The last 30 years have offered the weight loss market a variety of different clinical solutions for beating obesity – gastric bypasses included. However despite the 2006 directive which enforced the requirements that all Centers to have expert staff and equipment, these types of weight loss procedures are still prone to promoting health risks.
Even following recent modifications where complication rates have dropped by 2.2% from 12.2% of patients to 10%, and mortality rates has shrunk from 0.28% to 0.20% (a 0.08% drop) – these improvements are minimal when you add to the equation the thousands of slimmers who signup for these surgeries …
Yet, this could soon all be changing if the ReShape Medical’s double balloon is approved by the FDA.
Structured to help obese patients who are have a BMI above or below eligibility settings for gastric bypass and band placement procedures, or who are under 18; the double-balloon device could easily support this ignored niche. How does it work? As it stands, the dual balloon system is inserted down a patient’s throat using a tube before being expanded with saline. As these 2 oval sections are filled, slimmer’s will start to feel full and will naturally be able to reduce their meal portions and lose weight.
More importantly, once dieters attain their weight loss objective, this cosmetic device can easily by deflated and removed from the stomach without being cosmetically removed.
At the moment, this balloon device is meant to perform its first medical study at the start of March where 30 consumers across 3 medical centers will be equipped with the balloon. Should it prove safe and effective, this study will be expanded to 350 volunteers across ten surgeries and eventually will be to the Food and Drug Administration for approval.
Is it safe?
It is undeniable that this dual action balloon could essentially help hundreds of thousands of obese patients who are either too young for gastric bypasses or suffer from diabetes, coronary heart disease and muscle problems to lose weight, however this double balloon system has got a long way to go before it is approved.
26 years ago a similar single balloon mechanism was established by Garren-Edwards and was implanted into patients. However, with no backup membrane to protect it, this device was prone to rupturing and slipping into the small intestine where it produced dangerous blockages. As a result this product was quickly withdrawn the market.
When a weight loss programme or weight loss supplement, it is imperative to thoroughly research their effects first before incorporating them into your diet. If there is no medical evidence that they can produce safe weight loss, then they are properly fake.