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FDA Reports That 5 People Have Died After Weight Loss Balloon Treatments

13 August 2017

Intragastric balloons are created to treat obesity by taking up room in the stomach, making patients feel full.

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. The procedure, which is FDA-approved, involves inserting one or two silicone balloons into the stomach through the mouth and filling them with liquid until they are about the size of a grapefruit. The balloon is created to stay in place for several months to help the patient lose weight. And in three of those reports, death occurred as soon as one to three days after the balloon was placed, the agency notes.

Each of the five dead died within a month or less of receiving the balloon treatment.

The FDA is also investigating two other deaths, one from each company, due to "potential complications associated with balloon treatment.".

'The FDA's letter to health care providers does not indicate that the patient deaths were related to the Orbera device or the insertion procedures. The other is a dual balloon system made by ReShape.

Apollo Endosurgery (NASDAQ:APEN) says its ORBERA device has proven to be safe over the years in clinical trials and since its approval by the FDA in August 2015.

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According to NBC News, Apollo says it reported the deaths to the FDA itself.

RECOMMENDATION: 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.

Christopher Gostout, Apollo Endosurgery's chief medical officer, said the FDA letter is a reminder of the complications that could happen to obese patients. These approved devices are placed via the esophagus using endoscopy.

The (intra) gastric balloon for weight loss differs from the Sengstaken-Blakemore balloon used to stop esophageal and gastric bleeding.

In a statement to CNN, ReShape Medical said: "There is no responsibility that we take more seriously than patient safety".

FDA Reports That 5 People Have Died After Weight Loss Balloon Treatments