Gastric Balloon Weight Loss Device Investigation

Gastric balloons are a relatively new weight loss solution that cost less than lap bands or gastric by passes and do not require surgery. But five deaths have been reported after installation of the balloons since 2016, plus other problems, and we’re currently investigating to see if a class action is needed.

Gastric balloons (also called intragastric balloons) are based on a fairly simple idea. The deflated balloon is installed as part of an endoscopic process (that is, they put it down your throat), then fill it with a sterile saline solution. The procedure is done on an outpatient basis and can take as little as thirty minutes.

The balloon (or balloons) sit near the top or center of your stomach, which makes you feel full sooner and reduces the amount of room in your stomach for food. The balloons are left in place for six months and must then be taken out. Reportedly, most people who have this procedure do lose weight.

The Food and Drug Administration is investigating the deaths. Four occurred with the Orbera Intragastric Balloon System, from Apollo Endo Surgery, and one with the ReShape Integrated Dual Balloon System, from ReShape Medical, Inc. Three of the deaths happened within the first three days after installation, and all five occurred within a month after installation. The FDA cautions that it does not know the “root cause” of the deaths, nor can it say for sure that the deaths were caused by the devices or the insertion procedures.

The FDA has received two other reports of deaths, one caused by gastric perforation with the Orbera device and the other caused by perforation of the esophagus by the ReShape device.

And that’s not all. Two other problems have been associated with gastric balloons. One is spontaneous hyperinflation, in which the balloon overfills with air or liquid and becomes significantly larger than it’s supposed to be. The other problem is pancreatitis, which might be caused by compression in the gastrointestinal structures caused by the balloons. Both problems require early removal of the balloons.

John Morton, a Stanford bariatric surgeon who has implanted about seventy of the devices without incident, says, “Every death is a tragedy, and has to be investigated.” Since the devices are made for patients who are not excessively obese, he says, and since they provide only a modest weight loss, they should meet high safety standards.

The Apollo Endo Systems website claims that 220,000 of its Orbera devices have been installed worldwide. However, only around 5,000 gastric balloons of any type have been installed in the US. Morton says, “These devices need to be placed in centers that have adequate follow-up, the resources to provide that follow-up and the experience to recognize these complications.”

For now, the FDA says it’s continuing to work with Apollo Endo and ReShape Medical to try to understand the causes of the deaths and to monitor complications with hyperinflation and pancreatitis.

If you’ve had a gastric balloon implanted and had a bad experience with it, fill out the form on this page and let us know.

Article Type: Investigation
Topic: Consumer
No case events.
Tags: Defective Medical Devices, Gastric Balloon