The last 2 decades have offered the slimming market a number of different surgical procedures for preventing obesity – gastric bypasses included. Yet 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 very dangerous.
Even considering 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% (a 0.08% drop) - these improvements are small miniscule when you factor in the hundreds of thousands of people who undertake these procedures every single year…
Yet, hope could be around the corner for obese patients if the ReShape Medical's dual balloon design meets the approval of the Food and Drug Administration.
Structured to help obese patients who fall either side of the required guidelines for gastric bypass and laparoscopic gastric band placements cosmetic procedures, or who are considered to be too young (under18); the double-balloon device could easily cater for this excluded niche. In its current condition, the dual balloon system is inserted down a patient's throat using a tube before being filled with saline. As these 2 oval sections are pumped, patients will start tofeel full and will begin to lose weight.
More importantly, once patients reach their target weight loss, this double balloon system can easily by deflated and removed from the stomach without being cosmetically removed.
Currently, this dual action balloon is scheduled to perform its first medical trialat the beginning of March where 30 volunteers across 3 centers will be implanted with this balloon mechanism. Should it work, this research will be expanded to 350 consumers across ten surgeries and eventually will be presented to the Food and Drug Administration for permission to be used.
Is it safe?
It is undisputable that this dual action balloon could essentially 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 those excess lbs, but this double-balloon has got far to travelbefore it is recommended.
Back in 1984 a similar single balloon mechanism was produced by Garren-Edwards and was implanted into patients. However, with no backup membrane to protect it from punctures, this balloon was prone to rupturing and venturing into the small intestine where it produced dangerous blockages. As a result this weight loss product was quickly withdrawn the market.
