The U.S. Food and Drug Administration (FDA) has issued a warning about certain risks linked with the use of gastric balloons.

What Are Gastric Balloons?

Gastric balloons are a new kind of weight loss device. The implants are gastric balloons filled with liquid and implanted in a patient’s stomach. Essentially, 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 death may make this convenience less worth it.

The Risks of Gastric Balloons

According to a letter from the FDA to U.S. health care providers, there were two significant issues that have led to a slew of adverse event report filings pertaining to gastric balloons.

One of the major risks of using gastric balloons is the possibility of overinflation. Overinflation can occur when the balloon, which is already supposed to contain liquid, further inflates with either more fluid or with air once it has been placed in the stomach.

Overinflation is a significant problem, and usually necessitates removal of the device. According the FDA’s adverse event reports, patients can suffer overinflation as soon as nine days after the original implantation of the device. Symptoms of overinflation include abdominal distention, severe abdominal pain, breathing problems, and vomiting.

The other major complication linked with the use of gastric balloons is acute pancreatitis. This can occur when the balloons compress other parts of the gastrointestinal system. Symptoms include severe back and abdominal pain, which can start as soon as three days after implantation of the device.

Gastric balloons linked with these complications are the Orbera Intragastric Balloon System from Apollo Endosurgery and the ReShape Integrated Dual Balloon System from ReShape Medical. Despite the slew of reports, neither of these devices warn about the risk of either overinflation or pancreatitis.

On top of this, there have also been five “unanticipated deaths” tentatively linked with the devices, all within one month of the initial procedure. Some didn’t even make it a month—three of these patients reportedly died within one and three days of the gastric balloon procedure.

The FDA cautioned providers regarding the use of these devices. “We recommend that you closely monitor patients with these devices for adverse events, and to submit reports to help us better understand any complications from the use of these obesity treatment devices,” read the agency’s letter. The FDA is currently investigating whether or not this link is substantial.

If you’ve been considering undergoing a gastric balloon procedure, the FDA has not recommended avoiding this option, instead noting that “patients should speak to their doctors to determine which obesity treatment option is best for them.”

Filing a Lawsuit Over Complications With Gastric Balloons

If you or someone you love has suffered from complications of gastric balloons, 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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