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