Published: Sat, August 12, 2017
Medicine | By Earnest Bishop

Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

The deaths were all linked to Orbera, and Apollo Endo-Surgery reported the incidents - which occurred in four different countries - to the FDA, NBC reports.

The FDA said in one treatment, there was a gastric perforation with the Orbera Intragastric Balloon System.

At least five people have died after having balloons surgically implanted in their stomachs to help them lose weight, according to reports.

The FDA has not identified a root cause for the patient deaths and can not "definitively attribute the deaths to the devices or the insertion procedures for these devices", according to an agency notice.

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However, the agency has issued a warning to doctors treating patients with similar devices to monitor them closely. ReShape is committed to supporting the continued safe and effective use of the dual balloon and is proactively communicating with physicians about this FDA update.

In the treatment, a silicone balloon is inserted via the patient's throat into their stomach, then filled with a saline solution. The company also notes that some people - it does not say how many - died while using the device. One involves Orbera Intragastric Balloon System and the other involves ReShape Integrated Dual Balloon System.

The FDA warned that someone who has already had gastrointestinal surgery or who is "unwilling or unable to participate in a medically-supervised diet and behavior modification program" should not try either of the devices. It has not received any product liability claims in connection with the five deaths. It is meant to gather information about anything that happens while someone is using a device or drug, or soon after, so that investigators can determine cause and effect.

"Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously", said Apollo Endosurgery CEO Todd Newton in a statement. The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity.

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