Intragastric Balloon Treatment for Obesity: FDA Safety Updates.

Over the past year, the FDA has issued two letters to healthcare providers alerting them to adverse events associated with ORBERA and ReShape intragastric balloons (IGBs), including several deaths. Both IGB devices were FDA-approved for use in the US in the summer of 2015. Although the adverse events cited in the two letters occurred following FDA approval, there was already evidence prior to FDA approval that the safety and efficacy of ReShape and ORBERA were highly questionable. Since January 1, 2006, ORBERA and Reshape IGB have been implicated in 33 deaths. Given the cited evidence, we recommend FDA withdrawal of these two devices.