The U.S. Food and Drug Administration (FDA) issued a safety notice pertaining to gastric balloon systems after unanticipated deaths occurred in patients who had been implanted with the liquid-filled balloons.

The safety notice maintained that from 2016 to the present, five unanticipated deaths occurred after the gastric balloons were inserted .

The insertion of the gastric balloon system is a minimally invasive surgery that was approved by the FDA for the treatment of obesity. The notice states that the five unanticipated deaths all occurred within one month of the gastric balloon insertion.

Intragastric Balloon Complications

The FDA approved the intragastric balloons, or weight loss balloons, in 2015. The two balloons currently being sold on the market are the Orbera Intragastric Balloon System by Apollo Endosurgery and the ReShape Integrated Dual Balloon System by ReShape Medical.

The Orbera Intragastric Balloon System was approved by the FDA in August 2015, while the ReShape Integrated Dual Balloon System was approved in July 2015.

Allegedly, the intragastric balloon complications occurred with four of the five patients who were implanted with the Orbera weight loss balloon, while the fifth death occurred with the patient being implanted with the ReShape gastric balloon.

All of the intragastric balloon complications occurred within one month from which the patients were implanted with the balloon. Moreover, three of the five deaths that occurred happened within in one to three days of the gastric balloon implantation.

A point of question with the FDA, however, is whether the intragastric balloon complications and deaths occurred because of the gastric balloon implantation procedure or were caused by the gastric balloon system itself.

In addition, intragastric balloon complications and further deaths occurred while the FDA reported and announced the safety notice pertaining to these complications.

One death was due to a gastric perforation in a patient who had been implanted with the Orbera Intragastric Balloon System. The second death occurred in a patient who have been implanted with a ReShape Integrated Dual Balloon System. This patient suffered from an esophageal perforation.

The purpose of the implantation of a gastric balloon system is to treat obesity. Additionally, some patients who have a type-2 diabetes condition were allegedly able to reverse this disease after then implantation of a gastric balloon system.

Moreover, while traditional gastric procedures, such as the gastric bypass, are surgical procedures, the implantation of an intragastric balloon is done without surgery.

The intragastric balloon is implanted into the stomach with the aid of an endoscopy through the esophagus. Once the intragastric balloon is implanted in the stomach, it is filled with fluid and left implanted in the stomach for 6 months.

Through this procedure, patients with obesity may be able to lose one-third of their weight during the six months the balloon is implanted.

Intragastric balloon complications, however, have been tied to the implantation of this system. In addition to the deaths that have led the FDA to announce a safety notice pertaining to the device, two other serious complications were also reported by the FDA in February 2017 after receiving multiple accounts of such incidences.

These complications include a spontaneous overinflation in which patients have had to remove the system prematurely. Some symptoms of this complication include abdominal pain, breathing difficulty, vomiting, and distention or swelling of the abdomen.

The second serious condition that may result from gastric balloons is pancreatitis. According to the FDA, this is the result of “the compression of gastrointestinal structures created by the implanted balloon.”

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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