FDA Reports Five Deaths Among Weight Loss Balloon Users
According to FDA reports, five people have died since 2016 while using stomach balloons as weight loss treatments. Four of the deceased were people using Orbera Intragastic Balloon System, and one using ReShape Integrated Dual Balloon System. While these five people died within a month of having the balloons inserted, three other people died within three days of balloon placement.
The Balloon Weight Loss treatment consists of placing one or two uninflated balloons in the stomach using an endoscope through the patient’s mouth. Saline is used to fill the balloons, and they stay there inflated for six months. The balloons then make the person feel full while having eaten less.
The root cause and incident rate of the patient deaths are not officially known, and the FDA has not yet directly attributed the deaths to the balloon insertions or treatment. However, the FDA is in the process of investigation in order to conclude whether the balloons are at fault. Apart from the incidents already mentioned, two additional deaths are being investigated, one from each company. One is for stomach perforation and the other for esophagus perforation.
The FDA said it is working with both companies, Apollo Endo-Surgery and ReShape Medical Inc., to figure out the causes of the deaths and “to monitor the potential complications of acute pancreatitis and spontaneous over-inflation.” Both companies have expressed that they have received no indications from physicians about their products causing the deaths. They are committed to patient safety and have contacted physicians about the FDA update, supporting continued effective use of the balloons.
While the FDA and the companies involved keep investigating the deaths, weight loss balloons users should be on lookout for any indications of injuries in their bodies. Personal injuries due to pharmaceutical companies’ negligence occur too often, and legal action should be taken.
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