Policy

Science and Vanity

Implants: Medicine, Feminism and Freedom

|

THE UNITED STATES has become a society fragmented not only by ethnicity and race but also by a multiplicity of cultural divisions of the sort that the British scientist and writer C.P. Snow once warned could destroy a society's ability to communicate. These cultural divides are especially striking in the current debate over whether to ban silicone breast implants.

On an obvious level, someone living in Southern California, where plastic surgery is common, is less likely than a northeasterner to see the subject as trivial. In a culture of audacious self-fashioning, cosmetic surgery is just another manifestation of the will to determine one's identity.

But the breast-implant debate reveals at least three other fundamental divisions — about the interests of consumers, of women and of science — that reflect very different sets of values and ways of understanding the world: How much justification must consumers give the government for their choices? Are women liberated by rediscovering their natural femininity or by seizing control over their biological destinies? And, at least for the sake of public policy, how do we sort evidence from anecdote?

"Vital needs" Puritans vs. pro-choice consumers: Patients generally go to cosmetic surgeons not because their health is threatened but because they want to look different. This is as true of post-mastectomy patients and burn victims as it is of women who have small breasts. Cosmetic surgery is a matter of personal desire, not medical necessity. It is elective, voluntary and usually paid for directly by the patient.

In its letter to the Food and Drug Administration requesting a ban on the implants, the advocacy group Public Citizen repeatedly emphasized the frivolous nature of cosmetic surgery: "Because approximately 80 percent of these devices have been used for breast augmentation, as opposed to reconstructive purposes, the overwhelming 'public need,' not the public health need, for these devices is the psychological benefit of having more perfect or larger breasts . . . . We do not accept that the psychological needs of women, who seek breast augmentation, are legitimate public health needs within the meaning of the {Food, Drug and Cosmetic} Act."

This failure to "accept" the desires of women to decide how to spend their own money on their own bodies puts Public Citizen clearly on the side of defining "vital needs." A self-styled consumer group, its goal is to stand in for consumers, to make choices for them.

In part, Public Citizen is simply hewing to legalistic language. But the notion that inessential products should be outlawed, even when they don't present risks, is common among many environmental activists. Disposable diapers, juice boxes and Styrofoam are frequent targets of criticism and outright bans. Greenpeace has attacked facial tissues and the Worldwatch Institute's most recent "State of the World" report calls for a national ban on throwaway beverage containers. Products from private washing machines to 747s, from toilet paper to tailored clothing, have been condemned as inessential indulgences.

Against this onslaught are arrayed the consumers who want to buy these products and the manufacturers who supply them. They try to explain what disposable diapers mean to a mother's personal freedom or why outlawing juice boxes increases trucking costs and energy consumption. And, facing the FDA, we find women who want breast implants, whether for augmentation or restoration, defending their right to choose.

Rather than having sovereignty over their bodies and bank accounts, these consumers are forced by aggressive regulators to give a "good reason" for their choices. "We have pitted one group of women against another, those who currently have a happy outcome versus those who've had an adverse outcome. I think that is a mistake," said Norman Anderson, an internist at Johns Hopkins University Hospital, on "Nightline." But Anderson, who is one of the FDA advisers who pushed for the current moratorium, was unclear on the alternative to all-or-nothing regulation; he seemed to hope that women who want breast implants would change their minds.

In the medical context, "vital needs" advocates imply that a natural but unwanted condition must be a "disease" in order to warrant intervention. Medical consumers, however, vote with their dollars and their flesh, for a contrary view: People should be able to change their bodies just because they want them to be different. And this brings us to the second great divide.

Earth Mother feminism vs. self-made-woman Feminism: The debate over breast implants is, most obviously, a debate over the role of women and their personal choices: Should women be allowed to choose unnecessary and potentially risky surgical procedures? Should a woman be allowed to alter her natural form to conform with her ideal of beauty? To make her life more convenient?

The notion that breast augmentation is simply wrong undergirds much of the hostility to the procedure. In her widely discussed book, "The Beauty Myth," Naomi Wolf characterizes breast augmentation as "sexual mutilation." And Public Citizen declares in a press release, "The widespread use of silicone gel implants for surgery that is purely cosmetic is a particularly egregious aspect of the issue."

The Earth Mother argument goes beyond breast implants, however. Consider the Pill. It is a federal crime to obtain birth-control pills without a prescription, which, of course, entails seeing a doctor. To reduce unwanted pregnancies, some women's rights advocates want to make low-dose birth-control pills available over the counter. Planned Parenthood is studying the issue.

"I don't think anybody knows how many pregnancies occur because of delayed refills, or just not getting pills on time," Felicia Stewart, a Planned Parenthood staff physician told Ms. magazine. "But it is really a lot. Anyone who works in an abortion clinic can tell you that."

Making the Pill available over the counter would empower women, giving them new control over their bodies. But it would not please the Boston Women's Health Book Collective, publishers of "Our Bodies, Ourselves," and vocal opponents of breast implants. The collective is quite hostile to the Pill because it introduces synthetic hormones into women's bodies. In its discussion of birth-control methods, "Our Bodies, Ourselves" ranks the Pill below various rhythm methods and just after abstinence.

