Ask about approval before a gastric balloon, and ask for your balloon card afterwards

In this article

1. First question: is it approved in Türkiye?
2. Is FDA approval an extra assurance?
3. Ask for your balloon card after the procedure
4. Why does the card matter?
5. Frequently asked questions

First question: is it approved by the Turkish Ministry of Health?

Ask your doctor first: “Does the gastric balloon you will use have Ministry of Health approval?”

What people call “Ministry of Health approval” means the product conforms to Türkiye’s medical device regulations and has the required registrations. Ask for the balloon’s brand and model, its registration status in the Product Tracking System (ÜTS) and its conformity documents. ÜTS is the system where medical device information can be checked and devices can be tracked.

The first thing to look for is that the product meets the registration and conformity requirements to be used legally in Türkiye.

If it has FDA approval, is that an extra assurance?

Second, you can ask: “Does this balloon also have FDA approval?”

FDA approval shows that the model has also been evaluated in the United States for specific conditions of use, so it can offer the patient extra assurance. However, not every gastric balloon used in Türkiye has to be FDA-approved, and FDA approvals apply to a specific model and specific conditions of use.

The priority is therefore registration and conformity in Türkiye; FDA approval, if present, is an additional factor. No approval means a procedure is risk-free. Complications can also occur with approved gastric balloons.

Always ask for your balloon card after the procedure

After the procedure, ask your doctor for the patient card or document with the identification details of the balloon placed. Often called the “balloon certificate card”, this document or the accompanying procedure report should include:

• Brand and model of the balloon
• Serial or lot number
• Placement date
• Recommended duration of use
• Planned removal date, if applicable
• Details of the physician and centre that performed the procedure

Keep the card and the procedure report. Saving photos of them on your phone also makes it easier to reach this information when needed.

Why does this card matter?

After the procedure you may need to go to a different hospital or be assessed by another doctor. Especially in the event of a complication, it is important for the treating doctor to know which balloon was placed, when, and how long it was planned to stay in the stomach.

This information can help with assessment and the treatment plan. But if you don’t have your card with you, do not delay seeking medical help; always tell the care team that you have a gastric balloon.

In short: before a gastric balloon, check its approval and registration in Türkiye and ask about any FDA approval; after the procedure, don’t forget your balloon card. If you are considering a gastric balloon in Ataşehir or Istanbul, you can ask these questions at your first consultation.

Clinic in Ataşehir, Istanbul and nearby districts

For questions on this topic and a personal assessment, you can book an appointment at Op. Dr. Salim Balin’s clinic in Ataşehir.

The clinic is in Atatürk Mahallesi, Ataşehir, in Metropol İstanbul Block B. Besides the Barbaros, İçerenköy, Küçükbakkalköy, Kayışdağı, Yenisahra and Ferhatpaşa neighbourhoods of Ataşehir, we see patients from Kadıköy (Kozyatağı, Bostancı, Göztepe, Erenköy), Ümraniye, Maltepe, Çekmeköy, Sancaktepe, Üsküdar, Kartal and other districts of Istanbul.

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

Ask me

Get in touch with your questions about Gastric balloon approval and balloon card or to request an appointment.

💬 Ask me on WhatsApp — +90 506 520 30 55

✉️ Ask me by email — info@drsalimbalin.com