- Patients ingest a pill containing a deflated gastric balloon
- Inflated in the stomach, the balloon diminishes the appetite
- The treatment has worked wonders on Mandy's figure
- But there can be dangerous complications - and what happens when the balloon is taken out?
That's the promise of a cutting-edge treatment that launched in the UK last week.
Designed for people who are around a stone overweight, this pill contains a deflated gastric balloon, which is swallowed and then inflated in the patient's stomach through a thread-like attached tube that is then pulled back up the throat.
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Cutting-edge: A new treatment claims that their pill will have you drop a dress size within three months - and all without having to diet or exercise
The balloon takes up space in the stomach and this temporarily stops patients eating too much by diminishing their appetite. So could this be the answer to every slimmer's dreams - or is it a potentially dangerous weight-loss gimmick?
Dr David Ashton, one of the UK's leading obesity experts, says: 'The dangers are similar to those associated with conventional gastric balloons.
'There is a risk the balloon might deflate and pass into the small bowel, where it could cause an obstruction. If this happened it would require surgical removal. Gastric balloons can also cause gastric ulcers and injury to the stomach or oesophagus.'
Less dangerous complications could include reflux, indigestion, stomach cramps, diarrhoea and bloating.
'The difference is that this new model hasn't been around as long,' says Dr Ashton, 'and so doesn't have nearly such an extensive body of research and safety data to back it up.'
However, the pill - made by a firm called Obalon - is already being offered commercially to UK patients by Spire Healthcare, a large private medical provider.
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Guinea pig: Mandy Raven bravely volunteered to try out the new treatment
Mandy Raven, 46, who works as a line manager for the British distributor for Obalon, was one of the 12 UK guinea pigs who were brave - or some might say foolish - enough to try it out.
They were all sent to an independent weight-loss surgeon who had agreed to work with Obalon. Before the pill was taken, patients had a full medical to check they were suitable.
At 11st 10lb and 5ft 2in tall, Mandy was a size 16 with a BMI of 30, and so ashamed of her weight that she often made excuses not to socialise with her friends.
She had tried dieting in the past but always put the weight back on, and, while she would have been happy to undergo surgery, she wasn't overweight enough to qualify for a gastric band as the procedure is only offered to those with a BMI of above 40. Obalon is offered to those with a BMI above 27.
So last November, Mandy, from Taunton, Somerset, swallowed a small capsule containing the deflated gastric balloon under the supervision of Sally Norton, who is an independent consultant in bariatrics (treatment of obesity).
Once an X-ray checked it was in the right place in her stomach, Sally pumped nitrogen gas through the tube to inflate the balloon to roughly the size of an apple.
Most people would be terrified at the thought of swallowing something that could inflate in their stomach, or even explode, but Mandy insists she wasn't worried.
Sally assured her the balloon isn't inflated until an X-ray shows it's in exactly the right place, so there's no chance of it blowing up halfway down the throat.
The makers say that once it's in the stomach, it can't be over-inflated as it would pop, so there is no danger that it can expand to damage organs. It is also too big to make its way back up the throat and cause damage there.
Still, most would find the potential for human error troubling.
'It was strange looking at this thing that was about a third of the size of my little finger and knowing that it was going to change my life dramatically,' Mandy says.
'I swallowed it with a cup of water and could feel it making its way into my stomach. When the doctors began to inflate it, I felt a strange sensation, almost like a bubble in my tummy.
'As soon as it had been blown up and they'd removed the tube, I felt full - as if I'd eaten a good meal.'
Less than 20 minutes later, the mother-of-three left the clinic in Bristol and was on her way home.
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Ashamed: Before having the gastric balloon fitted, Mandy (right) had a BMI of 30
Conventional gastric balloons that are filled with saline solution have been around since the Eighties, but until now have had to be placed there in a complex and invasive operation.
Mark Mahmood, vice-president of Obalon, claims that once in place his device is a marked improvement: 'Existing balloons tend to cause side-effects, such as nausea and cramps, and require an invasive procedure, so we wanted to come up with an alternative,' he says.
While Obalon insists this balloon is a serious medical procedure that will improve health in the long-term, obesity expert Dr Ashton dismisses it as a short-term cosmetic fix.
'On the whole, conventional balloons just aren't an effective health solution,' he says. 'But if a patient with a BMI of 27 or 28 came to me saying she wanted to boost her weight loss for a big event - say a wedding or big birthday - in six months, providing that she understood the risks, including the fact that it was unlikely she would sustain the weight loss after the balloon was removed, I'd give her a balloon.'
But should doctors really be exposing patients to all the risks just so they can look nice for a birthday party?
And it's worth remembering that a gastric balloon doesn't come without side-effects. 'If you put any foreign object in your stomach, the first thing your body wants to do is reject it,' says Dr Ashton. 'In my experience, more than 80 per cent of patients who have a gastric balloon implanted will suffer from side-effects - retching, cramps, nausea.'
Obalon argue their device is less likely to cause problems, but even they admit that a proportion of patients have had problems with nausea and reflux.
Although your stomach can stretch to up to four times its normal size, it has, on average, a capacity of around 900ml (around one-and-a-half pints).
