
ParfumGigi@aol.com
31 décembre, 2006 13:05
Hutchison: Don't assume FDA is right about silicone implant safety
By Sue Hutchison
Mercury News
Here we were, trying to navigate the brave new world of cosmetic enhancements, ranging from injections of Botox to Restylane, when the Food and Drug Administration treated us to a little déjà vu. The agency just decided, after almost 15 years, to lift the virtual ban on silicone breast implants.
I suppose this completes our cultural time-travel back to the land of ``Charlie's Angels.'' Is this a good thing?
You may recall that in 1992, silicone implants were banned for most uses after a raft of patients' complaints, including suspicion that the devices caused autoimmune diseases. Now the FDA says that after years of study, there has been no evidence that these claims are true.
So women are free to go back to silicone, which most find to feel and appear more ``natural'' than the alternative saline implants. (Technically, saline solution is more natural. But never mind.)
Dispute continues
Still, advocates for women's health, including the National Research Center for Women & Families and the National Women's Health Network, have sounded the alarm: Silicone-implant buyers beware. They dispute that enough conclusive research has been done, and they point out that even the FDA recommends that silicone implants be checked every few years with an MRI scan to be sure they haven't ruptured. Most insurance plans probably won't cover the expense of an MRI.
Many surgeons who have continued to use silicone implants for cancer patients' breast-reconstruction -- which was allowed during the ``ban'' years -- say they have been very forthcoming with patients about the suspected risks of silicone, though they have not found the risks to be borne out. The thinking is that women need to have all the facts to make an educated decision, and then the choice is theirs.
But when it comes to the vagaries of the long-term effects chemicals can have on our health, is the ``choice'' defense simply a cop-out? In the words of Barbara Brenner, executive director of Breast Cancer Action in San Francisco: ``We always talk about `choice' like that's the answer, but at some point shouldn't we be asking about the kind of choices we are offering people?''
What can you live with?
Dr. David Kahn, assistant professor of plastic surgery at Stanford Medical School, said that though he had not had one complaint about silicone implants from his breast-reconstruction patients over the past decade, a little fewer than a third of his patients do request saline implants.
``Every person has their own risk-tolerance level, and I'm careful to make sure they have all the information,'' Kahn told me. ``But I tell patients that I can't promise what will happen 20 years from now. I don't know what future science will tell us.''
And that's something to keep in mind, not just about silicone but all the other ``miracle'' anti-aging potions that so many women are eager to have injected into their skin.
Nancy Evans, health-science consultant for the San Francisco-based Breast Cancer Fund, warned that the FDA has failed the public before. ``Let's not forget about what happened with Vioxx, and why is there almost no regulation of cosmetics?'' she said. ``In most cases, it's the industry itself that has done the studies about implant safety. Why don't we have more independent research?''
It's fine to say the results are in, and women can make their own decision about silicone. But be sure to ask yourself if you're comfortable with what those results might be 10 years down the road and if that's the kind of ``choice'' you can live with.