Fwd: Senator Enzi ~ Silicone Gel Breast Implants/Women's Health Issue

[Guest guest]

--- sey <fuchsmorrissey@...>

wrote:

> Date: Thu, 13 Oct 2005 17:44:49 +0000

>

--------------------------------

Please post. I do hope other mother's will write

letters too.

Take care, Fuchs-sey

Silicone Gel Breast Implants/Women's Health

Issue

ATTEN: Adam Briddell, Investigative Advisor

Please forward my e-mail to:

Senator Mike Enzi

Chairman, U.S. Senate Committe on Health,

Education, Labor and Pension

(Adam, I know this is long, but I needed to e-mail

you so that you & Senator Enzi knew I was out

here suffering this. Take care, )

Dear Senator Mike Enzi,

My name is Fuchs-sey from Macon, Missouri.

I am contacting you on behalf of women's health

issues; breast implants, the 2nd generation/ the

offspring who have been exposed to these damning

devices,(silicone gel breast implants) via the

placental barrier through fetal cells. Breast feeding

is just extra " hits " of this adjuvant and the

catalysts, like platinum.

I am not a scientist or nor am I a physician, but more

importantly I am a wife, (I have been married to my

husband, since 1978) mother and past 1976

McGhan/3M teenage silicone gel breast implant patient.

I opted for silicone gel breast implants seven days

after my 18th birthday in 1976 in hopes of correcting

a congenital deformity of my chest wall. I had

silicone gel breast implants from 1976-1993. The three

sets of breast implants I had in my body did NOT help

my situation at all, they just made my situation

worse. In 1993 at the age of 35 years old I had a

mastectomy of both breasts, (the extremely failed

breast implants attached) because of my totally failed

silicone gel breast implants, that contained platinum

excesses.

Senator Enzi, I fully regret ever opting for silicone

gel breast implants which did NOT improve my life in

any way. I fully regret placing my trust in my plastic

surgeon, my trust in the breast implants & those

companies, and my trust in the FDA to uphold their

oath of First, do no harm concerning breast implants,

which these devices do harm humans, and the offspring

do indeed take " hits " via the placental barrier

through fetal cells. Where are the studies on the

offspring Senator Enzi?

Where are all their many, many years of studies?

Breast implants have been on the market for over 45

years plus, so where are all of the many, many studies

on the offspring taking " hits " via the placental

barrier through fetal cells? Silicone gel breast

implants were under moratorium since 1992, so where

are all the studies on the offspring? They had plenty

of time to do many studies, so where are the studies

when it concerns the offspring being exposed to

silicone gel breast implants? Of course in medicine

they can make their study fall the way they want no

matter if it is the truth or not.

Are our children in AMERICA not that important that

these big companies failed to step up to the plate

early on and do studies proving the implants to be

safe via the placental barrier and with breastfeeding?

They do not want to spend their money to do the right

thing to uphold their oath of First, do NO harm. This

is a shame. Well, I have the evidence in human form,

and so do many other mothers who are suffering the

same plight with their children.

Our concerns are dismissed because the medical

community/the breast implant companies/plastic

surgeons/FDA and other medical organizations (IOM,

NCI, NIH) place business as usual ahead of their oath

of First, do no harm and the sake of the children, the

generations to come who will be exposed to the damning

devices. They rather cover their own tail while many

suffer the exposure from their self-serving ways of

products placed out to general population that exert

the human immune response, also via the placental

barrier through fetal cells.

Sir, I want you to know my breast implants were a

birthday present from my parents and to date, (October

2005 at the age of almost 48 years old. I will be 48

yrs old November 16th, 2005) I am still trying to blow

out the candle on this gift, but the flame has gotten

way out of control. I figured the flame will be out

the day I die or my children die.

Now, only am I very disfigured on my chest wall from

the breast implants. I have health concerns caused

from my toxic, very failed silicone gel breast

implants, as well as my three daughters who have

health issues elevated from the exposure to my failed

breast implants. But of course the companies have not

studied the offspring fully nor tracked the outcome of

children exposed to breast implants, so they are

further bushwhacking the generations to come if

silicone gel breast implants are placed back on the

market. This has been their free will choice and this

is not upholding their oath of First, do no harm to

that highest of high standard if silicone gel breast

implants make it back on the market. The breast

implant companies rather not spend their money on good

dispassionate studies, so their CEO's can retire with

alot in their pockets.

