FDA reports five deaths related to weight-loss balloons

This common way to lose weight may have just killed 5 people report

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

Five people who had a balloon system put into their stomach to treat obesity have died since 2016, the FDA warned Thursday.

Most of the adverse events involve Obera, which uses saline to fill a single stomach balloon, as opposed to the ReShape system that uses 2 balloons filled with saline and a blue due.

The patients all went under the knife earlier this year to get FDA-approved liquid-filled balloons fitted in a bid to lose weight. Three of the patients died just 1-3 days after the balloon was placed. The agency said two more death reports it received happened within the same time frame and are potentially related to complications from the balloon treatment.

It is unclear whether the devices or the surgeries used to implant them caused the deaths, officials said. The fifth was using the ReShape Integrated Dual Balloon System, made my ReShape Medical Inc.

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.




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

'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.

"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.

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

"Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure", Gostout said in the statement.

The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag. Symptoms include intense abdominal pain, swelling of the abdomen, difficulty breathing and vomiting.

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