FDA Warns of Deaths Following Gastric Balloon Surgery – Should you be concerned?
Written by Consumer Guide to Bariatric Surgery Last modified on May 23, 2018
Recent headlines calling attention to a handful of deaths among people who received liquid-filled gastric balloons for weight loss are raising some eyebrows among people who have balloons in place and those considering these devices.
But at least one expert cautions that these risks — while admittedly troubling — are relatively rare, and pale in comparison to the serious, proven risks associated with obesity.
Here’s what we know so far… The FDA issued an update to a health alert from February 2017 telling doctors that five people who received liquid-filled intragastric balloons died unexpectedly from 2016 until August 2017. The cause of death was unclear, but all deaths occurred within a month of balloon placement.
The FDA notes that three of the cases resulted in death within one to three days of balloon insertion, four involved the Orbera Intragastric Balloon System from Apollo Endo Surgery, and one involved the ReShape Integrated Dual Balloon System by ReShape Medical. Both devices are FDA approved for weight loss.
“The FDA continues to work with Apollo Endo-Surgery and ReShape Medical Inc. to better understand the issue of unanticipated death, and to monitor the potential complications of acute pancreatitis and spontaneous over-inflation,” the group states. “Additionally, as part of the ongoing, FDA-mandated post-approval studies for these devices, we will obtain more information to help assess the continued safety and effectiveness of these approved medical devices.”
Two additional reports of deaths in the same time period were noted in the FDA letter. One was related to gastric perforation with the Orbera Intragastric Balloon System and the other was due to esophageal perforation with the ReShape device. That takes the total number of gastric balloon patient deaths to seven.
The FDA-noted deaths occurred in people who received balloons filled with liquid, not air. Gastric balloon systems are considered less invasive than other weight loss procedures and are typically reserved for people who are not as obese as those who undergo surgery. In general, people who receive gastric balloons have a BMI of 30 to 40. By contrast, surgery is indicated for people with a BMI of 40 or above. Once inflated in the stomach, the balloons allow a person to feel fuller faster, and hopefully eat less and lose weight as a result. They can be left in place for up to six months.
Gastric balloons don’t promise as much weight loss as the more invasive surgeries, but they are supposed to be less risky. Most people lose between 5% and 10% of their weight with a balloon method.
Is Gastric Balloon Safe?
The combined mortality rate both Orbera and ReShape is approximately 1 in 10,000 procedures, according to the American Society for Gastrointestinal Endoscopy (ASGE) and the Association for Bariatric Endoscopy (ABE).
“Any death is a tragedy, and for patients who have these devices or who are considering them this news can be scary, but it’s important to note that these tragedies are rare, Moses K. Shieh, D.O., FACOS, a bariatric surgeon in Fort Meyers, Florida, tells the Consumer Guide to Bariatric Surgery.
Additionally, Dr. Sheih explains that there are other options on the market including gas-filled balloons for weight loss such as the Obalon system with no reports of death or serious complications associated with them.
“In light of recent media coverage, it’s encouraged that all health care providers have an in-depth discussion with their patients about the possible side effects prior to placement, monitor post-placement, and that the patient’s overall health is in good condition,” he says. “These balloons are indicated for use in conjunction with diet and exercise, so an overall healthy lifestyle is key for optimal weight loss and a positive experience.”
We will continue to monitor the situation and provide any additional updates from the FDA or our team of experts.