A relatively new treatment for obesity has recently been on the radar of the U.S. Food and Drug Administration (FDA) for unanticipated risks. The intragastric balloon procedure, a non-surgical method of delivering a gastric balloon via endoscopy, has been implicated in up to five deaths.

The gastric balloon is a weight-loss device made available to the public by two different distributors in July and August of 2015 respectively. ReShape Medical was the first to release their ReShape Integrated Dual Balloon System in July of that year.

Apollo Endosurgery released their Obera Intragastric Balloon System shortly following in August. The latter system is connected to four of the five supposed deaths related to this weight loss intervention.

The intragastric balloon procedure that implants the gastric balloon is supposed to be non-invasive, as opposed to gastric bypass which requires surgery. A endoscopic scope delivers the gastric balloon to the stomach where it is then inflated with fluid.

The intent is for the balloon to remain in the stomach for up to half a year. The balloon takes up space and, in so doing, helps the patient to eat less. With appetite and intake gravely reduced, weight loss can be dramatic within a short period of time.

The FDA has released a safety communication regarding the gastric balloons and the intragastric balloon procedure to the medical community. It followed analysis of five alleged deaths which all occurred within three to thirty days of implantation. No conclusions have been arrived at regarding two additional deaths currently under investigation, save the immediate cause.

The intragastric balloon procedure has been promoted as being less risky because surgery is not involved. However, this selling point may not be as true as once thought, as serious complications are being reported to the FDA.

In the two cases of death still under investigation, it is known that one was caused by perforation of the stomach and the other was caused by perforation of the esophagus. Whether these issues developed during implantation using the intragastric balloon procedure or later is unknown.

Two complications that have been identified are very concerning. The first one is over-inflation. This has happened without warning after the gastric balloon has been in place for several days. It is not necessary something done during initial inflation as part of the intragastric balloon procedure used for implantation. Patients have experienced the following symptoms with this issue:

• Nausea and Vomiting
• Difficulty Breathing or Shortness of Breath
• Distention of the Abdomen/Swelling of the Abdomen
• Severe Abdominal Pain

The second complication that has arisen is acute pancreatitis. Likely due to the compression of internal organs and structures of the abdomen with the gastric balloon in place, pancreatitis has been known to develop, but it is not a side effect that has been listed on any of the accompanying literature or label to the weight loss device. The symptoms of acute pancreatitis are:

• Severe Pain in the Back
• Severe Stomach or Generalized Abdominal Pain

This particular issue can occur and be completely missed by medical professionals because it is not mentioned in any side effects or warnings section of product labeling. The delay that this lack of knowledge can bring to getting substantial treatment might be the difference between life and death.

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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