My name is Linda MacDonald Glenn, and I am testifying today on behalf
of the Women’s Bioethics Project, a non-profit, nonpartisan public
policy institute dedicated to ensuring that women’s 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 Women’s 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 surgeon’s attitude towards his
patient. The implication is that plastic surgery 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 approval of
new silicone breast implants, which the 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 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. Mentor’s 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 Mentor’s 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.
Linda MacDonald Glenn, J.D., LL.M.
University of Vermont
School of Nursing and Allied Health Sciences
216 Rowell Bldg
Burlington, VT 05403
