After a month from the procedure of inserting an inflatable silicone balloon in the patients’ stomachs, there have been five reports of deaths.
The FDA is investigating the reason behind the sudden deaths to see whether the cause was the devices were at fault or the procedure caused their deaths. They are working with the companies which manufacture the products.
Since 2016 until now there have been 5 deaths which could be from complications after the treatment.
The companies which manufacture the products are found in California: Apollo Endosurgery which created OrberaIntragastric Balloon System and ReShape Medical with their product named ReShape Integrated Dual Balloon System. The first company had 4 cases of deaths and the second one had a single case.
The intervention lasts 30 minutes and consists of placing a balloon or two inside the patient’s stomach through their mouth with the help of an endoscope. The patient received a small dose of sedative. After the insertion of the silicone balloon, it is inflated with saline solution and gets to a size of a grapefruit, occupying part of the space so that there wouldn’t be much room for food. The balloon can stay inside for up to half a year and the patient must follow a diet and do physical exercises.
The rate of deaths in the Apollo Endosurgery in the last 11 years has reached 21 deaths, out of 277,000 interventions using the OrberaIntragastric Balloon System, meaning that the rate of deaths was less than 0.01%.
However, obese patients should be aware of complications, they must be properly evaluated, there are risks of anesthetics or the endoscopic procedures, they must be monitored during the treatment and they must contact their physician as soon as they have unexpected symptoms. They may feel over-inflated, may get abdominal pain, cannot breath or will vomit. They might get acute pancreatitis. In any case, the symptoms might come after a few days from the procedure and doctors should remove the devices at once.
