Some people who are desperate to lose weight turn to rather extreme measures to shed fat, including intragastric weight loss balloons. These weight loss systems are linked to 12 deaths since 2016, the U.S. Food and Drug Administration (FDA) said in a June 4, 2018 alert.
Intragastric weight loss balloons work by taking up space in a patient’s stomach, leaving less room for food. The balloon is placed in the patient’s stomach through the mouth via a minimally-invasive endoscopic procedure. Once the balloon is in place, it is filled with saline solution.
Four of the 5 new cases involve the Orbera Intragastric Balloon system made by Apollo Endosurgery Inc., and 1 is related to the ReShape Integrated Dual Balloon System made by ReShape Lifesciences.
In 4 of the cases, including the one for the ReShape device, the deaths were the result of a gastric perforation (a hole in the stomach wall) that occurred just over 3 weeks after surgery, the FDA said. The 5th death is still being investigated by Apollo Endosurgery.
FDA spokeswoman Deborah Kotz said:
“The FDA has approved new labeling for these 2 devices in order to adequately inform doctors and patients about these adverse events.
We have been working with the companies that manufacture these liquid-filled intragastric balloons to better understand the complications associated with these devices.”
Here is a video showing how these weight loss balloons work in general (note that this is not of the Orbera Intragastric Balloon).
In fact, complications from weight loss balloons are exceedingly rare. According to Apollo Endosurgery, as of March 31, 2018, the rate of spontaneous hyperinflation of its devices after operations was 0.07%, and the gastric perforation rate was 0.01%.
The rates of esophageal perforation, pancreatitis and mortality were each less than 0.01%. Separately, the company reported the US mortality rate in Orbera patients to be 0.036%, or fewer than four deaths per 10,000 patients.
The FDA is urging healthcare providers to take the following steps:
- Educate patients about the potentially life-threatening complications associated with intragastric balloons, such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation, as well as what to do if they experience these symptoms.
- Monitor patients closely during the entire treatment period.
- Report any adverse events through MedWatch, the FDA Safety Information and Adverse Event Reporting program.