Obese individuals who have been looking for effects comparable to the lap band or bariatric surgery had started using another procedure involving intragastric balloons, aka the weight loss balloon. However, this procedure may not be as safe as once believed.
The idea is that a special type of balloon filled with saline solution is inserted into the stomach. It starts with a smaller balloon to acclimate the patient to the sensation. Over time, those balloons are removed, and larger ones are inserted into the stomach.
The balloon is meant to fill the stomach with something that cannot be digested but that will safely remain in place. As a result, the patient will feel ore full all the time because the stomach will have something inside it. Therefore, the patient is less likely to overeat because hunger pangs won’t be as pronounced.
Recently, the U.S. Food and Drug Administration (FDA) issued an alert regarding the intragastric balloons. The reason is that there have now been 12 deaths associated with this procedure since 2016. These deaths were not exclusively in the United States. They occurred worldwide. However, there were recently five patients who died in the U.S. and who contributed to that worldwide total.
Many intragastric balloon systems have FDA approval as weight loss systems. They seemed promising because their application was very minimally invasive, suing an endoscopy.
Of the five new deaths associated with these systems, four involved the use of the Orbera Intragastric Balloon system. That product is made by Apollo Endosurgery Inc. The remaining death was linked with the use of ReShape Integrated Dual Balloon System, which as made by ReShape Lifesciences.
In three of the Orbera cases and the one ReShape case, the death occurred following a gastric perforation. This refers to a hole in the wall of the stomach. This occurred inside three and a half weeks following the balloon’s placement in the stomach, says FDA data. The fifth death continues to be investigated by Apollo Endosurgery in order to find out what went wrong.
This is not the first time the FDA has issued alerts about these devices. Two other alerts have been issued, once in February 2017 and once in August 2017. Both alerts were meant to notify health care providers that adverse events including death had been linked with the use of intragastric balloon systems for weight loss.
That said, the FDA has not reached the point that it feels obesity patients are being placed at an undue risk by using intragastric balloon systems. The FDA continues to label these systems as “an appropriate treatment option” for obesity patients.