Quality and Risk | Allurion Gastric Balloon

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Allurion Technologies is committed to designing and manufacturing medical products of the highest quality. Allurion received ISO13485:2016 certification of the quality management system that governs the production and manufacturing of the Allurion System.

This medical device is a regulated healthcare product, which under European regulations bears the CE mark.

© 2024 Allurion Technologies Inc., All rights reserved.

The Allurion Balloon is a temporary weight loss aid for adults over the age of 18 who are overweight or obese, defined as a body mass index (BMI) ≥ 27. The Allurion Balloon can only be administered by a healthcare professional who is knowledgeable about the use of the Allurion Balloon. The Allurion Balloon must be used in conjunction with a supervised nutrition and behavior modification program.

Some individuals may not be eligible to receive the Allurion Balloon. Your doctor will take a detailed medical history and perform a physical examination to determine your eligibility. It is important to provide your physician with a complete and accurate medical history.

In rare cases, the Allurion Balloon may require endoscopic or surgical intervention for removal.

To further clarify risks and benefits of the Allurion device, please discuss with your physician. 

IFU

*As with any medical solution, results may vary from one patient to another, and some patients may not respond to treatment. Please consult a doctor to carefully evaluate the risks and benefits before making your decision.
**Some patients may experience earlier deflation of the Allurion Balloon. The removal of the Allurion Balloon may, in very rare cases, require an endoscopic or surgical intervention. In rare cases, instead of being expelled through the digestive tract, the empty balloon may be vomited out.
***Eligibility for the placement of an Allurion Balloon will be assessed by a certified doctor after an initial consultation and a careful review of your medical history. In the case of an extended Allurion Program, your eligibility is reassessed before each placement to ensure you continue to meet the required conditions.

R. Ienca et al. The procedureless ellipse gastric balloon program: Multicenter experience in 1770 consecutive patients. Obes surg. 2020;30(9):3354-3362. Multicenter, prospective, non-randomized, open registry study conducted in patients with overweight or obesity from January 2016 to June 2019 in 19 international obesity centers participating in the study. A total of 1,770 patients with an average BMI of 34.4 ± 5.3 kg/m2 at baseline underwent treatment with the Elipse swallowable gastric balloon, with a monthly visit and a total follow-up of 4 months. 63 patients (3.6%) did not complete the program, and the balloon was removed before 4 months due to intolerance or other adverse effects.
World Health Organization – Key facts on Obesity and overweight (who.int).
European survey finds over three-quarters of adults with obesity have attempted to lose weight in the past year, but most have been unsuccessful – EASO.
This information is extracted from the instructions for use of the Allurion Gastric Balloon System. Version number CS137-02-ENG. If you have any questions regarding this document, please consult your doctor.

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