The FDA subcommittee Panel on General and Plastic Surgery Devices is hearing testimony today and tomorrow on on whether or not to approve new silicone gel filled breast implants. Linda MacDonald Glenn testified on behalf of the Women’s Bioethics Project, on ethical issues in long-term safety and informed consent. Here is a copy of her testimony:
My name is Linda MacDonald Glenn, and I am testifying today on behalf of the Womens Bioethics Project, a non-profit, nonpartisan public policy institute dedicated to ensuring that womens voices, health, and life experiences are brought to bear on ethical issues in health care and biotechnology.
I am a biomedical ethicist, attorney, educator, and longtime patient advocate. I spent 20 years as an attorney a prosecutor, government advisor, and general practitioner. During that time, I was called to the field of biomedical ethics both personally and professionally. I then 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 for Ethics. I hold a faculty appointment at the University Of Vermont. I was recently given the honor of being named a Womens Bioethics Project Scholar. I have no financial conflict of interest.
Tell me what you don’t like about yourself – this catch phrase is the opening line to the controversial TV drama “Nip/Tuck that sums up the plastic surgeons attitude towards his patient. The implication is that plastic surgery can fix what you dont like about yourself. And while were not here today to talk about plastic surgery, we are here to talk about the approval of new silicone breast implants, which the manufacturers have promoted as a womans choice in other words, let us help you feel better about yourself. But as I will follow-up and explain, the FDAs summary of the manufacturers 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 to control over your own body), Benefit (the good that is accomplished from the treatment or 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 a 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 no protection against 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. Mentors own data, and the data that Inamed provided in 2003, both show that on most measures, women feel the same about themselves and their lives 2 years after getting breast implants, compared to before getting breast implants. This is consistent with other research as well, as shown in the FDA summary of Mentors reports on pages 66 73, indicating that 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 measurable psychological and psychosocial benefits for women seeking breast augmentation. Each study had one or more of the following problems: short duration of follow-up (typically 3 months to 3 years); lack of an appropriate control population or baseline survey; use of different surveys before and after surgery; small study size; low response rate and/or high loss to follow-up; apparent exclusion of participants with adverse outcomes. (page 70 of FDA summary). And this result was not just for women who sought augmentation. 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 the potential risks are substantial: not only the risks of invasive major surgery, but also serious questions about long term safety issues regarding leakage of silicon into the body, silicon migration, and resulting auto-immune disorders. FDA research of women with implants for at least six years found that most women had at least one broken implant and that one in five implant patients had silicone leaking outside the scar capsule, but 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 this committee. Autonomy the right to choose is not a factor where 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 is established. Thank you for your thoughtful consideration and listening today.
— A decision is expected from the committee Wednesday.
