Gastric balloon systems may seem like a quick and relatively easy way to lose weight. However, recent reports of gastric balloon deaths have concerned both the medical community and patients alike.

What is Gastric Balloon Procedure?

Gastric balloon procedures are relatively new procedures that were approved by the U.S. Food and Drug Administration in 2015. It is a minimally invasive surgery that helps people to lose weight.

It does not require surgery and is reversible, so many people see this as a better option than gastric bypass surgery. Gastric bypass surgery requires surgery and is not reversible.

During the gastric balloon procedure, a balloon is implanted into the patient’s stomach via the mouth and esophagus, bypassing the need for a surgical incision. The balloon is then inflated in the patient’s stomach.

The gastric balloon procedure is an outpatient procedure after which a patient can return home the same day. The procedure itself only takes 20-30 minutes to complete and the patient only needs a few days to recover.

When the balloon is inflated and filled with liquid, there is less room in the patient’s stomach for food. The patient feels full for longer and quicker. Patients report that within six months, they can lose up to 30 percent of their excess weight. Gastric balloons are intended to be removed after about six months.

Gastric Balloon Deaths

Recently, there have been reports of gastric balloon deaths. At least five patients have suffered gastric balloon deaths, according to the FDA.

Five reports of “unanticipated deaths” have been reported to the FDA regarding gastric balloon procedures that have occurred between 2016 and 2017. These gastric balloon deaths have occurred with patients who have received a liquid-filled intragastric balloon procedure.

These reports of gastric balloon deaths concern two brands of gastric balloons: the Orbera Intragastric Balloon System manufactured by Apollo Endosurgery, and the ReShape Integrated Dual Balloon System made by ReShape Medical.

The FDA reports that all five patients died within one month of the balloon being implanted. Three of those patients suffered gastric balloon deaths within one to three days after balloon placement.

The FDA does not know the actual reason behind the gastric balloon deaths. They said in their safety communication, “At 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 says that two additional reports of gastric balloon deaths were also reported. One involved the death of a patient who suffered a gastric perforation and the other was a patient who experienced an esophageal perforation.

Not only have patients suffered gastric balloon deaths, but there have also been reports of spontaneous overinflation of the gastric balloon as well as acute pancreatitis. Fox News reports that in a study of 160 Obrera patients, ten percent had a serious complication occur such as dehydration, infection, and gastric perforation with sepsis. Additionally, patients suffered device intolerance, nausea, vomiting and reflux pain.

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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