TRANSCRIPT OF NEWS CONFERENCE OF FDA'S BREAST IMPLANT APPROVAL

August 15, 2005

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Political Transcripts by CQ Transcriptions

August 9, 2005

MARTHA BURK HOLDS NEWS CONFERENCE ON FDA'S BREAST IMPLANT APPROVAL

PROCESS - NEWS CONFERENCE

SPEAKERS: MARTHA BURK, CHAIR, NATIONAL COUNCIL OF WOMEN'S

ORGANIZATIONS

KIM GANDY, PRESIDENT, NATIONAL ORGANIZATION FOR WOMEN DIANA

ZUCKERMAN,

PRESIDENT, NATIONAL RESEARCH

CENTER FOR WOMEN & FAMILIES

CINDY PEARSON, EXECUTIVE DIRECTOR, THE NATIONAL WOMEN'S HEALTH

NETWORK

DR. SIDNEY WOLFE, DIRECTOR, PUBLIC CITIZEN HEALTH RESEARCH GROUP

SYBIL GOLDRICH, EXECUTIVE DIRECTOR, COMMAND TRUST NETWORK

BURK: Good morning. Thank you all for being here.

I am Martha Burk, chair of the National Council of Women's

Organizations.

The National Council of Women's Organizations is the nation's oldest

and largest coalition of women's groups.

We are here today to join with health advocates to talk to you about

this very serious problem with the FDA and

breast implants.

The reason the National Council of Women's Organizations, which

encompasses many groups, not just health

groups, is so concerned about this is because it is uniquely a

women's

issue and it uniquely affects the health and

lives of many, many women.

Breast augmentation is the second most popular cosmetic surgery

procedure. Over 334,000 procedures were

performed last year, and that was a 19 percent increase over the year

before.

Frighteningly, according to the American Society of Plastic Surgeons,

almost 4,000 of the augmentation procedures

done last year were done on girls age 18 and younger.

Breast implants are getting to be a popular graduation gift. This is

truly frightening.

Yet breast implant manufacturers' own data show that one in five

augmentation patients and over half of cancer

survivors require re- operation in less than three years because of

problems related to the implants.

FDA scientists have found that most implants break within 10 to 15

years and one in five broken silicone gel

implants leaks outside the breast area. Recommended treatment is

removal and re-implantation -- neither of which

is covered by health insurance.

This is most assuredly a women's problem. It is most assuredly a

health problem. And it is most assuredly a

corporate accountability problem.

How many times have women been told before that something affecting

their health and lives is safe and later we

find that it wasn't true; the data were not there, or the data were

there and they were not being made public?

Women's groups are concerned.

No one wants another Dalkon Shield. No one wants another Playtex

tampon. Yet these devices were said to be safe

as well. The manufacturers told us there was no problem -- and what

happened? Millions of women were affected.

Lives were endangered and lives were lost.

We do not want a repeat of the Dalkon Shield with breast implants.

The FDA owes it to women. The manufacturers owe it to women. If they

are not hiding anything, why don't they

release the data?

I would like to introduce the next speaker. She is Kim Gandy,

president of the National Organization for Women.

GANDY: Thank you, Martha.

As president of the National Organization for Women, I join with many

of my colleagues here today to call on the

United States Congress to step in and fully investigate the entire

circumstances surrounding the U.S. Food and Drug

Administration's decision to send an approvable letter to Mentor

Corporation regarding dangerous silicone gel breast

implants.

GANDY: From the allegations of fraud and deception coming from

managers at Mentor Corporation involving this

very data and these very implants, to the role of the senior manager

at the FDA who acted more like a

representative of the manufacturer than a person carrying out a

public

trust.

In their extensive public relations campaign to pressure the FDA to

approve these risky implants while denigrating

the women's health community for opposing their approval and those of

us who are requesting long-term safety

data, manufacturers are trying to position these dangerous breast

implants as a choice that women must be free to

make.

No reasonable person would suggest that untested drugs or drugs that

haven't been proven safe should be sold to

anyone who will pay the price on the basis that it's their choice to

use a drug that hasn't been proven safe. If that

were permitted, there would be a lot of charlatans on street corners

hawking cancer cures and making a lot of

people sick.

Come to think of it, that's exactly what the breast implant companies

are doing with these implants -- they're

making women sick.

Women will risk a lifetime of grave complications from faulty breast

implants because the Bush administration and

their appointees value short-term profits over women's long-term

health.

