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