The Medicines Safety Agency is calling for vigilance for patients who have an Allurion gastric balloon

Thousands of French people have a gastric balloon from the American brand Allurion fitted each year. This device is not reimbursed by Social Security.

The French Medicines Safety Agency (ANSM) is asking patients and doctors on Thursday, July 18, to be more vigilant regarding gastric balloons from the Allurion brand, franceinfo learned, having been able to consult this document. These balloons help you lose weight; they remain in the patient’s stomach for more than three months. Over the past two years, the ANSM has noted 23 cases of very serious adverse effects.

Every year, a few thousand French people have a gastric balloon from the American brand Allurion fitted. This is a device that is not reimbursed by Social Security. The patient swallows a capsule connected to a catheter. Once in the stomach, the doctor fills the balloon with liquid via the catheter, the device inflates and fills part of the stomach, creating a feeling of satiety. With this technology, the American manufacturer promises to lose 10 to 15% of its weight in a little over three months (16 weeks). Then, the balloon deflates and it is evacuated through the natural channels.

However, while it is inflated in the stomach, serious adverse effects can occur, the ANSM observed. “Over the last two years, we have had 23 reported cases, which is low, but sometimes with cases that required reinterventions. (sic) endoscopic surgical”explains Gwenaëlle Even, deputy director of medical devices, cosmetics and in vitro diagnostic devices. Among the complications cited by the ANSM, there are intestinal occlusions, pyloric obstructions (obstruction of the stomach outlet) or gastric perforations.

Patients are therefore urged to be more vigilant. The ANSM cites a number of warning signs: persistent nausea, vomiting, constipation, diarrhea, dehydration, pain, cramps or abdominal discomfort, abdominal distension, or any unexpected symptoms such as fever or gastrointestinal bleeding.

If any of these symptoms appear, the patient should “see a health professional, ideally the one who gave them the ball”advises Gwenaëlle Even. The ANSM asks patients and health professionals to report any problems related to these Allurion gastric balloons.