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August 15, 2015 by Nigel Hinchliffe Global Health & Policy 0 comments

FDA approves temporary balloon device to treat obesity – but is it needed in the UK?

The U.S. Food and Drug Administration approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System is intended to facilitate weight loss in obese adult patients. The ReShape Dual Balloon device is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure while a patient is under mild sedation. It should be removed six months after it is inserted. The ReShape Dual Balloon is indicated for weight reduction in obese adult patients with a body mass index (BMI) of 30 to 40 kg/m2.

But is it needed in the UK?

A very similar balloon was made available publicly in Europe and privately in the UK early last year. Obalon is a gastric balloon in pill form that can be swallowed to help overweight people achieve rapid weight loss without invasive surgery. It is intended to be used for a maximum period of three months. The balloon is designed to be used by people with a body mass index (BMI) of 27 or above. No sedation or anaesthetic is needed and you have to swallow the capsule with a very small tube attached. Once the capsule reaches the stomach, it opens up and releases the balloon. The main difference between the balloons is the amount and expense, Obalon uses three balloons placed in the stomach over a period of 12 weeks and costs £4500 whereas the ReShape dual balloon uses only one and costs £5500.

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