A gastric balloon FDA warning was released after five patients reportedly suffered sudden death soon after weight loss surgery.

All deaths reportedly occurred within a month of the procedures with three patients dying just one to three days later, according to the gastric balloon FDA warning letter that was sent to healthcare providers.

However the agency stated they are yet to determine the exact cause of death, including whether not the devices were made defectively or if the devices were properly implanted.

“At this time, we do not know the root cause or incidence per rate of patient death,” said the FDA.

In its gastric balloon FDA warning, the agency stated it was working with manufacturers to help determine the cause of failures.

The manufacturers involved in the investigation are two companies based in California, with four cases involving the Orbera Intragastic Balloon System by Apollo Endosurgery, and one involving the ReShape Integrated Dual Balloon System by ReShape Medical.

According to the gastric balloon FDA warning, the deaths occurred in 2016. Additionally, two more death reports occurred around the same time which may be related to gastric balloon complications.

In response to the gastric balloon FDA warning, Apollo Endosurgery stated that it had self reported the deaths of five patients that had the Orbera intragastric balloon implanted from four countries.

These deaths were reported since the Orbera intragastric balloon was approved by the FDA in August 2015. The company pointed out that this is a rate of less than 0.01%.

Overview of Gastric Balloon Complications

Gastric balloons are used as alternative treatment methods to treat obesity for patients who do not wish to undergo gastric bypass procedures and other similar surgeries. Many patients prefer gastric balloons because the devices do not require surgery, but enter the body orally using an endoscopy.

The patient is mildly sedated during this procedure and the gastric balloon is filled with saline which remains in the stomach for six months. This product is supposed to help patients lose weight by decreasing their appetite, with patients typically losing a third of their weight in just six months.

Gastric balloons have been on the market since 2015 when the FDA granted approval to two models currently on the market: the Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System.

However the gastric balloon FDA warning was announced in 2016, after four deaths occurred allegedly due to the defective nature of the device. Three of these deaths reportedly occurred just one to three days after the devices were implanted.

There was an updated gastric balloon FDA warning released in February 2017 after the agency had received multiple reports of two different serious side effects:

• Spontaneous over-inflation: The FDA stated there were several dozen patients had suffered from over-inflation issues, which forced patients to have the devices to be prematurely removed. This complication has been reported most with the Orbera gastric balloons, but has also been seen in the ReShape product. At the time the gastric balloon FDA warning, the agency noted that over-inflation was not listed as a potential complication on the device’s warning label.
• Acute Pancreatitis: Both the Orbera and ReShape gastric balloons have been linked to acute pancreatitis. The agency stated that this problem may be caused by “the compression of gastrointestinal structures created by the implanted balloon(s).”

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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