Complications from Orbera and ReShape Intragastric Balloons for Weight Loss Result in Updated FDA Warnings

As problems continue to be linked to the Orbera and Reshape intragastric balloons, federal health officials have updated warnings about the risk of complications associated with the weight loss implants.

The FDA issued a letter to healthcare providers on April 27, after the results were reviewed from two post-approval studies for Orbera and ReShape liquid-filled intragastric balloon systems, which are used to treat obesity.

The findings suggested patients may be at an increased risk for over-inflation injuries, acute pancreatitis events and death after receiving the weight loss balloons.

Orbera and ReShape are designed to help obese individuals lose weight. The balloons are made of soft silicone, and are implanted in a patient’s stomach for about six months, to take up enough space to help patients adapt to healthier portion sizes.

The weight loss balloon systems are advertised as a less invasive procedure than other types of bariatric surgery, since they are inserted orally through the esophagus, which eliminates scarring. The patient is placed under only a mild sedation and the procedure takes about 30 minutes.

In 2015, the FDA approved the two intragastric balloon systems for use in the U.S. under the condition that the manufacturers Apollo Endo-Surgery (Orbera) and Reshape Medical Inc. (Reshape) conduct a post-approval study assessing their post-market performance. Since the order, Apollo Endo-Surgery, Inc, bought out Reshape Medical Inc. and continued the post-market study of the Reshape devices.

After a recent review of these post-market studies by Apollo Endo-Surgery, Inc., officials determined patients could be at increased risks of balloon hyperinflation, acute pancreatitis and even death.

Hyperinflation involves the spontaneous filling of intragastric balloons with additional air or liquid while inside a patient’s stomach, typically resulting in the need for early device removal.

According to the results of the post-market approval study, over 200 patients experienced balloon hyperinflation within the first few weeks following balloon placement, with the majority of the events involving Orbera brands.

FDA officials have received nearly 30 adverse event reports of acute pancreatitis worldwide since the 2015 approvals of Orbera and ReShape, with over two-thirds of those reports received for Orbera.

Since the 2015, approvals Orbera and ReShape weight loss balloons, the FDA has also received 18 fatality reports nationwide that have involved the intragastric balloons, eight of which occurred inside of the U.S., and another 10 reported outside of the country.

Although the devices appear convenient and effective in many cases, serious risks of injury and death could threaten the more than 200,000 people worldwide who have gastric balloons implanted.

The FDA issued a warning letter in February 2017, warning of adverse health consequences reported in relation to the Reshape and Orbera balloon systems. In August 2017, the FDA issued a subsequent warning letter to healthcare professionals citing several adverse events involving five unanticipated deaths after the use of the Orbera and Reshape intragastric balloon systems.

Officials indicated it was unclear what the specific root cause was and could not directly attribute the deaths to the gastric balloons or insertion procedures. However, some doctors speculate part of the problem is caused by the technique used to place the balloon, which can be a tricky procedure, requiring a lot of skill.

In one case, the balloon caused gastric perforation; tearing of the gastrointestinal tract. Another case involved esophageal perforation. The FDA warned health care providers in February 2017 about potential risks, including acute pancreatitis and spontaneous over-inflation of the balloon.

The FDA indicates it continues to work with Apollo Endo-Surgery to understand the cause of the issue, as well as monitor complications. The agency will also continue to examine reports of side effects or adverse events from a gastric balloon implantation.