The Food and Drug Administration is investigating the sudden deaths of five people who had undergone an obesity treatment that places an inflated silicone balloon in their stomach.
All deaths happened within a month of the procedure, the FDA said in a letter earlier this week to health-care providers. Three people died just one to three days later.
The agency, however, cautioned that it has yet to determine whether the devices or the way in which they were placed in the stomachs directly caused those deaths.
“At this time, we do not know the root cause or incidence per rate of patient death,” the FDA said, adding that it is working with the companies that manufacture the devices.
The devices are manufactured by two California companies. Four of the cases involved the Orbera Intragastric Balloon System by Apollo Endosurgery. One involved the ReShape Integrated Dual Balloon System by ReShape Medical.
The deaths happened from 2016 to present, according to the FDA. The agency said two more death reports it received happened within the same time frame and are potentially related to complications from the balloon treatment.
The procedure lasts for up to 30 minutes. One or two balloons are placed inside the stomach through the mouth using an endoscope while a patient is mildly sedated. Once inside, it’s inflated with liquid, usually with saline solution. The idea is for the balloon, which is about the size of a grapefruit once inflated, to leave less room for food. It stays in the stomach for up to six months, while the patient also follows a diet and exercises regularly.
Apollo Endosurgery uses one balloon, while ReShape Medical uses two.
In a statement in response to the FDA letter, Apollo Endosurgery said the company self-reported the deaths of five patients from four countries who have received the…