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Stand Up for the Truth About Risky Silicone Implants
Implant Maker Trying to Mislead Congress and the FDA
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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