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Tuesday, August 15, 2017

US raises alarm over anti-obesity devices

https://guardian.ng/wp-content/uploads/2017/08/elipse-anti-obesity-balloon-1.jpg

But three of the five patients died within three days of their supposedly low-risk operation. The other two died within a month. The FDA said it is not clear whether the deaths were caused by the devices - which were approved in 2015 - or the surgical process.

Five people have died after have anti-obesity devices surgically inserted into their stomachs, United States (US) regulators have revealed.

The patients all went under the knife earlier this year to get Food and Drug Administration (FDA)-approved liquid-filled balloons fitted in a bid to lose weight.

But three of the five patients died within three days of their supposedly low-risk operation. The other two died within a month. The FDA said it is not clear whether the deaths were caused by the devices - which were approved in 2015 - or the surgical process.

However, the agency has issued a warning to doctors treating patients with similar devices to monitor them closely.

Four of the patients were using the Orbera Intragastric Balloon System, made by Apollo Endo Surgery. The fifth was using the ReShape Integrated Dual Balloon System, made my ReShape Medical Inc.

The Orbera balloon, approved in August 2015, is filled with saline and inserted in an obese patient's stomach to help them with portion control.



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