From McDonough's In The Know website on implants

[Guest guest]

http://www.intheknow.org/stories9-5.shtml

September 5, 2003 – In The Know Launch

McDonough

Since I went public with my breast implant problems six years ago,

hundreds of women have contacted me desperate for trustworthy

information about breast implants. Like me, they underwent various

operations they were told were perfectly safe then had terrible

problems. To add insult to injury, they couldn't find out how to get

better.

I founded In the Know as a support group for women in the

entertainment industry who are struggling with these issues. It is

essential that we all get " in the know. "

Over the years I have worked regularly with the brave women you see

in this room. These women have been courageous enough to publicly

talk about their problems with breast implants, some for years, some

for the first time today. Sally, Leigh, Leanza, Christy, Judy –

everyone – we are all unfortunately " In the Know " about the harm

breast implants can do. That is why we have gathered here today.

In October, the FDA will hold meetings about lifting restrictions on

the sale of silicone gel breast implants. They are considering LESS

THAN THREE years of data.

Less than three years of data? This is absurd for a device women

hope will last a lifetime. All of the women here will tell you that

their problems began after three years - and many of their health

issues got much worse over time.

There's so much that we DON'T know about silicone gel breast

implants - but we do KNOW that most problems begin YEARS after

implantation. I started to have serious problems five years after my

initial surgery. Researchers and clinicians agree that problems

begin, on average, at seven to ten years post-implantation.

Let's look at what else we DO know.

We do know that breast implants do not last a lifetime. They all

fall apart in the body over time. When mine were removed, the outer

lining was completely missing and the gel was held in place by my

own scar tissue. According to the FDA's own research – at five

years, most implants are still intact. At ten years, many are

ruptured. By fifteen to twenty years, most are broken. Knowing this,

the FDA is contradicting its own research by looking at only two to

three years of data when it considers approval in October.

We do know that women have painful and debilitating complications in

the breast area. I had so much pain I could not hold or hug my own

child. Once again, according to the FDA's own consumer handbook,

these problems get much worse over time.

We do know that women with breast implants require many repeat

surgeries. The New England Journal of Medicine said in 1997 that one

in four women need additional surgery within five years because of

problems related to their breast implants.

We do know that health insurance often does not pay for these repeat

surgeries or the replacement implants.

We do know that cancer survivors suffer at much higher rates from

painful complications and require more repeat surgeries.

We do know that hundreds of thousands of women have been hurt by

breast implants.

We do know that it's impossible to get a clean mammogram. Implants

obscure about 80 percent of breast tissue.

We do know that silicone gel escapes the implant and travels all

over the body.

We do NOT know the effect of silicone in the body.

Today you will hear from these women. Some of them only had a few

problems. Some of them got very, very sick. Their common

denominator? All of them were still fairly pleased with their

implants two to three years after augmentation and all had problems

that developed over time.

When I contacted the FDA recently with my concerns, they sent me

this statement, " We will be able to give reasonable assurance of

safety and effectiveness. "

What does that mean? It doesn't mean they are safe. What, exactly,

is reasonable assurance? Especially when the " reasonable assurance "

is coming from the very manufacturers who will make millions of

dollars from selling implants. How reasonable can their assurance

really be?

If the FDA is going to put their seal of approval on silicone gel

implants, they need to be able to assure women that these implants

will not harm them. That they will NOT fall apart in the body, that

they will NOT turn as hard as rocks, that women will NOT suffer the

rashes, fevers, headaches, shootings pains and completely failed

health you will hear about today.

Let me make one thing clear – I am not ANTI-implant. I am PRO-safety

and information. This is our last chance to get something that

works. If we allow the FDA to lift restrictions on silicone, I fear

we will NEVER have a good, safe implant. FDA - please study the

devices long enough to assure women they are safe.

We are here today to ask the FDA to do its job. Protect women.

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Blair

I am sharing my breast implant nightmare publicly for the first time

today. Even though this is very personal and private, I must speak

out.

No one ever warned me about the problems with breast implants. If

the FDA approves them, women will assume they are safe. They are

not. I am living proof. I was sick for years after I had my

implants. Now that they've been removed I am finally starting to

feel better.

It's crazy for the U.S. FDA to let these be sold after looking at

less than three years of information. A lot of women are still happy

with their implants after a few years. Our problems start later and

get worse and worse as the years go on.

Isn't it the FDA's job to protect people from harmful food, drugs

and devices? I am joining my colleagues in the entertainment

industry to ask the FDA to do its job.

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Mariel Hemingway

I was 19 years old when I got breast implants. I'd been athletic and

healthy my whole life, but after having implants for a few years I

started to get sick all the time. I always had sinus problems and a

terrible rash on my hands.

I finally found out that the silicone implants had ruptured. My

blood stream was full of silicone. I had to go through long, painful

treatments to clean out my system. My breast cavity had to be

scraped clean. After getting them out, a blood test confirmed that

silicone had leaked into my blood.

