Testimony_Jana Kueck_Eugene Goldberg_ Maharaj_Suzanne Baeke

[Guest guest]

Subj: Jana Kueck Testimony - FDA Panel Hearings -

April 2005

MS. KUECK: Good morning. My name is Jana Kueck, and

I'm a registered nurse from Branson, Missouri and a

sister of an injured breast implant consumer. I've

been a registered nurse for 21 years. My background

includes labor and delivery, newborn nursery, and

assisting new mothers as a former breast?feeding

educator. I have no financial relationship with the

PMA sponsors, their products, and their competitors.

Numerous studies have found that breast feeding

provides newborns with essential nutrition and

improved resistance to infections. By impeding or

preventing breast feeding, implants have become a

public and pediatric health problem as they are

essentially depriving newborns from these benefits.

According to the Institute of Medicine, any kind of

breast surgery, including breast implant surgery,

makes it three times more likely that women trying to

breast feed will have inadequate milk supply or

lactation insufficiency.

In a study conducted by nne Neifert and

colleagues of the University of Colorado at Madison,

women who had breast surgery were three times more

likely to have lactation insufficiency than those that

did not have surgery. The doctors compared the rate of

weight gain of breast fed infants born to mothers who

either did or did not have previous breast surgery.

Mothers whose babies did not gain at least one ounce

per day or required supplemental feedings with formula

were deemed to have lactation insufficiency.

Interestingly, the women who had breast surgery

through an incision in the nipple area or periareolar

incision had a higher incidence of problems. Those

women were more likely to suffer from insufficient

milk supply.

I frequently have observed decreased milk production

in mothers of breast implanted surgery. In addition,

implanted mothers' infants also had difficulty

latching onto the breast due to the firmness, usually

caused by capsular contracture, even a mild

contracture, from the implants.

We don't know how silicone breast implants affect what

is in the mother's milk, but it is certainly worthy of

more study. Recent research suggesting platinum in

breast milk due to the platinum used as a catalyst in

silicone breast implants concerns me a great deal.

Because of what is known and what is yet not known

about the risk of implants on breast?feeding, I am

asking you to vote against the approval of Mentor's

and Inamed's application. Voting against approval

will support women's health and the health of precious

newborns.

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Subj: Eugene Goldberg Testimony - FDA Panel Hearings -

April 2005

I'm Eugene Goldberg. I direct the Biomaterials Center

at the University of Florida. I have no financial

interest in breast implants. I traveled here at my

own expense.

My group has conducted research on the

biocompatibility of silicone implants for more than

ten years. In addition to my comments here, I have

appended more information for you.

We published the only large cohort clinical evaluation

of gel implants. This is a meta analysis of about

10,000 implants from 42 different papers. A high

prevalence of rupture and additional surgeries was

found. A plot of failure versus time showed 29

percent of rupture at 5 years and 70 percent of

rupture at 17 and a half years. When the next slide

comes up, you will see that.

One of every three women with implants required

additional surgery within six years due to pain,

hardness, disfigurement, or rupture. In an FDA-NIH

study using MRI plus explant surgery, Brown and

coworkers confirmed our results. They found 69

percent rupture at 16 and a half years. And that

falls directly on our implant rupture curve that is

shown up there.

A Mentor consultant states that " Rupture is a critical

safety parameter, " but Inamed in a letter to the FDA

says that rupture is " an unintended patient outcome. "

Frequent additional surgeries are truly also

unintended, but both pose major safety risks.

Inamed now tells us that surgical damage is the

leading cause of failure. If so, why aren't gel

implants properly designed for normal surgical

procedures? Inamed's 4 year clinical results show

still a high 10-22 percent rupture, despite a

presumably thicker shell with phenyl siloxane as a

barrier. Short-term rupture is actually not much

lower than reported before.

Also note that crazing and cracking of phenyl siloxane

coatings can occur after four to five years. And the

barrier properties and strength may deteriorate as a

result after five years. Four-year clinical data are

not adequate.

Finally, an increased risk for cancer of the lung,

cervix, and brain is reported for gel implant

recipients. It is simply not reasonable for Inamed to

blame this on lifestyle with no scientific evidence.

This is another potentially serious problem, and it

must be resolved.

Thank you.

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Subj: Maharaj Testimony - FDA Panel Hearings -

April 2005

DR. MAHARAJ: Good morning. I'm Dr. Maharaj,

and I am a professor of chemistry. I have no conflict

of interest. Today I am presenting the results of

Maharaj 2004, Maharaj and Lykissa 2004, and Lykissa

and Maharaj 2005.

Next slide, please. Maharaj 2004. The results show

that high levels of platinum are present in silicone

breast implant gel, shells, and in the corresponding

capsular tissue of women exposed to silicone breast

implants. The gel and shell platinum values in this

study are much higher than reported by manufacturers.

