The Agence nationale de sécurité du médicament et des produits de santé (ANSM, National Medicines Safety Agency) in France has suspended the marketing, distribution, use and advertising of Allurion gastric balloons. This decision follows the increase in the number of reports of adverse effects over the last two years, the lack of monitoring of gastric balloon insertions, the lack of specific training in the management of these complications outside the insertion sites, as well as the advertising of Allurion balloons that does not comply with regulations, the Agency has announced.
The Allurion gastric balloon is indicated for patients who are living with overweight or obesity when their body mass index (BMI) is greater than or equal to 27.0 kg/m2. The balloon is ingested under the supervision of a healthcare professional and then filled with liquid to inflate in the stomach.
According to the instructions, it is evacuated through the natural tract after approximately 16 weeks.
Over the past two years, several cases of gastrointestinal complications such as intestinal obstructions, gastric obstructions, gastric perforations have been reported to the Agency. These complications, mentioned in the instructions for the Allurion gastric balloon, have sometimes led to endoscopic or surgical intervention. Due to the urgency of the treatment, the latter is not always carried out within the establishment in which the medical device is fitted, creating the risk of a lack of training in the management of complications associated with this device for healthcare personnel.
Furthermore, adequate medical monitoring of patients with Allurion gastric balloons is not provided by the manufacturer, although this would prevent the occurrence of complications and ensure, if necessary, their management.
In order to reduce this risk, the agency has asked Allurion to inform all healthcare professionals of the recommendations regarding the management of patients in the event of serious gastrointestinal complications. In addition, it has also asked healthcare professionals and patients to report any adverse effects or incidents related to this device.
Furthermore, there are alternatives as first-line treatment for overweight or obesity. In addition, the Agency stated that the advertising for the Allurion balloon is not objective, particularly with regard to the risks of adverse effects and the contraindications associated with it.
For these reasons, the Agency has suspended the import, export, placing on the market free of charge or for a fee, wholesale distribution, possession for the purpose of sale or free distribution, advertising and use of the Allurion gastric balloon until measures are put in place to stop the potential risk to the health and safety of patients.
Advice for healthcare professionals includes:
Allurion gastric balloons can no longer be fitted in France, return them to your supplier.
Inform your patients who have this balloon of this decision and what to do in the event of an adverse effect.
Ensure close monitoring of your patients to detect as early as possible any adverse effects that would require treatment.
If one of your patients experiences an adverse event, report it on the Adverse Health Event Reporting Portal
If you are treating a patient and are not the one who initiated the balloon placement, consult the implant card presented by the patient to access specific information allowing appropriate management in the event of an adverse effect.
If the patient does not have their card, consult the leaflet to access specific information allowing appropriate care in the event of an adverse effect
Allurion response
In a statement, Allurion has said that whilst they disagree with ANSM’s decision, the company is cooperating fully and in active dialogue with the agency on developing and executing a remediation plan to reduce certain risks associated with the advertising, follow-up program, and adverse events for the Allurion Balloon.
The company stated that complication rates for the Allurion Balloon in France, as well as globally, remain in line with the rates reported in the published literature and lower than those published for other weight loss products.
The added that safety and effectiveness of the Allurion Balloon has been well-established in 20 peer-reviewed journal articles and with over 150,000 patients treated around the world. The benchmark serious adverse event rate of 0.34% for the Allurion Balloon was published by Ienca et al. in 2020 in a multicenter study of 1,770 patients treated with the Allurion Balloon.
To view the ANSM announcement, please click here
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