5 deaths associated with gastric-bypass procedure spur FDA warning

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Gastric balloons are among many different devices on the market to treat severe obesity. Placed in the stomach orally in a minimally invasive endoscopic procedure, they're created to be filled with fluid and stay in the stomach for six months. 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.

The FDA's adverse report system is very broad and is not created to immediately prove a device or drug caused a complication.

"FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications and that you report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting Program", the FDA said.

Four of the deaths involved people using the Orbera Intragastric Balloon System and one involved ReShape Integrated Dual Balloon System, the agency said.

"In three reports, death occurred as soon as one to three days after balloon placement".

In the product's package insert, there have been 21 deaths in ORBERA patients in the period from January 1, 2006 through March 31, 2017, out of more than 277K devices distributed during the same period, an incident rate below 0.01%.

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"Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the US clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death", it says on its website. It has not received any product liability claims in connection with the five deaths.

In a statement emailed to CNN, ReShape Medical said, "There is no responsibility that we take more seriously than patient safety".

"The FDA's letter reinforces the fact that complications and adverse events can occur within patients having obesity-related co-morbid conditions". Intragastric balloons are created to treat obesity by taking up room in the stomach, making patients feel full.

The ReShape balloon, approved by the FDA in June 2015, is inserted into a patient's stomach via their mouth to prevent surgical scarring.

APEN shares closed down -23.3% at $4.34 apiece yesterday.

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