Bravo Dr. : Limiting options for breast implants

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http://www.sfgate.com/cgi-bin/article.cgi?

file=/chronicle/archive/2005/05/12/EDGJ6CN3BM1.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).

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