Each of the five dead died within a month or less of receiving the balloon treatment.
In a report, the U.S. Food and Drug Administration (FDA) is warning health care providers about the liquid-filled balloon weight loss system created to fight obesity, announcing that since 2016, there have been five people dead after using it.
Apollo's Orbera intragastric balloon system is composed of a single balloon which is filled with saline, while ReShape's integrated dual balloon system uses 2 balloons filled with saline and methylene blue dye.
Gastric balloons are among the varied devices on the market to treat severe obesity.
Back in February, the FDA issued a similar warning to keep an eye on complications from these procedures including the balloons spontaneously overinflating, which can fill the patient's stomach with fluid, or acute pancreatitis.
At least five people have died soon after being fitted with balloons aimed at helping them lose weight, the Food and Drug Administration said Thursday.
The FDA said that five deaths have been linked to intragastric balloons albeit it remains unclear if the fatalities were caused by the device itself or the surgery.
An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States. "In our physician training, we are diligent to emphasize the factors that support the safe and effective use of ORBERA and we will continue to do so", CEO Todd Newton said in prepared remarks. What are the potential side effects of intragastric balloons?
The FDA update comes six months after the agency issued a letter recommending that healthcare providers keep an eye out for two types of adverse events in patients who have been implanted with Apollo and ReShape's devices.
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