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.
And in three of those reports, death occurred as soon as one to three days after the balloon was placed, the agency notes.
Five people have died after have anti-obesity devices surgically inserted into their stomachs, U.S. regulators have revealed.
The deaths were all linked to Orbera, and Apollo Endo-Surgery reported the incidents - which occurred in four different countries - to the FDA, NBC reports. In the procedures, patients are mildly sedated as a deflated balloon made of silicone is inserted through the throat and into the stomach, after which it's filled with saline to take up space in the stomach.
The company said the product can help overweight people lose more than three times the weight that diet and exercise alone can.
"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 FDA said.
'While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the Orbera device'. It has not received any product liability claims in connection with the five deaths. The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity.