Published: Fri, August 11, 2017
Medicine | By Megan Pierce

Deaths Linked to Weight-Loss Stomach Balloons

Deaths Linked to Weight-Loss Stomach Balloons

In three of the cases the FDA said it does not yet know the root cause or incidence rate of patient death, nor can it "definitively attribute the deaths to the devices or the insertion procedures for these devices". The company also notes that some people - it does not say how many - died while using the device. In three cases, the person died one to three days afterward.

Today's FDA warning follows another alert in February 2017, after dozens of patients suffered life-threatening side effects when their balloon spontaneously over-inflated with air or fluid.

Four of the reported deaths involved the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one other death involved the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc., the FDA said in a press release.

In the treatment, a silicone balloon is inserted via the patient's throat into their stomach, then filled with a saline solution. The remaining two deaths could be related to "potential complications associated with balloon treatment", - one was a stomach perforation and the other was a perforation in the esophagus, according to the FDA.

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

"FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications and that you report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting Program", the agency said.

"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.

They said that from January 2006 to March 2017, 21 patients using the Orbera device died.

'The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity'.

Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems.

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