Testimony of Linda MacDonald Glenn at the FDA on Silicone Gel Breast Implants

Linda MacDonald Glenn, Women’s Bioethics Project, April 2005

My name is Linda MacDonald Glenn. And I am testifying today on behalf of the Women’s Bioethics Project, a nonprofit, nonpartisan public policy institute dedicated to ensuring that women’s voices, health, and life experiences are brought to bear on ethical issues in healthcare and technology.

I am a biomedical ethicist, attorney, educator, and long-time patient advocate. I spent 20 years as an attorney, a prosecutor, government adviser, and general practitioner. During that time, I was called to the field of biomedical ethics, both personally and professionally. I went back to school to switch my career to biomedical ethics.

Upon graduating in 2002, I went to the American Medical Association, where I was a senior fellow at the Institute of Ethics. I hold a faculty appointment at the University of Vermont. And I was recently given the honor of being named a Woman’s Bioethics Project scholar. I have no financial conflict of interest.

“Tell me what you don’t like about yourself.” This catchphrase is the opening line to the controversial TV drama “Nip/Tuck” that sums up a plastic surgeon’s attitude towards his patient. The implication is that plastic surgeon can fix what you don’t like about yourself.

And while we’re not here today to talk about plastic surgery, we are here to talk about the new silicone breast implants, which manufacturers have promoted as a woman’s choice; in other words, “Let us help you feel better about yourself.” But, as I will follow up and explain, the FDA’s summary of the manufacturer’s own reports indicate that this is a hollow promise.

There are some key ethical issues involved in your decision today. Issues of long-term safety and truly informed consent are the primary concerns.

In biomedical ethics, there are four principles that are weighed and balanced against each other to arrive at an ethically sound decision. Those are the principles of autonomy, the right of control over your own body; benefit, the good that is accomplished from the treatment and the application of technology; no harm, the risks and burdens of the treatment; and justice, a question of fair and equitable access.

The public relations firm hired by the breast implant companies came up with a slogan, “Women have the right to choose breast implants, which chooses to emphasize autonomy. However, if autonomy were the only principle to be considered, there would be no need for the FDA. And there would be no protection against the claims of charlatans and those peddling magic elixirs.

The slogan “The right to choose” implies a benefit that a woman will feel better about herself and her appearance, but, in fact, the data submitted by Mentor Corporation does not bear out that benefit.

Mentor’s own data and the data that Inamed provided in 2003 both showed that on most measures, women feel the same about themselves and their lives two years after getting breast implants compared to before getting breast implants. That is consistent with other research as well, as shown in the FDA summary of Mentor’s reports on pages 66 to 73, indicating there is no measurable benefit for women who have received breast implants.

To quote, in summary, the literature does not provide strong scientific support that breast implants have a measurable psychological and psychosocial benefit for women seeking breast augmentation. Each study had serious flaws, including the apparent exclusion of participants with adverse outcomes. This was true for augmentation and reconstructive patients.

The summary on page 73 explains that Mentor did not provide adequate literature that evaluates the short-term or long-term psychological or psychosocial benefits of breast implants as a reconstructive procedure.

The burdens and potential risks are substantial, not only the risks of invasive major surgery but also serious questions about long-term safety issues regarding silicone leakage, silicone migration, and resulting autoimmune disorders.

Research of women with implants for at least six years found that one in five women had silicone leaking outside the scar capsule and didn’t even know it. Clearly, more studies on long-term safety need to be done.

In terms of ethically sound decision-making, this is what I would call a slam dunk for the Committee. Autonomy, the right to choose, is not a factor when the benefits are not measurable and the burdens and risks are significant. The path this Committee ought to take is clear. These implants should not be approved until clear benefits and long-term safety are established.

Thank you for your thoughtful consideration in listening today.