(Source-www.unicarna.com)
The National Agency for the Safety of Medicines (ANSM) has issued a warning on Thursday, July 18, about the potential risks linked to the Allurion gastric balloon. This warning follows several reports of serious gastrointestinal complications in France.
Serious Complications Linked to Allurion Gastric Balloon
The Allurion gastric balloon, marketed as a non-surgical weight loss solution, has been associated with significant health risks, according to the ANSM. “We urge caution regarding the use of these gastric balloons following multiple reports of serious gastrointestinal complications,” the agency stated in a press release.
A gastric balloon is designed to assist obese or overweight individuals in losing weight by reducing the stomach’s capacity for food, similar to the function of a gastric band but without the need for invasive surgery. The Allurion balloon, developed by a US-based start-up with a strong presence in France, is unique in that it is ingested in capsule form and remains in the stomach for four months before being naturally excreted.
Debate over Efficacy and Cost
Despite its innovative approach, the Allurion gastric balloon has faced scrutiny regarding its long-term effectiveness and high cost, which can amount to several thousand euros. While French health authorities permit its use, they do not recommend it due to these concerns. Additionally, the procedure is not covered by insurance, though it is offered by numerous private clinics.
Since 2016, the ANSM has recorded approximately twenty incidents involving the Allurion gastric balloon, including cases of intestinal obstructions and gastric perforations. These severe side effects highlight the importance of proper patient and professional education about the potential risks associated with the device.
Lack of Adequate Information
The ANSM has criticized the lack of comprehensive information provided to both patients and healthcare professionals about the risks. The agency emphasizes that the procedure should be strictly overseen by a qualified physician, particularly given that many aesthetic medicine centers offering the balloon are not equipped to handle emergencies.
In light of these concerns, the ANSM has called on Allurion to enhance their communication with healthcare providers regarding the management of serious gastrointestinal complications. This step is essential to ensure that all involved parties are fully informed and prepared to address any adverse events promptly.
The warning from the National Agency for the Safety of Medicines serves as a critical reminder of the potential dangers associated with the Allurion gastric balloon. While the device offers a non-surgical weight loss solution, the risks must be carefully weighed, and proper medical oversight is crucial. As the debate over its efficacy and safety continues, it is imperative that patients receive thorough information and that healthcare professionals are well-prepared to manage any complications.
