Health Care

Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says”

The FDA sent a letter to healthcare providers warning of reports of seven deaths with liquid-filled intragastric balloon systems used to treat 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.

In five cases, the cause of death was unclear, but all occurred within a month or less of balloon placement, the agency said. Four of the deaths occurred after patients used the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one took place after a patient used the ReShape Integrated Dual Balloon System, which is made by ReShape Medical Inc.

The process involves placing one or two uninflated balloons using an endoscope that goes through a patient's mouth into the stomach.

Shares sold off nearly 26% yesterday after the FDA published a letter warning healthcare providers of the risks of liquid-filled intragastric balloons. The object of the balloon is to reduce how much a person can eat by filling the stomach with the balloon, NBC News noted.

According to Apollo Endo-Surgery, there has been one additional death of a person who received its device.

The FDA has not determined the root cause or incidence rate of patient death. It states that of more than 277,000 devices distributed, there have been 21 reported deaths from January 1, 2006, through March 31, 2017. "Patients must be monitored closely during the entire term of treatment in order to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms", added CMO Dr. Christopher Gostout. 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 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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