Alarm over gastric balloons in France, also used in Italy

Weight Loss Solutions for Severe Obesity: Gastric Balloons

In patients with severe obesity, one of the solutions to lose weight is the use of gastric balloons.
This minimally invasive procedure involves inflating a balloon in the stomach, which reduces hunger and induces satiety much earlier due to the limited space it occupies, ultimately leading to weight loss.

European Adoption and French Regulatory Alert

This weight loss solution is widely adopted throughout Europe, including Italy.
However, the French Agency for the Safety of Medicines has recently issued a warning regarding gastric balloons, particularly those manufactured by an American company, urging patients and healthcare professionals to exercise caution.
Let’s delve into the reasons behind this alert.

Alarm Bells Ringing: Adverse Effects of Gastric Balloons

The French Agency has reported several cases of adverse effects related to gastric balloons branded as Allurion, a brand present not only in France but also in Italy.
Over the past two years, there have been 23 severe adverse cases, prompting a call for heightened vigilance and caution.

Thousands of individuals choose to undergo gastric balloon placement in their stomachs annually to aid in weight loss.
The installation of Allurion balloons is a relatively simple process – the patient swallows a capsule that inflates in the stomach, providing a sensation of fullness by occupying space.
Patients may expect to lose between 10 to 15 kilograms within three months.
Subsequently, the balloon deflates and passes through the intestines without issue.

Complications and Warning Signs

However, according to the French National Agency for the Safety of Medicines (ANSM), issues may arise when the balloon is inflated in the stomach.
Complications include intestinal obstruction, pyloric obstruction, and gastric perforations.
In certain instances, endoscopic surgical intervention has been necessary to address these complications.
Patients must be vigilant for symptoms that may signal a problem, such as persistent nausea, vomiting, constipation, diarrhea, dehydration, pain, cramps, abdominal discomfort, bloating, or any unexpected symptoms like fever or gastrointestinal bleeding.

If any of these warning signs manifest, consulting a healthcare provider, ideally the physician who oversaw the balloon placement, is recommended.
Patients and healthcare professionals are advised to be cautious during the placement procedure to minimize adverse events.
The ANSM has requested patients and healthcare providers to report any issues associated with Allurion gastric balloons.

Unique Features of Allurion Balloons

Unlike traditional gastric balloons, the Allurion balloon does not require endoscopy or anesthesia.
It can be placed on an outpatient basis without the need for hospitalization.
By simply swallowing a pill, the balloon expands in the stomach until full.
After four to five months, it is naturally expelled.
Obese patients eligible for the Allurion balloon placement undergo a comprehensive multidisciplinary program involving various specialized healthcare providers.

For further information, read about how a new insidious disease is spreading in Italy and Spain.