- The Washington Times - Monday, September 1, 2003

Silicone-gel breast implants are back. Eleven years after Food and Drug Administration Commissioner David Kessler essentially banned them, despite contrary advice from two FDA advisory panels, mountains of studies have continued to show they’re safe.

Makers are now seeking FDA approval. But they’ll fail if the so-called National Organization for Women succeeds.

That’s “so-called,” because while they’re clearly “national,” NOW’s efforts to prevent access to the implants shows they’re hardly “for women.”

NOW gave congressional and press briefings in late July, based on promulgations from their hand-picked panel, slamming the “all clear” findings from a 1999 National Academy of Sciences’ Institute of Medicine (IOM) report.

IOM based its conclusion on all existing scientific literature in the area, more than 1,000 published studies in all, concluding that diseases attributed to silicone implants “are no more common in women with breast implants than in women without implants.”

In contrast, NOW’s material was long on theory and anecdotes, with barely enough science to fill a training bra. Its major complaint was that, “Reasonable assurance of safety and effectiveness could not be provided unless clinical data were collected for much longer periods of time than historically required by and acceptable to the [FDA] for approval.”

Yet since the completion of the Institute of Medicine study, at least two-dozen additional, peer-reviewed articles have been published in medical journals that do report such long-term findings from epidemiological studies of women with silicone-gel implants.

These focus on such diverse issues as: cancer, cancer detection, cancer survival, cause of death, health of offspring, immune disorders, implant rupture, neurological disorders and local complications. More than a dozen studies involved an average patient follow-up of 10 years or longer, with at least six comprising an average of 15 or more years of follow-up.

In fact, the IOM report itself contains many such lengthy studies. Further, those ignored FDA panels also evaluated published and unpublished data going back to the early 1960s when the implants first came into use.

For example, one published in the prestigious Journal of the American Medical Association evaluated the potential influence of implant duration on health outcome for what had been the major allegation against implants, that they cause what’s called connective tissue or autoimmune illness. With data ranging from 1991 to 1962 involving almost 11,000 women with implants, it found no statistically significant effect of duration of use and illness.

A Swedish study in the British Medical Journal in 1999 followed about 7,500 women with silicone-gel implants, also for 30 years. It “showed a slight reduction (though not statistically significant) for all definite connective tissue disease.”

“There’s probably no plastic surgery procedure that has had more public and media exposure or more scientific scrutiny than this,” Dr. Bernadine Healy told me. She was the first woman to head the National Institutes of Health and a strong supporter of a women’s right to choose breast augmentation.

So if 10 or 15 or even 30 years aren’t enough for NOW, what is? Nothing, of course. NOW opposes all implants, but with saline ones already approved it can only target silicone. It does so because breast augmentation offends NOW’s crusty old feminist dogma.

“Breast surgery, in its mangling of erotic feeling, is a form of sexual mutilation,” wrote uber-feminist Naomi Wolf in her 1991 best seller “The Beauty Myth.”

“Enlarging one’s breasts to suit male fantasies” represents the exploitation of women, declared fellow feminist Susan K. Brownmiller in her landmark 1984 book “Femininity.” Indeed, she said, “Big breasts are one of many factors that have slowed women down in the competitive race of life,” she said.

Goodness. What solar system does this woman live in? “In evolutionary biology, height in men and larger breasts in women has given them advantages,” notes Dr. Healy.

And why doesn’t the $25,000 and five surgeries for a full hair transplant constitute exploitation of men? But don’t worry, NOW surely has a good explanation lying around somewhere.

NOW also realizes that moldy radical feminist propaganda isn’t going to sway the media and public, and hence the FDA. So it resorts not even so much to pseudoscience as to sheer nihilism. Give ‘em 1,000 studies and they’ll demand 2,000; give ‘em 30-year studies and they’ll demand 40-year ones.

It also helps to know that NOW is allied with Sidney Wolfe’s Public Citizen group, which has made big bucks selling litigation packets to trial lawyers suing implant makers.

No matter, though, for each year greater numbers of women are getting augmentation because it is what they want. They will flock to silicone implants if given an informed choice. They will be dictated to neither by nature nor NOW. Just call it “women’s liberation.”

Michael Fumento a senior fellow at the Hudson Institute and the author of the 1996 monograph, “Silicon Breast Implants: Why Has the Science Been Ignored?” This article distributed by Scripps Howard News Service.

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