There's a new weight-loss procedure that is boasting itself as the best, non-surgical way to safely shed some pounds.
Two popular brands are the Orbera Intragastric Balloon, manufactured by Apollo Endo Surgery, and the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.
Patients are mildly sedated while a deflated balloon is inserted through their throat and into their stomach. The balloon is then filled with saline to take up space in the stomach, which in theory will help people refrain from eating too much food because they feel full.
The balloon stays in place for several months, and helps patients lose weight.
Woman Claims She Lost 50 Pounds From Swallowing Balloons
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"I have literally been on a diet since I was 13 years old," Trice tells PEOPLE. "I've tried every fad diet out there but I've never been able to keep weight off until now."
The program costs between $7,000 and $10,000, and Trice says it comes with a 1-year nutritional support program so they can still maintain their progress once the balloon is removed.
But the FDA has now issued an alert for this new weight-loss technique.
According to a new report from the FDA, five people have died using this method of weight-loss since 2016. Four of the deaths are from the Orbera Intragastric Balloon, and the other is from the ReShape Integrated Dual Balloon System.
"At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices," the FDA writes, adding that it is looking into two other deaths.
The FDA is noting that despite the perceived connection between the five deaths, it does not mean the balloons caused them. They are urging doctors to monitor patients who have undergone this procedure closely.
Would you ever try this method of weight-loss? Let us know.