In the few years they’ve been on the market in the U.S., weight-loss balloons have been making headlines as a cheaper, less intense alternative to invasive weight-loss surgeries. However, according to an FDA alert posted last week, the gastric balloons may come with unforeseen consequences: Five people died in 2016 within weeks of receiving their balloons.
“All five reports indicate that patient deaths occurred within a month or less of balloon placement,” the FDA alert reads. “In three reports, death occurred as soon as one to three days after balloon placement.” Of the five patients who died, four had received the Orbera balloon, which is manufactured by Apollo Endosurgery, and one had received Reshape Medical Inc.’s dual balloon system. A third type of balloon, the Obalon (which is filled with air), has also recently been approved by the FDA, but was not mentioned or linked to any deaths in the report.
Essentially, the balloons are inserted via the esophagus, placed in the stomach, and inflated with saline for six months, Amir A. Ghaferi, M.D., assistant professor of surgery at the University of Michigan, tells SELF. “They occupy space in the stomach and give a sensation of fullness, the idea being that patients will eat less [without altering] their anatomy in any permanent way.” But, he says, the balloons are far from perfect. In addition to causing nausea as your stomach adjusts to having a foreign, inflatable thing inside, these balloons might come with even more serious side effects.
The new FDA alert comes just a few months after the agency advised health care providers to pay especially close attention to patients receiving the balloons. In that letter, sent in February of this year, the agency detailed two major complications connected to the balloons: over-inflation and acute pancreatitis, an infection in the pancreas. If the balloons become over-inflated, they can cause stomach pain and difficulty breathing, and may need to be surgically removed.
However, the FDA hasn’t identified exactly what caused each death. And the agency can’t say for certain whether or not the weight-loss balloons actually had anything to do with the deaths. So, for now, it’s simply reminding everyone that serious complications are possible, and that doctors should monitor their patients closely after giving them the balloons.
“Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously,” Todd Newton, CEO of Apollo Endosurgery said in a statement. “The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity,” he continued, suggesting that the company believes it’s these other conditions that contributed to the deaths.
Dr. Ghaferi also points out that this is a relatively small number of cases compared to the hundreds of thousands of people who have gotten the balloons successfully worldwide. He also wonders whether the intense scrutiny the balloons have received is due, at least in part, to our society’s bias against those seeking treatment for obesity. “Every time there is a treatment for obesity that’s different from diet and exercise, people feel like it’s a cop-out, it’s a shortcut,” he says. “It’s not viewing obesity as the chronic disease that it is that requires treatment—sometimes invasive treatment.”
Obviously, the balloons aren’t the right choice for everyone. But people looking for any kind of treatment deserve access to safe, reliable options.
Correction: This article has been updated to clarify that Obalon was not mentioned in the recent FDA report.
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