These implants are bad news. The U.S. FDA can't get enough

information to tell women they are safe after only two years. I

enjoyed them for a year or two, then from ages 20 to 32, I was

asking myself, 'Why do I have these? I hate these.'

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Christie Houser

For many years, I loved my silicone breast implants. They never got

hard on me and they looked great. But I started to have health

problems four years after I'd been augmented. At first, I didn't

connect my problems to my implants. But I kept having strange

illnesses that wouldn't go away and that got worse over the 10 years

that I kept my implants in.

I had itchy, red rashes in various areas on my body. And when I went

to the dermatologist, they told me they didn't know exactly what

they were. They thought the rashes might be a sort of eczema, but

the cortisone creams prescribed to me would not make them go away.

My knees, ankles and hips started to ache. I would get really

nauseas and have to lay down at least once a week. It felt like I

was coming down with the flu - especially if I over exerted myself

physically. I remember one time I went for a run and collapsed

beside a lake. A stranger had to drive me home. This was very

unusual for me because I had always been very active and had

competed in triathalons and 10Ks for 10 years previous to this.

I also became very sensitive to chemicals. I couldn't use hair

spray, perfume, fabric softener, or heavy detergents. I couldn't

even walk down the laundry detergent aisle in the grocery store

because I would start itching all over and my eyes would water like

crazy. Towards the end of the time I had my implants in, I had a

terrible cough that wouldn't go away, which continued for two years

until I had them removed.

Finally, in 1993 I had an MRI. The technician said he felt something

was terribly wrong. My left implant was definitely ruptured and the

right one looked as though it might be also. I had the implants

removed two weeks later. When they took them out, both of the outer

shells had completely dissolved. They also found a golf ball-sized

cyst filled with silicone behind the left implant, which technicians

were unable to detect with an ultrasound and a mammogram before my

MRI.

I didn't even realize how sick they had made me. Because it happened

gradually over a period of ten years, I felt that a lot of my

symptoms were from old age and motherhood. After the implants were

removed my rashes, allergies and joint aches all began to improve. I

have no doubt my health problems were a direct result of those

ruptured implants. I also have no doubt that the improvement in my

health was a direct result of those implants being removed from my

body.

The U.S. FDA simply MUST consider more than two years of data before

they approve silicone implants back on the market. Women need to be

more informed and know what they are getting themselves into. I feel

that it is an insult to women, a huge slap in the face, not to study

these devices long enough to ensure their safety.

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Sally Kirkland

I first got silicone gel breast implants in 1986. Three years later,

I began to have health problems which got progressively worse the

longer I had the implants. Before I had them removed, I was in

crippling pain, particularly in my arms, chest, back and neck. I had

shooting pains down my legs. I had constant infections and

inflammations. I was always sick with viruses. Over the years I was

diagnosed with Epstein-Barr, rheumatoid arthritis, borderline MS and

borderline Hepatitis. I went from being a Yoga master and aerobics

instructor to a very ill woman – at a very young age.

I had the silicone implants taken out and replaced with saline in

1995. After several unsuccessful saline surgeries, I had the saline

implants removed in 1998. When the silicone implants were removed,

there was silicone all over my body - in my blood, joints and

organs. I literally saw test tubes of my blood that looked like it

had glue in it. The silicone was causing me terrible joint pain and

preventing my organs from working correctly. My pancreas, gall

bladder and kidneys were not functioning properly.

Since being explanted in 1998, the inflammation has miraculously

improved. But I still have silicone in my system. I undergo constant

treatments to detoxify myself and boost my immune system.

The FDA should NOT remove restrictions from the sale of silicone gel

breast implants, especially after reviewing less than three years of

data. I didn't get sick until 1989 – three years after having

implants – and continued to get sicker every year after that. The

FDA should protect American women. No one should have to live

through the nightmare I've been through and continue to endure.

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Judy Norton

When I got breast implants in 1983, I was never warned of any

possible side effects. A lot of women were getting them and I

assumed they were safe.

It was nearly eleven years before I began to notice problems related

to the implants. I was concerned about scar tissue which had

thickened and become much harder. It even hurt to wear clothes that

were tight across the scar tissue. I was also planning to start a

family and I was concerned about being able to safely breast feed,

without pain or danger to the baby's health.

Many women got a lot sicker than I did. But I wish I'd been told

more about the potential health dangers and pain before I got them.

The FDA needs to look at more than three years of data - my problems

didn't start for over a decade. Failing to properly evaluate product

safety will allow companies to continue to place this unhealthy

product in women's bodies, rather than working to create a better,

safer implant.

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andra

The first time I remember being dissatisfied with how I looked was

when I was in 9th grade, and I saw Isabelle, a beautiful frail

senior, weigh herself regularly in the dorm bathroom at my New

England boarding school. I felt like an ungainly cow next to pale,

blonde, petite Isabelle, and I began to wonder if I was too big.

