MOST NOTABALE COMMENT FROM
April 13, 2005 FDA HEARING
Dr. Barbara Manno was a voting member of the FDA panel who voted to approve Mentor's pre-market
approval for silicone gel breast implants. Her explanation of the reason why she voted yes may be more than a mere "slip
of the tongue" but the real feeling behind her vote.
Dr. Manno's experience and introduction to the panel.
MEMBER MANNO: I'm Dr. Barbara Manno. I am a toxicologist. I'm a
professor
with the Department of Psychiatry at the Louisiana State
University Health Sciences Center in Shreveport, Louisiana and
voting
today.
Here is the comment from Dr. Barbara Manno explaining the reason she
voted in favor of Mentor.
http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4101t3.htm
CHAIRMAN CHOTI: Dr. Manno?
DR. MANNO: I wish I had said that. I voted yes much based on many of the things that
Dr. Li commented on, and I think that given the testimony here, etcetera, from the public and what I heard from the public
the last time, if the doctors and the company provide the information, I think we have got enough to approve this and that
the recipients of the device will have a choice. And it isn't to have a choice, they can make a choice and it's tough
luck if it doesn't work. No, I don't mean that. I would like that stricken. No, I believe it will work, I think,
based on what I have seen here and, please, I did not mean that the way it sounded.
