Testimony_ Antolick_Christianne Corbett_Bettye Green_ Melmed

[Guest guest]

Antolick Testimony - FDA Panel Hearings - April

2005

MS. ANTOLICK: Good morning, ladies and gentlemen. My

name is Antolick. And I live in Columbus,

Mississippi. I have no conflicts of interest.

My desire for implants began at the age of 15. And

then at the age of 22, I took my savings along with a

small loan and had silicone breast implants placed.

I was told by my plastic surgeon that sometimes

implants could hard and have to be replaced but that

if I massaged my breasts as instructed, that this was

most likely not going to happen. I was told that

breast implants were a lifetime investment and safe.

I also did not receive any literature outlining the

potential risk.

I thought that my life could only improve with

implants. And after my surgery, I felt implants were

the best thing that had ever happened to me.

Within the first year, however, I began having serious

medical problems. Over the years, I was in and out of

doctors' offices with various symptoms: chronic

fatigue; memory loss; migraines; chronic pain; hearing

loss; burning in my chest; and numbness in my lips,

hands, and feet. I did not know, nor did the doctors,

that most of these symptoms are autoimmune symptoms

and common with breast implant patients.

The pain and burning in my chest along with nipple

discharge became so severe that I went to a plastic

surgeon to have the implants removed. Once removed,

my doctor told me that both implants were ruptured,

capsulated, and had been leaking for many years.

During the surgery, she removed lymph nodes because

they had become contaminated with silicone. This was

very surprising to me because each year my mammogram

showed that my implants were intact.

I am not unusual. I now know that FDA study found

that most augmentation patients had at least one

broken silicone implant within ten years. And

silicone migrates outside of the breast capsule for 21

percent of women with implants.

I was young and naive when I received implants. I

didn't have the foresight to see that my health is

much more important than my breast size. Instead of

providing me with self-esteem, like I thought, they

provided me with a life of pain and dependency.

Now, 23 years later, I can no longer work as I used

to. I had to move closer to my parents so that they

could help care for my children. Probably the most

difficult change I have had to come to terms with is

not being able to care for and enjoy my children the

way that a mother should.

Please make sure that young girls who are considering

implants will not have to sacrifice their health for a

certain body type like I did. Thank you for your time

and consideration.

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Subj: Christianne Corbett Testimony - FDA Panel

Hearings - April 2005

EXECUTIVE SECRETARY KRAUSE: Are you Christianne

Corbett?

MS. CORBETT: Yes, I am.

EXECUTIVE SECRETARY KRAUSE: Okay.

MS. CORBETT: Yes. Good morning. My name is

Christianne Corbett. I am the Program Coordinator at

the National Council of Women's Organizations, NCWO.

NCWO is am umbrella group for 200 women's groups. And

I am speaking on behalf of the over ten million women

nationwide that NCWO represents.

NCWO is very concerned about the safety of medical

products used by women. The key question for this FDA

advisory panel is whether silicone gel breast implants

are safe, whether the benefits outweigh the risks.

In my testimony, I will focus on what we know and

don't know about long-term safety. We know from

hearing testimony of the women at the 2003 panel

meeting and again today that many of these women were

very happy with their implants for the first few

years. But after seven or more years, especially

after their implants broke and started to leak, many

women reported serious problems.

Local complications are the best established problems.

These complications can be short-lived, like most

infections, or can be devastating. Chronic pain is

very difficult to live with.

Having breasts that are hard as rocks is not a goal

for most women. And if things go wrong and implants

have to be removed, then what happens?

I have some photographs that I want to share with you.

The photograph up right now is a photograph of a

29-year-old woman who had her implants removed after 7

years. She had capsular contracture that was so

painful that she decided to have her implants removed.

This photograph is from the FDA website.

Here is another woman -- you can go to the next slide

-- who wasn't so lucky. This woman's ruptured implant

had leaked into her healthy breasts. And when the

silicone was removed, that is all that was left of her

breasts.

Now let's look at some long-term studies of diseases.

The National Cancer Institute looked at thousands of

women who had implants for at least eight years. They

found women with implants were twice as likely to die

from brain cancer, three times as likely to die from

lung cancer, and four times as likely to commit

suicide compared to other plastic surgery patients.

