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FDA updates gastric balloon warning after 5 deaths

13 August 2017
FDA updates gastric balloon warning after 5 deaths

Five people have died after have anti-obesity devices surgically inserted into their stomachs, United States regulators have revealed.

The FDA issued an update to alert healthcare providers of 5 deaths that occurred since 2016 in patients with liquid-filled stomach balloons.

In the treatment, a silicone balloon is inserted via the patient's throat into their stomach, then filled with a saline solution. These balloons are meant to stay inside the body for six months before deflating and eventually exiting the body the old-fashioned way.

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. The enterprise said it "received no product liability-related claims in connection with these five cases", and noted that the incidence rate "remains less than 0.01%", exactly what's specified in the directions of use of the gastric balloon.

But three of the five patients died within three days of their supposedly low-risk operation.

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

The FDA's adverse report system is very broad and is not created to immediately prove a device or drug caused a complication.

Four of the cases involve Apollo Endo Surgery's Orbera Intragastric Balloon System while one involves ReShape Medical Inc.'s ReShape Integrated Dual Balloon System.

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.

"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.

Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems.

The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag. These approved devices are placed via the esophagus using endoscopy. "There is no responsibility that we take more seriously than patient safety", ReShape says in a statement.