Existing gastric balloons take up anything from 600-800ml of space. They reduce the stomach capacity, making you feel fuller, but they sit at the bottom of the stomach, so can also interfere with the passage of food, causing discomfort.
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Introvert: Mandy often made excuses not to socialise with friends because she was so embarrassed of her weight
The Obalon device is only a fraction of this size at 250ml - about half a pint - and filled with gas so it floats at the top of the stomach. This means food can easily pass into the digestive system, and also that the balloon stimulates the satiety receptors (the things that tell you you're full) at the top of the stomach. And, unlike conventional balloons that are in place for six months, it's only there for three.
'Our research showed that most of the weight loss happens within the first three months so why leave it in for another three?' says Mr Mahmood.
'And using a smaller volume of gas seems to make it more comfortable for the patient, and minimises side-effects.
'After about a month, the stomach begins to expand slightly to accommodate the balloon but we can add another one to keep weight loss on track - and even a third if necessary.'
The £3,000 price tag includes a second balloon. If you have three, it will cost £4,000.
The balloon has been designed to safely stay in the stomach for 12 weeks. It can remain there without being checked for that period, but after that it must be removed. This is done via an endoscopy - the patient is sedated and given local anaesthetic, a tube is passed down the throat with various tools on it including a camera and a needle, then the balloon is pricked and removed.
According to the manufacturers, after three months you can expect to lose on average of 1st 3lb, around a dress size or two, with 'minimal impact to diet or daily routine'.
But is that really true? Bariatric consultant Sally Norton says that to be a success, patients need to follow a diet and exercise plan. And even Mr Mahmood admits: 'It's not a silver bullet. It's one part of the jigsaw and does have to be accompanied by a change in lifestyle.'
Zoe Harcombe, a nutritionist and obesity researcher, is sceptical as to the long-term success of the mini balloon. 'This is for people who can't stick to a diet,' she says. 'Moreover, many women who over-eat don't do so because they're hungry but for emotional reasons, so making them feel fuller isn't going to change that.'
Helene Fleckney, 44, a sales administrator who also works for the balloon's distributor, disagrees. Like Mandy, she is eight weeks into a two-balloon treatment.
'Even Mr Mahmood admits: "It's not a silver bullet. It's one part of the jigsaw and does have to be accompanied by a change in lifestyle."'
She began putting on weight following surgery seven years ago, before seeing a photo of herself at a party spurred her into action.
She vowed to get back to her pre-marriage weight of 8st, which, at 5ft 1in would have given her a healthy BMI of 21.2. It wasn't just how she looked that bothered her: 'In my family, there's a history of heart disease and diabetes. I'm at an age where I think I could be more susceptible to these conditions and I knew that losing weight would lower my risk.'
With a month to go before her balloons are removed, Helene has lost more than a stone, going from 10st 12lb to 9st 9lb.
'I'm delighted,' she says. 'It's made me feel so much better in myself.'
Many will wonder whether she really needed medical intervention to do this. But Sally Norton insists the balloon is vital.
'We're an increasingly obese society. One of the issues is portion size and this balloon can re-educate people to eat less. It's a three-month window that gives the patient the motivation to adjust their mindset.'
Whether it's the balloon, her new lifestyle, or the fact that spending £3,000 would motivate most people to do almost anything, Mandy Raven is certainly finding the procedure is working for her. She has lost 18lb and is now a size 12-14, with a BMI of 26.7. 'I'd aimed to lose a stone and a half so I hope to have lost another 3lb before the balloon is removed in three weeks' time.'
She is delighted with her weight loss, and how the procedure has changed her lifestyle. 'I used to rely on convenience foods but my shopping list these days is vegetables and chicken - I know people will say I should have been able to do that before, but without the balloon, I just didn't have the motivation,' she says.
'The balloon means I'm not hungry in the way I was before. And because that's helping me lose weight, I've been inspired to eat healthier foods to maximise the weight loss.'
But while Obalon's marketing materials proudly tout the weight loss, none of its studies have tracked what happens after the balloon has been removed.
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Before and after: Mandy lost more than a stone in eight weeks
In fact, research suggests many patients who have gastric balloons actually put more weight back on.
One study that followed 100 patients who'd had a gastric balloon concluded that only 25 per cent had managed to maintain the weight loss two-and-a-half years after the balloon had been removed, and a staggering 60 were actually heavier than when they had the balloon put in.
Bad habits creeping back is a concern already borne out by Mandy's experience. Like most of the patients in Obalon's studies worldwide, she had a second balloon placed in her stomach.
'After Christmas, I'd noticed that while I was still eating healthily, my portion sizes were beginning to creep up. Apparently that's quite normal as your stomach stretches to accommodate the balloon, so in early January, eight weeks after I'd had the first balloon put in, I went back to swallow a second capsule.' She says it has left her feeling full again.
But if Mandy can't even stick to the diet with a balloon in her stomach, what will happen when it's gone?
And Dr Ashton is just one medic who remains unconvinced by the new procedure.
'To my mind, this new balloon offers no obvious advantages over existing options and there's less evidence of its safety and efficacy. I won't be offering it to my patients,' he says.
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