A 30-minute outpatient procedure, gastric balloons are filled with silicone and inserted through the mouth and into the stomach while the patient is sedated. Balloons are left in for up to six months and typically result in a 10 to 15% body weight loss, according to Mayo Clinic.
Risks associated with the procedure include pain, nausea, ulcers, or a gastric blockage if the balloon were to deflate.
Risk of death is not usually associated with this procedure, yet three people died within one to three days of swallowing a silicone balloon and another two lost their lives after one month.
The balloons used on these patients came from different manufacturers: One was made by the Apollo Endo Surgery and called the Orbera Intragastric Balloon System, another named ReShape Integrated Dual Balloon System was made by ReShape Medical Inc.
The FDA doesn't know why the deaths occurred, or if it's even the balloons that caused them.
"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.
According to TIME, the agency is also looking into two additional gastric balloon-related deaths. Officials advise that patients "speak to their doctors to determine which obesity treatment option is best for them" and say it'll communicate more information to the public as it is discovered.