infromed consent

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Informed Consent and Women's Health

EditorialWomen, Breasts, and the Failure of Informed Consent Neveloff Dubler, LLB; Schissel, MA

Informed consent is intended in part to level the playing field in the face of the discrepancies of knowledge, skill, and experience between physician and patient. It is designed to enable the patient to make health care decisions consonant with her preferences and values. In most instances, a patient's consent to a medical procedure is considered valid when she is capable of making health care decisions and voluntarily weighs the various risks and benefits of the procedure and the alternative methods of treatment.

But in the case of breast augmentation-where both the supply and the demand for the medical procedure originate in the medical marketplace and are stimulated by manufacturer and physician self-interest-informed consent fails to protect patients. Advertisements promising "natural looking" and "voluptuous" figures that fail to highlight statistics on adverse outcomes, coupled with the plastic surgeon's need to "sell" her services can render this informed consent process all but meaningless. Because of the tension between commerce and medicine, providers have an obligation not just to inform the patient/consumer, but to affirmatively warn. Advertising of medical, and particularly cosmetic, devices should be held to the same standards as prescription drugs are: Statements of possible side effects and complications must be clearly and fully represented alongside the promises of curves if the patient is to make a truly informed decision about her medical care.

The Food and Drug Administration (FDA) convened hearings this past March to decide whether saline breast implants were safe and effective. This premarketing application process brings a new product to the attention of the FDA and is the basis for deciding whether the device is safe and effective and can enter the market. Saline implants, which have been continuously on the market for four decades, had until the hearings been "grandfathered" into the system because they were developed before the FDA's jurisdiction included implantable devices.

Consider the context of the panel's discussions as illustrated by the following quotations from advertising material from the two major marketers of saline implants, Mentor Corporation and McGhan Medical (bold in original):

The skimpy fashions of summer just intensify your wish for a more flattering figure. Admit it, You'd feel more confident with a more naturally balanced figure. Nothing fake-looking or obvious, though. Perfectly natural Anatomical Breast Implants from McGhan Medical may be the answer. Anatomically shaped and totally natural in appearance, they'll be your big secret....

Or, also from this manufacturer: Have you ever imagined feeling more voluptuous? Did you ever wish you could look more alluring? Perhaps you'd like to wear a provocative outfit that reveals more cleavage. Now your dream can become a reality. [And finally, the clincher:] Now you can have the breasts you've always wanted with a convenient, flexible monthly payment plan customized to fit your budget. 100% financing on approved credit.

The advertisements from the Mentor Corporation present less text but deliver a punchier message (bold in original): An attractive young woman named Amber O'Brien, age 25, is having the time of her life. Recently, she decided it was time to have breast augmentation. Life Mission: "Always open to new ideas." Proudest Achievement: "Buying a condo." Thoughts on Breast Augmentation: "I drove my doctor nuts with questions. But once she explained the options, I felt really good about it." How I Feel Now: "My friends say I look incredible. I like that." What I'd Tell Women Considering Breast Augmentation: "Check it out yourself. Then do it for yourself!"

These clever advertisements are designed to enhance the market for a medical intervention. But are they compatible with the medical/ethical notion of informed consent?

The legal doctrine of informed consent was designed to redress the imbalance of power between doctor and patient. It was tailored by case law [1] and statute [2] to support the right of self-determination and underscored the moral importance of individual choice. It supported patient choice over the powerful notions of physician beneficence, professional experience, skill, and even wisdom. It was not, however, a doctrine that envisaged doing combat with the sophisticated advertising forces that intend to stimulate demand and bend individual will to profit margins. [3,4] With stimulated demand, informed consent for breast augmentation is too fragile a reed to withstand the storm of commerce.

As medicine evolves from a profession responding to illness and disease to a workforce advertising its skills, the already imperiled notion of informed consent becomes even less adequate to regulate the doctor/patient relationship. In cosmetic surgeries, for example, where physicians are attempting to "sell" an image that their skills can produce, the process of informed consent provides inadequate individual protection. Physicians cannot neutrally present the pros and cons of a procedure that they are simultaneously selling.

