The U.S. Food and Drug Administration (FDA) recently issued an alert to physicians, surgeons, and the public to warn about recent deaths associated with a surgical treatment for obesity. A handful of deaths of patients who had recently undergone surgery to have the intragastric balloon implanted have been reported since 2016. The FDA is recommending that patients be closely monitored after undergoing the procedure as the agency continues to investigate the actual causes of death and how they are related to the medical device.
Intragastric Balloon for Obesity
The intragastric balloon is a relatively new procedure used for treating obesity. It involves the insertion using an endoscope in the esophagus of a silicone balloon filled with saline solution into the stomach. Like other gastric surgeries for obesity, the purpose is to make the patient feel fuller faster and to restrict eating. The procedure is only supposed to be used for patients who are obese, who have not been able to lose significant weight by dieting and exercising, and who are committed to making healthy lifestyle changes.
Risks Announced in February
The FDA had already made an announcement regarding safety issues with the intragastric balloon when it made the most recent announcement about related deaths. In February this year the agency issued a statement to physicians and surgeons warning that the device may spontaneously over-inflate. It may also cause acute pancreatitis, a very serious illness. The recommendation at the time was that doctors monitor their patients carefully after the procedure. Also in response to the statement, the manufacturers of the device updated their package labeling to include the risks.
Warning of Deaths after Intragastric Balloon Inserted
Now the FDA has issued a new warning, following the reports of five separate deaths seemingly related to the intragastric balloon. The devices in question are made by Apollo Endo Surgery and ReShape Medical Inc. All five deaths, reported through the FDA’s adverse events reporting system, occurred within a month of having one of these balloons inserted. Exact causes of death are still unknown, but the FDA has determined that all of them were related to either the device or the insertion procedure. Three of the deaths occurred just one to three days after the procedure.
In two of the patient deaths, the FDA was also notified that the patients suffered serious tissue damage from the balloons or the procedure before they died: one case of esophageal perforation and one case of gastric perforation. While the FDA will continue to examine these cases and monitor the safety of the device, some doctors have suggested that the technique for inserting the balloons is the root cause of the problems. Inserting the balloon through the esophagus requires experience and skill. Lack of follow up to monitor patients for tissue damage or issues with the balloon may also have contributed to the deaths.
The FDA is not issuing any restrictions on the intragastric balloons at this time, and it is not issuing or recommending a recall. The current recommendation is only that patients are better monitored after the procedure is completed. The agency has also stated that it will continue to work with the manufacturers and to investigate the causes of the deaths of the patients in question.