October 19, 2017

FDA Reports That 5 People Have Died After Weight Loss Balloon Treatments

12 August 2017, 12:56 | Winifred Adams

Deaths prompt renewed FDA warning on intragastric balloons

Five Die While Using Obesity Devices, FDA Says

All 5 patients died within 1 month of receiving the weight-loss balloon.

The FDA said that five deaths have been linked to intragastric balloons albeit it remains unclear if the fatalities were caused by the device itself or the surgery.

Gastric balloons are among the varied devices on the market to treat severe obesity.

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.

The FDA said that they also received two other reports of fatal cases in the same period which were associated with potential complications linked to balloon treatment.

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"All five reports indicate that patient deaths occurred within a month or less of balloon placement", the FDA said in a statement cited by NBC. In three reports, the patients died in as little as one to three days later.

"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. No product liability lawsuits have been filed against it, the Austin, Texas-based company said, claiming an incident rate since the beginning of 2006 of less than 0.01%.

An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States. 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. "In our physician training, we are diligent to emphasize the factors that support the safe and effective use of ORBERA and we will continue to do so". Pancreatitis and balloon over-inflation were not listed as potential side effects until February 2017, so doctors might not be aware of the risk.

APEN shares closed down -23.3% at $4.34 apiece yesterday.

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