The answer to the first question is, yes, it is totally Health Canada and FDA-approved.
The answer to the second question about the balloon is it stays in for six months. There are balloons now being developed that could stay in for up to 12 months. But it comes out. So the chance of regaining the weight is higher than with the lap band because it's not a permanent device.
I should mention too in response to Patrick Brown's question, the balloon was approved by Health Canada first and still hasn't been approved by the FDA, although it's been proven to be quite safe and effective.
The third question was about the complications of the lap band; there are two complications. One is slippage of the band. It can slip out of position. This complication has gone down significantly since the new design of the band that came out in approximately 2009. The way it's designed, it stays in position. We have a technique whereby we sew it in position in the stomach. So number one is slippage, which is very rare.
Number two is erosion. The band can erode through the wall of the stomach. Usually it's not life-threatening bleeding, but it can cause bleeding much as an ulcer would. That's correctable. We go in and unbuckle the band. In the majority of cases, the erosion will heal on its own. We just have to remove the band. Then six months later, once it's healed, we go back in and put in another band. Slippage is also quite correctable. We go back in and reposition it and re-secure it with a new tunnel around the stomach.