FDA reports five deaths resulted from obesity treatment procedures since 2016. Namely, all patients had weight loss balloons inserted into their stomachs as part of the treatment. All five people died within a month after having the balloon inserted.
FDA Found No Cause of Death
According to the FDA report, four of the patients followed the procedure to insert the Orbera Intragastric Balloon System and one the ReShape Integrated Dual Balloon System. On Thursday, FDA announced:
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.
Three of the deaths occurred after one to three days after the balloon was inserted. FDA suspects that the other two occurred due to complications associated with this type of treatment. One patient died from a perforation of the esophagus while the other died from a perforated stomach.
This obesity treatment procedure entails the insertion of an uninflated balloon into the stomach with the help of an endoscope. Saline solution is then used to fill the balloons in order to take up enough space in the stomach. The balloons have to stay in the body for the next six months and will help the patient feel full more quickly.
Apollo Endo-Surgery and ReShape Medical Inc. were the two companies that provided the procedure. FDA is currently working with both to understand the cause of the five deaths and if there will be any more potential complications. The agency recommended that health care providers should firstly monitor the patients who have undergone such treatment for acute pancreatitis and spontaneous over-inflation.
Apollo Endo-Surgery reports that the incidence rate is in line with the directions used to explain the device. ReShape Medical issued a statement to CNN that the company will work with the FDA to ensure patient safety.
Image source: Pixabay
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