Statement by ASGE/ABE in Response to FDA Letter re: Intragastric Balloons

On August 10, the U.S. Food and Drug Administration (FDA) issued an update to a letter to healthcare providers about potential risks of liquid-filled intragastric balloon devices that have recently been approved for weight loss. This letter reported that seven deaths have occurred unexpectedly in patients with an implanted intragastric balloon since 2016.

Although not included in the FDA letter, these cases include patients treated with fluid-filled balloons both within and outside of the U.S. During U.S. trials of the two approved fluid-filled balloon devices currently in use, no deaths occurred.

In its letter, the FDA noted that the agency has not been able to identify the root cause of mortality in these patients, and cannot attribute the cause to the devices or the procedure used to place them in the patient.

The American Society for Gastrointestinal Endoscopy (ASGE) and the Association for Bariatric Endoscopy (ABE)* are taking this opportunity to reinforce what our physicians know: that any weight loss procedure, whether surgical or endoscopic, should not be entered into lightly. Patients are selected for these procedures based on their full medical history, and with extensive consideration given to all other methods for losing weight, including diet and lifestyle modifications.

Any weight loss procedure must be evaluated for its risks as well as benefits. Obesity comes with many serious effects that are important to modify through weight loss. For some patients, obesity is life threatening. This is why it is important to evaluate the total picture for patients with obesity.

In 2015, ASGE’s Bariatic Task Force published an analysis of data on the Orbera balloon, which was the only such device for which sufficient data was available at the time. This analysis found a mortality rate of .08 percent, or 8 in 10,000 patients. By our estimate, the new data from the FDA, looking at both Orbera and ReShape procedures, indicates a mortality rate of approximately .01 percent, or 1 in 10,000.

Any patient death related to a medical procedure is a tragedy. Because we do not yet know the root cause in these cases, ASGE and ABE urge cautious interpretation and further investigation of the adverse event reports, and will be closely monitoring all information related to patient safety, including management of complications.

Our societies will continue to provide the best available information and education to our physician members on this topic. Patients should carefully consider the qualifications and training of any physician with whom they partner on medical procedures.

In summary, the FDA remains vigilant in updating healthcare providers on patient risk not previously reported in FDA safety documents. Based on the data recently released by the FDA, Apollo Endo-Surgery, and ReShape Medical, Inc., the estimated risk of unanticipated death in patients treated with fluid filled balloons may be less than previously reported. ASGE and ABE look forward to continuing to work with both the FDA and device manufacturers to ensure the best possible outcomes for patients.

*The Association for Bariatric Endoscopy is a Division of ASGE.