(August 2017) – When they were first approved in the summer of 2015, two new “intragastric balloon” devices for weight loss – the Orbera and ReShape – received widespread news coverage. Intragastric balloons are weight-loss systems intended to treat obesity by taking up space in a patient’s stomach. In 2015, the U.S Food & Drug
Administration approved the ReShape Integrated Dual Balloon System, which uses 2 balloons, and Apollo’s Orbera Intragastric Balloon System, which uses one balloon. About 220,000 people worldwide have gastric balloons implanted. International sales reached $120 million in 2015.
Both devices involve placing one (Orbera), or two (ReShape) gastric balloons in the stomach through the mouth. When in place, the balloons are filled with saline so they expand and take up space in the stomach. For instance, in a trial involving 255 patients, individuals receiving the Orbrera device “lost an average of 21.8 pounds (10.2% of their body weight) after the device had been in place for six months,” according to the FDA.
Fast forward to this summer and the news shifts from excitement to concern, with reports that at least 5 people have died while using the balloon systems; four while using the Orbera system and one using ReShape:
- CNN: 5 deaths reported while using weight loss balloon treatment, FDA says
- NBC News: Five Die While Using Obesity Devices, FDA Says
- LA Times: FDA investigating deaths of patients who had gastric balloon procedure for obesity
- Washington Post: 5 dead after FDA-approved obesity treatment that places silicone balloon in stomach, agency says
All five deaths occurred within a month of balloon placement, and FDA has been unable to definitively link the deaths to the devices or insertion procedures. The FDA is also investigating two additional cases of individuals who died after their Orbera or ReShape stomach balloon perforated their esophagus or stomach.
Two known problems with the gastric balloons are pancreatitis and”spontaneos hyperinflation” (over-filliing of the gastric balloon).
- Spontaneous Hyperinflation: The FDA said “several dozen” people were injured when their gastric balloons filled up with too much fluid as soon as 9 days after implantation. The reports mostly involved Obera, but also ReShape.
- Acute Pancreatitis: Four people were hospitalized and several more were diagnosed with pancreatitis as soon as 3 days after implantation of Orbera or ReShape — possibly because balloons compressed the pancreas or other organs.
We are currently investigating potential claims related to use of these medical products. If you or someone you know was injured by an Orbera or ReShape intragastric balloon, contact us online or call us at 1-866-252-3535.