Obesity continues to be a growing problem, as yet another study just revealed. Now, one of the recently-touted procedures to combat obesity is itself under new scrutiny after mounting patient deaths from gastric balloons.

Doctor evaluates patient for gastric surgery

As reported by CNN on June 4, weight loss gastric balloons are now linked to 12 deaths since 2016. This death toll prompted a recent alert by the U.S. Food and Drug Administration.

Gastric Balloon Competitors

In 2015, as part of medicine’s efforts to control obesity, the FDA approved two intragastric balloon systems in the U.S. The ReShape Integrated Dual Balloon System is manufactured by ReShape Medical Inc., and uses two balloons. The Orbera Intragastric Balloon System manufactured by Apollo Endo-Surgery uses one balloon.

Both brands of balloon have caused deaths, but four of the five new cases are attributed to the Orbera brand.

As patients increasingly ask health care providers about these reported deaths, the FDA recommends providers instruct patients regarding symptoms of potentially life-threatening complications such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation.

ReShape issued a statement noting that 5,000 of its liquid-filled gastric balloons have been performed around the world, and that the occurrence rate of death is currently 0.06 percent.

Obesity-Controlling Alternatives

Given the high profile that the FDA alert received last week, are there other alternatives which are safer and at least as effective?

One alternative, approved in 2017 the FDA approved a second kind of gastric balloon encased in a capsule that patients simply swallow. These balloons, developed by Obalon, lodge in the stomach and physicians inflate the balloon with gas via a tiny tube attached to the capsule. The Obalon balloons were not linked to any deaths nor mentioned in the FDA report.

Physicians can expect patients and the public in general to continue to ask about the risks and rewards of these balloons as media coverage of them continues.

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Scott Mace

Scott Mace writes about healthcare, technology and related topics such as computer security, digital identity, and workflow automation. His journalism career spans more than 30 years, writing for such media as InfoWorld, Personal Computing, Byte, Boardwatch, IT Conversations, NurseWeek, HealthLeaders, and Identiverse. In 2015, he was a recipient of a Jessie H. Neal Award, an annual national journalism competition in business reporting, for best technical content in the January/February 2014 HealthLeaders cover story, "The ROI of EHR." For six years, he also served on the international board of directors for CalConnect, the Calendaring and Scheduling Consortium.

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