22 février, 2005 05:42
Thanks to Cindy for sending the following article...Myrl
What about silicone gel breast implants being placed out on the market with a BLACK BOX warning?
Think that could not happen? Think twice, it could & may sooner that we all may think.
Not only ARE THE ORAL testimonies very important, but so are having many WRITTEN SUBMISSIONS. SO get your written testimony done and sent...deadline March 28, 2005
I have been informed:
Written submissions will be copied, given to all on the blue-ribbon panel at the FDA meeting, April 2005. They can either read the written testimonies or not. It is their own choice. I thought if alot of written testimonies were sent, then they may hear the voices of many.
The FDA may read/will take note of the written submissions.
So back to the black box warnings and silicone gel breast implants....the FDA may want to try to PLEASE EVERYONE (which is NOT possible but they are going to possibly try)...a black box warning is their out of taking responsibility of harm while putting the harmful medicine (like VIOXX/BEXTRA) or harmful MEDICAL DEVICES, (silicone gel breast implants) on the market....but we all must remind the FDA and the so-called blue ribbon panel that a black box warning is NO REAL SOLUTION of the problem that is harmful...
So, you may wish to include this in your oral or written testimony....about black box warning and breast implants. The choice is yours.
Ladies, we all must cover ALL of the bases in the game in order to make a homerun or even win....so please, think about my words.
Take care, Cindy Fuchs-Morrissey
