At least five people have died from gastric balloon complications within a month of balloon insertion, says the FDA.

The FDA issued a warning to the health care industry regarding gastric balloons made by two different companies: Apollo Endosurgery and ReShape Medical. Apollo Endosurgery makes the Orbera Intragastric Balloon System, and ReShape Medical makes the ReShape Integrated Dual Balloon System.

Gastric balloons are used to help overweight patients lose weight by eating less. Obese patients receive a balloon placed into their stomach through the mouth. The doctor inflates the balloon with either gas or a saline solution until the balloon is about the size of a baseball. Patients with the full balloon tend to eat fewer calories.

The FDA reports that three of the five deaths occurred just one to three days upon receiving the weight-loss implant.

“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),” said the FDA in a written statement.

Two additional deaths are possibly related to gastric balloon complications, said the FDA. One Apollo patient had a gastric perforation, and one ReShape patient suffered an esophageal perforation.

Gastric Balloon Complications Can Appear Suddenly

Gastric balloons were approved by the FDA in 2015 to treat patients seeking to lose 30 to 100 pounds. The device was seen as a safer option than traditional surgical treatments such as a gastric bypass or Lap-Band procedure.

The gastric balloons are designed to stay within the stomach for up to six months.

Long-term gastric balloon complications are not known, but some patients have developed acute pancreatitis  The FDA indicates pancreatitis is caused by abnormal pressure that is placed upon the pancreas by the full gastric balloon.

Pancreatitis causes severe abdominal and back pain. Signs of pancreatitis usually appear within days of gastric balloon implantation. Pancreatitis is not listed among possible gastric balloon complications, but it can be a reason the balloon needs to be removed prematurely. Some patients have needed hospitalization until the pancreas returns to normal.

In some patients, the balloon will spontaneously over-inflate, requiring early removal of the device. A patient experiencing abdominal pain, swelling or distention of the abdomen, difficulty breathing and vomiting can be suffering the effects of an over-inflated gastric balloon. The FDA reports receiving several dozen complaints related to over-inflation. In some instances, over-inflation symptoms have occurred up to nine days after balloon implantation.

Because pancreatitis and over-inflation are omitted as possible gastric balloon complications, doctors and emergency room personnel might take longer to diagnose the core issue. Delaying treatment can cause more stress on the body and result in further complications.

If you or someone you love has suffered from gastric balloon complications, you could be eligible for compensation through legal representation.

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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