But, does the technique have more pros than cons? We take a look to see who exactly could benefit from the use of an Obalon balloon, and how.
What is the Obalon Gastric Balloon Pill?
The Obalon Gastric Balloon pill is a temporary procedure that promotes weight loss by filling a part of the stomach with a balloon, which reduces stomach capacity.
The Obalon balloon includes a small capsule attached to a slender tube. You simply swallow the capsule, and follow it with a glass of water. No sedation is required. Gas is used to inflate the balloon, and the tube is removed.
Up to 3 balloons can be placed to continue to facilitate weight loss over the 12-week treatment. The second and third balloons are inserted in separate procedures, with around four weeks between each procedure. This is because the addition of extra balloons is not always required. By inserting up to three smaller balloons rather than one large balloon, the chances of side effects such as discomfort and vomiting are reduced.
At the end of the treatment period, the balloons are removed in a short endoscopic procedure that takes less than 30 minutes.
Where is Obalon Balloon Available?
Currently the Obalon Balloon is not approved by the FDA, meaning that the procedure is not available in the U.S. Clinical trials of the Obalon Balloon are permitted in the US as the procedure is permitted “for experimental purposes” only.
The main market that the Obalon balloon is aimed at is within Europe and the UK. Within the UK, availability is limited. The procedure is not approved by the NHS, and so can only be obtained privately. Because this is a new procedure and product, the number of clinics that offer to fit Obalon balloons is very limited, primarily being available within and around London. This means that the costs for the client is even further raised, as they must travel to have the device both inserted and removed. The use of additional balloons would also increase the travel time and cost, as each balloon must be placed separately.
The procedure is also available currently in Austria, Belgium, Germany, Italy, Luxembourg, the Netherlands and Spain, as well as Mexico.
Who is it Intended For?
The Obalon gastric balloon is intended for people with a BMI of 27 or more, who meet the extensive criteria. It is generally aimed at overweight and obese patients, who have failed to lose weight using other medically prescribed options and traditional weight loss measures.
Obalon has a full list of the exclusions on their website. The huge list suggests that the procedure does incur some risks, as any medical procedure would.
Obalon is marketed as an alternative to more permanent weight loss surgeries that are serious life-altering medical interventions. Typically people who opt for permanent weight loss surgery choose between gastric band surgery and gastric bypass surgery. Both of these reduce the capacity of the stomach, preventing the patient from over eating. The gastric bypass also redirects food to lower in the small intestine from the stomach, preventing it from travelling through the rest of the stomach and a large portion of the bowel. This means that not only can people eat less, but less food can actually be absorbed by their body. This can lead to a life-long battle with malnutrition.
Gastric band and gastric bypass surgeries carry a far higher risk of serious complications than non-surgical alternatives, with gastric band surgeries having a 1 in 10 risk of complications and gastric bypass surgeries having a 1 in 5 risk of complications. This is despite them being performed as laparoscopic surgery whenever possible, to minimise the chances of complications, as well as minimising healing time and patient pain and discomfort. In comparison, Obalon has not released any statistics about the rates of complications from the treatment, and so it is not possible to judge the safety of the product accurately yet.
The cost may be prohibitive to some patients, as at this time the Obalon balloon is only available as a private procedure, which is not funded by the NHS.
Cost of the Obalon Gastric Balloon Pill
As the procedure is not available on the NHS, clients will have to seek out private clinics that will perform the procedure. The cost of being treated privately is fairly steep, ranging between two and four thousand pounds, depending upon the number of balloons that are inserted.
Patients tend to have only one balloon, perhaps two, in the stomach by the end of the treatment, and three balloons are reserved for those who see little appetite suppression and weight loss results from the presence of one or two balloons.
As the treatment is currently only available in London and the surrounding areas, additional travelling costs may be incurred by the patient.
The Guardian has reported that clinical trials of the Obalon gastric balloon;
in the UK and in the US have shown that patients can lose an average of 7.7kg in 12 weeks.
They also noted that;
Clinical trial results showed around 7% of patients had some side-effects including vomiting, cramps and reflux, which generally subsided in a day or two.
One French pilot study of 17 overweight and obese people concluded that participants;
showed no significant side effects induced by up to three balloons, and a significant weight loss.
This weight loss was evident and significant at all three check-ups, dated at 4, 8 and 12 weeks after initial balloon insertion.
Only one insertion attempt failed out of the 44 balloons used by the participants, suggested a very high success rate of insertion. The removal of all balloons was noted to be “uneventful”.
Another preliminary trial, entitled Feasibility Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss, concluded that the ‘adverse events’ or side effects that resulted from the use of an Obalon balloon for up to 12 weeks was a ‘safety issue’. More details of this trial are unavailable, but the locations of the trial, Belgium and France, suggest that at least some of this trial overlaps with the above mentioned pilot study. The trial was not independent, being funded directly by Obalon Therapeutics Inc.
