The U.S. Food and Drug Administration has issued a warning of a possible link between a gastric balloon procedure and the recent deaths of five patients who have undergone the procedure. The FDA is currently investigating whether or not this link is substantial.

The FDA issued an alert this month, warning medical professionals involved in treating obesity that there may be a connection between the new gastric balloon procedure and a string of recent deaths. According to the alert, five “unanticipated deaths” occurred within one month of undergoing gastric balloon procedure since 2016.

Some didn’t even make it a month—three of these patients reportedly died within one and three days of the gastric balloon procedure.

While the FDA notes that no connection has of yet been confirmed, the agency still reached out to alert physicians of the possibility of a fatal 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,” the agency said.

The balloon systems involved in these deaths came from two different manufacturers. One of the patients was implanted with the ReShape Integrated Dual Balloon System from ReShape Medical. The four others were all implanted with the Orbera Intragastric Balloon System from Apollo Endosurgery. These devices were approved by the FDA in July and August 2015, respectively.

The FDA noted that the manufacturers are cooperating with its investigation. The agency “continues to work with Apollo Endosurgery and ReShape Medical Inc. to better understand the issue of unanticipated death, and to monitor the potential complications of acute pancreatitis and spontaneous overinflation.”

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

And 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.”

Gastric Balloon Procedure Basics

Gastric balloon procedure is a new kind of weight loss implant. 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.

Filing a Gastric Balloon Procedure Lawsuit

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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