Patients who have had a gastric balloon weight loss procedure are at risk for suffering “unanticipated deaths,” according to a safety alert announced by the U.S. Food and Drug Administration, or FDA.

According to the report, there were five “unanticipated deaths” in patients who have had a gastric balloon weight loss procedure in which they were inserted with a liquid filled intragastric balloon system, in 2016.

The report maintains, moreover, that the gastric balloon weight loss procedure is a relatively minimally invasive procedure. It was also approved by the FDA to help treat obesity. Allegedly, the reported “unanticipated deaths” had all occurred within a month of the procedure.

Gastric Balloon Weight Loss Procedure Facts and FDA Warning

These gastric balloons are also termed intragastric balloons or weight loss balloons. According to reports, they were approved by the FDA in 2015. Two gastric balloon types are currently on the market; one, called the Orbera Intragastric Balloon System, approved in August 2015 by the manufacturer Apollo Endosurgery, and another, the ReShape Integrated Dual Balloon System, that was approved by the FDA in July 2015, and manufactured by ReShape Medical.

Allegedly, the five total deaths that have resulted include four deaths of patients who were implanted with the Orbera gastric balloon weight loss and one patient who was implanted with the ReShape gastric balloon weight loss. Of the five deaths, three patient deaths all took place within one to three days of the gastric balloon weight loss procedure, or implantation, while the other two occurred within a month of its implantation.

According to the report, the FDA does not definitively know if the device had caused the death itself or if it were the result of the gastric balloon weight loss procedure.

The report maintains that another two alleged patient deaths were announced while the FDA had announced its reported findings of gastric balloon weight loss complications. Of the two most recent deaths, the patient had suffered from a gastric perforation due to the alleged implantation of the Orbera Intragastric Balloon System. The second of the two most recent deaths occurred due to an esophageal perforation, while the patient had been implanted with the ReShape Integrated Dual Balloon System.

How the Gastric Balloon Weight Loss Procedure Functions

To treat obesity, the Intragastric balloons of one of many different gastric procedures. Some patients with type-2 diabetes reported improvement in their diabetes symptoms after a gastric procedure. One other known gastric procedure is the gastric bypass, a well-known surgery in which some of the food ingested will no longer go into some parts of the stomach and small intestine that are used to absorbing food.

The gastric balloon procedure is non-invasive. The balloon enters the stomach through the mouth and esophagus and is implanted with the help of an endoscopy. Once it is in the stomach, the gastric balloon weight loss balloon is filled with fluid and a left implanted in the stomach for six months. The difference between the two types of balloons, the Orbera and Reshape, is that the Orbera uses one balloon and the Reshapy system uses two.

Some side effects of the gastric balloon weight loss procedure include spontaneous over-inflation, in which patients have had to remove the device prematurely, and acute pancreatitis, the condition in which the pancreas, which lies behind the stomach, becomes inflamed.

Join a Free Gastric Balloon Side Effects Class Action Investigation

If you or a loved one has suffered from complications following a gastric balloon procedure, you may be entitled to compensation.

Fill out the form on this page now or call 1-(855)-JONES-LAW (1-855-566-3752) for a FREE case evaluation. In general, gastric balloon lawsuits are filed individually by each plaintiff and are not class actions. After you fill out the form, the attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. Hurry — statutes of limitations may apply.

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