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Allurion gastric balloons are being singled out by the ANSM. The cause: the reporting of several incidents reporting gastrointestinal complications for patients.
Gastric balloons are medical devices that help people who are obese or overweight. They are placed in the patient’s stomach to reduce the space available inside.
A device that does not require surgery
One of the advantages of the gastric balloon is that it does not require surgery. In particular, that of the start-up Allurion, which is presented in the form of a capsule to be swallowed. Connected to a catheter, the balloon will be filled with water once installed in the stomach, to reach the size of a grapefruit. The balloon thus ingested remains active for four months in the patient’s stomach, before being reabsorbed. The manufacturer promises a loss of 10 to 15% of the patient’s body weight, after this period of time.
A warning from the ANSM
In March 2023, Doctissimo interviewed Dr. Jean-Nicolas Boullenois, a bariatric surgeon, who considered that the device was not “magic”, but admitted that it is a product with “very interesting” effectiveness, causing few side effects and complications (around 2 in 1,000).
Today, the National Agency for the Safety of Medicines (ANSM) warns of its risks.”We call for vigilance regarding the use of these gastric balloons following the reporting of several incidents reporting serious gastrointestinal complications.” she said in a press release.
Risks of gastric occlusion or perforation
Currently, this type of medical device is authorized in France, but not particularly recommended by the health authorities and not reimbursed. Now, added to this are the reports of serious side effects, such as gastric perforations or intestinal occlusions. In total, around twenty reports have been brought to the attention of the ANSM since 2016.
The Agency therefore invites patients to remain vigilant and reminds them of the warning signs:
In the presence of one or more of these symptoms, it is recommended that patients consult a doctor without delay, with their implant card. Finally, be aware that the installation of a gastric balloon, like any medical procedure, presents a benefit-risk balance to be weighed with an obesity specialist, because zero risk does not exist.