Could Stomach Balloons Offer Safer Weight Loss?
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, hope could be around the corner for slimmers if the ReShape Medical’s dual action balloon system meets the approval of the FDA.
Designed to help obese patients who have a BMI above or below the required guidelines for gastric bypass and band placement procedures, or who are under 18, the double-balloon mechanism could easily support 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.
And, once the patients attain their ideal weight loss, this double balloon device can easily be deflated and removed from the stomach without being surgically removed.
Currently, this double balloon is planned to perform its first medical trial at the start of March where 30 volunteers across 3 medical centers will be implanted with this balloon mechanism. Should it be found to be safe, this study will be extended to three hundred and fifty patients across ten medical centers and eventually will be shown to the FDA for approval.
Is it dangerous?
It is undisputable that this device could potentially help hundreds of slimmers who are either too young for gastric bypasses or suffer from diabetes, heart disease and severe joint problems to lose weight, yet this balloon device has got far to travel before it is approved.
26 years ago, a similar single balloon system was produced by Garren-Edwards and was implanted into patients. However, with no backup membrane to prevent leakages, this mechanism was prone to rupturing and entering into the small intestine where it produced dangerous blockages. Consequently, this device was quickly removed from the market.
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