Published: Sun, August 13, 2017
Medical | By Carla Vaughn

Five People Die After Using Weight Loss Balloons for Obesity

Five People Die After Using Weight Loss Balloons for Obesity

Five people who had a balloon system put into their stomach to treat obesity have died since 2016, the FDA warned Thursday. The less space, the less food the stomach can contain and digest.

The FDA said it is not clear whether the deaths were caused by the devices - which were approved in 2015 - or the surgical process.

The deaths were all linked to Orbera, and Apollo Endo-Surgery reported the incidents - which occurred in four different countries - to the FDA, NBC reports. Both of these companies focus on less invasive therapies for obesity treatment. Gastric balloons is one of the many devices available in the market for treating severe obesity. Three of them died within the first three days, the administration said.

All deaths happened within a month of the procedure, the FDA said in a letter earlier this week to health-care providers. According to the corporation, one of those deaths was caused by a stomach perforation and the other one by an esophagus perforation.

The FDA said the deaths occurred from some time in 2016 to the present and have issued the warning as a precautionary measure, as the regulatory body has yet to directly link the intragastric balloons to the cause of death. Pancreatitis and balloon over-inflation were not listed as potential side effects until February 2017, so doctors might not be aware of the risk.

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Apollo company declared it had not received any communication from the official investigators indicating the deaths have been due to the Orbrera device.

CEO Todd Newton says, "Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously". The capsule is attached to a catheter used to inflate the balloons with air. Some of them are made from silicone and hold dye - such as methylene blue - or some other radio-opaque material as a radiographic marker.

Here is an excerpt from Wikipedia that describes gastric balloons. Less intake of food will result in weight loss. An appropriate diet is also prescribed for the patient. After a maximum of up to six months, the device is removed using endoscopy again.

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

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