Hearing about other girls talk about their dissatisfaction with

their bodies made me unhappy with mine. My body was changing, and it

wasn't turning into the small-waisted, curvaceous figure that Betty

and had in the Archie comics I devoured as a kid. Instead,

I was tall with big shoulders, strong legs, and no waist. I also had

the babyfat typical of teenagers. Thus, at 14 years old, began

decades of war with my physical body.

I am 40 now, and it has been over 12 years since I was bulimic –

overcoming bulimia was one of the biggest accomplishments of my

life. Therapy got me ready to change, and I was in the 12 Step

Program Overeaters Anonymous when I finally stopped throwing up for

good at 28 years old. For years afterwards, I couldn't discuss it

without becoming teary with gratitude that I had managed to free

myself of that terrible burden. I often wonder how those years might

have been different if I hadn't had to deal with my food obsession

day after day, everyday — but, then again, maybe I wouldn't be

blessed with this self-awareness or empathy for others if my teens

and twenties had gone swimmingly. And does anyone have an easy time

of it as a young adult anyway? I struggled with food, but for others

it is drugs, sex, alcohol, self-confidence, assertiveness and on and

on. I suspect that if our challenges don't come then, they come

later. Now, at 40, I feel blessed to not feel the pull to binge and

purge. Life seems so much easier without that secret, that torture.

Not that I am now unconcerned with weight and food – to pretend that

would be a lie. I have a nutritionist that I consult regularly,

daily exercise is a very high priority to me, and I crave sweets

more than the average person. I am still diligent about maintaining

my weight, and I hate it when I gain 5 pounds, but I don't turn to

food as automatically when I am sad or bored or frustrated. There is

no longer that literal emptiness inside that I tried to stuff full

with food, and I no longer founder myself on late night icecream-and-

anything-else-my-mom-never-let-me-have-as-a-kid binges, purging for

relief. In these 12 abstinent years, I can count on one hand the

times I wanted to binge and throw up, and each time I recognized the

pull and called my sister to talk it through. What a change from the

woman who might throw up 3 times in a day. What is different? I was

so afraid of being disliked that I wasn't honest with people about

what I wanted. I could not say " no " – no I don't want to be your

friend, no I don't want to do that extra work, no I don't want to

drive all the way to that restaurant. For comfort and for respite

from being that good girl I turned to food and broke all the rules

there. Now I have firm boundaries, and I lead the life that I

choose. I am more willing to really feel anger, sadness and hurt,

and when I am really feeling there is no room for food. It is in

that limbo of not knowing what I am feeling that my wild craving to

eat comes up, to distract me from knowing.

Ironically, I look better now and my weight is more stable than when

I was throwing up, which proves that my bulimia wasn't really about

weight at all. But seeking a concrete number on the scale seemed

simpler than dealing with the complications of growing up into a

powerful, emotion-filled woman. But it wasn't. My life is actually

simpler now, even with all those messy emotions and the risks that

come with sticking up for myself. And when I hear women talk about

their dissatisfaction with their own bodies, I can relate, but I

don't hate myself also. I am grateful for my body — it ain't

perfect, but it works.

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Leigh Young

I had silicone gel breast implants for over ten years before I began

having problems with them. Then I started to notice that my breasts

were getting hard, painful and, a little later, I had problems

raising my right arm.

I had the implants replaced. It took the doctor over three hours

just to scrape the calcification and scar tissue out of my chest. My

left breast would not heal from surgery. I then received a third

implant in my left breast. Within one month, I had severe pain that

wrapped around my breast and ran down my back. The pain was so

intense that, if it happened while I was driving, I would have to

pull the car off the road. It literally hurt to breathe. Soon it

became difficult for me to lift my left arm.

I finally decided to have the implants permanently removed. After

this surgery, I began to lose mobility in both of my arms and was in

constant pain whether I was moved or was still. I couldn't raise

them more than a foot from my sides. It took almost a year to regain

full use. In some of those months, I needed full time care to eat,

dress myself or drive.

I spent a minimum of $70,000 (probably more) in care and treatment,

and all of my time getting better. None of the repeat surgeries or

treatments was covered by insurance. I was often unsure whether I

would succeed and recover, as there was no information readily

available to explain, diagnose or treat my condition. Today, I can

gratefully say that I have come to full restored health. To me it is

a miracle given the odds and the lack of information.

There is no question that I answer and account for my own choices.

In the soul searching I have done, I am clear that all women can and

will benefit from MUCH MORE information regarding the ramifications

over time of the presence of silicone in the human body. Thousands

of women have already been harmed by implants and millions more

could be harmed if restrictions are lifted now, and more years of

extended study are not implemented.

I'm joining my colleagues in the entertainment community to call on

the FDA and our elected officials to protect women with much more

thorough and long term study regarding silicone implants. We have

the right, and need, to be as fully informed as possible about

medical devices and procedures. We can then make clearer choices for

our health, rather than succumb to the aesthetic pressure of our

culture, at such great risk.