Five people have died unexpectedly shortly after being treated with weight loss balloon devices.
In a report, the U.S. Food and Drug Administration (FDA) is warning health care providers about the liquid-filled balloon weight loss system designed to fight obesity, announcing that since 2016, there have been five people dead after using it.
In the treatment, a silicone balloon is inserted via the patient's throat into their stomach, then filled with a saline solution. The balloon is designed to stay in place for several months to help the patient lose weight.
Four of the deaths occurred after patients used the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one took place after a patient used the ReShape Integrated Dual Balloon System, which is made by ReShape Medical Inc.
Each of the five died within a month or less of receiving the balloon treatment. In three cases, the person died within one to three days of treatment.
The FDA's announcement does not mean that the weight loss balloons caused the patients' deaths, but they are looking into two more deaths and advising doctors to closely monitor their patients using these devices.
“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 FDA wrote.
Photo Credit: ReShape