The last three decades have presented numerous different cosmetic solutions for combating obesity – gastric bypass and laparoscopic gastric band placements included. Yet despite the 2006 directive which enforced the regulations that all Cosmetic Centers to have expert cosmetic surgeons and tools, these methods of weight loss surgeries are still very risky.
Even following recent enhancements wherecomplication rates have fallen from 12.2% of patients to 10%, and mortality rates have reduced from 0.28% to 0.20% (a 0.08% drop) - these improvements are small miniscule when you factor in the thousands of people who undergo these surgeries every single year…
However, hope could be on the horizon for obese patients if the ReShape Medical of San Clemente's double balloon is approved by the FDA.
Structured to help slimmer's who fall have a BMI above or below the required settings for gastric bypass and laparoscopic gastric band placements surgeries, or who are too young for such critical surgeries; the double-balloon device could easily support this excluded niche.
Currently, the dual action balloon mechanism is inserted into a slimmer's throat using an attached tube before being filled with saline. As these two oval balloons are inflated, patients will begin tofeel full and will naturally be able to reduce their meal portions and lose weight.
And, once slimmer's reach their ideal weight loss, this device can easily by deflated and removed from the stomach without risk.
As we speak, this device is planned to undergo its first medical studyat the beginning of April where 30 patients across 3 centers will be equipped with this balloon mechanism. Should it work, this study will be expanded to 350 consumers across 10 medical centers and eventually will be presented to the FDA for approval.
Is it dangerous?
It is unignorable that this balloon device could potentially help thousands of slimmers who are either below age of consent or suffer from diabetes, coronary heart disease and muscle problems to lose those excess lbs, however this balloon device has got far to travelbefore it is deemed safe.
Twenty six years ago a similar single balloon mechanism was produced by Garren-Edwards and was implanted into patients. However, with no backup membrane to prevent leakages, this device was prone to breakingand entering into the small intestine where it produced dangerousblockages. As a result this product was quickly withdrawn the market.
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