Bush-appointed FDA Commissioner Lester Crawford is rewarding a

company

that's been accused by former

employees -- in fact, former managers -- of falsifying and

withholding

data about these implants and the company

that was itself the subject of a long-term criminal investigation by

the Food and Drug Administration.

Lester Crawford is a veterinarian, but at the FDA he's treating women

like dogs.

GANDY: The FDA's not being coy about its political agenda.

The testimony of women who suffered from silicone gel leakage,

migration to other organs, painful capsular (ph)

contraction and disfigurement, and increased risk of death from

suicide, brain cancer and lung cancer -- all of which

have been documented by clinical research and rec ognized by the FDA

staff -- apparently aren't enough for the FDA

to offset a lobbying campaign directed at political appointees like

Lester Crawford.

What happened to the FDA that once protected women from the cruelty

of

thalidomide and other dangerous drugs,

putting the public interest and the public health above the greed of

corporate interests?

The FDA must not put corporate profits ahead of women's health and

Lester Crawford must stop being a lap dog for

the industry.

Approval of a device that is potentially harmful, and in fact, we

believe, proven harmful for hundreds of thousands

of women, is both duplicitous and dangerous, especially when taken by

the federal agency whose main mission is

not to support industry, but to protect the public health.

It's time for Congress to step in and conduct a thorough

investigation

of how the FDA came to make this

compromised and deceptive decision.

NOW and many other groups have sent a Freedom of Information Act

request for copies of documents pertaining to

this criminal investigation, documents we think were not available to

the advisory panel when they made their

recommendations, and they are also asking for specific details about

the conditions under which the FDA issued this

approvable letter to Mentor Corporation.

We are asking the Food and Drug Administration to withdraw the

approvable letter immediately, to open its files to

Congress for an investigation and to comply with our request.

Women deserve the facts. Without them, there is no real choice.

And now I'd like to introduce Dr. Zuckerman, who is the

president of the National Research Center on Women

and Families.

ZUCKERMAN: Thank you.

I'm Dr. Zuckerman and I'm an epidemiologist, and I'm going to

talk about why we're so concerned about the

research that's been done and that hasn't been done.

ZUCKERMAN: This morning, I was on a TV program with a plastic surgeon

who said breast implants are the most

studied product in American history. That would be sad if it were

true, but it is not true.

Let's start with one undeniable fact: Silicone breast implants have

been sold for 40 years, but the companies have

only provided two or at most three years of data.

If these implants are so safe, why don't the companies prove it by

studying women who've had them for a long

time? And why does our center keep hearing every day from women who

have breast implant problems, many of

them with leaking silicone breast implants that are leaking silicone

into their bodies and that they can't afford to

have removed?

And some of these photos give you some ideas of what these women are

dealing with. They send us their photos

and ask us for help.

The first 30 years of research on breast implants can be summarized

quickly in just a few seconds.

I was a congressional investigator in 1990 when I initiated a hearing

on the FDA regulation of breast implants. And I

can tell you, at that time, after 30 years of selling breast

implants,

there were zero clinical trials and epidemiological

studies that were published -- zero.

A million women had breast implants, zero published epidemiological

or

clinical studies.

So in 1991, the FDA finally required implant companies to submit

safety data. And the data were so -- pathetic is

really the only word I can use. They were so pathetic that the FDA

rejected their applications.

So how did the companies respond? Did they respond by improving their

research and continuing those studies to

make them better? No. Instead, they stopped the studies and they lost

track of all of those women. And if they had

continued the studies that were started in the early '90s, we would

have really good data today.

Meanwhile, in the '90s, there were reports in the medical literature

and in physicians' offices that there were a lot of

implant patients who were getting sick and some of the doctors were

reporting things like silicone dripping from

women's nipples. Dow Corning, which was the maker of silicone and

still is, started spending millions of dollars on

research designed to prove that their product was safe which they

used

to defend themselves in a class-action

lawsuit.

Then in 1999, the Institute of Medicine did a review of all the

research on breast implants up until that time. That is

probably the most misunderstood IOM report in history.

First, IOM did express very strong concerns about what they called

local complications.

ZUCKERMAN: That's the kind of thing you see here. That's a scar over

there on the left.

This woman over here had breast augmentation. When her implants

leaked, the silicone had leaked into her breasts.

When the silicone was removed, her breasts ended up puckered and very

deformed.

She looks almost like she had a mastectomy, but she didn't. She's an

augmentation patient.

