2024-07-18 04:22:41
The balloon works similarly to a ring, reducing the space in the stomach that can hold food but requiring little surgery. According to ANSM, serious side effects have been reported.
The Medicines Agency warned on Thursday (July 18) that startup Allurion’s gastric balloon, which promises to help with weight loss without surgery, might cause serious complications.
The National Agency for the Safety of Medicines (ANSM) said: “Following several reported incidents of serious gastrointestinal complications, we are calling for vigilance around the use of these gastric balloons.” a statement.
Little or no surgery required
A gastric balloon is a device designed to help obese or overweight people lose weight. The principle is similar to a ring, reducing the space in the stomach that can hold food, but a balloon requires little or no surgery.
In the case of the balloon developed by Allurion, a startup founded in the United States but active in France, the device must be swallowed in capsule form and then remain active for four months before being absorbed.
According to details from ANSM, this is the only gastric balloon that works in this way and is the most widely used in France.
serious side effects
But its interests are far from unanimous. In France, health authorities have approved the practice but do not recommend it due to doubts regarding its long-term benefits and costs that run into thousands of euros. Therefore, the cost will not be reimbursed, but that does not prevent dozens of private clinics from offering such balloon implants.
In addition to these considerations, there is also the issue of risk. Serious side effects, such as intestinal obstruction or stomach perforation, have been reported, according to the ANSM. The agency said it has logged regarding 20 reports since 2016.
Risk of complications
These risks are certainly noted in the balloon’s instructions, but the drug agency laments the lack of information for patients and even the professionals who oversee implantation of the device.
In fact, this service is often provided in institutions, mainly simple cosmetic medicine centers, which are not equipped to treat potentially serious problems urgently.
ANSM cautioned that the procedure absolutely must be performed under physician supervision and asked Allurion to “inform all health professionals regarding recommendations for the management of patients in the event of serious gastrointestinal complications.”
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