Federal health officials are warning about problems with a weight loss gastric balloon, which may have resulted in the deaths of at least five people and pose a serious risk for individuals undergoing the obesity procedure.
According to an FDA safety alert issued August 10, five people died within one month of having the weight loss balloon implanted, some as soon as one day after the device was placed in their body.
The warning was an update to an initial alert about weight loss balloon risks, which was issued to health care providers by the FDA in February.
The deaths occurred between 2016 and the present, after liquid-filled intragastric weight loss balloons were implanted into patients’ stomachs to treat obesity. Four reports involved Orbera Intragastric Balloon System manufactured by Apollo Endo Surgery. One report involved ReShape Integrated Dual Balloon System manufactured by ReShape Medical Inc.
The report indicates that the patient deaths occurred within one month or less of placement. Three deaths occurred within one to three days after the device was placed.
The FDA indicates it was unclear what the specific root cause was and could not directly attribute the deaths to the gastric balloons or insertion procedures. However, some doctors speculate part of the problem is caused by the technique used to place the balloon, which can be a tricky procedure, requiring a lot of skill.
In one case, the balloon caused gastric perforation; tearing of the gastrointestinal tract. Another case involved esophageal perforation. The FDA warned health care providers about potential risks, including acute pancreatitis and spontaneous over-inflation of the balloon back in February. Both companies revised the product labeling as a result.
The gastric balloon is approved to help patients who are less obese, with a body-mass index between 30 and 40, lose weight. It is considered less invasive and cheaper than bariatric surgery.
During the weight loss procedure, a balloon is inserted into the stomach through the mouth. Once in place, it is inflated with saline, taking up room in the stomach, which is designed to reduce hunger. The patient is placed under mild sedation and the procedure takes about 30 minutes.
It is designed to be in place for six months and may help patients lose 5 to 10% of bodyweight. Side effects include, nausea, stomach discomfort, ulcerations, balloon deflation, migration, esophageal perforation, cardiac complications, and death. Most people only experience mild side effects, which subside within a few days.
About 220,000 people worldwide have gastric balloons implanted. International sales reached $120 million in 2015. Most devices are used in Brazil, Mexico, and Europe. About 5,000 are sold in the US.
The FDA indicated it continues to work with Apollo Endo-Surgery and ReShape Medical to understand the cause of the issue, as well as monitor complications. The agency will also continue to examine information from post-approval studies of the devices.
To report side effects or adverse events from a gastric balloon contact the FDA’s MedWatch Adverse Event Reporting Program online or via fax at 800-FDA-0178.