With the recent FDA gastric balloon warning, the medical community and patient population have been wary of using the alternative weight loss device. The FDA gastric balloon warning was recently issued after five unanticipated deaths were reported in conjunction with these devices.

Even though gastric balloons were approved to be safe and minimally invasive options for patients who cannot or do not wish to undergo gastric bypass surgery, the FDA gastric balloon warning raises serious questions about how safe the medical devices really are.

Overview of FDA Gastric Balloon Warning

According to EndocrineWeb the first thing to take note of is which gastric balloon models are affected by the FDA notification. These are the Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System. Both gastric balloons were approved by the FDA in July 2015 to be safe and convenient solutions for obese patients looking for weight loss solutions.

The gastric balloon systems approved by the FDA in 2016 are not involved, but the reported deaths are still very concerning. These medical devices are prescribed to patients with a BMI of 30 or higher, and have been unable to lose weight despite lifestyle changes like diet and exercise.

The second thing to note is what the FDA gastric balloon warning stated regarding the alleged gastric balloon deaths. Two of the five alleged deaths occurred when the device was still inside the patients. The FDA gastric balloon warning states that four of the deaths occurred in conjunction with the Orbera device, and the fifth death was associated with the ReShape balloon.

Three of the deaths occurred within three days of implantation. The FDA stated that it was not known if the deaths occurred from mistakes made during the implant procedure or gastric balloon defective nature.

The third thing the public should note is the concern of medical professionals who have expressed concern for gastric balloon complications. While the FDA stated these devices needed “close monitoring”, this could mean different things between people.

According to Dr. Caroline Apovian of the Boston University School of Medicine, who is also a member of the EndocrineWeb editorial board, there are no official guidelines for monitoring. She advised that patients who recently had a gastric balloon implanted, checking with their physicians once a week for the first month and once a month for the following five.

The American Society for Gastrointestinal Endoscopy and the Association for Bariatric Endoscopy have also expressed concern and have released a joint statement. The medical organizations advised doctors to talk thoroughly with patients wanting to use gastric balloons, and evaluate the risk and benefit ratio.

At this point in time, ReShape Medical states patient safety is a very serious matter to them and they have been discussing the FDA gastric balloon warning. Apollo Endosurgery has responded similarly, with company CEO Todd Newton and other corporate authorities calling for a conference regarding the matter.

Newton stated that while there was no evidence suggesting device malfunction, the cause of the deaths were still unknown.

Recently, a FDA gastric balloon warning was released in February 2017 stating the deaths were linked with gastric over-inflation and acute pancreatitis. Like the FDA warning, EndocrineWeb says that because of the potential device complications of gastric balloon, the situation needs further investigation.

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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