| Ilena Rose 2005-07-28, 10:54 pm |
| Press Release Source: National Research Center for Women & Families
Statement of Dr. Diana Zuckerman, President of National Research
Center for Women & Families
Thursday July 28, 8:48 pm ET
WASHINGTON, July 28 /PRNewswire/ -- The Food and Drug Administration
(FDA) has issued an "approvable letter" to Mentor regarding their
silicone gel breast implants. This does not mean that these implants
have been approved, but it is a warning sign that corporate pressure
on the FDA has once again put women's health at risk.
The FDA letter is a stumbling step in the wrong direction, amid
mounting questions about FDA decision-making. Approval would be an
embarrassment unless the Senate and the FDA give Mentor a "clean bill
of health" after thoroughly investigating allegations that Mentor
misrepresented the rupture rate of its implants.
A Senate investigation of the Mentor safety data and the FDA approval
process is currently underway, and concerns are growing. Just before
the FDA announcement today, key women members of the U.S. Senate sent
a letter to the FDA Commissioner, expressing their strong concerns
about the lack of safety data on silicone gel breast implants. And, as
the public learns about defective pacemakers, recalls of
defibrillators and the dangers of several other medical devices,
questions still remain as to how safe these breast implants are.
Every week we hear from women with leaking breast implants, who can't
afford the surgery to have them removed. FDA needs to make sure that
they don't approve a product that adds to this frightening situation
for so many women across the country.
The FDA needs to listen to its scientists and demand more long-term
safety data before issuing any kind of decision. They also need to
make sure that the data they are given are accurate. The credibility
of the FDA is on the line, as is the health of millions of women.
Dr. Diana Zuckerman is the president of the National Research Center
for Women & Families, a nonprofit research and education organization
that works to improve policies and programs that affect the health and
safety of women, children, and families. Dr. Zuckerman is a
nationally-recognized health policy expert with post-doctoral training
in epidemiology from Yale Medical School. She was on the faculty of
Vassar and Yale, and a researcher at Harvard, prior to becoming a
Congressional investigator in the U.S. House of Representatives, where
she initiated the first Congressional hearing on the lack of safety
data on breast implants, held in 1990. She is widely quoted on a wide
range of health issues, especially FDA and medical products. For more
information about the Center's work, see
http://www.center4research.org and http://www.breastimplantinfo.org.
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Source: National Research Center for Women & Families
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