Obesity Balloons Alert: FDA Finds 5 Deaths Within a Month

Obesity Balloons Alert: FDA Finds 5 Deaths Within a Month

Obesity Balloons Alert: FDA Finds 5 Deaths Within a Month

The root causes for the deaths are unknown, the agency said, "nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction)".

Since 2016 five people who have had balloons inserted into their stomachs to treat obesity have died.

Five people have died after have anti-obesity devices surgically inserted into their stomachs, United States regulators have revealed.

In three of the reports, the patients died within three days of device placement, while in the other two, the patients died within one month of the procedure, the FDA said.

The FDA said four patients who died used the Orbera Intragastric Balloon System, made by Apollo Endo Surgery, and one used the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.

The FDA also said another two patients died from complications from balloon implantation: a gastric perforation in an Orbera patient and an esophageal perforation in a ReShape patient. Then saline is used to fill the balloons.

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However, the agency has issued a warning to doctors treating patients with similar devices to monitor them closely. The inflated balloons stay there for six months, taking up space inside the stomach so the person feels full.

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

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. 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%.

'The FDA's letter to health care providers does not indicate that the patient deaths were related to the Orbera device or the insertion procedures.

Apollo Endosurgery (NASDAQ:APEN) says its ORBERA device has proven to be safe over the years in clinical trials and since its approval by the FDA in August 2015.

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