Expected Results from Obalon
Expected weight loss results vary, but the results of preliminary clinical trials suggest that significant weight loss is achievable over the 12 week treatment period.
Whilst the actual amount of weight loss varies between individuals, preliminary studies suggest an average weight loss of “8.2% of their Total Body Weight and 48.9% of Excess Body Weight”. All participants had a beginning BMI of 27 or over, making them overweight or obese.
The Guardian reported that the weight lost in preliminary studies was an average of 7.7kg, or 1 stone and 3 pounds.
Whilst this does sound like an impressive amount of weight loss, it should be compared to other methods of weight loss, as well as being analysed in more detail. The above mentioned rate of weight loss equates to nearly 1.5lbs of weight loss per week.
The benefit of the Obalon balloon is that is promotes regular and steady weight loss over a moderately long time. This gives it a plethora of benefits over crash dieting and short term very low calorie diets, which cause fast weight loss that is often quickly regained once the diet is completed. Many dieticians and doctors recommend slow and steady weight loss over a prolonged period of time, with no more than 2lbs being lost per week on average. This slow and steady attitude allows the body to adapt to the weight loss, and reduces the chances of weight being regained at a later date. Crash diets often cause the metabolism to drop, sometimes severely, an effect that a slow and steady approach minimises.
Results obviously do vary, and people who are eating a very high calorie diet will not see huge results, even if they are eating less food over all. To optimise weight loss results, a low calorie diet should be followed, which focuses upon foods with a low calorie density. Like a gastric band or gastric bypass, it is possible for the dieter to thwart their own weight loss attempts by finding foods that are high in calories.
An example of this is people drinking large amounts of melted ice cream, an activity that does not promote a feeling of fullness despite the large number of calories consumed. Only people who are really dedicated and not self-sabotaging will see the maximum results from this procedure. Because of the ability to cheat, as well as it being a temporary weight loss measure, the Obalon balloon is not a magic bullet.
Long Term Results
Very studies at present have looked into the long term effects and weight loss results in patients who have used an Obalon gastric balloon. This is because the technology involved is only a few years old, and has only been available to the public since January 2014.
It is possible that patients may regain some weight after the balloon is removed, as the capacity of their stomach increases. It is hoped by the manufacturers that the Obalon balloon will be used as a kick-start to a weight loss program, rather than a quick fix that may need repeating further down the road. Patients will have to maintain their reduced eating habits to either continue to lose weight or to maintain their new lower weight.
Safety of the Gastric Balloon Pill
Potential participants are not allowed to either fly or scuba dive during the course of the treatment program. It is advisable that these activities are avoided whilst undergoing treatment, because of the changes in pressure that the body undergoes, which may affect the balloon, potentially causing premature deflation.
The chances of premature deflation are said to be low, but there is still a risk. The risk of balloon deflation dramatically increases after the 12 week period, being the primary reason for the temporary nature of the weight loss measure.
Numerous side effects have been reported, especially in the first few days after the balloon is inserted. When more balloons are added later in the treatment program, it is possible that these side effects may reappear, or worsen.
According to the official Obalon website, possible side effects include:
Gastro-oesophageal reflux, Indigestion, Stomach pain, Constipation, Stomach cramps, Diarrhoea, Nausea, vomiting, A feeling of fullness, bloating, and/or heaviness in the abdomen, Gastric ulceration, Anxiety during swallow, Psychological intolerance of the balloon presence, Oesophageal laceration or bleeding, Insufficient or no weight loss’, and finally, ‘Failed capsule transit from oesophagus into the stomach during device administration.’
This huge list of potential side effects is worrying, especially as the chances of each side effect occurring are not listed. This lack of information is possibly because it is simply not known yet, due to the newness of the technology and procedure, but also because of the lack of long term mass studies into the Obalon Balloon.
Is the Obalon Balloon a Viable Weight Loss Option?
For the majority of people who wish to lose a few pounds, the Obalon weight loss balloon is not a viable weight loss option. Many people will not qualify for the procedure, due to the large number of exclusions and potential side effects. The number of people who are able to access the procedure is also limited, thanks to the high price of the treatment.
Further to this, it is not a suitable method of weight loss for people with a BMI less than 27. However, for a few people who meet the criteria, who have struggled with dieting previously, this medical intervention could be a viable alternative to strong diet pills such as amphetamine based appetite suppressants, which have a similar length of treatment time.
The Obalon Balloon is also a viable alternative to other surgical procedures that have a more permanent nature, such as gastric bypass surgery and gastric band surgery. However, potential patients should consult their own doctor, and undertake a healthy and nutritionally balanced diet and exercise regimen, before considering the procedure.