Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

Obesity

Placed in the stomach orally in a minimally invasive endoscopic procedure, they're created to be filled with fluid and stay in the stomach for six months.

Four of the patients were using the Orbera Intragastric Balloon System, made by Apollo Endo Surgery.

In an August 10 letter to health care providers, the FDA says all five reports indicate that the deaths occurred within a month or less of balloon placement.

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The FDA issued a safety alert warning health care providers that since 2016, five patients who were treated with liquid-filled intragastric balloons for obesity died unexpectedly.

The FDA has also received two other reports of deaths since 2016 related to potential balloon treatment problems: one case where a person got stomach hole, with the Orbera Intragastric Balloon System, and one who got an esophagus hole, with the ReShape Integrated Dual Balloon System. Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure. Then saline is used to fill the balloons. The object of the balloon is to reduce how much a person can eat by filling the stomach with the balloon, NBC News noted. The agency recommends that doctors closely monitor patients who are using these devices. It has not received any product liability claims in connection with the five deaths.

'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'.

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In the product's package insert, there have been 21 deaths in ORBERA patients in the period from January 1, 2006 through March 31, 2017, out of more than 277K devices distributed during the same period, an incident rate below 0.01%.

In a statement emailed to CNN, ReShape Medical said, "There is no responsibility that we take more seriously than patient safety". The fifth was using the ReShape Integrated Dual Balloon System, made my ReShape Medical Inc.

'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'.

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