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ibusinesslines.com July 16, 2018


Obesity Balloons Alert: FDA Finds 5 Deaths Within a Month

11 August 2017, 10:27 | Melissa Porter

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The balloon is created to stay in place for several months to help the patient lose weight.

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

It's still unclear whether there's a definitive link between the devices and the deaths.

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

The FDA said in one treatment, there was a gastric perforation with the Orbera Intragastric Balloon System. These balloons are meant to stay inside the body for six months before deflating and eventually exiting the body the old-fashioned way.

The FDA said it's working with both companies, Apollo Endo-Surgery and ReShape Medical Inc., to understand the deaths and "to monitor the potential complications of acute pancreatitis and spontaneous over-inflation".


According to Apollo Endo-Surgery, there has been one additional death of a person who received its device.

"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. It has not received any product liability claims in connection with the five deaths. It states that of more than 277,000 devices distributed, there have been 21 reported deaths from January 1, 2006, through March 31, 2017. The exact causes in three of the deaths remained unknown.

"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", said Apollo Endosurgery CEO Todd Newton in a statement.

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 ReShape balloon, approved by the FDA in June 2015, is inserted into a patient's stomach via their mouth to prevent surgical scarring.



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