Deaths Reported After Balloon Obesity Treatments

13 August, 2017, 01:05 | Author: Colin Gill
  • Aurora Colorado.                       John Moore

Gastric balloons are among the varied devices on the market to treat severe obesity.

FDA is issuing an update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.

One of the devices is a balloon that can be placed in the stomach and filled with saline water, the Orbera balloon made by Apollo Endo-Surgery. It stays in the stomach for up to six months, while the patient also follows a diet and exercises regularly.

In each case, the person who received the weight loss balloon died within a month or less of having the balloon placed. Three of them died within the first three days, the administration said.

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. The other is a dual balloon system made by ReShape.

Four of the patients were implanted with Apollo Endosurgery's Orbera balloon, while the fifth was implanted with ReShape Medical's Integrated Dual Balloon System.

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It says it has not received any communications or indications from physicians or hospitals that the deaths were due to ORBERA, adding that the FDA's letter did not indicate the deaths were related to the device.

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

According to NBC News, Apollo says it reported the deaths to the FDA itself.

"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.

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

The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag. The company confirmed that only 21 devices from 277,000 distributed all over the world had been linked to deaths between January 1, 2006, and March 31, 2017.

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