A history of intragastric balloons.

The history of intragastric balloons (IGBs) began in 1985 with the Garren-Edwards Bubble. It was approved by the U.S. Food and Drug Administration (FDA) for temporary use as a weight loss device, but its manufacture was discontinued in 1988, and approval was withdrawn in 1992 because of significant complications and limited and recidivistic weight loss. A number of IGBs have appeared since that time, mostly originating in Europe or South America, but none has acquired FDA approval until recently; the ReShape Duo Integrated Dual Balloon System (ReShape Medical Inc., San Clemente, California) received FDA approval in August 2015. The conclusions of an important 1987 international conference on IGBs and the characteristics, effectiveness, and problems of most other IGBs are described in this text. The common purpose of these devices as preliminary interventions before gastric bariatric surgery and their favorable effects on this purpose are emphasized and may have played a key role in the FDA's change of outlook of the IGB.