Two companies make an intragastric balloon treatment for obesity – Apollo Endosurgery and Reshape Medical. The implantation of an intragastric balloon is a relatively simple procedure when compared to other bariatric interventions.

This medical device is introduced to the stomach via the mouth during an endoscopy. Once placed, the intragastric balloon is then filled with saline or a combination of saline and methylene blue dye.

Apollo Endosurgery’s intragastric balloon system is comprised of a single balloon with saline whereas ReShape Medical’s intragastric balloon system is comprised of dual balloons with the mixture of fluids. According to Mass Device, the balloons are designed to remain internally placed in the stomach of obese patients for a maximum of six months.

The Food and Drug Administration (FDA) has received reports regarding suspicious deaths that might possibly be related to the implantation and use of intragastric balloon systems.

The deaths have not yet been directly attributable to the medical device, but the deaths occurred within three to thirty days of balloon implantation. Given the likelihood that patients also had co-existing conditions related to being overweight such as diabetes and/or heart disease, it may be difficult to prove a direct relationship.

According to the FDA, five deaths in total have been associated with intragastric balloon systems since the inception of Apollo’s Obera in August 2015. Four deaths seem to be related by proxy to the Obera system and another related to ReShape’s dual balloon system.

A clear cause, such as bowel obstruction or perforation of the alimentary canal, has not been identified. To date, it’s unknown whether any lawsuit has been filed against the companies, but investigations are underway.

The FDA has also stated that there have been two deaths related to implantation of the intragastric balloon treatments – one from gastric and another from esophageal perforation.

Apollo Endosurgery has spoken about the adverse events reported and alleged deaths by proclaiming their commitment to company transparency and safety.

According to Mass Device, the CEO of the company, Todd Newton, has reinforced his communication strategy to physicians and emphasized the importance of thorough pre-implantation health evaluations of co-morbid conditions.

Included with the health evaluation would be the determination of the ability of the obese patient to withstand the general anesthetic and invasive nature of intragastric balloon placement.

The same online article indicates that patient training is a vital and integral part of this pre-implantation process as well. Physicians need to train patients what to look for in terms of symptomology that could be a potential post-implantation problem. These symptoms should be clearly identified so that the patients know when it is critical to seek immediate medical intervention.

How Does the Intragastric Balloon Work?

Intragastric balloon systems work by taking up space in the stomach and making less room for food. A patient recipient allegedly eats less and feels fuller faster after placement and can lose up to 30% of their excess weight during the six-month period the balloon remains.

Provided there are no complications, the weight loss can allow for dramatic improvement in diabetes, as well as arthritic conditions, high blood pressure and high cholesterol.

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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