FOXNEWS: Breast Implants: A Women's Choice, But a Safe Choice? BRAVO DR. ZUCKER

[Guest guest]

http://www.foxnews.com/story/0,2933,154086,00.html

Breast Implants: A Women's Choice, But a Safe Choice?

Wednesday, April 20, 2005

By Zuckerman, Ph.D.

Women have the right to buy products that will make them look better

or feel better about themselves. Are silicone breast implants part

of that inalienable right to choose?

The companies that make silicone breast implants (search), the

plastic surgeons who use them, and the women who want them are all

focused on that right, and angry that it has been restricted for the

last 13 years. They question the motives of government officials,

women's organizations, and health advocates that question that right.

On the other side of the debate, consumer groups, public health

advocates and others remind us that the Food and Drug Administration

has the responsibility of approving medical products only if they

are proven safe and effective. Implants are especially worrisome

because it costs thousands of dollars to have them removed. If these

products are risky or can break inside the body, that risk should

outweigh the benefits.

Breast implants have become such a hot topic that pundits who

otherwise wouldn't talk about the FDA or women's issues have

gravitated toward the topic. Many pundits have become instant

experts on the subject, even if they have never spoken to any woman

about her implant experiences and never read any of the safety

studies they quote.

But like most hot topics, this one is complicated. If you talk to

women, read the research, and try to figure out why there are such

strong opinions on both sides of the issue, you'll find out why the

controversy has continued for 15 years and is not yet resolved.

This is what we already know about breast implants:

Dozens of studies of women who had implants for a short time find no

significant increase in diseases. Most of these studies are funded

by companies with a financial interest in breast implants. Studies

conducted by implant makers and analyzed by the FDA found that more

than one in three patients report complications such as breast pain

and hardness and the need for additional surgery within the first

three years.

Only two studies have been conducted on the health of women with

leaking silicone implants. One, conducted by FDA scientists, found a

significant increase in fibromyalgia (search) and other autoimmune

diseases (search). A study funded by a silicone manufacturer found

an increase in autoimmune symptoms such as fatigue and mental

confusion but not in diagnosed diseases.

Studies conducted by the National Cancer Institute are the best-

designed because they compare women who had implants for at least

seven years to other plastic surgery patients and to women in the

general population. They found that all plastic surgery patients,

including breast augmentation patients, tend to be healthier and

wealthier than women of the same age in the general population.

Plastic surgery patients also have similar health habits.

However, compared to other plastic surgery patients, breast

augmentation patients are twice as likely to die of brain cancer,

three times as likely to die of lung cancer, and four times as

likely to commit suicide. They are more likely to report autoimmune

diseases, but their medical records indicate that patients are not

always accurate in their reporting (for example, many women who

report having rheumatoid arthritis (search) actually have osteo-

arthritis (search) instead). These government scientists concluded

that the results were inconclusive and more research was needed.

The testimony of women with breast implants was surprisingly

consistent with these research studies. Many of the women praising

their implants had them for just a year or two. The women who were

testifying against implants usually had them for 10 years or more.

Many spoke of being happy with their implants for years, and then

slowly becoming disabled from chronic fatigue, mental confusion, and

aches and pains at the ripe old age of 32. After years of being told

that their illness was unrelated to their implants, they eventually

had their implants removed, and only then learned that the implants

had ruptured and were leaking.

Ed Brent, a widower from Atlanta, described his wife, P.J., as very

happy with her implants for years. When she became ill, she sought

medical treatment but none of the doctors were able to help her.

Frustrated by the lack of effective medical care and feeling guilty

because her children became seriously ill after she breastfed them

with implants, P.J. Brent committed suicide.

Ed testified that after her death, doctors found exceptionally high

levels of platinum in her blood, and in the blood of the children

she breastfed after implants (but not those breastfed before).

Platinum is a potentially toxic substance that is used to make

breast implants. Research published last year found high levels in

the breast milk, blood and urine of women with implants, compared to

other women.

This is what we don't know about breast implants:

We don't know how long they last, although many studies suggest that

10-15 years is likely.

We don't know how often they leak silicone outside the implant area,

but the FDA estimates one in four women with leaking implants have

such leakage. Will that eventually become 100 percent if a woman

doesn't have her implants removed? Nobody knows.

We don't know what percentage of women will get sick from breast

implants that are intact and what percentage will get sick from

breast implants that are leaking. No studies have been done to

examine that over time.

We don't know if breast implants make most women feel better about

themselves. According to the companies' own studies, women who got

breast implants two years earlier tend to feel worse about their

lives and themselves, not better, than they felt before getting

their implants.

Can women make an informed choice about breast implants? Most women

who make a decision about breast implants get their information from

their plastic surgeon, the implant maker's patient booklet, or the

Internet. The plastic surgeons tend to be very positive, the company

brochures tend to be confusing, and the Internet has information

ranging from extremely positive to extremely negative and everything

in-between.

The bottom line: men and women have a right to choose safe medical

products, and it is the FDA's job to determine if a medical product

is safe. Whether the product is a painkiller, an anti-depressant, or

a breast implant, FDA approval should be made on science, not

wishful thinking or philosophical musings about choice.

Zuckerman, Ph.D. is president of the National Research Center

for Women & Families, a nonprofit research and education

organization that advocates to improve the health and safety of

women, children, and families.