Five unexpected deaths within days or weeks of intragastric balloon insertion procedures are pointing to intragastric balloon risks.

This treatment for obesity is a procedure in which one or two silicone balloons are placed in the stomach of a patient who is under light sedation via endoscope in a gastroenterology office or day surgery center.

Once in place, the balloons are then filled with a fluid to take up space in the stomach and reduce appetite. This displacement of space and reduction of appetite is supposed to allow for weight loss over the six-month period the balloon stays in place.

The two companies which make gastric balloons globally are based in the State of California–Apollo Endosurgery Inc. located in San Diego, and ReShape Medical Inc. located in San Clemente. Apollo Endosurgery Inc. makes the Orbera balloon system, which has been linked to four of the five sudden deaths.

The device was approved domestically by the Federal Food and Drug Administration (FDA) in August 2015, a little over two years ago.

Apollo Endoscopy was quick to point out that this device has been available in other countries for 11 years and out of 277,000 distributed units, there have been only 21 deaths possibly associated with the product. Intragstric balloon risks based on this statistic are very low.

The other sudden demise of a patient was linked to ReShape Medical Inc.’s dual balloon system, which was also approved in 2015. According to ReShape Medical Inc.’s website, the dual balloon system comes with less intragastric balloon risks because of the use of two balloons.This discourages migration of the balloons.

Although none of the five deaths have been proven definitively to be caused by either system, according to the FDA, only one of the five were closely connected to use of the ReShape Gastric Balloon device.

FDA Sends Out Warning Letter Regarding Intragastric Balloon Risks

On Aug. 10, 2017, the FDA sent out a warning letter to the medical professional community regarding intragastric balloon risks. This was due to the five sudden deaths of patients within 1 to 30 days of being implanted with gastric balloon devices from either source.

According to the FDA, it is still unknown at this time if there were further contributing factors to these deaths such as accidental esophageal or gastric perforation during endoscopic implantation or contraindicating health conditions not adequately screened out.

The FDA recommended close monitoring of all gastric balloon patients. They requested prompt reporting of all adverse medical events through the Federal Adverse Event Reporting System, or FAERS, for tracking purposes.

The FDA has identified two intragastric balloon risks which might play a part in these recorded sudden deaths and lead to others, if not properly monitored. The first one is spontaneous over-inflation of one or both balloons, which can lead to impairment of other gastrointestinal systems. The second risk is acute pancreatitis, which probably stems from this impairment. Bowel blockages have also been seen as part of this obesity treatment.

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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