The last 20 years have offered the slimming market a number of different scientific procedures for combating obesity – gastric bypass and band included. Yet despite the 2006 directive which required all Centers to have experienced staff and equipment, these types of weight loss surgeries are still life threatening.
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 minimal when you add to the equation the hundreds of thousands of people who willing undergo these surgeries …
However, this could soon all be changing if the ReShape Medical of San Clemente’s dual balloon design is approved by the FDA.
Created to help obese patients who fall have a BMI above or below the required settings for gastric bypass and band procedures, or who are under 18; the double-balloon device could easily support this excluded niche.
Will it work?
As it stands, the dual action balloon mechanism is inserted into a slimmer’s throat using thin tubing before being filled with saline. As these 2 balloons are filled, slimmer’s will start to feel full and will begin to lose weight.
And, once patients attain their ideal weight loss, this double balloon system can easily be removed without risk.
Currently, this dual action balloon is planned to undergo its first medical study at the beginning of May where 30 patients across 3 centers will be implanted with this device. Should it be found to be safe, this study will be expanded to 350 volunteers across ten medical centers and eventually will be presented to the FDA for approval.
Is the balloon safe?
It is undisputable that this double balloon mechanism could essentially help hundreds of slimmers who are either under 18 or suffer from diabetes, heart disease and muscle problems to lose those excess lbs, however this double balloon system has got far to travel before it is recommended.
Back in 1984 a similar single balloon system was created by Garren-Edwards and was implanted into patients. However, with no backup membrane to protect it, this device was prone to bursting and entering into the small intestine where it caused serious blockages. Consequently, this device was quickly removed from the market.
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