The Food and Drugs Administration issued a safety alert last week after at least five people reportedly died shortly following weight loss balloon treatments in 2016.
On Thursday, the FDA announced that four patients died after receiving the Orbera Intragastric Balloon System from Apollo Endo Surgery and one died after receiving the ReShape Integrated Dual Balloon System from ReShape Medical Inc. The agency reported that all five deaths happened less than a month after patients underwent the procedures, which entails placing one or two balloons in the stomach and filling them with a saline solution to help patients feel fuller and therefore lose weight. The balloon is taken out roughly six months later. Overall, both products are relatively new, with Apollo and ReShape’s latest balloons approved in 2016 and 2015, respectively.