Tags: intragastric | balloons | deaths | weight | loss

5 More Deaths Linked to Intragastric Balloons: FDA

5 More Deaths Linked to Intragastric Balloons: FDA
(Copyright Dreamstime)

Tuesday, 05 June 2018 07:46 AM EDT

The U.S. Food and Drug Administration on Monday notified healthcare providers that it had received reports of five more deaths in patients using liquid-filled intragastric balloon systems to treat obesity, bringing the total death toll to 12 since 2016.

The balloon systems associated with the reports are made by ReShape Lifesciences and Apollo Endosurgery, the FDA said.

Shares of Apollo Endosurgery and ReShape were both down about 10 percent in late-afternoon trade.

The FDA said that it was working with the device manufacturers to better understand the issues, and had approved labeling changes last week to reflect information about possible deaths associated with the devices.

Apollo said four deaths had occurred in patients who received the company's Orbera Intragastric Balloon device since August 2017, when the regulator issued a letter warning healthcare providers of seven patient deaths.

ReShape said there has been one reported death of a patient implanted with a ReShape Balloon since the FDA issued the letter last year.

ReShape said it has not received any product liability-related claims in connection with the death.

© 2026 Thomson/Reuters. All rights reserved.


Health-News
The U.S. Food and Drug Administration on Monday notified healthcare providers that it had received reports of five more deaths in patients using liquid-filled intragastric balloon systems to treat obesity, bringing the total death toll to 12 since 2016.The balloon systems...
intragastric, balloons, deaths, weight, loss
176
2018-46-05
Tuesday, 05 June 2018 07:46 AM
Newsmax Media, Inc.

Sign up for Newsmax’s Daily Newsletter

Receive breaking news and original analysis - sent right to your inbox.

(Optional for Local News)
Privacy: We never share your email address.
Join the Newsmax Community
Read and Post Comments
Please review Community Guidelines before posting a comment.
 
Find Your Condition
Get Newsmax Text Alerts
TOP

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved
NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved