Women's Health: A red-flag warning

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?

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