Saturday, 21 October, 2017

Deaths Linked to Weight-Loss Stomach Balloons

Aurora Colorado.                       John Moore Aurora Colorado. John Moore
Tracy Craig | 13 August, 2017, 01:07

Five people who had a balloon system put into their stomach to treat obesity have died since 2016, the FDA warned Thursday. In addition to saline, the balloon that is made from silicone may contain some radio-opaque material as a radiographic marker and a dye such as methylene blue to alert the patient when the balloon would leak.[1] Studies have suggested that fluid is superior to air for distending gastric balloons.[2] Inflated balloons reduce the operative volume capacity of the stomach. These balloons are meant to stay inside the body for six months before deflating and eventually exiting the body the old-fashioned way. Four of the deaths occurred after patients used the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one took place after a patient used the ReShape Integrated Dual Balloon System, which is made by ReShape Medical Inc.

Apollo said in a press release that the deaths of the patients using their weight-loss balloon were not necessarily caused by their products. In three reports, the patients died in as little as one to three days later.

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

All deaths happened within a month of the procedure, the FDA said in a letter earlier this week to health-care providers.

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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. Four reports involve 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.

Apollo Endo-Surgery said in a press conference they are responsible for one death in the U.S., one in Great Britain, one in Mexico, and two in Brazil.

The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag.

"Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the US clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death", it says on its website. 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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