The FDA has reported 5 people who underwent gastric balloon placement for weight control have died within days to weeks of the procedure.
Four people used the Orbera Intragastric Balloon System and one used ReShape Integrated Dual Balloon System.
Although the direct causes have not been established, the FDA stated the following, “All five reports indicate that patient deaths occurred within a month or less of balloon placement. In three reports, death occurred as soon as one to three days after balloon placement. At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction). The Agency has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment (one gastric perforation with the Orbera Intragastric Balloon System and one esophageal perforation with the ReShape Integrated Dual Balloon System).”
The balloons work by filling up the stomach volume, increasing signals of satiety to the brain. Balloons are delivered through the mouth by endoscope into the stomach where they are inflated with saline solution. The balloon remains in place for 6 months and Bariatic Surgery Source reports a 30% “excess” weight loss. The cost of the procedure is approx. $8100 and the procedure takes less than 30 minutes.
Some risks can include overinflation of the balloon, perforation, blockages and pancreatitis.
This is a developing story.