All deaths happened within a month of the procedure, the FDA said in a letter earlier this week to health-care providers. However, what role the balloons played, if any, in the deaths has not been determined.
In an alert issued Thursday, the FDA said that from 2016 to the present, five “unanticipated deaths” had occurred within a month or less in patients who had liquid-filled gastric balloon systems implanted in their stomachs.
The U.S. Food and Drug Administration has alerted physicians and surgeons who treat obesity that it is investigating whether there is a link between gastric balloons — a new-generation weight-loss device — and the deaths of five patients.
The FDA is investigating after five people have died since 2016 following an anti-obesity procedure involving silicone balloons, the Washington Post reports. The procedure, which is FDA-approved, involves inserting one or two silicone…
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.
Five people who had a balloon system put into their stomach to treat obesity have died since 2016, the FDA warns.
Four deaths involve the Orbera Intragastric Balloon System and one death involves the ReShape Integrated Dual Balloon System. News Alerts