Alert from the Swedish Medicines Agency: Many complications with gastric balloons

According to the Swedish Medicines Agency, an increasing number of serious complications are being reported in procedures with gastric balloons as a method for weight loss. The authority fears significant shortcomings in the information to patients both before and after the procedure.

“We are getting indications that some clinics are performing these interventions at the first doctor’s visit without informing the patient of the risks and complications that an intervention can entail. This is serious, and if complications occur, emergency care may be required,” says Helena Henriksson, Group Manager at the Swedish Medicines Agency, in a press release.

Gastric balloons, or intragastric balloons, were first used in Sweden in the 1990s, but the procedure was discontinued after extensive problems with side effects. After the product was developed with, among other things, new materials, the procedure was started again in 2017.

The gastric balloons are meant to contribute to weight loss by filling the stomach with liquid or air to increase the feeling of satiety thus partially preventing food intake. The balloon can be left in the stomach for up to 6–12 months, depending on the make.

However, there are risks with the procedure. According to the Swedish Medicines Agency, there have been deaths in patients who received a gastric balloon in other countries, and several serious incidents have led to the need for emergency hospital care, also in Sweden.

The Swedish Medicines Agency also suspects an under-reporting of the complications.

“A healthcare provider is always obliged to inform patients about the risks of gastric balloons and which preparations are required before the procedure. We now urge everyone who has suffered complications to report it to the Swedish Medicines Agency,” says Helena Henriksson.

According to the Swedish Medicines Agency, the risks with gastric balloons are not limited to individual brands but apply to the entire product range.

Treatments with gastric balloons are aimed at people with a BMI in the range of 27 - 40.

According to the Swedish Medicines Agency, the patient must first have tried to lose weight with a changed diet and exercise for 6 months to be considered for the intervention against obesity. Before the procedure, a doctor must always assess the suitability and investigate whether there are circumstances that make the treatment unsuitable. The patient must also receive detailed information about the procedure and possible risks.

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