Who Is the Smart Capsule Not Suitable For? Contraindications

The Allurion Smart Capsule (swallowable gastric balloon) is a weight management program that requires no surgery, no endoscopy, and no anesthesia. The program is generally evaluated for individuals aged 18 and over with a BMI (body mass index) of 27 and above. However, it is not suitable for every candidate; certain health conditions constitute a contraindication (a condition in which it should not be applied). Eligibility is determined only through a physician's examination.

Absolute Contraindications — Not Applied

The Smart Capsule is not applied in the following situations:

• Previous upper gastrointestinal or bariatric (stomach) surgery (sleeve gastrectomy, gastric bypass, etc.)
• Active stomach or esophageal pathology: ulcer, erosive gastritis, large hiatal hernia, stricture, or similar structural problems
• Untreated active H. pylori infection (must be treated first)
• Pregnancy or breastfeeding
• Bleeding disorder (hemorrhagic diathesis) or regular blood thinner (anticoagulant) therapy
• Known allergy to the balloon material
• Uncontrolled severe psychiatric disorder or active eating disorder
• Alcohol or substance dependence

Conditions Requiring Careful Evaluation

Some conditions, while not constituting an absolute barrier, require additional evaluation, and the decision is made by the physician:

• Chronic NSAID (pain reliever) or steroid use
• Severe gastroesophageal reflux (GERD)
• Uncontrolled chronic illnesses
• Advanced age or accompanying serious medical conditions

Who May Be Eligible?

Individuals who do not have the contraindications listed above, who are aged 18 and over with a BMI of 27 and above, and who are ready for lifestyle change may be candidates. In clinical studies, a mean 14.9% total body weight loss has been reported with the Smart Capsule program (Ienca et al., Obes Surg 2020, n=1,770, PMID 32279182). Individual results may vary.

How Is Eligibility Determined?

The process begins with a preliminary evaluation consultation. During this consultation, your medical history, your BMI, and possible contraindications are assessed. When the physician deems it necessary, they may request an H. pylori test or a stomach evaluation. The Smart Capsule program received FDA PMA Class III approval on 23 February 2026; the procedure is performed only at an authorized clinic and with physician approval.

This content is for informational purposes and does not replace medical advice. The eligibility decision is made only through a physician's examination.