Gastric balloons have been touted as an option for patients who need to lose 30 to 100 pounds and do not want to undergo traditional surgical treatments such as gastric bypass or Lap-Band procedures. However, it’s not without risks.

Gastric balloon complications may include abdominal pain, vomiting, pancreatitis, and even death.

The FDA issued a safety alert regarding gastric balloons after five people died from “unanticipated deaths” from 2016 to the present after having gastric balloons inserted.

The FDA approved gastric balloons in 2015 as a minimally invasive procedure to treat obesity. Patients swallow a pill that is actually the balloon. A doctor uses a micro-catheter to inflate the balloon with either gas or saline solution until it is about the size of a baseball. Balloons are meant to stay in place for six months.

Two brands of gastric balloons currently compete for the market. The Orbera Intragastric Balloon System by Apollo Endosurgery has been linked to four of the reported deaths. The fifth person who died had received the ReShape Integrated Dual Balloon System by ReShape Medical.

All of the deaths occurred within a month of gastric balloon implantation, and three of those occurred just one to three days after implantation.

The FDA has not determined whether these deaths were caused by the balloons themselves or by the insertion procedure that was used to implant the balloons.

“The agency (FDA) has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment (one gastric perforation with the Orbera Intragastric Balloon System and one esophageal perforation with the ReShape Integrated Dual Balloon System),” says an FDA press release.

Gastric Balloon Complications Can Include Pancreatitis, Over-inflation

The possibility of long-term gastric balloon complications is unknown, but acute pancreatitis has developed in some patients. The FDA says pancreatitis is caused by abnormal pressure that is placed upon the pancreas by the gastric balloon.

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

Spontaneous over-inflation is another gastric balloon complication that can necessitate early removal of the device. A patient experiencing abdominal pain, swelling or distention of the abdomen, difficulty breathing and vomiting can be experiencing the effects of an over-inflated gastric balloon.

The FDA reports receiving several dozen complaints of spontaneous over-inflation from patients. In some instances, the over-inflation has occurred up to nine days after balloon implantation.

Neither pancreatitis nor over-inflation are listed as possible gastric balloon complications, which means doctors and emergency room personnel might not be aware of either issue. Inappropriate or delayed treatment can make matters worse for those suffering.

If you or someone you love has experienced gastric balloon complications after implantation, you could qualify 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.

Learn More