Recently the FDA issued a warning regarding weight loss balloon medical devices, stating five patients who recently received these devices had unexpectedly died.

The agency sent the warning to healthcare facilities, stating these the deaths occurred from 2016 to present with the following weight loss balloon models: Orbera Intragastric Balloon by Apollo Endosurgery and the ReShape Integrated Dial Balloon System by ReShape Medical Inc.

The FDA issued a recent update in February 2017, in a letter addressed to healthcare facilities that recommended that weight loss balloon patients be closely monitored. Patients could be at risk for acute pancreatitis and spontaneous over-inflation.

Since the letter was issued, Apollo and ReShape have revised their weight loss balloon warning labels to address the potential complications. Weight loss balloon devices, also known as gastric or stomach balloons, are silicone balloons that can be inserted into the patient’s stomach endoscopically and are then inflated with sterile saline solution.

When the weight loss balloon is fully inflated, it is supposed to interfere with the patient’s appetite and encourage healthier meal sizes. The devices are intended to say inside the patient for six months, which is supposed to be long enough to manipulate the patient’s eating patterns.

Weight loss balloon devices have quickly grown in popularity for patients, as they are considered cheaper and less invasive than tradition gastric bypass surgery. Even though insurance companies will most likely not cover the procedure, the procedure costs under $10,000 and is meant to be a hassle-free and temporary weight loss helper.

Even though these medical devices have reportedly helped numerous patients with obesity issues, the safety of stomach balloons has been called into question. According to a recent study that observed 160 patients prescribed the ORBERA device, with 10% of the patients reports serious adverse events including: dehydration, infection, and gastric perforation with sepsis.

In addition, there have been reports of acute pancreatitis and spontaneous over-inflation submitted since gaining FDA approval but these events are very rare.

Overview of FDA Weight Loss Balloon Warning

According to the initial 2016 warning, four reports stemmed from the Apollo weight loss balloon and another one with the Reshape weight loss balloon.

All five death reports indicate the patients died within a month or less after the weight loss balloon was ingested, with three deaths reportedly occurring after just one to three days. At this time, the FDA does not know the exact cause of these patient deaths or definitely confirm if the weight loss balloon devices are responsible.

The FDA also received two additional reports of deaths relating to the weight loss balloon device known as the Orbera Intragastric Balloon. Reports accuse that device of causing gastric perforation and other reports name that the ReShape Integrated Dual Balloon System allegedly causing an esophageal perforation.

The FDA is continuing the monitor the situation in collaboration with Apollo Endo-Surgery and ReShape Medical Inc., to better understand how the deaths may have been caused. As part of the ongoing investigation, the FDA mandated post-approval studies for these weight loss balloon devices.

The FDA continues to monitor the situation closely, recommending that healthcare providers and patients report any weight loss balloon injuries to the FDA’s Safety Information and Adverse Event Reporting Program.

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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