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Realize Band not FDA approved anymore?

(deactivated member)
on 3/17/11 6:34 am
I ust called a surgeon for my inital appointment. They advised that the Realize band is no longer a FDA approved device and the FDA has pulled there approval due to the compications and leaks from the device. So, the surgeon has discontinued the Realize Band and will only place a LAP-BAND.

Will some of you please advise your experiances with the Realize Band and if anyone has heard the Realize claims or the FDA dropping their approval.

Thanks so much,
M ike
Kim H.
on 3/17/11 7:10 am - Duluth, MN
I just had my Realize Band surgery 2 weeks and 3 days ago...when did this supposedly take effect, because I NEVER heard anything about it..IF indeed it is TRUE!

~Kim~

                    
carriesb
on 3/17/11 8:23 am
Haven't heard that. My surgery was a month ago and my Dr said he preferred Realize. A Googling I will go.
carriesb
on 3/17/11 8:27 am
Nothing on the Fda website and Realize's website still has information on it about the surgery. Only thing I could find was a thing I already heard about a couple of months ago and it isn't bad.
https://www.realizemysuccess.com/VoluntaryRecall.htm
Stephanie M.
on 3/17/11 8:52 am
There is nothing out there about this...perhaps your surgeon was mis-informed??  There was a voluntary recall of some older models (just to get them out of hospital inventories) a few months ago.

 

  6-7-13 band removed. No revision. Facebook  Failed Lapbands and Realize Bands group and WLS-Support for Regain and Revision Group

              

(deactivated member)
on 3/17/11 8:53 am
I googled too before I posted. I did not find anything either. The lady on the phone said the doc does not perform the Realize band anymore because it is not an FDA approved product and has complications like leakage and ballon popping that holds the saline.

I think they are saying that because he chooses not to do the procedure and is blowong smoke on the FDA thing. 

I am still searching for the revocation of the approval.

Overall I am wanting the Realize Band because of the comfort, super low profile port, and some other factors.

Please let me know if things have changed.

Thanks again,
Mike
carriesb
on 3/17/11 11:30 am
Maybe call another surgeon in the area and ask them. I have only had the band for a month but my port seems really small in comparison with some lap band ports I have felt/seen in the waiting room at the Dr( yes they show me ports) mine is in a super weird place to so it would suck if it was big. Good luck with your process I don't actually know if one band is better than the other. I'll see in time how mine works out!
Tom C.
on 3/18/11 12:11 am - Mount Arlington, NJ
I just spoke to a Realize rep and was told this is not accurate. Not much more was said.

Now they could be giving me company p.r. answers, but that's the word I got.

Please excuse typos. Sent via Android
Good Luck on your Journey !!

Tom

“Nothing I will ever eat will give me the feeling I get as when I lose weight”  The views expressed are based on my own experiences - and should NOT BE FOLLOWED IN LIEU OF DOCTOR’S ADVICE/INSTRUCTIONS. Only your Doctor knows your condition, and make sure you talk to them before making any changes to your diet
Country
on 3/18/11 7:21 am
I just got my band, March 8-I haven't read or seen anything saying it wasn't approved, and USC is really on top of their game.  Best of luck.

-c
        
Amy B.
on 3/18/11 9:24 pm
 I also had mine 3 weeks ago. In fact, they just updated it and I got the new one. If it's true, I'll be shocked, but if it's not, I'd definitely do a lot more research into your surgeon.

Amy
One day at a time.  
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