IMPORTANT: Petition for Truth about Dangerous Silicone Breast Implants
Ilena Rose
Action Alert
Stand Up for the Truth About Risky Silicone Implants
Implant Maker Trying to Mislead Congress and the FDA
March 24, 2005
Action Needed:
A lobbyist for implant manufacturer Mentor Corporation is trying to
convince Congress and the Food and Drug Administration that silicone
implants are safe, despite the clear evidence we provided to Congress
on March 2 showing they are not. It is essential that members of
Congress and the FDA understand the truth about the risks of silicone
implants.
We need you to help Congress and the FDA see their way through the
implant industry’s deception. A new letter is being circulated around
Congress and the FDA that refutes the comments from Mentor and
provides additional evidence to support the concerns we have about the
risks of silicone implants.
Please send a message to Congress and the FDA to help them get the
facts straight. Don't let the silicone implant industry mislead
Congress and the FDA into approving silicone implants for general use.
They are simply too risky.
Background:
The silicone breast implant industry and its lobbyists are trying to
distort the facts about silicone implants in order to persuade the FDA
to approve them, despite the fact that they are far too risky for
general use. The facts are clear. Silicone breast implants are far too
risky to be approved for general use. And implant manufacturers are
trying to cover these facts up by withholding evidence and playing
word games.
What is at risk if the FDA approves silicone breast implants for
general purposes? Women and teenagers will be put at risk. Thousands
of teenaged girls are getting implants each year and the American
Society for Aesthetic Plastic Surgery (ASAPS) and the American Society
of Plastic Surgeons (ASPS) agree that demand increased dramatically
among teenagers between 2002 and 2003. While demand has subsided a bit
between 2003 and 2004, it still remains much higher than it was as
recently as in 2000. Overall, more than 300,000 breast augmentations
occur each year and about 2,000,000 women have them already.
It is well known that plastic surgeons have been lobbying for
reintroduction of silicone breast implants for general use. In 2003,
one of the Advisory panel members, Dr. Michael J. Miller, had received
a $25,000 grant from the applicant and not only voted for approval,
but was a cheerleader on behalf of the applicant.
Just two weeks ago, the American Society for Aesthetic Plastic Surgery
and the American Society of Plastic Surgeons launched a website,
www.breastimplantsafety.org, that encourages women to lobby the FDA in
support of silicone breast implants. Some of the language in their
website is taken verbatim from implant manufacturers' websites.
It should be pointed out that both breast implant makers and plastic
surgeons stand to reap enormous profits should silicone gel implants
be approved by FDA for general use. Analysts with CIBC World Markets
and Sun Trust Robinson Humphrey have estimated that silicone gel
breast implant prices are double that of saline implants. In addition
to plastic surgeons and implant makers reaping more profits from
approval, the additional costs will compound our already serious
problem of escalating healthcare costs.
The risks facing women with silicone implants are real and they are
serious. Concerns about silicone leakage, increased risk of death from
suicide, brain cancer, and lung cancer have been clearly documented by
clinical research and recognized by the FDA. Complications resulting
from silicone implants are common and usually occur within a few years
after the initial surgery.
Lobbyists for Mentor, Inc., a leading silicone implant manufacturer,
have attempted to mislead Congress and the FDA by using research on
saline implants to talk about silicone implants. Further, the silicone
implant industry has never provided more than three years worth of
clinical data, despite 30 years of clinical use. Industry researchers
have been able to omit much of this data because they have
systematically failed to adequately follow-up with patients to see
what complications they have experienced. It may be convenient for
them, but it is disastrous for the women who suffer from
complications.
Again, please send a message to Congress and the FDA to help them get
the facts straight. Don't let the silicone implant industry mislead
Congress and the FDA into approving silicone implants for general use.
They are simply too risky.
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