Deaths Reported After Balloon Obesity Treatments

Obesity

"The Agency has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment (one gastric perforation with the Orbera Intragastric Balloon System and one esophageal perforation with the ReShape Integrated Dual Balloon System)", the FDA added.

Five unexpected deaths have occurred in patients with liquid-filled intragastric balloon systems used to treat obesity, according to the Food and Drug Administration. Three patients died 1 to 3 days afterward.

However, the agency has issued a warning to doctors treating patients with similar devices to monitor them closely.

"The FDA's letter reinforces the fact that complications and adverse events can occur within patients having obesity-related co-morbid conditions". In the procedures, patients are mildly sedated as a deflated balloon made of silicone is inserted through the throat and into the stomach, after which it's filled with saline to take up space in the stomach.

Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries. Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure.


Shares sold off nearly 26% yesterday after the FDA published a letter warning healthcare providers of the risks of liquid-filled intragastric balloons. The exact causes in three of the deaths remained unknown. Apollo, which says it has sold 180,000 of the devices globally, said it was preparing a statement.

The company said it "received no product liability-related claims in connection with these five cases" and noted that the incidence rate "remains less than 0.01%", which is in line with what it reports in the directions for use of the device.

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

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.

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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