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Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

The U.S. Food and Drug Administration (FDA) released a report that since 2016, five people died after using liquid-filled balloon weight loss system meant to treat obesity. Three patients died 1 to 3 days afterward. However, the FDA says it hasn't determined if the deaths were, in fact, caused by the silicone balloons or the procedure to insert them.

The devices are manufactured by two California companies. The other is a dual balloon system made by ReShape. Four reports involve Apollo-Endo Surgery's Orbera Intragarstric Balloon System, and one report involves ReShape Medical Inc.'s ReShape Integrated Dual Balloon System.

The deaths happened from 2016 to present, according to the FDA.

The procedure last for up to 30 minutes.

The FDA said in one treatment, there was a gastric perforation with the Orbera Intragastric Balloon System. While the typical gastric volume is about 900 ml, an inflated balloon may take up most of the space, about 700 (+/-100) ml.[3] Thus the balloon limits the amount of food the stomach can hold and creates thereby an early feeling of fullness and satiety. The balloons remain in the stomach for six months to help facilitate weight loss before being removed during an outpatient endoscopy. The use of the balloon is complemented with counseling and nutritional support or advice.

'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.

More than 180,000 of Apollo Endo-Surgery's Orbera balloons have been placed in patients since the product was approved by the FDA in 2015.

The (intra) gastric balloon for weight loss differs from the Sengstaken-Blakemore balloon used to stop esophageal and gastric bleeding. That rate is also less than 0.01 percent. Apollo, which says it has sold 180,000 of the devices globally, said it was preparing a statement.

An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States.

Endoscopic placement of the balloon is temporary and reversible without surgical incisions. "Patients with questions about this FDA update should contact their physicians directly".

One risk is spontaneous over-inflation.

The symptoms of balloon over-inflation or pancreatitis include severe abdominal or back pain, abdominal swelling, trouble breathing, fever or vomiting. Both complications require the removal of the device.

Now there are three FDA approved balloons in the USA.

Other materials different from saline are used to fill the balloons.

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