Platinum tissue concentrations in women exposed to

silicone breast implants are higher than in tissue

samples of women not exposed to these devices. And,

in fact, the values do not overlap.

Next slide, please. Maharaj and Lykissa 2004 and

Lykissa and Maharaj 2005. Mean platinum concentration

in whole blood and urine samples of women exposed to

silicone breast implants was higher than in control

subjects.

Mean platinum concentration in whole blood and urine

samples of children conceived after their mothers were

implanted was higher than in children conceived before

their mothers were implanted.

Next slide, please. Mean platinum concentration in

hair, nails, and sweat samples of women exposed to

silicone breast implants and in children conceived

after their mothers were implanted were higher than

that of the general population and higher than in

children conceived before their mothers were

implanted.

Mean platinum concentration in breast milk samples of

women exposed to silicone breast implants was much

higher, about 100 times higher, than samples from

women not exposed to these devices.

Next slide, please. Mean platinum oxidation states in

explanted silicone breast implants occur mainly in the

+2, +4, and +6 valence states. This is a very

important point. Manufacturers are claiming and FDA

believes that platinum is in the zero valence state.

Mean platinum oxidation state in whole blood samples

of controlled subjects was mainly in the zero

oxidation state.

Next slide, please. Mean platinum oxidation states in

whole blood and urine samples of exposed women were

mainly in the +2, +4, and +6 oxidation states. Mean

platinum oxidation state in whole blood samples of

children conceived by mothers after implantation and

in a brain tissue sample of an exposed individual were

in the zero, +2, and +4 oxidation states.

Next slide, please. In conclusion, my main three

points are as follows. Number one, the platinum

concentration in gel and shell material of silicone

breast implants is actually much higher than reported

by manufacturers.

Number two, the platinum concentration in many

different types of samples is consistently higher in

women exposed to silicone breast implants than in

non?exposed individuals and is higher in children

conceived after implantation than in children

conceived prior to implantation.

And, number three, silicone breast implants contain

highly reactive forms of platinum.

Thank you very much.

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Subj: Suzanne Baeke Testimony - FDA Panel Hearings -

April 2005

MS. BAEKE: I am Suzanne Baeke. I am a registered

nurse, patient educator specializing in plastic

surgery. I have no financial ties with any of the

breast implant manufacturers.

I chose to have breast implants seven years ago.

Three years later, my life with silicone gel breast

implants would be best described as the roller coaster

ride from hell.

Each day brought with it new horrors: fevers up to

103, chills, memoryloss. Concentrating on everything

became a problem, hair loss, repeated bladder

infections, zero sex drive, dry mouth, severe joint

pain, painful feet, and crippling muscle spasms to the

point where I had to have three deep tissue massages

per week.

The mood swings were crippling, not just for me but my

entire family. At times I wished I were not alive. I

suffered the chronic fatigue, yet suffered from

insomnia. I would at times have to pull into a

parking lot and shut my eyes for what I thought would

just be a minute but turned out to be 45.

I was evaluated by my rheumatologist at the Mayo

Clinic for chronic fatigue syndrome. MS,

fibromyalgia, ankylosing spondylitis were all

considered. Members of the Committee, I would not have

wished my life on anyone, but I refuse to give up. I

refuse to live this way. And I was on a mission to

find out what was wrong with me.

I bought every product on late night television that

promised to fix me. Eventually I found an

endocrinologist, Dr. Bernard Rice. He performed on me

the most comprehensive evaluation I had ever

witnessed. Eventually he took me by the hand, took my

husband, and said, " Your wife needs hormone

replacement. The fact that you are still married is

incredible. Most men get out when things get this

bad. "

Dr. Rice is one of the pioneering investigators in the

gradual but debilitating effects of hypo-ovarian

syndrome. Call it premenopause if you wish. All

women begin to suffer the effects of low ovarian

testosterone production early in life, progressing

until full menopause. For me, the hysterectomy with

an oophorectomy sped up this insidious process.

Distinguished panel, I am here to set the record

straight. It is no coincidence the symptoms of which

I suffered are identical to many of the women

testifying today. I submit that silicone implants

have been ridiculously maligned when more likely the

culprit is the low testosterone levels in the

pre-menopause and menopause patient. With expert

estrogen and testosterone replacement, all of my

symptoms immediately reversed. And I still have my

silicone gel implants.

To the National Organization of Women, I challenge

you. If your motives are truly honorable, consider

that you may be wrong. Read my lips. The real

problem afflicting millions of women is not silicone

gel implants. It's, rather, inadequate hormone

replacement therapy.

Thank you.