Image of the balloon implanted in the stomach
A new obesity treatment with US Food and Drug Administration (FDA) approval has reportedly led to the deaths of five people. The FDA is now investigating the deaths, which all occurred within just a month after the treatment. Three of the five individuals one to three days after the procedure.
The procedure, which lasts up to 30 minutes, entails placing one or two balloons in a patient's stomach through the mouth. A liquid, usually saline solution, will then be siphoned into the balloon. The patient will be under mild sedation during the procedure.
This balloon will be the size of a grapefruit, and it's meant to keep patients from overeating. The patient is supposed to go on the right diet and exercise while the balloon stays in his or her stomach for six months. Two companies, Reshape Medical and Apollo Endosurgery, manufactured the balloons in the unfortunate cases that ended in death. Both companies have self-reported multiple deaths that were somehow linked to the intragastric balloons.
A Risky Obesity Treatment?
Patients had to exercise and eat right even when they had the balloons
Apollo Endosurgery has reported that five patients in four countries have died since 2015. The company also reported a total of 21 deaths since January 2006 to March of this year. Over 277,000 balloons have made their way around the world during the same time period, which means that there is only less than a 0.01% chance that the balloon will cause death.
Back in February, the FDA released a statement to all healthcare providers about the potential dangers of using intragastric balloons as part of an obesity treatment program. Potential complications include the spontaneous over-inflation of the balloon, which can cause vomiting, difficulty breathing, and abdominal swelling and pain. Patients can also develop acute pancreatitis, which can cause severe back and abdominal pain.
These complications can occur just days after the balloon is placed into the patient's stomach. When these complications arise, it may be necessary for doctors to prematurely remove the balloons from the patient's stomach.
Both Apollo Endosurgery and Reshape Medical have committed to cooperating fully with the FDA during the investigation. Both companies have released their own statements in response to the FDA's. Hopefully, this investigation can lead to better obesity treatments in the future.
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