Unexplained deaths in people who had gastric balloons implanted for weight loss should have you extremely concerned if you’ve already had the procedure…and extremely skeptical if you’re considering it.

At first view, the balloon procedure (also called “intragastric”) may seem a lot less drastic, and therefore safer, than other surgical options for people who are extremely overweight. Those operations—typically called bariatric surgery—alter the physical structure of your stomach in ways that make you feel full very soon after you start eating. Some involve surgery to tie off part of the stomach, while others remove part of the stomach, the idea being that a smaller stomach leads to less food eaten and weight loss.

With the balloon implant, a medical-grade balloon is placed into the stomach through the esophagus using a tool called an endoscope and then partly filled with liquid. Because it takes up space in your stomach, you feel full faster when you eat and therefore eat less. Plus, it’s temporary—it’s left in place for up to 6 months, long enough for patients to lose up to 15% of their body weight.

But there’s a problem—a big one. In the past two years, a dozen people who had the procedure soon died, typically within a month of getting the balloon, but sometimes in just a few days. It’s suspected that a tear occurred in the esophagus or the stomach of these patients, leading to the deaths. While the FDA calls the link between their deaths and the balloon procedure only “possible,” the agency has ordered labeling to make the public aware of this.

It also reiterated warnings made in 2017 about other problems with the only two FDA-approved brands of liquid-filled balloons currently available: the Orbera Intragastric Balloon System manufactured by Apollo Endosurgery and the ReShape Integrated Dual Balloon System made by ReShape Lifesciences. The warnings…

  • These balloons may over-inflate with air or liquid in the stomach. Why this happens isn’t known, but it may occur within days of insertion or months later. Symptoms include severe belly pain and swelling, vomiting and difficulty breathing. When this happens, the balloon must be removed.
  • These balloons may damage the pancreas, causing potentially life-threatening pancreatitis. This complication may be from pressure from the balloon and can occur as soon as three days after insertion. Symptoms may include severe belly or back pain. When this happens, patients often must be hospitalized and have the balloon removed.

These problems are in addition to potential complications that were already known when the devices were approved: Liquid-filled balloons can deflate or cause a stomach ulcer. There have also been reports of perforations of the esophagus or stomach when the balloon is put in place…and cases of people not getting the balloon removed as directed within six months, which increases the chance for deflation and for the balloon causing a dangerous blockage.

Finally—and this may leave you wondering why you even considered a gastric balloon—although it can give you a much-needed jumpstart on losing weight after everything else has failed, once the balloon is removed, there’s nothing stopping you from regaining any weight you lost unless you’ve made significant and permanent lifestyle changes.

The FDA is still allowing the liquid-filled balloon systems to be used, but strongly advises all patients considering either of those two models of balloon to have thorough conversations about the benefits and the risks—and the alternatives—with their doctors before deciding. This is the same conversation you should have regarding any weight-loss procedure and should include going over the health risks of staying obese.

Note: It’s also important to check the credentials of the bariatric surgeon who will be doing the implant and choose one trained and experienced in endoscopy.

An FDA-approved balloon system that hasn’t been linked to serious complications is the Obalon, which involves swallowing three capsules that release self-expanding balloons.

And if you already have either of the liquid-filled balloons in your stomach and you don’t want it removed right away, be sure you are closely monitored by your doctor until it is removed.