5 dead after FDA-approved obesity treatment that places silicone balloon in stomach, agency says

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…

Complete article from the original source…