Federal health officials are currently investigating at least five stomach balloon deaths which allegedly occurred soon after the victims underwent these weight loss procedures. The FDA issued a safety alert to doctors and hospitals regarding intragastric balloon systems mentioning the alleged stomach balloon deaths.

Four of these alleged stomach balloon deaths involve the Apollo Endsurgery’s Orbera Intragastric Balloon System, with the remaining one involving ReShape Medical Inc.’s ReShape Integrated Dual Balloon System. At this time, it is unknown if there is a definitive link between the devices and the stomach balloon deaths.

Each of these alleged stomach balloon deaths occurred between one to three days after implantation.

“All five reports indicate that patient deaths occurred within a month or less of balloon placement. In three reports, death occurred as soon as one to three days after balloon placement. [A]t this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction),” the FDA said.

Overview of Stomach Balloon Deaths

Gastric balloons, also called intragastric or weight loss balloons, were approved by the FDA in 2015 to be an alternative to invasive weight loss surgery.

There are currently two gastric balloons on the market: the Orbera Intragastric Balloon System by Apollo Endosurgery that entered the market in August 2015, and the ReShape Integrated Dual Balloon System by ReShape Medical that entered the market in July 2015.

They are implanted through a simple outpatient procedure and are meant to be filled up with liquid to reduce appetite. The balloons are meant to stay inside the patient for six months before deflating and eventually being expelled through the gastrointestinal tract.

These devices are meant to be an alternative treatment option for obesity, in place of traditional bariatric surgery. However, serious problems have allegedly been occurring with the devices, which may have resulted in the stomach balloon deaths.

The FDA recently issued a safety alert regarding gastric balloon systems in 2017 after five “unanticipated deaths” were reported from 2016 to present. The agency issued the warning after “multiple reports” of two different serious problems were reported in conjunction with these devices:

• Spontaneous Over-Inflation: The agency stated it received reports of this injury from several dozen patients which forced the device to be removed early. Over-inflation of the stomach balloon sometime occurs within nine days after the procedure, with the device causing abdominal pain and swelling of the abdomen.
• Acute Pancreatitis: Both stomach balloon devices have been linked to acute pancreatitis, with the agency stating the devices can cause “compression of gastrointestinal structures created by the implanted balloons.”

At this point in time, the FDA stated it was not known if these alleged stomach balloon deaths were from the devices improperly implanted of it was the device was defective in nature.

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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