Swallowable gastric balloon in Ataşehir, Istanbul: FDA approval, Ministry of Health oversight and 10 questions
Short answer: A swallowable gastric balloon is a non-surgical obesity treatment: a capsule swallowed with water is filled with fluid in the stomach, takes up volume for about 4 months, then empties itself and passes naturally. No endoscopy or anaesthesia is needed and placement takes about 15 minutes. The Allurion Gastric Balloon System received premarket approval (PMA) from the US Food and Drug Administration (FDA) on 23 February 2026; in Türkiye it is used in a hospital setting under the oversight of TİTCK, the Ministry of Health’s medicines and medical devices agency.
The swallowable gastric balloon at a glance
- Duration: The balloon stays in the stomach for about 4 months; the programme runs 6 months with dietitian follow-up.
- Procedure: About 15 minutes under physician supervision in a hospital setting, with no endoscopy or anaesthesia.
- Who it is for: People aged 16–65 with a body mass index (BMI) of 27 or above who have tried to lose weight before; under 18, parental consent is required.
- Approval: FDA premarket approval in the US (February 2026); in Türkiye under TİTCK oversight, unrestricted since March 2025.
- Ataşehir and Istanbul: Op. Dr. Salim Balin plans the treatment with dietitian support at his practice in Ataşehir, for patients from both sides of Istanbul.
A meta-analysis of seven prospective studies of the swallowable balloon reported an average total body weight loss of about 12% and an early deflation rate of about 1.8% (Ramai et al., J Clin Gastroenterol, 2021). Results depend on adherence to the nutrition programme, physical activity and the starting point; this is not a promise of individual results.
FDA approval: February 2026 premarket approval (PMA)
The FDA granted premarket approval to the Allurion Gastric Balloon System on 23 February 2026. PMA is the FDA’s most rigorous pathway for high-risk medical devices.
- The approval rests on the multicentre, randomised AUDACITY trial of 550 participants and real-world data from outside the US.
- The trial reported a 3.1% serious adverse event rate, which the manufacturer describes as the lowest in any FDA pivotal trial of a fluid-filled intragastric balloon.
- Outside the US the device has been used in more than 200,000 patients.
Türkiye: Ministry of Health and TİTCK oversight
- In January 2025 TİTCK temporarily suspended use of the device as a precaution during a European review; this was not a licence cancellation or recall.
- In March 2025 the Ministry of Health concluded that serious risks had been resolved for the Allurion system supplied in Türkiye and lifted the earlier measures.
- Experts stress that placement should only be done in a hospital setting by a general surgeon or gastroenterologist.
- Medical devices in Türkiye are registered in the Product Tracking System (ÜTS); you can ask your physician to show the device’s ÜTS record and original packaging.
How the process works in Ataşehir and Istanbul
Ataşehir is close to Kadıköy, Ümraniye, Maltepe, Üsküdar and Çekmeköy, with metro and motorway links that make it easy to reach on Istanbul’s Asian side. Patients from the European side can reach it easily via Kadıköy.
- Initial consultation, BMI and medical history review
- Blood tests and any required examinations
- Placement in about 15 minutes in a hospital setting
- Liquid and soft diet in the first days, with physician follow-up
- A 6-month nutrition programme with a dietitian, with remote tracking via a smart scale and mobile app
The initial consultation, nutrition plan and follow-up visits take place at Op. Dr. Salim Balin’s clinic in Ataşehir; the balloon itself is swallowed in a hospital setting in line with regulations. For details, see our swallowable gastric balloon in Ataşehir page.
Address: Atatürk Mahallesi, Ertuğrul Gazi Cad. No: 2H, Metropol İstanbul B Blok, Floor 18, No: 282, 34750 Ataşehir/Istanbul · Monday–Saturday 09:00–18:00 · +90 506 520 30 55 · WhatsApp · Address and directions
The clinic is in Atatürk Mahallesi, Ataşehir (Metropol İstanbul Block B), close to the Barbaros, İçerenköy, Küçükbakkalköy, Kayışdağı, Yenisahra and Ferhatpaşa neighbourhoods and to Kozyatağı, Bostancı, Göztepe and Erenköy in Kadıköy. Patients from Sancaktepe and Kartal are also welcome.
