FDA updates gastric balloon warning after 5 deaths

FDA updates gastric balloon warning after 5 deaths

Since 2016 five people who have had balloons inserted into their stomachs to treat obesity have died. The balloon is created to remain in place for several months.

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. Apollo's Orbera intragastric balloon system is composed of a single balloon which is filled with saline, while ReShape's integrated dual balloon system uses 2 balloons filled with saline and methylene blue dye.

The agency added that it has also received two reports of death related to possible complications associated with the balloons occurring in the same time period, one of which was a gastric perforation associated with the Orbera balloon, and the other an esophageal perforation associated with the ReShape balloon. Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure. The inflated balloons stay there for six months, taking up space inside the stomach so the person feels full.

The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag. In three cases, the person died one to three days afterward.

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"The FDA's letter reinforces the fact that complications and adverse events can occur within patients having obesity-related co-morbid conditions".

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.

The alert from the FDA does not mean that the agency has definitively proven that the balloons caused the deaths, but that they are looking into it. It states that of more than 277,000 devices distributed, there have been 21 reported deaths from January 1, 2006, through March 31, 2017.

In a statement emailed to CNN, ReShape Medical said, "There is no responsibility that we take more seriously than patient safety. 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", CEO Todd Newton said in prepared remarks.