Statement from the Ministry of Health for those planning to get a 'gastric balloon'!

The Ministry of Health, Turkish Medicines and Medical Devices Agency (TİTCK), has announced that the supply and availability of a specific company's gastric balloon system have been suspended as a precautionary measure until a final decision is reached by the European Union (EU) Commission.

A statement was issued by the Ministry of Health regarding the news report titled "gastric balloon is now banned" that appeared in the media.

The statement, which noted that the source of the news in question was an announcement on the official TİTCK website, shared the following information: "In its announcement dated January 2, 2025, TİTCK stated that it has decided to suspend the supply, availability, recommendation, or display of all barcodes of a specific company's gastric balloon system as a precautionary measure until a final decision is made by the EU Commission; furthermore, it has been decided to restrict the product's movements within the TİTCK Product Tracking System."

The statement further explained that France, based on the view that the product in question could pose risks to patients when inserted under inappropriate conditions, has banned the application of this company's gastric balloon system within its borders and has also applied to the EU Commission for a total ban across Europe, adding: "The Turkish Medicines and Medical Devices Agency under the Ministry of Health has also suspended the application of the gastric balloon system in question in Turkey for the duration of the decision-making process by the EU Commission."

News Source: 12punto