FDA: 5 deaths tied to weight-loss balloon treatments

Brandon Parsons
August 13, 2017

Gastric balloons are among the varied devices on the market to treat severe obesity. 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 balloon is created to stay in place for several months to help the patient lose weight.

In an alert issued Thursday, the FDA said four reports involved the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.

In its statement released on August 10, the agency said that all of the five fatalities occurred within a month or less after the placement of the balloon.

The agency says they don't know the root cause or the incidence rate of death with these devices, nor have they confirmed that the balloon systems definitely caused the deaths. In the other death, there was an esophageal perforation with the ReShape Integrated Dual Balloon System.

The FDA said the deaths occurred from 2016 to present. Four of the cases involved the Orbera Intragastric Balloon System by Apollo Endosurgery.

Image credit Dr Dirk
Image credit Dr Dirk

In three of the reports, the patients died within three days of device placement, while in the other two, the patients died within one month of the procedure, the FDA said.

Apollo Endosurgery uses one balloon, while ReShape Medical uses two.

Still, the company said it has not received product-liability claims in connection to those five cases, and it has not received information from physicians and hospitals indicating that its Orbera device had caused those deaths.

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

Endoscopic placement of the balloon is temporary and reversible without surgical incisions. 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. The agency recommends that doctors closely monitor patients who are using these devices. Symptoms include intense abdominal pain, swelling of the abdomen, difficulty breathing and vomiting.

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