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The last 20+ years have presented a number of different scientific procedures for combating obesity – gastric bypass and laparoscopic gastric band placements included. Yet despite the Centers for Medicare and Medicaid Services directive in 2006 which required all Centers to have experienced staff and equipment, these types of weight loss surgeries are still incredibly risky.
Even taking into consideration the fact that complication rates have fallen from 12.2% of patients to 10%, and the 30 day mortality rate has shrunk from 0.28% to 0.20% - these improvements are not enough when you factor in the thousands of individuals who undergo these procedures every single year…
However, this could soon all be changing if the ReShape Medical of San Clemente’s dual balloon design is approved by the FDA.
Designed to help slimmer’s who are just below or above eligibility guidelines for gastric bypass and laparoscopic gastric band placements surgeries, or who are considered to be too young (under18); the double-balloon mechanism could easily cater for this excluded niche.
In its current condition, the double-balloon mechanism is inserted down a patient’s throat using an attached tube before being inflated with saline. As these 2 oval sections are inflated, patients will begin to feel full and will naturally be able to reduce their meal portions and lose weight.
More importantly, once slimmer’s reach their target weight loss, this balloon device can easily by deflated and removed from the stomach without being surgically removed.
Currently, this device is scheduled to undergo its first clinical trial at the beginning of spring where 30 patients across 3 medical centers will be implanted with the balloon. Should it prove safe and effective, this research will be expanded to 350 patients across 10 medical centers and eventually will be presented to the FDA for approval.
Is it safe?
It is undeniable that this balloon device could potentially help thousands of consumers who are either too young for gastric bypasses or suffer from diabetes, coronary heart disease and severe joint problems to lose weight, but this double-balloon has got a long way to go before it is approved.
In 1984 a similar single balloon device was created by Garren-Edwards and was implanted into patients. However, with no backup membrane to protect it, this balloon was prone to rupturing and entering into the small intestine where it caused serious blockages. As a result this product was quickly taken off the market.
Hopefully this device will not encounter the same problems as the Garren-Edwards, but only time will tell if the Reshape balloon will pass the FDA’s approval and become available.
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