ANSM warning on Allurion gastric balloon: serious risks and complications detected
The ANSM issues a warning on the use of the Allurion gastric balloon, pointing out the risks of serious gastrointestinal complications
The device under indictment is the gastric balloon produced by the American start-up Allurion, which is popular in France. The gastric balloon is a device that is used to help obese or overweight people lose weight. It works by inserting a balloon into the stomach via a capsule ingested by the patient. This reduces the space available for food by promoting satiety and weight loss.
Incidents and complications due to the Allurion gastric balloon
To date, ANSM has recorded numerous incidents reporting serious gastrointestinal complications related to the use of the Allurion balloon. These include cases of intestinal obstruction and gastric perforation.
A controversial device
Despite being authorized in France, the Allurion gastric balloon does not enjoy unqualified support from health authorities. In fact, the ANSM raises doubts about its long-term benefits and its high cost, which can reach several thousand euros and is not reimbursed by the National Health System. In addition, the agency points out the lack of adequate information for patients and professionals who perform the device implantation. In fact, the procedure is often performed in facilities, such as aesthetic medicine centers, that are not equipped to handle any serious complications.
Call for greater transparency
The ANSM urged Allurion to provide all healthcare providers with clear and precise guidelines and necessary recommendations for the management of patients in case of serious gastrointestinal complications. The agency also reiterates that the gastric balloon insertion procedure should always be supervised by a physician and urges patients to thoroughly inform themselves about the risks and benefits of the device before undergoing any treatment.
A call for caution
The ANSM alert emphasizes the need for increased caution in the use of the Allurion gastric balloon. Patients and health professionals need to be aware of the potential risks and the still uncertain long-term benefits of this device. The choice to undergo this type of treatment should be made in an informed and informed manner, after careful evaluation of individual risks and benefits by balancing weight loss expectations with potential complications.
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