http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2005/05/12/EDG
J6CN3BM1.DTL
Limiting options for breast implants
Jane Zones

Thursday, May 12, 2005




 

Last month, the Food and Drug Administration held three days of
hearings on two new device applications for silicone gel-filled breast
implants. In the end, the advisory panel recommended against approval
for the implants of one company (Inamed) and for conditional approval
of those of another (Mentor). In the next few months, the FDA will
decide whether to go along with the panel's recommendations. Over the
past 13 years, women have had only limited access to these implants
for breast augmentation -- including for reconstruction after
mastectomy.

At the hearings, more than 150 individuals testified on behalf of
themselves, or for groups that they represented. I testified against
approving the implants. For more than 20 years, I have been pushing
for plastic surgeons and the breast-implant industry to provide
convincing data that these implants are safe in women's bodies. That
time has not yet come.

Do women have the "right to choose" to have these devices surgically
implanted in their bodies? One woman after another stood up to claim
this right, and the plastic surgeons were out in droves to assert the
right of choice on behalf of women.

In 1991, the American Society of Plastic Surgeons assessed $1,050 from
each of its members. The money was allocated to finance a
public-relations campaign to counteract negative publicity about
silicone breast implants. One of the main features of the campaign was
to appropriate the feminist slogan "women have the right to choose."
The plastic-surgery industry brought women to the nation's capital for
the heavily publicized 1992 FDA meeting considering the safety and
efficacy of silicone breast implants. These women used the phrase in
various forms in their testimonies.

In the October 2003 FDA advisory panel meeting to reconsider silicone
breast implants, 25 women with silicone implants testified in favor of
the manufacturer's application. Virtually all of them employed the
notion of "choice" in their argument. One woman used the word
"choice," "choose," "chose" or "option" eight times in her 3-minute
testimony. Pro-approval surgeons also used this language.

Interestingly, an analysis of the transcript of these hearings shows a
number of themes that individual supporters of silicone-breast
implants employed, including that women with silicone implants are
healthy and physically active women with families; have good reasons
for wanting implants; and have thoroughly researched the silicone
implants and found them to be safe. Additional themes that arose
include that women consider silicone implants to be much more
beneficial than saline-filled implants; that they had discussed their
decision with their families (children's ages and names were sometimes
mentioned); and that they had good, kind, thoughtful plastic surgeons
who respected their wishes and gave complete informed consent.

Ultimately, the message that industry wanted to convey was that women
with silicone implants are very happy with the results of their
devices and that women with them think all women have a right to
choose silicone breast implants.

These themes recurred so frequently, it was clear that the women had
been guided in writing their testimony. At the hearing last month, the
great majority of supporters repeated these themes in their
testimonies; many also noted that their expenses had been paid by the
manufacturers or the American Society of Plastic Surgeons.

The "right to choose" is a slogan of the abortion-rights movement
going back 35 years. The "choice" there refers to a highly personal
and often moral decision that has a tremendous impact on women's
lives. But the choice involving breast implants is one with the
potential for serious health implications, which the FDA is mandated
to consider for public-health protection.

Public-health policy has frequently limited individuals' choices to
benefit the health of the population. For example, arthritis sufferers
no longer have access to the popular painkillers that have been so
heavily marketed in recent years. In some states, motorcyclists must
wear helmets to prevent head injuries that often are treated at great
public expense. Seat- belt and child-seat laws require compliance to
limit injury while driving.

The right to choose requires an understanding of the risks and
benefits of those choices, and it is those risks and benefits that the
FDA is addressing.

Jane Zones is a board member of Breast Cancer Action
(www.bcaction.org).

Page B - 9

~~~~~~~~~~
For updates on this unfolding controversy:

www.BreastImplantAwareness.org