Published: Fri, August 11, 2017
Culture | By Stewart Greene

Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

One of the devices is a balloon that can be placed in the stomach and filled with saline water, the Orbera balloon made by Apollo Endo-Surgery.

Apollo Endo-Surgery said, per NBC News, that worldwide 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. The FDA says it can't confirm the devices are responsible for the deaths.

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

In an alert issued Thursday, the FDA said four reports involved 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. "Patients with questions about this FDA update should contact their physicians directly".

The FDA's announcement does not mean that the weight loss balloons caused the patients' deaths, but they are looking into two more deaths and advising doctors to closely monitor their patients using these devices. The exact causes in three of the deaths remained unknown. It has not received any product liability claims in connection with the five deaths.

Five Die While Using Obesity Devices, FDA Says
Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

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

In an August 10 letter to health care providers, the FDA says all five reports indicate that the deaths occurred within a month or less of balloon placement.

"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.

'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'.

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