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tinyfav.com December 11, 2017


FDA: 5 deaths tied to weight-loss balloon treatments

13 August 2017, 01:10 | Lucy Hill

Aurora Colorado. John Moore

Aurora Colorado. John Moore

In February 2017, the agency sent out a letter to health care providers recommending close monitoring of patients using the balloon device to treat obesity for the potential risks of acute pancreatitis and spontaneous over-inflation.

The U.S. Food and Drug Administration revealed on Thursday that at least five people have died after they were fitted with liquid-filled intragastric balloon created to help people lose weight.

In the treatment, a silicone balloon is inserted via the patient's throat into their stomach, then filled with a saline solution. The balloon is created to remain in place for several months.

At least three patients died within one to three days following a procedure for a liquid-filled intragastric balloon system.

An obesity treatment that involves placing balloons inside the patient's stomach may have resulted in five deaths since 2016, the U.S. Food and Drug Administration said in a new warning.

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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.

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. The other two died within a month. The FDA says it can't confirm the devices are responsible for the deaths. The other is a dual balloon system made by ReShape.

Apollo Endo-Surgery said, per NBC News, that global sales of gastric balloons were estimated to total about $120 million in 2015, driven by broad use in Brazil, Mexico and Europe, and the death reports came from all around the world, and did not necessarily include USA patients.

Apollo Endosurgery also said that 21 deaths have been reported in the last 11 years, from January 2006 to last March, out of more than 277,000 Orbera balloons distributed during that time period.

An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States. "There is no responsibility that we take more seriously than patient safety", ReShape says in a statement.



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