Since 2016, five people who have used weight loss balloon treatments for obesity have died within a month of having them placed.
The U.S. Food and Drug Administration (FDA) has stated that they “do not know the root cause” of these patients’ deaths, and they put out a safety alert to the public to alert them of potential risks associated with the treatment.
Weight loss balloons work by being placed in an obese patient’s stomach and filled with saline in order to make the patient feel fuller, which then helps with weight loss.
Four of the patients were using the Orbera Intragastric Balloon System, while one was using the ReShape Integrated Dual Balloon System. Both companies, Apollo Endo-Surgery and ReShape Medical Inc., are now under investigation for other recent deaths that may be related to issues with the balloons.
Apollo Endo-Surgery stated that they have “received no product liability-related claims” related to the deaths, and that between January 1, 2006 and March 31, 2017 there have been 21 reported deaths after the completion of 277,000 procedures.
ReShape stated that they are “committed to supporting the continued safe and effective use of the dual balloon” and are “proactively communicating with physicians about this FDA update”, and that if patients have any questions about the FDA’s update on the situation then they should speak with their physician.
The FDA made it clear that they were investigating both companies for the deaths, but they weren’t indicating that they were directly related to the procedures the patients received.