FDA updates gastric balloon warning after 5 deaths


Federal regulators are investigating at least five patient deaths which occurred within a month of gastric balloon procedures meant to fight obesity.

In a report, the U.S. Food and Drug Administration (FDA) is warning health care providers about the liquid-filled balloon weight loss system created to fight obesity, announcing that since 2016, there have been five people dead after using it. In addition to saline, the balloon that is made from silicone may contain some radio-opaque material as a radiographic marker and a dye such as methylene blue to alert the patient when the balloon would leak.[1] Studies have suggested that fluid is superior to air for distending gastric balloons.[2] Inflated balloons reduce the operative volume capacity of the stomach. It stays in the stomach for up to six months, while the patient also follows a diet and exercises regularly. Of these, three occurred between one and three days after balloon placement.

An obesity treatment that involves placing balloons inside the patient's stomach may have resulted in five deaths since 2016, the U.S. Food and Drug Administration said in a new warning.

"At this time, we do not know the root cause or incidence per rate of patient death", the FDA said, adding that it is working with the companies that manufacture the devices.

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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Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries. Four of them, named Orbera Intragastric Balloon Systems, were manufactured by Apollo Endo Surgery, while the other one, named ReShape Integrated Dual Balloon System, was fabricated by ReShape Medical Inc.

The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag.

A spokeswoman for Apollo said the reports were from around the world and did not necessarily involve USA patients.

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

In a statement to CNN, ReShape Medical said: "There is no responsibility that we take more seriously than patient safety".