Report the Lap Band to the FDA

(deactivated member)
on 8/21/08 8:08 am - AZ
Been banded previously?  Did the band not work?  Harm you?  Cause a problem?  Report it to the FDA so  newbies can at least have some factual data to work with.  You can do it yourself, you do not have to use your name, and it will go into a data base so that others can see both sides of the Lap Band issue.

www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

For the patient identifier you cannot use your name or SS#.  I used my DOB.


(deactivated member)
on 8/23/08 2:24 am - Brampton, Canada
If you are reporting band problems anonymously how genuine is the data base going to be?  Anyone could claim things IMO.   Anyways how's your revision going, well I hope.
(deactivated member)
on 8/23/08 4:29 am - AZ
I doubt many people would have a desire to go to the trouble of filing a report for a bogus lap band claim.  ;o)

Regardless, the MedWatch portion of the FDA is not about specifics, it's about stats.  It is their system that requests you use an identifier.  If you want to file a formal complaint with the FDA for an ADE you can do that too.

If you go through MedWatch and they get enough problems they do contact you and ask for more information.

I may well go the route of filing a formal ADE, not sure yet.

MARCIAM
on 8/25/08 3:06 am, edited 8/25/08 3:06 am - Sayville, NY
I just filed my report.  I took the time because my lapband caused me months and months of suffering and pain.  I really believe that the FDA should look at just how many people are having problems such as ours.  Thanks for giving me the link!

I wish I had know about potential problems like this before I was banded. I choice what I thought was "safe" surgery and I was wrong...

Marcia 297/169 so far/140
RNY on 9/22/08
My life is starting over & yours can too!
 





(deactivated member)
on 8/25/08 3:18 am - AZ
On August 25, 2008 at 10:06 AM Pacific Time, MARCIAM wrote:
I just filed my report.  I took the time because my lapband caused me months and months of suffering and pain.  I really believe that the FDA should look at just how many people are having problems such as ours.  Thanks for giving me the link!

I wish I had know about potential problems like this before I was banded. I choice what I thought was "safe" surgery and I was wrong...


I couldn't agree more.  The band makers are great at claiming it's the safest surgery around.  While it is the safest SURGERY between band, sleeve, and bypass, it is NOT the safest long term.  That would be the sleeve.

(deactivated member)
on 9/14/08 12:35 am - AZ
:::bump:::

Garys
on 9/27/08 7:52 am - Mesa, AZ

I would think a better statement would be, regardless of what type of surgery you have, please give feedback on any negative factors of the surgery so that everyone can make informed decisions.

Positive feedback is good also in the decision process.  



 

"Controlling my food,    instead of my food controlling Me!

(deactivated member)
on 9/27/08 10:25 am - AZ
Well, for the sake of MedWatch they aren't really looking for compliments.  They really are just looking for problems.  If this was a general post on the band board I'd tend to agree.  With that said, once I listed the long term risks on the band board for bands, sleeves, and RNY.  I was told by a poster that I should only list the pro's of banding, not the cons when posting on the band board.

Like I'd do that...

Garys
on 9/27/08 2:39 pm - Mesa, AZ
I agree, Medwatch and the FDA are not really concerned with sucess stories as that is is really not their job,

I think I was referring to posts within the forum.  I agree that people should have acess to the facts, the good, bad and ugly before making a life changing decision.



 

"Controlling my food,    instead of my food controlling Me!

(deactivated member)
on 9/27/08 2:44 pm - AZ
Sometimes I think back to when I was learning about the band.  I saw nothing but positives.

When I got a band I started having problems after 4 days.  I went to the band boards and was pushed out, I was told I was clearly not following the "band rules" that apparently existed.  I wasn't chewing well enough.  I was on clear liquids.  I was told I was drinking too fast on the post op diet.  I was drinking one ounce per hour.  It was insanity.  I finally cancelled my OH account.

Today... different story.  I TELL my story.   I tell the good and bad about the band and I defy anyone to hush me today, it will not happen.

I do question, if I would have known the truth about the band I don't know if I would have gotten it or not.  I really didn't believe it would work anyway.  I thought when it did not work I would just have it removed and then I'd be able to say I tried.

I was floored when it did work.  I had no idea I could lose weight.

When I discovered WLS works I revised to a sleeve.  Life is good now.  It wasn't before, it is now.

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