reflux disease is not under control
- Those who have had prior stomach surgery
- Those with certain connective tissue disorders
- Those with severe liver disease
The presence of these conditions does not necessarily rule out the balloon treatment; however, it makes a physician evaluation mandatory.
Pre-Treatment Safety Checklist
Authorized clinics routinely perform the following assessments:
- Endoscopic stomach examination (or history review)
- Blood tests (liver, kidney function)
- Pregnancy test (for female patients)
- Medication interaction review
- History of prior stomach surgery
A Comparative Safety Perspective
In a large-scale comparative analysis published in 2026 (n=2,454), Allurion was shown to exhibit a similar efficacy and safety profile compared with balloons that require endoscopy².
² PMID: 41705686 — Bastid et al., 2026
Conclusion
The gastric balloon is an FDA-approved method with a good safety profile when applied with proper patient selection and under authorized clinical conditions. While serious complications are rare, making the decision together with a specialist is the most appropriate approach.
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An Authorized Clinic in a City Near You
You can have the Allurion Program performed at more than 60 authorized clinics across Türkiye. For clinics in major cities:
Clinical Sources
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