The FDA recently issued a safety warning regarding stomach balloon deaths after five unanticipated deaths were reported in 2016.

Each of these patients had the medical device inserted for weight loss purposes, but had suffered unexpected stomach balloon deaths due to unexpected device complications. The official FDA warning was issued in February 2017, with the agency stating two major complications that may be linked to stomach balloon deaths:

• Spontaneous Over-inflation: The FDA stated that several dozen patients have experienced over-inflation issues, resulting in premature removal of the devices. This complication has been primarily reported in Orbera patients, but some have also been reported in conjunction with the ReShape system. At the time the stomach balloon warning was issued, it was pointed out that over-inflation was not listed as a potential complication on the warning label.
• Stomach Balloon Induced Pacreatitis: This complication has been reported in users of both of Orbera and ReShape stomach balloons. The FDA says it may be caused by “the compression of gastrointestinal structures created by the implanted balloon(s).” The devices had to be removed prematurely, with some of the patients needing to be hospitalized. This complication occurred within days of the having the device implanted. This problem was also not mentioned on the medical device’s warning label, according to the FDA warning.

The FDA stated it it was not known how the stomach balloon deaths were caused, and that further investigation was needed to determine if the deaths were caused by the devices or how the devices were implanted.

There were also two more stomach balloon deaths reported, with one death allegedly caused by gastric perforation from the Orbera stomach balloon while there one was allegedly caused by esophageal perforation from the ReShape stomach balloon implanted.

Overview of Stomach Balloon Complications

Stomach balloons were approved as alternatives to traditional gastric bypass surgery, which are considered minimally invasive and less expensive.

These medical devices first entered the market in 2015, with two models on the market: the Orbera Intragastric Balloon System by Apollo Endosurgery, approved in August 2015, and the ReShape Integrated Dual Balloon System made by ReShape Medical, approved in July 2015.

Stomach balloons are implanted by endoscopy, then expand over time. They are meant to take up space in the patient’s stomach, reducing appetite and encourage gradual life change. The stomach balloon is then expelled through the gastrointestinal tract after six months.

Even though these medical devices are meant to give convenient and minimally invasive options for patients wanting to undergo weight loss surgery, stomach balloon deaths have been reported. Four of the reported stomach balloon deaths occurred in patients who had the Orbera stomach balloon implanted. The fifth patient was implanted with the ReShape gastric balloon.

Each of the reported stomach balloon deaths were reported within a month of the device’s implantation, with three of the stomach balloon deaths occuring within one to three days after implantation.

At this point in time, the FDA has called for further investigation of potential causes for the stomach balloon deaths and is cautioning the medical community.

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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