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Dr Ashton - Sept 2011- "No" to EndoBarrier™

Dr David Ashton, Medical Director Healthier Weight

In January 2010 I expressed major reservations about a new anti-obesity device called Endobarrier.  Talking to colleagues at the beginning of this year and reviewing the available data did not cause me to change my initial opinion.  Despite the optimistic claims regarding the new generation of Endobarrier devices, the latest experience is not encouraging.  Due to a variety of complications the early explantation (removal) rate remains unacceptably high.  Until these difficulties can be resolved and the safety and efficacy of the device has been confirmed in the form of published results, Healthier Weight will not be offering it.

January 2010 First Comment on Endobarrier

There has been a lot in the press and media recently about a new anti-obesity device called the EndoBarrier™.  Essentially this is a very thin sleeve which is passed through the mouth and is then anchored in the stomach and small intestine.  It provides a barrier or a lining between the contents of the intestine and the bowel wall, which means that food – and therefore calories – cannot be absorbed.  And of course fewer calories, means weight loss.  Obesity “experts” are already talking about a 15-minute cure for obesity and how much money this device will save the NHS. 

At the moment, as is often the case with new developments in weight loss, the claims and the hype exceed the available evidence.  The fact is that we know very little about how effective and how safe the EndoBarrier™ actually is, because there have been very few properly conducted trials.  The most recent study was a randomized trial involving 30 patients, 26 of whom had the sleeve successfully implanted.  Although subjects lost weight, all (100%) experienced at least one adverse event, especially abdominal pain and nausea.  Four devices had to be removed because of obstruction or because the sleeve became dislodged. 

The EndoBarrier

So although it looks promising, we are at a preliminary stage in the development of this technology and there are many unanswered questions.  Before the EndoBarrier™ can be regarded as a safe and effective intervention, we will need to see more convincing results from longer term studies.  A major hurdle is that the device has to be removed after 3 months.  That being the case, experience suggests that patients will almost invariably replace any weight they may lose.  This is exactly what happens in patients who have the gastric balloon; whilst they lose weight initially, as soon as the device is removed, they quickly replace any weight they may have lost. 

So the message for now is we will not be offering the EndoBarrier™ until we are satisfied that it is a safe, effective and durable treatment.

 

Dr David Ashton MD PhD
Medical Director

 

Update by Dr David Ashton May 2011

Time flies. I was surprised to see that it’s well over a year since I last wrote about this innovative device, so perhaps an update would now be in order, especially since there are new data to be considered from two additional studies.  

The first was another randomized trial, which compared weight loss in two groups prior to weight loss surgery.  One group (13 subjects) actually had the Endobarrier™ Gastrointestinal Liner (EGL) implanted, whereas the second (control) group of 24 subjects underwent a sham implantation.  Both groups received identical nutritional counseling. The study ran for 12-weeks, at the end of which the EGL group had lost 8.2kg, compared with 2.1kg in the controls. In fact there were originally 21 subjects in the EGL group, but eight terminated early because of problems, including abdominal pain, nausea, vomiting and bleeding. These symptoms resolved after removal of the EGL device. 

The second study involved a group of diabetic patients, to determine the impact of the EGL on diabetic control and other metabolic measurements. The device was implanted in a total of 39 diabetic subjects (79.5% women) with the intention of leaving the device in place for 12 months. Unfortunately, there were a total of 15 early device removals due to a variety of unwanted effects, including abdominal pain and obstruction of the liner. In the 24 subjects who completed the 12-month trial period, there were significant improvements in diabetic control, blood pressure and cholesterol levels. There was halso a reduction in average waist measurement from 116.5cms to 95.9cms. 

These additional data suggest that the Endobarrier™ can deliver significant weight loss, with marked improvements in metabolic control, especially in patients with type 2 diabetes. However, the problems of device migration, obstruction, abdominal pain and bleeding resulting in early removal, represents a major technical hurdle. Furthermore, whilst there are definite improvements in diabetic control, we still have to face the fact that after 12-months the device is removed. What happens to the diabetic control after the device is removed is not clear, but given that weight re-gain is almost certain, I suspect that the improvements in diabetic control will diminish as the weight increases.

Colleagues who are currently implanting the Endobarrier™ tell me that the early problems with migration, abdominal pain and obstruction have largely been overcome and they are hopeful about the long-term future of the device. Time will tell. 

In the meantime, I don’t think my overall view has changed significantly from where we were more than a year ago.  The Endobarrier is still work in progress and there are too many unanswered questions for us to recommend this device at present. We continue to monitor developments closely however and will bring you further updates as they become available.