The IOM report is long but most of the studies were done on animals

or

cells. There were very few studies actually

of women. And almost all of them were funded by Dow Corning.

And the studies that were funded by Dow Corning had three major

flaws.

First of all, they studied small numbers of women.

Secondly, they studied women who had breast implants for a very short

period of time. For example, there was one

study where none of the women in that study had implants for more

than

two years.

And third, they didn't actually conduct medical exams of the women.

So

they relied on either self report or medical

records without doing medical exams.

And so it's not surprising that those studies did not find conclusive

evidence that breast implants cause disease and

they didn't look at things like local complications that can cause

breasts to become painful, hard or terribly

deformed.

After the Institute of Medicine report came out, scientists at the

NIH, the National Cancer Institute and the FDA did

their own studies. And these studies were much better designed than

the industry studies. For starters, they looked

at women who had breast implants for at least six or seven years.

So these were women who had implants for quite a while. In many

cases,

the implants had started to break and

leak and the women were reporting that they got sick.

ZUCKERMAN: And they found a statistically significant increase in

several illnesses. And, for example, women with

breast implants were twice as likely to die from brain cancer and

three times as likely to die from lung cancer. And

that was compared to other plastic surgery patients of the same age

and similar health habits -- for example,

smoking.

Other government studies have found silicone in women's lymph nodes

under their arms and from there, it can

travel to other organs throughout their body, including their brains

and their lungs.

But a funny thing happened to those NCI and FDA studies when the

implant makers presented their data to the FDA

just a few months ago -- those studies just disappeared.

So the companies did a summary of the research evidence in favor of

their product and just ignored the government

studies showing these very serious, frightening problems. It's as if

they don't exist.

And only the studies that were funded by Dow Corning of which there

are now dozens of such studies, those were

the only ones that were reported by Mentor and Inamed in their

research literature review.

And it won't probably surprise you to know that those studies did

claim that breast implants were safe.

But the FDA doesn't just rely on research reviews -- they require

implant manufacturers to study their own products

to see how women are doing with those specific breast implants. And

they required them to look at local

complications such as pain and hardness, scarring and deformities.

And

they didn't really expect to find very much

in the first couple of years, but they did.

They found that these local complications increased every year. And

they also required the companies to look at

auto-immune symptoms such as joint pain, fatigue and mental confusion

or memory loss.

ZUCKERMAN: And surprisingly, in just two years, both companies found

increases -- increases in memory loss,

increases in joint pain and increases in chronic fatigue -- compared

to the women just before getting breast

implants. They didn't think they'd find them in two years, but they

did, and it was statistically significant even when

they controlled for age, the women's age.

But most importantly, we want to talk about what happens when breast

implants break.

We know that breast implants do break in the body. When silicone

breast implants break, there are often no

symptoms at all. They can leak. They can get into the lymph nodes.

They can get throughout the body through the

lymphatic system. And the women may not know it, and this can go on

for years. And that is exactly why we need

long-term data, because we need to know what happens to women when

that silicone is leaking in their body.

I just want to say, I personally think the worst part of this whole

situation is that the companies did not provide

meaningful data on breast cancer patients.

As we all know, breast implants are an option for women with breast

cancer, but neither company provided longterm

data on breast cancer patients. They only provided two or at most

three years of data on breast cancer

patients.

Most breast cancer patients live long lives now. The survival rate is

very good. And those women deserve to know

whether implants are going to cause problems. And we know one of the

women who are here today can talk about

the problems that she had with her implants after getting them for

breast cancer.

Unfortunately, because the companies don't study it, we don't know.

In summary, 2 million women in America now have breast implants. The

companies could have provided really good

data by now. They've had these implants on the market for a long

time.

They could have taken these women,

studied them, found out how they were doing, had doctors examine

them,

check them out really thoroughly.

Just taking a few thousand randomly selected women would have gotten

us the information we need. But they

didn't.

And in addition to that, we have reason to be concerned about the

integrity even of the data that they have

provided.

And Pearson, who's the executive director of the National

Women's Health Network, will tell you more about

that.

Thank you.

PEARSON: Thank you.

I represent the National Women's Health Network, which is an

independent, member-supported advocacy group.

Our purpose is to improve the health of women by serving as a

watchdog, by looking at important women's health

issues and making an analysis which individual women can use to

support their informed decision-making and which

can drive policy in the direction of protecting women's health.

