The US Food and Drug Administration is looking into whether there is a link between the use of gastric balloons and the deaths of five patients from 2016 until the present.
The FDA issued the alert on Thursday, saying that there were five “unanticipated deaths” within a month or less in patients who had undergone this new weight-loss procedure, The Los Angeles Times reports. Gastric balloons are filled with liquid and implanted in the stomachs of patients. Three of the patients involved died between one and three days after the device was placed.
The agency told doctors treating obesity,
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.
The statement further stated that it would investigate the possibility that the patients suffered gastric and esophageal perforation or intestinal obstruction, either during implantation or after.
Four of the patients had used the Orbera Intragastric Balloon System, which is manufactured by Apollo Endo Surgery based in Austin, Texas. The fifth involved the ReShape Integrated Dual Balloon System, made by ReShape Medical Inc. in San Clemente. Both devices were approved by the FDA in 2015.
The FDA’s inquiry into weight-loss devices comes after safety concerns were raised. It had received reports in which liquid-filled gastric balloons overinflated while in patients’ stomachs in a phenomenon called spontaneous hyperinflation. This, in turn, caused doctors to remove the devices earlier than planned.
There were also reports of acute pancreatitis due to the implant, which likewise resulted in early removal of the balloons, the FDA added.
Dr. John Morton, president of the American Society for Metabolic and Bariatric Surgery, has implanted around 70 of the ReShape balloons. He says he has not encountered any complications. “Every death is a tragedy, and has to be investigated,” he said, and added that the standard of safety should be high for such devices.
Both the Orbera and ReShape systems are approved for patients who have a body mass index between 30 and 40. They are a less invasive, cheaper alternative to bariatric surgery.