Over 700 comments received by FDA reqarding Citizen Petition by CANDO

Note from Ilena Rosenthal: We will be updating the CANDO page and
accessing the comments page shortly.

www.BreastImplantAwareness.org/CANDO.htm


Sent: Saturday, October 14, 2006 2:40 AM
Subject: Over 700 comments received by FDA



Please post the following:



Many thanks to Ruby Rahn for discovering the FDA comment page “Stay
the Current Approvable Letter with Conditions of any and all PreMarket
Applications for Silicone Gel-filled Breast Implants” regarding the
citizen petition filed by CANDO. The comment period was closed on
October 9th, 2006 but the FDA has confirmed that over 700 people made
comments (the FDA is behind in posting all of the comments for viewing
which becomes part of the public record). Also, congratulations are
in order to Ernest Lykissa, PhD. And S.V.M. Maharaj, PhD. for having
one of the five most downloaded research papers “Total Platinum
Concentration and Platinum Oxidation States in Body Fluids, Tissue,
and Explants from Women Exposed to Silicone and Saline Breast Implants
by IC-ICPMS” at Analytical Chemistry.



Marlene Keeling

Chemically Associated Neurological Disorders (CANDO)

Organization : MDRC Category : Device Industry Issue
Areas/Comments GENERAL GENERAL

I would like the FDA to stay the current approval letter and all
Premarket Application for silicone gel-filled breast implants (SGFBI)
until studies on platinum levels in women who have had SGFBI are
conducted. The lack of research on platinum is an example of the
unknown risks of breast implants. Many consumer groups have repeatedly
insisted that the FDA require comprehensive long-term studies before
approving these products. I would like to add my voice to this request
especially since recent studies have shown significant levels of
platinum and platinum salts in the bodily fluids of women with SGFBI
including breast milk. I would like to urge further studies to
investigate this issue through either the National Institute of
Environmental Health Study (NIEHS) or CDC. It should include a
significantly large number of women, who have had SGFBI for 10 years
or longer and include women with leaking and ruptured SGFBI. It is
imperative to determine if platinum and platinum salts are found in
women with SGFBI. So far, the FDA has relied on implant makers and
their paid consultants to examine this essential questions regarding
SGFBI. Implant makers and their consultants claim that the platinum in
implants is safe, but have failed to study the platinum in the bodies
of women with SGFBI. With hundreds of thousands of women having
already reported serious health problems, as a result of their
SGFBI-it would be unconscionable to decide upon approval without
further investigating this grave and unknown risk to American women.
Sincerely, Ruby Rahn