We've been involved with breast implant issues for quite some time.

I've personally been at every FDA implant

panel meeting since 1990 -- not quite as long as some of the people

on

this panel, but a long time.

And I'll just say quickly that the network as an organization shares

the concerns about the lack of sound scientific

data on which women could base -- have a reasonable assurance of

safety, as Dr. Zuckerman has covered.

But we also have another concern. And I was so struck by the comments

made by Martha Burk and Kim Gandy

when they opened of don't let us have another Dalkon Shield IUD. Why

isn't the FDA stepping in to assure safety

the way it did with thalidomide?

PEARSON: Those are iconic events in the United States' history of

public regulation and the FDA's role as a

consumer watchdog and a guarantor of the safety of women.

In both cases, the products were very dangerous -- deadly, in some

cases.

But in one case, the FDA was able to act to spare women and children

in the United States from the harm

experienced around the rest of the world in thalidomide, which was

never approved in the United States.

What made the difference? Why was there a Dalkon Shield tragedy in

the

United States, but not a thalidomide

tragedy in the United States?

It was because, in the case of thalidomide, the FDA had access to the

data which enabled them to stop approval.

The manufacturer of the Dalkon Shield IUD, A.H. Robbins, was not a

good corporate citizen. It had information

about lower effectiveness and higher risks, but it withheld that

information.

Learning those lessons, we now feel that we need to watch carefully

for any other instance of bad corporate

behavior, of withholding of information, of trying to mislead the FDA

and prevent it from making a decision based on

good information -- on all the information available.

And there are many things about, specifically, the Mentor submission

and request for approval of silicone breast

implants that trouble us.

We don't know for a fact that they are a bad corporate citizen in the

way that A.H. Robbins was in selling the Dalkon

Shield IUD when they knew it to be defective and dangerous. But we're

troubled and we have no assurance from

the FDA that they have completely examined the things that trouble

us.

In the New York Times it was reported, in May of this year, I

believe,

that Mentor employers -- former Mentor

employees have stated in sworn depositions that they observed Mentor

to falsify information, to minimize the

reports of complications and, in fact, to even hide defective

implants

when the FDA came for inspections.

There are sworn statements that implants were hidden in the ceiling

tiles when the FDA came to call, and tucked

away. There are sworn statements that the company received, on

average, during a three-year period, 6,000

reports of complaints and only reported in an eight-year period a

total of 8,000 complaints.

Some of these reports and allegations date back to the mid- and late

1990s, but they do include the devices that

Mentor asked the FDA to consider for approval this very year. The

concerns that have been raised are current, they

are important, they apply directly to what women need to know about a

product that could potentially be approved.

We raised these concerns -- some that we were aware of -- at the FDA

meeting. We brought up reports that we

had, had from women who believe they have been dropped from the

studies, that the studies that appear to give

good safety rates may have left out women with problems.

We have brought these issues up, we brought them up again in a

personal meeting with the commissioner. We have

filed formal requests for information about the FDA's investigation.

We have asked directly whether panel members

knew the information that had been alleged and that the FDA had tried

to investigate and none of our questions

have been answered.

We have not been assured. We have not been told what the results of

the FDA's actions were to investigate these

issues. We have not been told to what extent they have been

investigated. We have not been told whether or not

panel members know.

PEARSON: And with these grave questions raised, our belief is that

the

FDA should stop its process now until women

and the public are assured that the allegations and the appearance

that Mentor is a bad corporate citizen have been

put to rest.

We can't risk another Dalkon Shield IUD in the United States.

We need the FDA to be the strong and tough regulator that it was at

the time of thalidomide -- keep women's health

protected until there's enough evidence to show that a product is

safe.

And we are going to continue asking the FDA through formal means to

release this information and also to slow up

on the process until the questions have been answered.

Thank you.

And next you'll hear from Dr. Sidney Wolfe, who is the longtime head

of Public Citizen Health Research Group.

WOLFE: Thanks, .

I just want to review a little bit the, I guess, 17 years involvement

I've had with this.

In 1988, we received a package of internal documents from the FDA

signed by different FDA employees in the

device division all pointing to the direction of a serious group of

problems with the device.

We read these memos carefully, did a literature search, and in the

end

of 1988, we filed a petition to ban silicone

gel breast implants.

