Five people have died after have anti-obesity devices surgically inserted into their stomachs, U.S. regulators have revealed.
In its statement released on August 10, the agency said that all of the five fatalities occurred within a month or less after the placement of the balloon.
"The Agency has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment (one gastric perforation with the Orbera Intragastric Balloon System and one esophageal perforation with the ReShape Integrated Dual Balloon System)", the FDA added. The fifth was using the ReShape Integrated Dual Balloon System, made my ReShape Medical Inc.
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Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries. The balloon is inserted via an endoscope down the esophagus to the stomach.
Apollo said in a press release that the deaths of the patients using their weight-loss balloon were not necessarily caused by their products. The exact causes in three of the deaths remained unknown.
"FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications and that you report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting Program", the agency said. It has not received any product liability claims in connection with the five deaths.
Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems.