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Statement of Diana Zuckerman, PhD, President, National Research Center
for Women & Families

WASHINGTON, Nov. 17 /PRNewswire/ -- The following is a statement
of
Diana Zuckerman, PhD, President, National Research Center for Women &
Families:
The FDA's decision to approve silicone gel breast implants is a
triumph
of corporate lobbying and hype over sound science and women's health.
The
FDA's standards for implants have reached a new low with this
decision.
It's important for women to know that the FDA has not determined
that
silicone gel breast implants are safe -- only that they are
"reasonably
safe." What does that mean? In this case, it means that if a woman
lives
for 25 years after getting these implants, she will need to remove
them at
least once, probably twice, and possibly more than that. If she
doesn't,
the implants are likely to break inside her body, and possibly leak
silicone into her breasts, lungs, and other organs.
What do we know about the risks? Most women with silicone gel
breast
implants experienced at least one complication within the first three
years
of getting implants, including breasts that were hard or painful,
oddly
shaped, or had lost sensation, or the need for additional surgery to
fix
implant problems. The additional surgery is often very expensive, and
almost never covered by health insurance. FDA scientists found that
women
with silicone breast implants for two years had a significant increase
in
several auto- immune symptoms, such as joint pain and chronic fatigue.
Contrary to the hype, breast augmentation patients did not report a
significant improvement in self- esteem and tended to report a lower
quality of life after implants. Perhaps that is why scientists at the
National Cancer Institute found that women with breast implants were
twice
as likely to kill themselves, compared to other plastic surgery
patients.
The impact of silicone implants on breast milk is unknown. The
long-term health risks (after three years) are unknown. Given the
known
risks and the unknown risks, silicone breast implants should be
considered
less "reasonably safe" than sky diving or other high-risk adventures.
Most
sky divers are not harmed, but some are harmed a little, and some die
as a
result. According to the information provided by implant manufacturers
to
the FDA, most women with silicone breast implants will be harmed. The
harm
can be to her health, her mental health, her appearance, or to her
pocketbook, or all four.
We support the FDA's decision to require 10-year studies of 40,000
women. We will do all we can to make sure that the FDA enforces that
requirement, but we wonder what the FDA will do if the companies do
not
complete those studies.
We support the FDA's recommendation that women have breast MRIs to
check for leakage every two years, but we know that most women can't
afford
the $2,000+ that breast MRIs cost.
We support the FDA's age restriction, limiting augmentation with
silicone gel breast implants to women ages 22 and over. We strongly
encourage plastic surgeons to abide by those restrictions, since
younger
women are still developing physically and emotionally.
The FDA's announcement was made at 5:30 on the Friday before
Thanksgiving, in an effort to reduce media coverage. Since FDA offices
are
normally closed at 5 pm, apparently even they are ashamed of their own
decision.
The National Research Center for Women & Families is a nonprofit
research and education organization focused on health and safety
issues.
The Center is not opposed to silicone implants but is opposed to FDA
approval of any implanted medical devices that are not proven safe for
long-term use. For more information about breast implants and the
personal
stories of women with implants, see http://www.breastimplantinfo.org.
For
information about numerous other women's health issues, see the
Center's
website at http://www.center4research.org


SOURCE National Research Center for Women & Families