Dear Friends,
When the FDA approved silicone gel breast implants in November, they did so with numerous warnings about the risks, and with a requirement that the implant companies each study at least 40,000 women with implants for at least 10 years. We want to make sure that the women who are considering implants are aware of these caveats. One way we do this is to talk to reporters and editors of newspapers across the country. We're delightedthat Dr Susan Wood, the well-respected former Director of Women'sHealth forthe FDA (and a member of our National Advisory Board), is helping. Today's Seattle newspaper shows that this effort can be very effective.
Best wishes, Diana
Diana Zuckerman, Ph.D.PresidentNational Research Center for Women & Families1701 K Street, NW, Suite 700Washington, DC 20006(202) 223-4000www.center4research.orgWe're Combined Federal Campaign # 1988SEATTLE POST-
INTELLIGENCERhttp://seattlepi.nwsource.com/opinion/299388_implanted.htmlWomen's Health:
A red-flag warningFriday, January 12, 2007
We've never had much faith in the FDA, but its approval of silicone gel-filled breast implants marks an all-time low for the agency.Restricted since 1992, the implants were deemed unsafe because of the healthrisks associated with them, such as cancer. The FDA currentlyrecommendsthat only women over the age of 22 get the implants. It also asks the makers of the implants (which can rupture during a mammogram), Allergan Corp. andMentor Corp., to carry out a 10-year, 80,000-patient study in orderto"fully answer important questions" regarding the products safety.
Say what? The approval of the implants is completely backasswards.
Clearly,(lobbying) money talks, and in this case, it jiggles for a few years before it hardens and leaks toxins into your lymph nodes, joints, uterus and liver.
Roughly 5 percent of U.S. women likely will get the implants in the next decade.
We spoke to two experts on the matter:
Diana Zuckerman, president oftheNational Research Center for Women and Families at the University of Pennsylvania Center for Bioethics, and Susan Wood, a research professor at George Washington University's School of Public Health. The two scientists want you to know a few things:
a.. Post-approval studies are common, but the sheer scope of this one shouldbe a red flag.
Also, neither the age of breast-implant recipients nor the collection of data by the two companies can be enforced.
a...Although you can pay for the implants in installments, you can'tdo sofor their removal -- and they will need to be removed or replaced.Health insurance seldom covers those additional surgeries.
a.. You'll need to get pricey MRIs regularly. And no, your insurance probably won't cover them
.a.. By no means should you take the FDA's approval of the implants to meanthat they're safe.
For example, their effect on breast milk, saysZuckerman,has "never, ever, ever been tested" by the FDA.
How's that for looking after public safety?
© 1998-2007 Seattle Post-Intelligencer
Friday, January 12, 2007
Health Canada and the FDA On Implant Approval
Hi everyone I did an interview last night with a reporter and I came to realize while talking with her that the Health Canada Regulatory agency along with the FDA regulatory agency went and set avery reckless precident when they decided to approve Inameds and Mentors breast implants.
They recklessly decided it is Ok to approve now and study later so this is very dangerous to all consumers in the U.S. and in Canada, they also with the approval decided corporate america is more important than womens lives and health.
When political lobbying and donations be it corruption of government officials,scientists, and Doctors becomes more important we are in a sad state of affairs.
I find the plastic surgeons who insert these devices to actually be lower than the manufacturers because they knowingly insert these, knowing they are not safe, and knowing they will cause disfigurement, diseases, re-operations, even in some cases toxic shock resulting in deaths. In all of this they have never been held accountable for there lies or actions. I was asked last night if I thought we could do anything to stop this or to change it and I said honestly no I don't, and I said the reason why is because unlike the manufacturers and the plastic surgeons we don't have the money to fight it or to buy what we want.
Health Canada and the FDA lied, they touted studies that were and have been shown factually to be flawed mainly because of manufacturer bought involvement and the same with the plastic surgeons bought involvement.
The FDA and Health Canada have had since 1992 to demand adequate studies since the moratorium came in and yet we aresitting here with inadequate studies from Inamed and Mentor of only 3and 4 years. Even those studies eliminated alot of women, mastectomy women were not studied with one of them I think they had around 30 don't quote me on that but that is not a study.
Women have not been followed in the study after being implanted I have talked to many and even on the FDA's adverse section women have stated after entering the study and having a rupture they were not followed through. I recently talked with a woman who is a relative of mine she had implants in two years ago I did not know this till 2 weeks ago she said oh they are not silicone they are gel I shook my head and said what do you mean they are not silicone, I then asked her how she got them when health canada had supposed strict guidlines that onlymedically necessary women could get approval then enter into thestudy she got hers because she said she wanted to feel better about herself, this is not a medical condition like a mastectomy. It is also another case where the plastic surgeon got automatic approval.
I feel Health Canada knew all along that all would be approved and that the guidlines were a farce just like the tainted panel they had convened for hearings on whether mentor or inamed should get approval. I feel Health Canada broke the law and they violated there own rules. So now the FDA and Health Canada has granted approval for women to be used as lab rats so where do we go from here, won't itbe a scarey thing to watch, the next will be pharma companies demanding they get approval on all drugs then test later.
Sandra
They recklessly decided it is Ok to approve now and study later so this is very dangerous to all consumers in the U.S. and in Canada, they also with the approval decided corporate america is more important than womens lives and health.
When political lobbying and donations be it corruption of government officials,scientists, and Doctors becomes more important we are in a sad state of affairs.
I find the plastic surgeons who insert these devices to actually be lower than the manufacturers because they knowingly insert these, knowing they are not safe, and knowing they will cause disfigurement, diseases, re-operations, even in some cases toxic shock resulting in deaths. In all of this they have never been held accountable for there lies or actions. I was asked last night if I thought we could do anything to stop this or to change it and I said honestly no I don't, and I said the reason why is because unlike the manufacturers and the plastic surgeons we don't have the money to fight it or to buy what we want.
Health Canada and the FDA lied, they touted studies that were and have been shown factually to be flawed mainly because of manufacturer bought involvement and the same with the plastic surgeons bought involvement.
The FDA and Health Canada have had since 1992 to demand adequate studies since the moratorium came in and yet we aresitting here with inadequate studies from Inamed and Mentor of only 3and 4 years. Even those studies eliminated alot of women, mastectomy women were not studied with one of them I think they had around 30 don't quote me on that but that is not a study.
Women have not been followed in the study after being implanted I have talked to many and even on the FDA's adverse section women have stated after entering the study and having a rupture they were not followed through. I recently talked with a woman who is a relative of mine she had implants in two years ago I did not know this till 2 weeks ago she said oh they are not silicone they are gel I shook my head and said what do you mean they are not silicone, I then asked her how she got them when health canada had supposed strict guidlines that onlymedically necessary women could get approval then enter into thestudy she got hers because she said she wanted to feel better about herself, this is not a medical condition like a mastectomy. It is also another case where the plastic surgeon got automatic approval.
I feel Health Canada knew all along that all would be approved and that the guidlines were a farce just like the tainted panel they had convened for hearings on whether mentor or inamed should get approval. I feel Health Canada broke the law and they violated there own rules. So now the FDA and Health Canada has granted approval for women to be used as lab rats so where do we go from here, won't itbe a scarey thing to watch, the next will be pharma companies demanding they get approval on all drugs then test later.
Sandra
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