The last 20+ years have offered the slimming market numerous different cosmetic procedures for preventing obesity gastric bypasses included. Yet despite the 2006 directive which required all Medical Centers to have qualified staff and equipment, these methods of cosmetic procedures are still life threatening. weight loss is a tricky problem.
Even considering recent enhancements wherecomplication rates have fallen from 12.2% of patients to 10%, and the 30 day mortality rate have reduced from 0.28% to 0.20% – these improvements are minimal when you add to the equation the percentage of individuals who signup for these surgeries …
However, hope could be around the corner for slimmers if the ReShape’s dual balloon design is approved by the FDA.
Designed to help obese patients who are just below or above the required settings for gastric bypass and band placement procedures, or who are under 18; the double-balloon device could easily support this excluded group.
How does it work?
Currently, the dual action balloon mechanism is inserted into a patient s throat using an attached tube before being filled with saline. As these two oval balloons are inflated, patients will start tofeel full and decrease their appetite and lose weight
More importantly, once dietersattain their ideal weight loss, this device can easily be removed without surgery.
Currently, this device is planned to complete its first clinical trial at the beginning of May where 30 volunteers across 3 centers will be inserted with this balloon mechanism. Should it prove safe and effective, this clinical trial will be expanded to three hundred and fifty patients across ten surgeries and eventually will be shown to the FDA for approval.
Is it dangerous?
It is unignorable that this device could essentially help thousands of dieters who are either under 18 or suffer from diabetes, coronary heart disease and severe joint problems to lose those excess lbs, yet this double balloon system has got a long way to go before it is deemed safe.
In 1984 a similar single balloon system was produced by Garren-Edwards and was implanted into patients. However, with no backup membrane to prevent leakages, this device was prone to breakingand slipping into the small intestine where it produced dangerousblockages. As a result this product was quickly taken off the market.
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