Question:
Not a question. I saw this on my local new website and thought I would share

I don't really know how accurate it is. There was a weight loss surgery report on the news last night and I missed it. I decided to go to their web page and see if I could find the story, and I happened to come across this. I thought some might be interested in this. Note: I AM NOT SUGGESTING THAT THIS IS A BAD SURGERY. I THOUGHT SOME MIGHT BE INTERESTED IN IT. Does anyone know how we can find out if other types of WLS ARE FDA Approved? FDA Votes Not to Recommend New Surgical Implant for Obesity June 19, 2000 The Food and Drug Administration has voted not to recommend approval of a new surgical implant for obesity. It has been used in thousands of patients around the world. The simple, surgigal procedure is called Lap-Band surgery. A band is put around the top part of the stomach giving patients a smaller stomach. Studies show patients 100 pounds or more overweight can lose about 40-percent of their excess weight, but the FDA says more studies are needed.    — enjo4 (posted on June 23, 2000)


June 23, 2000
As you know the FDA is there for our protection. In the interest of protecting us, yes, they may be a little heavy-handed. They have re-visited and re-voted on products before after more clinical data is introduced. They may be waiting on more results from the U.S. Clinical trials being done using this product. It is difficult to criticize the FDA if one has not analyzed the studies and case reports from the other countries where the procedure is allowed and compare the success rate against the failure rate. And, compare the percentage of overall complications against those procedures currently being done in the U.S. If their complication rate is much higher, than they will not approve it. As I said before, they may just need more data. As a consumer, I want to be assured that everything I get my hands on, or everything that is offered to me is as safe as our current knowledge knows it to be. If it is not, then I don't want it. If we need more info before it's released to the public, we'll wait. Everything that's approved in other countries aren't necessarily for us. Just think of the number of class action suits if this procedure shouldn't have been allowed. But, on the other hand, just think of the lives it will enhance if it is truly safe.
   — Tonya K.




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