Several years later, FDA declared a moratorium on silicone gel breast

implants. And it's interesting that at time --

this is now 13 years ago -- they asked the companies, 13 years ago,

to

do core studies that will focus on the

frequency of implant rupture and leakage, calcium deposits, frequency

and severity of capsular contracture (ph),

the extent of interference with mammography and frequency of changes

in breast nipple sensation. This is in '92.

And in '98, as several people have mentioned, the Institute of

Medicine convened a panel on this. The main thing

that the FDA and, I think, even more so the companies say about the

IOM is that it failed to show any evidence for

systemic disease. I want to quote you, though, from the IOM

recommendations. Again, these are now 1999, six

years ago. Quote, " First, re- operations and local and peri-operative

complications are frequent enough to be a

cause for concern and to justify the conclusion that they are the

primary safety issue with silicone gel breast

implants. Complications may have risks themselves such as pain,

disfigurement and serious infection and may lead

to medical and surgical interventions such as re-operations that have

risk. "

WOLFE: " Second, risks accumulate over the lifetime of the implant,

but

quantitative data on this point are lacking

for modern implants " -- again, six years ago -- " and deficient

historically. "

" Third " -- and this is already seven years after the FDA asked

companies in '92 for these kinds of data -- " third,

information concerning the nature and the relatively high frequency

of

local complications and re-operations, "

quote, " is an essential element of adequate informed consent. "

That goes back on what Kim and others have said, that you can't have

informed consent if you don't have the longterm

data. The IOM asked for this now six years ago.

Then and now, the fundamental question is: Are silicon gel breast

implants safe? Have the companies done studies

that provide reasonable assurance of safety as required by FDA law?

This means long-term data, since women could be having implants in

their bodies for 10 to 30 years, and data on

long-term breakage rates are therefore essential.

Why -- 13 years after the moratorium on silicon gel breast implants

imposed by the FDA, and the agency's

simultaneous request for long-term data -- have the companies failed

to provide at least 10 years of data? They

have not, as you heard, provided even five years of reliable data.

This industry failure represents a combination of disrespect and

reckless disregard for the health of women, and

arrogance for the law.

In December 2003, Mark McClellan, President Bush's first FDA

commissioner, reviewed this issue and rejected

approval, ruling that Inamed had not demonstrated reasonable

assurance

of safety because of a lack of long-term

data. That's almost two years ago.

McClellan's FDA then issued a guidance for the companies consisting

of

a road map of what companies needed to

demonstrate to do disseminary (ph) safety.

The centerpiece was long-term data. Yet, a few months later, in the

spring of 2004, shortly after the guidance had

been issued, the companies sent in what couldn't possibly have

fulfilled the long-term data obligations since it was

only a few months after the guidance.

The FDA staff reviewed it and concluded that the data were deficient

because no long-term data on breakage was

provided.

Now, as one of his first acts as commissioner, Commissioner Crawford

has proposed to overturn the decision of his

predecessor, Commissioner McClellan, and 13 years of FDA precedent

and

approve breast implants on the theory

that FDA can grant the approval now, even though they lack sufficient

data, which they propose to get later -- and

then get the data later.

This turns the statute on its head and is plainly unlawful.

If the agency goes ahead and grants full approval to either the

Mentor

or the Inamed silicon gel breast implants, we

will seriously consider filing a lawsuit to challenge what plainly

would be unlawful, arbitrary and capricious agency

action.

The dangerous doctrine of " approve now, test later " must be firmly

rejected.

Just a couple further comments.

One, the context in which this comes is at a time when there are

those

that are claiming that the FDA is being too

cautious. I think that this is, at best, arguable in the drug area.

In the device area, if anything, they are entirely reckless. They

have

recently shown their inability to deal promptly

with this massive disaster concerning Guidant defibrillators and

pacemakers.

They have approved, with no evidence of effectiveness, a risky device

for treating depression, the Cyberonics vagal

nerve stimulator, which has a number of unexplained deaths associated

with it -- which the FDA claimed that the

company would have to explain, but they haven't explained.

WOLFE: So the FDA is really clearly dysfunctional, and this at least

apparent attempt to approve the Mentor implant

goes more into that.

This also raises the issue of congressional oversight.

In the 1970s and '80s, one Senate committee, the Senate Small

Business

Subcommittee, had 135 days of FDA

oversight hearings, mainly on drugs, some on devices. There have been

very few hearings in the last five or 10

years, and although there were a few on drugs, there's virtually no

significant oversight of medical devices.

In the last three years, according to data from the American Society

of Plastic Surgeons, there have been 172,000

breast implants surgically removed in the United States.

