07.01.2025 19:10
The Ministry of Health has temporarily suspended the application of a stomach balloon system belonging to a company until the final decision of the European Commission, according to the Turkish Medicines and Medical Devices Agency (TITCK).
The Ministry of Health announced that the market release and availability of a stomach balloon system belonging to a company has been temporarily suspended until a final decision is made by the European Union (EU) Commission.
MARKET RELEASE SUSPENDED FOR PRECAUTIONARY REASONS
An explanation was made regarding the news titled "stomach balloon is now banned" that appeared in the media from the Ministry of Health. In the statement, it was noted that the source of the news was the announcement on the official website of the Turkish Medicines and Medical Devices Agency (TİTCK), which stated, "In its announcement dated January 2, 2025, TİTCK announced that the market release, availability, recommendation, or display of all barcodes of a stomach balloon system belonging to a company has been suspended for precautionary reasons until a final decision is made by the EU Commission; furthermore, it was decided to restrict the product movements in the TİTCK Product Tracking System."
CAN POSE A RISK TO PATIENTS
In the statement, it was reported that France banned the application of this stomach balloon system in its country based on the view that it could pose a risk to patients due to improper conditions of use, and that it also applied to the EU Commission for a ban across Europe. It was stated that "The Turkish Medicines and Medical Devices Agency, which is affiliated with the Ministry of Health, has also suspended the application of the said stomach balloon system in Turkey until the decision process from the EU Commission is concluded."