French health authorities decided today, Tuesday, to immediately withdraw a gastric balloon designed to combat obesity from the markets. The balloon is intended to assist in weight loss without the need for major surgical intervention. However, the National Agency for the Safety of Medicines stated in an official announcement accompanying the withdrawal decision that it "may cause serious complications." The agency added, "The company Alurion (the manufacturer) must immediately remove the gastric balloons it produces from the French market to protect patient health and safety."
The gastric balloon aims to help individuals suffering from severe obesity or excess weight lose weight, and its principle of operation is similar to a band, as it reduces the available space for food in the stomach, but does not require significant surgical intervention. The balloon, developed by Alurion, a startup founded in the United States but very active in France, should be swallowed in capsule form and remains effective for four months before being reabsorbed.
However, its use is controversial; while health authorities in France allow it, they do not recommend it due to doubts surrounding its long-term benefits and its high cost, which may reach several thousand euros. Its risks have been proven, as according to the National Agency for the Safety of Medicines, serious side effects have been reported, such as intestinal obstruction or stomach perforation. The agency, which had previously issued a warning about it in mid-July, has decided to stop the sale and use of the balloon, knowing that several thousand of these balloons are used annually.
