Seven months after suspending sales of its weight loss balloon in France due to safety concerns, Allurion’s products are back on sale in the country.
In August 2024, the US company agreed to pull the balloon from sales in France after the country’s National Medicines Safety Agency (ANSM) identified adverse events linked with the device. Allurion said that the French regulatory authority has now cleared the company to resume sales.
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Talking to Medical Device Network, Allurion CEO Shantanu Gaur said: “ANSM requested changes to our advertising, patient follow-up, and physician training, which we have now implemented and look forward to deploying now that we are free to resume sales in France.”
Gaur confirmed that no changes were requested to the design of manufacturing of the balloon, the sales of which in France account for around 15% of Allurion’s revenue. The balloon has been approved in Europe since 2015.
Allurion reported positive results in January 2025 from a pivotal trial intended to make up the final module in a pre-market approval application to the US Food and Drug Administration (FDA) as it eyes approval in the world’s largest obesity market. In that trial, named AUDACITY, Allurion reported a serious adverse event rate of 3.1%. According to the company, this is the lowest value for a device of its kind recorded in an FDA pivotal trial.
Allurion’s device is swallowed as a capsule and then filled with liquid. From there, the balloon acts like a traditional gastric balloon that promotes weight loss by mimicking a full stomach. Unlike other approaches, Allurion’s balloon does not require surgery, endoscopy, or anaesthesia. After around four months, the balloon releases the liquid on its own and it passes out of the body naturally.
Gual stated: “The safety of the Allurion Balloon has been well-established in 20 peer-reviewed publications and over 150,000 patients we estimate that we have treated commercially. Adverse event rates for the Allurion Balloon remain at historical lows.”
The safety concerns that catalysed the withdrawal in France were linked to gastrointestinal complications. Some adverse events from the balloon, Allurion say, may require removal by endoscopy.
Safety hasn’t been Allurion’s main concern over the past year, however, as the company continues to battle weakening financial performance. With pressures exerted mainly from the increase in popularity of glucagon-like peptide-1 receptor agonist (GLP-1RA) weight loss drugs, the company’s revenue decreased from $18.2m in Q3 2023 to $5.4m in Q3 2024.
In a turn of form, Allurion pivoted to embrace the pharmaceutical industry’s new offerings, announcing plans for a clinical study to evaluate its balloon in combination with GLP-1RAs. The company is targeting the loss in lean mass seen in patients taking GLP-1RAs. Although its weight loss programme does not lead to as much weight loss as blockbusters Wegovy (semaglutide) and Mounjaro (tirzepatide), it does conserve more muscle mass.
Shares in the NYSE-listed company rose 77% at the time of the announcement in late January and although stock has since fallen, the decision could provide an avenue to turnaround financial performance. On the back of the return to the French market, Allurion is targeting clinics in the country for its new study.
“As we expand our clinical research pipeline, we are also exploring with French clinics a trial to demonstrate how the Allurion balloon may be combined with GLP-1s to solve one of the biggest problems in obesity… a successful trial could lead to the development of a gold-standard obesity treatment,” Guar said in a statement.
