Gastric balloons are among many different devices on the market to treat severe obesity.
In a report, the U.S. Food and Drug Administration (FDA) is warning health care providers about the liquid-filled balloon weight loss system created to fight obesity, announcing that since 2016, there have been five people dead after using it.
One of the devices is a balloon that can be placed in the stomach and filled with saline water, the Orbera balloon made by Apollo Endo-Surgery.
The patients all went under the knife earlier this year to get FDA-approved liquid-filled balloons fitted in a bid to lose weight.
The FDA's adverse report system is very broad and is not created to immediately prove a device or drug caused a complication.
In a statement in response to the FDA letter, Apollo Endosurgery said the company self-reported the deaths of five patients from four countries who have received the Orbera intragastric balloon since the FDA approved the device in August 2015.
Apollo Endo-Surgery said, per NBC News, that worldwide sales of gastric balloons were estimated to total about $120 million in 2015, driven by broad use in Brazil, Mexico and Europe, and the death reports came from all around the world, and did not necessarily include US patients.
Two additional deaths since 2016 were related to potential complications - one stomach perforation due to Orbera, and one esophageal perforation with the ReShape weight-loss balloon.
CEO Todd Newton says, "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". The agency recommends that doctors closely monitor patients who are using these devices.
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