A gastric stomach balloon procedure might seem like a good option for some patients attempting to lose weight. However, a recent FDA report of potential risks has alerted the medical community about five patient deaths that have occurred.

The U.S. Food and Drug Administration released a report on Aug. 10, 2017, noting “five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.”

The FDA reports that four of these unanticipated deaths related to stomach balloons occurred with Apollo Endosurgery’s Orbera Intragastric Balloon System and one death related to stomach balloons had to do with the ReShape Integrated Dual Balloon System made by ReShape Medical.

How Do Stomach Balloons Work?

Stomach balloons are balloons that are inserted into a patient’s stomach through their esophagus. The procedure itself is considered minimally invasive and many consider it a better option than gastric bypass surgery.

Gastric bypass surgery is a surgical procedure, while the insertion of a gastric balloon is not. Recovery time is much quicker with stomach balloons.

Once the stomach balloon is inserted into the stomach, it is filled with fluid. It is then left in place for up to six months. The filled gastric balloon gives the patient the feeling of being full and patients have reported losing up to a third of their body weight. Usage and the concurrent weight loss can also reverse some weight-related health problems such as sleep apnea, type two diabetes, high blood pressure, stroke and arthritis.

Stomach balloons are not permanent solutions, however. They must be removed after six months and the patient must adhere to a special diet.

Deaths Associated with Stomach Balloons

When the FDA reported that five deaths had been associated with the insertion of stomach balloons, they were clear to note that they have not been able to “definitively attribute the deaths to the devices or the insertion procedures for these devices.” In essence, they do not know if the devices themselves caused the deaths or if it was something related to the procedure in which the stomach balloons were inserted.

Each of the five reported deaths happened less than one month after the stomach balloon was placed and in three of the reported deaths, the patients died within three days of insertion.

Additionally, the FDA reports that two more deaths were reported in association with stomach balloons. One reported death had to do with gastric perforation and one was as a result of esophageal perforation.

The FDA asks that healthcare providers watch their patients who have stomach balloons closely for potential other side effects such as acute pancreatitis or spontaneous over-inflation of the stomach balloon.

The symptoms of spontaneous over-inflation of a gastric balloon include swelling of the abdomen, difficulty breathing, vomiting and abdominal pain.

Acute pancreatitis can occur with stomach balloons because gastrointestinal structures are compressed by the added pressure of the balloon. When this happens, the gastric balloon must be removed and the patient may need to be hospitalized.

If you or someone you love has been affected adversely by symptoms of stomach balloons, you may benefit from speaking to an experienced attorney.

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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