A gastric balloon is a medical device that is placed in the stomach for a longer period of time (4-12 months). Gastric balloons are used for people with obesity who have not achieved sufficient weight loss through dietary changes or medication. A gastric balloon takes up space in the stomach, leaving less room for food and making the patient feel satiated sooner when eating. This causes the patient to eat less and lose weight. There are risks associated with the use of gastric balloons. RIVM has studied whether scientific research identified risks that are not currently stated on the instructions for use. This is not the case.
There are risks associated with the use of gastric balloons. The instructions for use states all known risks. Furthermore, the study showed that long-term weight loss is largely determined by how closely the patient follows a diet and/or lifestyle intervention after the gastric balloon has been excreted or removed.
Satiated feeling
Gastric balloons are used for people with obesity who have not achieved sufficient weight loss through dietary changes or medication. A gastric balloon is a soft, plastic balloon filled with a saline solution and/or a gas. Depending on the type of gastric balloon, it is excreted after 4 months or removed through the oesophagus after 6 to 12 months. It is not known how many people have had a gastric balloon inserted. This is not registered in the Netherlands. A gastric balloon takes up space in the stomach, leaving less room for food and making the patient feel satiated sooner when eating. This causes the patient to eat less and lose weight. The idea is that the patient will continue to eat less after the gastric balloon has been excreted or removed in order to maintain weight loss.
Gastric balloon safety and risks
The insertion of a gastric balloon is associated with risks, but the risks that can develop after insertion vary. For instance, people might experience nausea and vomiting during the first week after insertion. The balloon can also end up in the intestines and cause a blockage. The balloon must then be removed surgically. Very rarely, the balloon may cause perforations in the intestines. In exceptional cases, this complication may result in the death of the patient. This study found no unknown risks. The risks are described in the instructions for use of the various types of gastric balloons.
Most effective in the first few months
The analysis of the scientific research showed that the greatest effect on body weight is achieved in the first few months after insertion. Whether this effect was entirely due to the gastric balloon could not be determined by this research. The study also found that body weight could increase gradually again after the excretion or removal of the gastric balloon. Another finding was that the weight loss achieved through a combination of a gastric balloon, diet and/or lifestyle intervention varied considerably from patient to patient. For this reason, gastric balloons should be seen as just a tool.
Wide variety in publications on gastric balloons
This RIVM study also gives an overview of the European gastric balloon market. That market consists of 8 gastric balloons from 7 different manufacturers. Of these balloons, 5 gastric balloons from 4 manufacturers are available to Dutch patients, partially through clinics abroad. The number of scientific publications varies widely, from 1 to 29 per gastric balloon. In the future, more and larger-scale studies should yield more insight into the safety, risks and effectiveness of those gastric balloons for which few publications exist.
RIVM carried out this study on behalf of the Health and Youth Care Inspectorate (IGJ).