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Science Forum Index » Medicine - Nursing Forum » FORBES: Quote from Dr. Diana Zuckerman on FDA decision on S
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| Ilena Rose |
 Posted: Sun Nov 26, 2006 4:08 pm |
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Guest
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Note from Ilena Rosenthal of the Humantics Foundation:
Our beliefs mirror those of Dr. Diana Zuckerman ... who states it so
well.
www.BreastImplantAwareness.org/
www.BreastImplantAwareness.org/blog.htm
http://www.forbes.com/prnewswire/feeds/prnewswire/2006/11/17/prnewswire200611171948PR_NEWS_B_NET_DC_DCF051.html
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 -0- 11/17/2006
/CONTACT: Diana Zuckerman of National Research Center for Women &
Families, +1-202-316-0230,
Web site: http://www.center4research.org
http://www.breastimplantinfo.org |
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