At least three patients died within one to three days following a procedure for a liquid-filled intragastric balloon system. 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 an August 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.
The alert from the FDA does not mean that the agency has definitively proven that the balloons caused the deaths, but that they are looking into it. Used to treat obesity, the balloon is inserted into the stomach and filled with liquid to partially fill the stomach so that patients will achieve fullness eating less food.More news: NFL's ruling on Cowboys' Ezekiel Elliott expected soon
The agency recommends that doctors closely monitor patients who are using these devices.
Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries.
The ReShape balloon, approved by the FDA in June 2015, is inserted into a patient's stomach via their mouth to prevent surgical scarring.More news: Running With The Trending Stocks: AbbVie Inc. (ABBV), Sealed Air Corporation
Shares sold off nearly 26% yesterday after the FDA published a letter warning healthcare providers of the risks of liquid-filled intragastric balloons. The exact causes in three of the deaths remained unknown.
"The FDA's letter to Health Care Providers does not indicate that the patient deaths were related to the ORBERA device or the insertion procedures". No product liability lawsuits have been filed against it, the Austin, Texas-based company said, claiming an incident rate since the beginning of 2006 of less than 0.01%. It says it has not received any communications or indications from physicians or hospitals that the deaths were due to ORBERA, adding that the FDA's letter did not indicate the deaths were related to the device.
In a statement emailed to CNN, ReShape Medical said, "There is no responsibility that we take more seriously than patient safety". 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.More news: Britney Spears feared fan had gun during stage invasion
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