Released on Aug 10, 2017

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 (within the stomach) 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


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About Gastrointestinal Endoscopy
Gastrointestinal endoscopic procedures allow the gastroenterologist to visually inspect the upper gastrointestinal tract (esophagus, stomach and duodenum) and the lower bowel (colon and rectum) through an endoscope, a thin, flexible device with a lighted end and a powerful lens system. Endoscopy has been a major advance in the treatment of gastrointestinal diseases. For example, the use of endoscopes allows the detection of ulcers, cancers, polyps and sites of internal bleeding. Through endoscopy, tissue samples (biopsies) may be obtained, areas of blockage can be opened and active bleeding can be stopped. Polyps in the colon can be removed, which has been shown to prevent colon cancer.

About the American Society for Gastrointestinal Endoscopy
Since its founding in 1941, the American Society for Gastrointestinal Endoscopy (ASGE) has been dedicated to advancing patient care and digestive health by promoting excellence and innovation in gastrointestinal endoscopy. ASGE, with more than 15,000 members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit www.asge.org and www.screen4coloncancer.org for more information and to find a qualified doctor in your area.

American Society for Gastrointestinal Endoscopy
3300 Woodcreek Drive Downers Grove, IL 60515
P (630) 573-0600
F (630) 963-8332
 www.asge.org
 www.screen4coloncancer.org

Media Contact

Gina Steiner
Director of Communications
630.570.5635;gsteiner@asge.org