The FDA has issued a warning about deaths from stomach balloons, noting that five deaths so far have been linked with the use of gastric balloon devices.

Gastric balloon procedure is a new kind of weight loss implant. The implants are balloons that are implanted in a patient’s stomach and filled with liquid. The implants are simply meant to take up space in the stomach, helping patients to feel fuller and encouraging them to eat less.

Gastric balloon procedure is considered less invasive than surgery, but the potential increased risk of complications and even death may make this convenience less worth it.

Health providers were warned by the U.S. Food and Drug Administration (FDA) last month about a potential risk of deaths from stomach balloons. According to the federal agency, five patients using these gastric balloon devices to treat obesity have unexpectedly died in just the last year, raising concerns about the safety of these devices.

So far, no conclusive evidence shows the balloons were the cause of these deaths. Still, five unexpected deaths, all of which have occurred within one month of the procedure, is nothing to ignore. Three of these patients reportedly died within one to three days of the gastric balloon procedure. The FDA is currently investigating whether or not this link is substantial.

In the meantime, the federal agency has reached out to alert physicians of a possible risk. “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.”

Multiple manufacturers have so far been involved in deaths from stomach balloons, including ReShape Medical and Apollo Endosurgery. The devices in question are the ReShape Integrated Dual Balloon System and the Orbera Intragastric Balloon System. These devices were both approved by the FDA in mid-2015.

The FDA noted that the manufacturers are cooperating with its investigation into these untimely deaths from stomach balloons. The agency “continues to work with Apollo Endo Surgery and ReShape Medical Inc. to better understand the issue of unanticipated death, and to monitor the potential complications of acute pancreatitis and spontaneous overinflation.”

If you have a gastric balloon, you should be on the lookout for symptoms of complications. Symptoms of overinflation of gastric balloons include:

• Abdominal pain
• Swelling
• Difficulty breathing
• Vomiting

The FDA’s investigation will continue looking into this potential link and “will communicate publicly when we have new information to share.”

Filing a Gastric Balloon Procedure Lawsuit

While gastric balloons have not been recalled due to their risks, the FDA has urged that health care providers “closely monitors” patients who have been implanted with these balloon systems in case of complications.

If you or someone you love has suffered from complications after undergoing a gastric balloon procedure, you may be able to file a lawsuit. While filing a lawsuit cannot take away the pain and suffering caused by injuries or bring a loved one back to life, it can help to alleviate the financial burden caused by medical expenses and lost wages.

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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