FDA's scientists did the best study of the health of

women with ruptured silicone implants. All the women

in their study had breast implants for at least six or

seven years. So some had implants that had been

leaking for several years. They found that women with

implants that leaked outside the scar capsule were

significantly more likely to report fibromyalgia and

several other painful connective tissue diseases.

Dow-Corning paid for another study on ruptured

implants, referred to as the Danish study in the FDA

review that was provided to you. Unfortunately, the

Danish study included only 23 women with implants that

leaked outside the scar capsule. They found that

those women had more pain and other problems

than women whose implants were not leaking, but

because of the small sample size, those differences

were not statistically significant. The study is not

conclusive because the number of women with

extracapsular leakage is much too small.

Implant makers often say that there are more than 100

studies of women with implants and that these studies

prove that implants are safe. When they say this,

they tend to ignore the studies that don't agree with

them, which tend to be the studies of women who had

implants the longest, such as the FDA and the NCI

studies.

Most of the studies that the implant makers quote as

proving safety were funded by Dow Corning. Almost all

of the studies in the often quoted Institute of

Medicine report, including the Mayo Clinic study and

the Harvard study, were funded by Dow-Corning. And,

like the Danish study I mentioned, they tend to have

rather small samples. And most studied women who had

implants for a short period of time. For example, the

Mayo Clinic study included only 749 women with breast

implants, and only 375 of them had had implants for

more than 7 years.

Autoimmune diseases take years to develop and be

diagnosed. And the sample would have to be larger to

adequately study diseases that are so rare in young

women. You don't have to take my word for it. The

authors point that out themselves.

Listen to the testimony you will hear from the women

today. It took years for them to develop diseases

after getting their silicone implants. First, they

had symptoms that they didn't take very seriously.

When they were tired or their joints hurt or they had

trouble concentrating, they thought that perhaps they

just weren't getting enough sleep or they were working

too hard.

Those are the same symptoms reported by Inamed in

their patients who had implants for only two years.

They aren't sick or diagnosed with diseases like

rheumatoid arthritis, but it will take at least a few

more years to find out if they will be.

One more thing is that almost all of the women in the

core studies are white. Women of every racial group

got breast cancer, but only six African American women

and five Asian American women are in the Inamed

reconstruction study. Race is an important issue

because African American women are more likely to get

autoimmune diseases than white women.

In conclusion, not enough research has been done on

large diverse samples of women that proves that

silicone breast implants are safe in the long term.

Because of this, on behalf of the National Council of

Women's Organization and the ten million women NCWO

represents, I urge you to vote against the approval of

silicone breast implants.

Thank you.

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Subj: Bettye Green Testimony - FDA Panel Hearings -

April 2005

MS. GREEN: I'm Bettye Green. I'm the President of

African American Women in Touch. And I am a breast

cancer survivor. And I chose reconstruction after a

mastectomy. However, I believe breast cancer patients

deserve more information than they are getting.

Fortunately, there are many more options than there

used to be for breast cancer patients. More than

three out of four are eligible for lumpectomy. So

relatively few women with breast cancer have a need to

undergo a mastectomy in the last few years or in the

coming years.

And, fortunately, women who undergo mastectomies have

two other alternates to silicone breast implants.

They can choose saline breast implants, which have a

lower complication rate and are easier to remove when

they break, or they can choose an autologous tissue

transfer, a very popular procedure that moves tissue,

in fact, from the abdomen or other areas to create a

breast that is much more natural looking and feeling

than a breast implant reconstruction.

Over the years, FDA panels have heard from some breast

cancer survivors about the mental health benefits of

silicone breast implants for mastectomy patients who

want to reconstruct their breasts, but now that there

are so many choices, do silicone breast implants offer

benefits that are greater than other options, so great

that they are more important than safety?

Research by Dr. Roland of the National Cancer

Institute and her colleagues found no difference in

the quality of life of women who underwent

lumpectomies, women who underwent mastectomies, and

women who have had mastectomies with reconstruction.

Even more surprisingly, the women who had

reconstruction felt their sex lives had been harmed

more than mastectomy patients. If we look at the data

presented by Inamed and Mentor, these findings make

sense.