The brief ascendancy of informed consent has been eclipsed by a myriad of factors: the smorgasbord notion of informed consent, supported by risk management and risk-averse legal counsel, that requires all possible dangers to be shared, thus masking the important in a wash of the trivial; direct marketing of drugs to patients in glossy presentations that extol benefits in the language used to sell detergents; the growth of tertiary care institutions that provide episodic and impersonal care; and medicine as market in which both physician practices and medical centers compete in the language of hype: "Come to us - we are the best!" What can be done about this increasing assault of the market on the practice of the profession? What will not work, I would like to suggest, is the usual.

The American College of Surgeons argued to the saline breast implant panel that the process of informed consent is both necessary and sufficient to protect patients. [5] In instances of surgical enhancement, however, the surgeon is clearly a self-interested party, not the neutral arbiter of alternative interventions. [6] Physicians were assumed to be the appropriate ones to articulate the risks and benefits of alternative treatments, as they were most knowledgeable and were under an obligation of beneficence. But cosmetic surgery is a fast-growing arena that exists almost entirely in the shrinking fee-for-service medical market. Surgeons and manufacturers advertise their skills and products to increase patient desire. Can they present the risks as passionately as the benefits? Clearly not.

Perhaps what is needed is equal firepower for the opposition. [7] The process for informed patient decision making, respected and followed by the FDA, presents an evenhanded view of clinical study results and potential risks. But it does not take into account the glitzy advertising that encourages the creation of a market for bigger or rounder or bouncier breasts. A strong warning against must counterbalance advertising to entice.

How might such a warning be constructed? It would highlight the data on: capsular contracture and breasts with rock-hard and painful centers; rupture and deflation; reoperation rates; interference with sexual pleasure, mammography, and breastfeeding; and the dangers of skin wrinkling. [8] The warnings should be presented as cleverly and professionally as the advertisements they are designed to counterbalance. The antismoking campaigns initiated in California and other areas present good models [9] (New York Times. April 4, 1997:D2, and January 20, 2000:A1).

Is this total delusion? Perhaps. Saline breast implants have just been declared "safe and effective." How can we possibly compare them to cigarettes? We can't. But despite their designations, the data produced by the companies themselves and the independent research of scholars document problems with implants that patients should consider seriously before committing to what may be years of medical management. [8]

What is the solution? Because we are unlikely to witness an "antibreast implants" advertising campaign, I propose that advertisers of medical devices, and particularly cosmetic devices, where both demand and supply originate in the medical marketplace, be mandated to disclose statements of side effects, complications, and other adverse outcomes within the advertisements.

The federal regulations relating to advertising for prescription drugs [10] serve as a good model, and the justifications for these regulations apply equally to the advertising of medical devices: that such disclosure is necessary to enable consumers to make fully informed choices about their medical care, upon weighing true risks and benefits. The federal regulations require information on side effects, contraindications, and effectiveness, and forbid the use of false, misleading, or confusing information in any part of the advertisement. They preclude any suggestion or representation that the drug is safer or has a lower incidence of or less serious side effects than demonstrated by clinical evidence. Although compliance with these regulations may not have been optimal in the past [11] (USA Today. May 3, 2000:1A), recent Congressional activity indicates that patient safety and knowledge is again a primary concern. A bill introduced in June would encourage compliance by denying tax deductions for "unbalanced" pharmaceutical advertising that places greater emphasis on product benefits than on risks or that otherwise fails to comply with FDA requirements. [12]

This suggestion is unlikely to be welcomed by anyone. The FDA sees itself as fulfilling its role in assuring safe and effective devices and supervising the informed consent materials. Companies see their right to increase market share with clever materials. Women see their right to choose surgical interventions that enhance their sense of body image and self-worth. All are correct. But as medicine becomes the market, as "do no harm" evolves into "buyer beware," new approaches that warn must replace methods that merely inform.

The original idea of the informed consent process presupposed a physician whose primary focus was the welfare and the best interest of the patient. Many physicians continue to adhere to these values, but some stand at the boundary between patient interest and market share. For these, and for the products they use, merely informing is too passive a process.