STORY FROM: Drugs & Medical Devices

Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

WASHINGTON, D.C. — Five unexpected deaths have occurred in patients with liquid-filled intragastric balloon systems used to treat obesity, according to the Food and Drug Administration.

In an Aug. 10 letter to health care providers, the FDA says all five reports indicate that the deaths occurred within a month or less of balloon placement. And in three of those reports, death occurred as soon as one to three days after the balloon was placed, the agency notes. Four reports involve Apollo-Endo Surgery’s Orbera Intragarstric Balloon System, and one report involves ReShape Medical Inc.’s ReShape Integrated Dual Balloon System.

In ...



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