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June 28, 2006
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TELL FDA THAT RESEARCH IS URGENTLY NEEDED ON TOXIC
PLATINUM SALTS IN SILICONE BREAST IMPLANTS A new
peer-reviewed study shows that platinum in silicone gel breast implants could
be toxic for women and their babies. The frightening results found toxic
platinum in breast milk, blood, and other bodily fluids of women with breast
implants. The FDA is now deciding whether to ignore the research, or delay
approval of implants until the government conducts research to confirm or
refute the results. The FDA has asked
for public comments, so they need to hear from you! Meanwhile, the FDA is
quoting an industry-funded researcher who questions the findings and insists
that implants are safe, despite this research to the contrary. This might be the
last opportunity to take a stand and demand that government scientists do the
research necessary before the FDA makes a decision to approve silicone gel
implants. The FDA will review all the comments that are received through
their official process. Although the comment period doesn't end until
October, the decision to approve silicone breast implants could happen much
sooner. We need to act quickly! We are not
providing a sample letter, because the FDA will take your comments more
seriously if they are not identical to everyone else's. Feel free to cut and
paste or use any information from the talking points below. Anything you do
to make your wording unique (but still sound reasonable) is a plus. Make comments
directly to the FDA using the FDA's website! Suggested Talking
Points for Comments:
WHAT WE WANT:
FDA should ask a government agency such as the CDC or the National Institute
of Environmental Health Study (NIEHS) to conduct a study of a large number of
women who have had silicone gel breast implants for at least 10 years. The
study should focus on women with leaking silicone implants, and evaluate the
amounts of platinum salts in their blood, urine, hair, nails, and breast
milk. The women's sensitivity to platinum should also be studied, as well as
their health. The FDA should not consider approving silicone gel breast
implants until this study is completed. Silicone gel breast implants have never been approved by the FDA, but
last summer the FDA announced its plan to approve them if certain undisclosed
conditions could be met. That plan is under scientific fire, because a new
study published in the Journal of Analytical Chemistry found very high levels
of a toxic form of platinum, called platinum salt, in the blood and breast
milk of women with breast implants. Concerned consumer groups, including breast cancer support groups,
have requested that the FDA delay approval of silicone breast implants until
there is additional independent research on the health risks of platinum from
silicone breast implants. One consumer group filed a formal petition to the
FDA on this topic. Unfortunately, the FDA has hunkered down, claiming that
there is no evidence that silicone breast implants expose women to dangerous
levels of platinum -- without taking time to conduct additional research to
review the latest study. The lack of research on platinum is one example of the unknown risks
of breast implants, which is why consumer groups have repeatedly insisted
that the FDA require comprehensive long-term studies before approving these
products. Approximately 200,000 women have reported serious health problems
linked to their breast implants. |
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SUPPORT NOW: TAKE ACTION: LISTS: |
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