Türkiye lifts ban on swallowable gastric balloons after safety review
The capsule is attached to a tube, through which water is put into the ballon before the tube is removed. (Photo via Allurion)
In a major development, Türkiye’s Health Ministry has lifted its earlier ban on swallowable gastric balloons following a safety review. The ministry’s decision comes after the European Commission completed its examination, concluding that the product no longer poses significant health risks.
Earlier this year, Türkiye had joined several European nations in banning the swallowable gastric balloon after concerns arose regarding its safety. Specifically, the European Commission found that the balloons were often not administered by general surgeons or gastroenterologists, and in some cases, were inserted in inappropriate conditions, leading to health complications. Consequently, Türkiye had complied with the ban. However, with recent findings, the ban has now been lifted.
Improved safety assessment
According to the Health Ministry’s recent statement, the concerns over the swallowable gastric balloons have been resolved. The ministry mentioned, “It has been concluded that there are no longer any indications of serious risks related to the products marketed under the label ‘Allurion Stomach Balloon System‘ by Biocalis Medical Medical Equipment Marketing and Trading Limited Company.”
The statement clarified that all previous restrictions on the sale, distribution, recommendation, and display of these products have been lifted.
Important conditions for swallowable gastric balloon’s safe use
Professor Oktay Banli, president of the Turkish Bariatric Surgery Foundation, emphasized that the swallowable gastric balloon can only be applied in hospital settings. He explained that the balloon is swallowed in capsule form, where it inflates inside the stomach. After about five to six months, there is no need for removal, as the balloon naturally dissolves. Although this procedure became popular due to its simplicity, it was found that complications arose when it was used outside appropriate medical conditions.
“Because the balloon was swallowed without proper examination, some patients developed gastric or intestinal problems,” said Professor Banli.
Repercussions of ban
The swallowable gastric balloon procedure has been widely practiced in both Türkiye and Europe. In 2024 alone, approximately 6,500 individuals in Türkiye and 25,000 people in Europe underwent the procedure.
With the ban lifted, the procedure will continue under strict medical supervision to ensure patient safety and avoid complications. However, the Health Ministry has made it clear that the balloons will only be available in hospital settings, administered by certified specialists, in line with the European Commission’s guidelines.