Now, a large proportion of these are saline implants, but a growing

proportion of them are silicone gel implants. And

if the approval were to go through, a large proportion -- the

majority

-- would turn out to be women who have

silicone leaking into their chest because of rupture.

Amongst the reasons stated for these kinds of withdrawals are

physical

symptoms related to problems such as

rupture, hardening of the fibrous capsule, and other local and

regional complications.

Imagine what kind of congressional oversight there would be, contrary

to what there has been now, if there were

172,000 penile implants removed surgically in the United States. The

answer is, we'd have hearing after hearing

after hearing.

And there has been very little congressional involvement, and

particularly most of it has been on the part of women.

This is -- stated correctly, this is a problem that really affects

women. That does not mean men cannot be involved.

So in summary, we are seriously considering legal action against the

FDA if this is approved. And as mentioned by

other people, we are insisting on FDA release of the approvable

letter

so we can see exactly what kind of conditions

were attached, how many of them are in the future, unfortunately, and

also a release of this extensive investigation

into the possible criminal activity of Mentor.

Thank you.

BURK: Thank you very much to all the speakers. I want to just add a

footnote in behalf of the National Council of

Women's Organizations.

We have also filed a Freedom of Information Act request on these data

in behalf of our 220 national groups and our

corporate accountability task force.

Before we start questions, I would like to introduce two people that

are with us today and will be available for

questions as well.

Sybil Goldrich is a cancer survivor who had four sets of implants

after her mastectomy. Biopsies revealed silicone in

her liver, uterus and ovaries. Sybil was the first person to go

public

with her story in the late '80s, and her activism

is what led to the restriction on the sale of implants in the 1990s.

Many of you might recognize McDonough, who is also with us. She

played on " The Waltons. " She received

silicone implants in 1982. She is the founder of In the Know, which

is

an L.A.-based support group for victims of

plastic surgery disasters.

And now we will take questions for these two and for anyone on the

panel. Please identify yourself before asking

your question.

QUESTION: Beyond the Senate health investigation that's going on into

silicone breast implants that Senator Enzi is

leading, what other people on the Hill do you have in support of a

more comprehensive investigation?

BURK: The question is, what other people on Capitol Hill are in

support of a further investigation?

ZUCKERMAN: As many of you know, seven women senators wrote a letter

to

Dr. Crawford.

It so happened that it kind of crossed in the mail the same day that

the FDA announced its approvable letter. So

those are not Senate investigators, but those are senators who

expressed some very, very strong concerns about

the quality and integrity of the data for Mentor and also the quality

of the data for Inamed. And that's a bipartisan

group that was led by Senator Olympia Snowe and Senator Dianne

Feinstein.

In addition to that, on the House side, the Energy and Commerce

Investigative Subcommittee has in the past

looked into this issue, and I believe still is looking into this

issue, and my understanding is they have a box of

documents that have never been made public.

ZUCKERMAN: And that is part of our request that we see what are in

those boxes which have to do with an FDA

investigation of Mentor to determine if, in fact, they had misled the

FDA about both rupture rates and other things

pertaining to the safety of their product.

QUESTION: Do we know for sure what are the reasons for women choosing

implants?

Aside from personal choices, are there business or commercial reasons

for women choosing breast implants? I am

aware of motivation for women in the commercial sex and pornography

industries choosing implants, but what role

are legitimate businesses like restaurants, nightclubs, entertainment

fields playing in women making these

uninformed choices?

BURK: I will answer that briefly and then anyone else can add to it

if

they would like.

I think the popular culture is most definitely feeding the desire for

implants. We have restaurants like Hooter's

where breast size is unquestionably part of the hiring decision. I

was

told about a major mainstream news

organization that considered asking one of its anchors to have breast

implants.

So there's no question that the demand is being driven by the popular

culture. I think it is truly frightening, as I said

earlier, that young girls younger than 18 are being given these

things

as graduation gifts.

MCDONOUGH: Hi.

McDonough, founder of In the Know.

Having come from an acting background, addressing the entertainment

aspect of it, of course, you know, when I

got finished with " The Waltons " it wasn't enough for me to just be

America's little sister anymore. I felt an incredible

sense of pressure to look a certain way to compete in my field. And,

granted, I was an actress and that was

expected, but now it has expanded.

I get letters all the time from women who feel that they're buying

into this idea that if my self esteem is better, then

I will get a better job.