The collective uses the same language about the Pill that it uses about implants. Because both technologies may have long-term effects, women who use them "become subjects in prolonged experiments." So the collective would rather not allow women to choose their own risks, whether by permitting implants or legalizing over-the-counter oral contraceptives.

Lately, some feminists and environmentalists have even begun to attack tampons and other menstruation-related technologies. In the quarterly, Whole Earth Review, Lara Owen wrote, "The technology of suppression — tampons, vaginal deodorants, sophisticated pain-killing and mood-altering drugs — has acted together with the myth of the superwoman to create a predominant cultural attitude that a menstruating woman is no different from one who is not bleeding."

In a more-mainstream critique, Garbage magazine assistant editor Hannah Holmes criticized tampons (especially the plastic-applicator variety that consumes "precious petroleum") for contributing to solid-waste problems and for leading to toxic shock syndrome. Like silicone breast implants, tampons can be defined as medical devices and, also like silicone implants, they are not absolutely necessary; substitute technologies exist. So we may yet find tampons under regulatory attack. Certainly the connection between tampons and toxic shock syndrome is far better documented than most of the allegations against silicone breast implants. That risk assessment suggests the third great divide.

The clinical view vs. the statistical view: This is the deepest cultural chasm, dividing medical practitioners from medical scientists and everyday experience from systematic research. The groups that stand on either side of this divide do not even comprehend each other's arguments.

Take the claim that silicone breast implants cause scleroderma, a connective-tissue disorder that leads to a painful tightening of the skin. To lead in to its program on the implant controversy, "Nightline" featured a woman who had had a breast implant and who had later developed scleroderma. Reporter Judy Muller told viewers that the woman's doctor "believes the disease was caused by silicone leaking from the breast implants."

Muller did not inform viewers that there is no epidemiological evidence to back up that diagnosis. To tell whether there is indeed a connection between implants and scleroderma-like disorders would require a large sample of women who had received implants, whose medical histories were well-documented and whose symptoms were unambiguous. Such evidence may be forthcoming, although a May 1991 literature search under the auspices of the American Medical Association turned up only 28 women who had developed connective-tissue disorders after receiving silicone gel implants. For now, it is scientifically incorrect to say that implants cause such auto-immune diseases.

To such arguments, implant opponents reply by pointing to scleroderma victims. See, they say, it happened to this woman. She had an implant and now she has a disease. Post hoc, ergo propter hoc. The statistical standards of proof on which epidemiologists rely do not make for powerful journalism. And they run counter to the case-oriented culture of clinical practice.

Sociologist Eliot Friedson described that culture in his seminal 1970 book, "Profession of Medicine": "The consulting professions in general and medicine in particular encourage the limitations of perspective by its members through ideological emphasis on the importance of firsthand, individual experience . . . . Such emphasis is directly contrary to the emphasis of science on shared knowledge, collected and tested on the basis of methods meant to overcome the deficiencies of individual experience. And its efficacy and reliability are suspect." Friedson notes that clinical practitioners often give expert testimony, generalizing from personal experience to conclusions for which they have insufficient evidence.

Such testimony can have a powerful effect on juries, especially since the court system — like high-school debate judges crediting evidence cards — tends to grant all experts equal credibility. The effect is what Peter Huber, author of "Galileo's Revenge," calls "junk science," evidence that meets legal but not scientific standards.

Clinically based junk science, promoted by aggressive litigators, has run the morning-sickness drug Bendectin off the market, due to a controversy over whether it is connected to birth defects. Since it became unavailable, the number of hospitalizations for severe morning sickness has doubled. Although no connection between Bendectin and birth defects has ever been established, and although its manufacturer won in court, the $100-million cost of defending the drug against continuous lawsuits has made it too expensive to produce.

The cultural divide between the small number of people who understand statistical reasoning and the large number who do not affects more than health policy. Edward Deming's celebrated techniques of statistical process control are designed to maintain quality standards not only by telling workers when production equipment needs to be adjusted, but also by telling them when it does not — when changes in output are within random fluctuations and adjustments would lead to more, not less, deviation from the norm.

Similarly, Japanese managers have observed that American managers do not understand statistics well enough to distinguish between random earnings or production fluctuations, and real changes. Making decisions based on quarterly earnings is wrong, in this analysis, because it leads managers to react to statistical "noise."

Because it is sensitive to public outcry, the regulatory process also tends to respond to noise — specifically, to the noise made by clinicians claiming harm. The FDA is culturally biased, as are the victim-loving media.

In evaluating the safety of breast implants, the FDA and the courts should view the evidence rationally, with an eye toward real epidemiological proof rather than emotional claims. Regulators should seek to inform women of risks, not deprive them of choices. And those women who do want the freedom to make informed choices must take responsibility for the consequences, rather than going to court later to demand compensation for bad outcomes. Above all, the FDA should avoid taking refuge in extremist, paternalistic views of what women should be and what women should want.