The last 30 years have presented a variety of different clinical solutions for combating obesity – gastric bypass and laparoscopic gastric band placements included. However despite the Centers for Medicare and Medicaid Services directive in 2006 which required all Cosmetic Centers to have expert surgeons and equipment, these types of weight loss procedures are still prone to promoting health risks.
Even considering the fact that complication rates have dropped by 2.2% from 12.2% of patients to 10%, and mortality rates have reduced from 0.28% to 0.20% (a 0.08% drop) – these enhancements are not enough when you add to the equation the percentage of people who are willing to undergo these surgeries every single year.
However, this could soon all be changing if the ReShape’s dual balloon design is approved by the FDA.
Structured to help slimmers who have a BMI above or below eligibility guidelines for gastric bypass and band procedures, or who are considered to be too young (under 18 years old) – the dual action balloon system could easily cater for this overlooked group.
How does it work?
Currently, the dual action balloon mechanism is inserted into a patient’s throat using a tube before being inflated with saline. As these 2 balloons are filled, patients will soon feel full and will naturally be able to reduce their meal portions and lose weight.
More importantly, once a patient reach their weight loss goal, this cosmetic device can easily be deflated and removed from the stomach without being cosmetically removed.
As we speak, this dual action balloon is meant to perform its first medical trial at the beginning of April where 30 volunteers across three surgeries will be inserted with this balloon mechanism. Should it work, this study will be applied to 350 volunteers across ten surgeries and eventually will be presented to the FDA for approval.
Does it work?
It is undeniable that this double balloon mechanism could potentially help hundreds of thousands of obese patients who are either under 18 or suffer from diabetes, coronary heart disease and muscle problems to lose those excess lbs, but this double balloon system has got a long way to go before it is approved.
In 1984, a similar single balloon device was established by Garren-Edwards and was implanted into patients. However, with no backup membrane to protect it, this mechanism was prone to breaking and slipping into the small intestine where it produced dangerous blockages. Consequently, this device was quickly removed from the market.
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