The last 2 decades have offered the weight loss market numerous different scientific solutions for beating obesity – gastric bypasses included. However despite the Centers for Medicare and Medicaid Services directive in 2006 which required all Surgeries to have expert surgeons and equipment, these methods of cosmetic procedures are still very risky.
Even following recent improvements wherecomplication rates have dropped by 2.2% from 12.2% of patients to 10%, and the 30 day mortality rate has shrunk from 0.28% to 0.20% – these enhancements are not enough when you add to the equation the percentage of slimmers who undertake these surgeries …
Yet, this could soon all be changing if the ReShape Medical’s dual balloon design is approved by the FDA.
Designed to help obese patients who fall just below or above the required guidelines for gastric bypass and band surgeries, or who are too young for such critical surgeries; the dual action balloon system could easily cater for this excluded group.
As it stands, the dual balloon system is inserted into a patient’s throat using an attached tube before being pumped with saline. As these two oval balloons are inflated, patients will soon will feel full and will immediately be able to reduce their portions.
More importantly, once patients attain their target weight loss, this cosmetic device can quickly be removed without risk.
As we speak, this balloon device is meant to perform its first clinical studyat the beginning of March where 30 patients across three cosmetic centers will be inserted with the balloon. Should it prove safe and effective, this study will be expanded to 350 patients across 10 centers and eventually will be shown to the FDA for approval.
Does it work?
It is undisputable that this balloon device could essentially help hundreds of thousands of obese patients who are either below age of consent or suffer from diabetes, coronary heart disease and muscle problems to lose weight, however this dual action balloon has got far to travelbefore it is recommended.
26 years ago a similar single balloon mechanism was established by Garren-Edwards . However, with no backup membrane to prevent leakages, this mechanism was prone to breakingand venturing into the small intestine where it triggered riskyblockages. As a result this product was quickly withdrawn the market.
