Balloon obesity devices linked to 5 patient deaths, says FDA

Aurora Colorado.                       John Moore

Two companies manufacture the balloons used for the patients who died.

Four of the reports to the FDA involve the Orbera Intragastric Balloon System (Apollo Endosurgery), and one report involves the ReShape Integrated Dual Balloon System (ReShape Medical), the FDA said in a safety alert.

Five people have died since 2016 from complications relating to non-surgical balloon systems placed in their stomachs as obesity treatments.

Back in February, the FDA issued a similar warning to keep an eye on complications from these procedures including the balloons spontaneously overinflating, which can fill the patient's stomach with fluid, or acute pancreatitis.

MORE: I Swallowed a Balloon For Weight Loss and Lost 40 Lbs.

It's still unclear whether there's a definitive link between the devices and the deaths.

In the treatment, a silicone balloon is inserted via the patient's throat into their stomach, then filled with a saline solution. In the other death, there was an esophageal perforation with the ReShape Integrated Dual Balloon System.

Three died one to three days after the balloon placement.

"Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the USA clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death", it says on its website. It has not received any product liability claims in connection with the five deaths.

A fourth patient died from a stomach hole and a fifth from a tear in the esophagus.

The FDA warned that someone who has already had gastrointestinal surgery or who is "unwilling or unable to participate in a medically-supervised diet and behavior modification program" should not try either of the devices.

This is less than 0.01 percent of the more than 277,000 Orbera balloons distributed during that time period, their statement said.


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