The swallowable gastric balloon in 10 questions
What is a swallowable gastric balloon and how does it work?
It is a non-surgical obesity treatment placed by swallowing a capsule attached to a thin catheter. An X-ray confirms the capsule is in the stomach, then fluid is given through the catheter to fill the balloon. The balloon takes up space, so you feel full sooner and portions shrink naturally.
Is the swallowable gastric balloon FDA-approved?
Yes. The Allurion Gastric Balloon System received premarket approval (PMA) from the US Food and Drug Administration on 23 February 2026, based on the randomised AUDACITY trial of 550 patients.
Is it permitted by the Turkish Ministry of Health?
Yes. TİTCK suspended the device as a precaution in January 2025 and lifted the measure in March 2025 after concluding serious risks had been resolved. It is used today under TİTCK oversight, in a hospital setting, by specialist physicians.
Who is a candidate for a swallowable gastric balloon?
People aged 16–65 with a BMI of 27 or above who have tried dieting; under 18, parental consent is required. Eligibility is decided individually after examination, blood tests and an assessment of stomach health.
Who should not have a swallowable gastric balloon?
People with previous stomach surgery, during pregnancy or breastfeeding, or with an active ulcer, severe reflux, a large hiatal hernia or difficulty swallowing. Blood thinner use requires separate planning with your physician.
How is it placed and how long does it take?
About 15 minutes, with no endoscopy, anaesthesia or surgery. The capsule is swallowed with a glass of water, its position is checked by X-ray and the balloon is filled. Most patients go home the same day.
How much weight can you lose?
Results vary and cannot be guaranteed. Data submitted to the FDA reported an average total body weight loss of about 14% when the balloon was combined with a behaviour change programme. Lasting success depends on dietitian follow-up and lifestyle change.
How does the balloon leave the body?
After about 4 months a timed valve opens, the fluid drains and the balloon passes naturally. No endoscopy is needed. If appropriate, a second balloon can be placed about 2 months after the first has passed.
What are the side effects and risks?
Nausea, vomiting and cramps are common in the first 2–3 days and ease with prescribed medication and a liquid diet. The FDA trial reported a 3.1% serious adverse event rate, which is why placement should be done in a hospital setting by an experienced general surgeon or gastroenterologist.
What does a swallowable gastric balloon cost in Ataşehir and Istanbul?
The cost depends on the device, consultation and tests, and the length of dietitian follow-up; it is not covered by SGK. Op. Dr. Salim Balin’s practice is at Atatürk Mahallesi, Ertuğrul Gazi Cad. No: 2H, Metropol İstanbul B Blok, Floor 18, No: 282, Ataşehir / Istanbul. For current information and appointments, call or WhatsApp +90 506 520 30 55. Details: gastric balloon cost 2026
Where is the swallowable gastric balloon provided in Ataşehir?
The consultation and follow-up take place at Op. Dr. Salim Balin’s clinic at Atatürk Mahallesi, Ertuğrul Gazi Cad. No: 2H, Metropol İstanbul B Blok, Floor 18, No: 282, 34750 Ataşehir/Istanbul; the balloon is swallowed in a hospital setting in line with regulations. For appointments, call or WhatsApp +90 506 520 30 55.
Related guides
Swallowable gastric balloon treatment ↗
Gastric balloon: endoscopic or swallowable? ↗
Sources and further reading
Ramai D et al. Influence of the Elipse intragastric balloon on obesity and metabolic profile: a systematic review and meta-analysis. J Clin Gastroenterol. 2021;55(10):836–841 ↗Patient Care · FDA approves first smart capsule for obesity: AUDACITY results (23 Feb 2026) ↗MassDevice · Allurion gets FDA nod for weight loss balloon (23 Feb 2026) ↗Allurion · Indications and safety information ↗CNN Türk · Turkish Ministry of Health lifts measures on the swallowable balloon (7 Mar 2025) ↗Diken · Nature of the TİTCK measure and SGK coverage (2025) ↗For information only. Diagnosis and treatment require medical assessment; your personal treatment plan is decided at consultation.
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Get in touch with your questions about Swallowable gastric balloon or to request an appointment.
💬 Ask me on WhatsApp — +90 506 520 30 55
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Metropol İstanbul Block B, Floor 18 · Ataşehir/Istanbul · Directions ↗