Most reconstruction patients require a lot of

complications. They report more autoimmune symptoms

two years after implants, such as joint pain and

mental confusion, compared to before getting breast

implants.

According to a study of women who had reconstruction

five years earlier, most implant patients were no

longer satisfied. In contrast, most of these

autologous tissue transfer reconstruction patients

remain satisfied. The implant makers remind us that

their studies show that patients are satisfied.

But as a cancer survivor, a nurse, and a leader of a

national group for breast cancer patients, I can tell

you that most breast cancer patients don't tell their

plastic surgeons that they are unhappy. They have

been through cancer. Most don't like to complain

about how they look now, especially in a study when

being honest will not help them in any way and could

potentially harm their relationship with their doctor.

I have another concern that nobody has mentioned and

that is very important. There are very few African

American women or Asian American women in the Inamed

or in the Mentor study. For example, there are only

six African American breast cancer patients in the

Inamed core study and only five Asian American women.

This is a big problem because African American and

Asian women are more likely to develop a cheloid

scarring. This scarring tendency could potentially

increase the risk of capsular contracture as well.

African Americans are also at an increased risk of

autoimmune diseases. So it is essential that silicone

gel breast implants not be approved until they are

carefully studied on women of color.

In summary, research suggests that women who have had

reconstruction after mastectomy do not have a higher

quality of life than women who do not undergo

mastectomy. Their sex lives seem to suffer more, not

less.

Independent researchers found that the majority of

implant reconstruction patients are not satisfied five

years later. These findings are more credible than

those funded by implant companies.

In one study, reconstruction patients were ten times

as likely to commit suicide as mastectomy patients who

do not undergo reconstruction. More African American

and Asian American women need to be included in breast

implant study, especially studies of breast cancer

patients. Neither Inamed nor Mentor have studied

enough women of color to determine if the risks are

any different for them compared to white women.

Thank you so much for listening.

===============================================

Subj: Melmed Testimony - FDA Panel Hearings -

April 2005

DR. MELMED: Good morning. I'm Melmed. I have

no conflict of interest. I am a plastic surgeon who

has done breast implants since the day they were

introduced. I did my first year of residency in 1963,

when Cronin first introduced silicone implants. So I

have seen the evolution through the Cronin implant;

the (phonetic) inflatable, which was a balloon

through to the silicone pads; the Dacron patches; Meme

implants, et cetera.

I wrote extensively about this in the Plastic and

Reconstructive Journal in the '90s. But from 1992, I

had a complete change-around. I started seeing the

devastation and complications from breast implants.

And since 1992, I have explanted over 800 women with

breast implants. I wrote about this in Plastic and

Reconstructive Surgery in 1998.

My statistics that I wrote in 1998 showed a rupture

rate at 10 years of approximately 50 percent, a

rupture rate at 15 years of 70 percent, and a rupture

rate at 20 years of 94 percent. My current figures

show no deviation from this. It's a time-dose-related

phenomenon. Research that shows two, three, or four

years' duration, my statistics show the same. It

shows a four percent rupture rate.

The problems become manifest the longer the implants

are in. The implants will rupture and just

disintegrate. And sometimes no wall of the implant

can be found.

I have brought some short clips that I'd like to just

show in the background of what implants really look

like when you get into the 10-15-year rate of removal.

The silicone will simply well out with no visible

evidence of any wall.

Now, if we take the statistics that are currently

available, approximately 330,000 women received breast

implants in -- at least 2004. If we extrapolate that

figure -- sorry. Let me backtrack and say that if we

accept that no medical device is safe -- and I think

we must say that -- then just assuming there's one

percent failure rate, at 10 years, you're going to

have 33,000 women with problems, which if it becomes 3

percent is 100,000 women.

Now, no batch can be identified of what implants

disintegrate. So we're left with this uncertainty of

the future of these women. So a girl of 16 who you

are going to allow this device in is very different

from the 70-year-old who has a hip prosthesis that

might fail, a woman who is going to be left with an

inevitability of having four or five operations in

their lifetime.

Lastly, how do you recall implants? If I buy a new

Ford and it has a brake problem, the National Highway

Traffic Safety will report it if there was more than

one percent failure rate. Here we've got 17 percent

failure rate.How do we recall them?

Thank you very much.