So it has expanded into the workplace. It has expanded into the

business place. The myth, the glass ceiling: I must

look this way in order to get a better job.

So it is not just about women in the entertainment industry or doing

porno films. It is an idea and a concept that

has expanded to young girls who are 16 and instead of getting cars,

their parents are giving them breast implants

because I think they believe everything that's out there that the

manufacturers and the plastic surgeons have put

out saying these are safe.

They do not know the risks, unfortunately, until something horrible

happens to them. And then they write to me and

say, " Why didn't anybody tell me? Why didn't my plastic surgeon tell

me the facts? "

And that's why we're here today.

Women have to have the facts. And it's not just about the

entertainment industry. It is about Hooter's, but it's not

about Hooter's. It's everywhere. It's in women's thought that it will

help my self esteem.

Well, how will the self esteem be helped when the woman is completely

disfigured or she cannot even work, and she

loses her job and she drops out of college?

So I question that greatly.

GOLDRICH: Hi. I just want to say one word. I'm Sybil Goldrich.

And I want to address the fact that part of the industry is the

plastic surgery industry. They have a great investment

in selling these products, because they put them in at one price,

they

take them out at a higher price. They put

them back in at another price. And for the life of a woman, it will

be

an extremely costly venture.

However, for the life of the plastic surgeon, it will be a very

successful venture.

So we can't deny that plastic surgeons and, by the way, anybody who

practices medicine is entitled to put a breast

implant in, will profit tremendously from this product. Therefore,

they support it generously.

QUESTION: My question is have this group of women considered ways to

promote lifestyles and ways to enjoy a

woman's natural body as a counterway to counteract this?

And I know that your group, In the Know, does do that as well. What

kind of efforts (inaudible)?

BURK: I will answer for the National Organization for Women. Kim

Gandy

had to leave.

But for years, NOW has had a " Love Your Body " campaign. And it is

about teaching young girls and women that

their bodies are OK as they are and that we don't need to aspire to

some ideal that is impossible to achieve anyway

and isn't going to enhance our lives at all.

Did you want to add to that?

MCDONOUGH: There are so many actresses who have implants and so few

who will come forward and actually talk

about it.

I guess, you know, everybody has a mission and purpose. And I guess

the reason I had this was so I could come

and speak about it.

I have toured colleges and high schools and talked about women's body

image and women's health. And certainly,

my lesson through 10 years of being sick and now having been

diagnosed

with lupus, my message has always been

that it is about who I am inside. And I had to go through a horrible

experience to learn that.

But, yes, we try and pass that on as much as possible. But a lot of

times, we just don't have that many women

talking about it. And unfortunately, women get sick before they hear

the message and they really understand it.

Being young, you think you're invincible.

MCDONOUGH: But definitely, my lesson was learning to love me, how I

am, how I was, was such a value, that

nobody ever told me that I was OK. That it was OK just to be who I

am.

And I think there is an effort now to actually teach young girls to

love their bodies as they are.

BURK: There was also a body imag

e tour last year by a number of the women's groups, including NOW,

including

National Council of Women's Organizations, that concentrated on body

image, eating disorders as well as implants.

So it was a very successful tour in terms of the acceptance of

college

women to start really thinking about this.

QUESTION: What kind of research do you think needs to be done to

prove

that breast implants are safe?

ZUCKERMAN: Well, this isn't rocket science -- a good day to be

talking

about rocket science, I think. This is not

rocket science.

Really, what we need are studies of a few thousand women and what

happens to them over time. That is what the

FDA required, but they let the companies stop after just two or three

years. And as has been mentioned, in the case

of Mentor, they said, " Well, we can approve breast implants now, as

long as you continue those studies after we

approve them. "

You know, what kind of deal is this? It would, perhaps, be

understandable, even for a long-term product like a

breast implant, if it was a new product. But these products have been

around for a long time.

So what the research really should be doing, they should go back to

those women they started studying in 1991,

and they should find those women -- it wouldn't be that hard to do,

they know who their plastic surgeons are and so

on -- and then they should have medical exams for those women. They

should have MRIs to find out if their silicone

breast implants are leaking or broken. They should find out if the

women had their implants replaced. T hey should

get a full medical history. And they should examine them now.

Do they have symptoms of auto-immune disease? Are there any signs of

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TRANSCRIPT OF NEWS CONFERENCE OF FDA'S BREAST IMPLANT APPROVAL

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