Last year I had myself along with two of my three

daughters tested for platinum in the urine. Our middle

daughter could not be tested because she was away at

college & was unable to make it home.

The results are as followed:

myself- 17.1 ug/L (parts per billion per liter of

urine)

1st born daughter: 15.3 ug/L

3rd born daughter: 16.9 ug/L

I understand your investigation to date is limited to

specific accusations regarding the 2005 FDA Advisory

Committee panel meeting and the PMA's reviewed at that

meeting. The problem is the breast implant companies

along with the plastic surgeons, who act as enablers

are making a free will choice to make a mockery of

everyone (you, me, the medical community as a whole

and all of humanity and the innocent generations to

come) by not upholding their oath of First, do no

harm. They failed by NOT " telling all " about silicone

gel breast implants. They only disclose what they want

to, but there is more to the story as many have

suffered as they failed to " tell all " in the 2005 FDA

meetings and with the PMA's that were being reviewed

at that meeting. This is being self-serving.

Also, the offspring, the generations to come are

forgotten souls when it comes to the breast implant

issues. Children on this earth now and the

generations to come have no voice. I guess this is why

mother's are placed on this earth, so that children do

have a voice, so I also am contacting you on behalf of

the children, (all children) who have been exposed to

their mother's breast implants. I am their voice

seeing I myself am a past teenage breast implant

patient whos children were exposed to very failed

silicone gel breast implants. I have walked the walk

and I am very capable of talking the talk.

Our youngest daughter, has scleroderma in the

form of PSS. She has problems swallowing and this may

wax and wane, but the swallowing problem has gotten

worse. is in the 10th grade. She also suffers

with a very severe bone dysplasia of the hands and

feet. Her hands and feet are the size of an 11-15

month old baby & have fused. Meaning they will not be

growing anymore. She also has AN, acanthosis nigricans

which is black skin on top of the shiny scleroderma

skin. She has learning delays and other health issues.

She is going through an advanced aging process, and I

do have her in many studies. She is basically being

used as a lab animal, like I was when I opted for

silicone gel breast implants in my youth. I really

think our lives are of more value than this, but

someone needs to uphold the oath of First, do no harm,

so this is why I have tried to get our family into

studies. But in research they can make their studies

fall the way they want no matter if it is the truth or

not.

I believe our is a McGhan/3M silicone gel

breast implant birth defect and one day she is going

to die a McGhan/3M silicone gel breast implant birth

defect. And not one soul will ever be able to take

this fact away from this young girl no matter how hard

everyone tries to get around the FDA moratorium on

silicone gel breast implants with their " words of art "

or " medical words of art " to cover their own tail of

the medical harm they have caused.

Gosh Senator Enzi, even the FDA's own scientists have

studies showing that silicone gel implants are

harmful, but of course the FDA does NOT listen to

their own scientists...this is why good scientists are

leaving the FDA lately. Everyone is fed up with the

FDA, along with the medical community selling their

souls to the highest bidder, industry.

In the case of breast implants that would be selling

one's soul to Mentor and Inamed. Inamed which is

really McGhan who made my breast implant lot numbers.

Inamed, McGhan whatever name they want to call

themselves they still cause harm to patients who

should think twice before they place their trust in

what they ever market...because all they care about is

business as usual, not about upholding their oath of

First, do no harm with silicone gel breast implants.

This is poor medicine.

Also, I would like to share with you some of what is

in my medical records when I had the failed devices

submitted for review and evaluation.

My records state: " Indeed , the implant appears to

have lost original contour in addition to its

structural integrity. Macroscopic examination reveals

that nearly all the silicone gel content was

extravasated outsede the prosthesis. The remaining

silicone gel has lost it's transparent and colorless

nature and acquired a slight yellowish tint. Color

changes in the gel are indicative of chemical

alteration in the medium. A moderate number of fine

precipitates are noted in the gel medium. Under the

microscope, these particles appear as fine,

needle-like, aggregated structures and granular

formations. They appear to have chemical and

biological origins. We have found that chemical

aggregates are composed of metals which can induce

immunogenic reactions when prolonged contact with

living tissues " .

The records continue to state: " More importantly,

silicone particles were seen in close contact with

blood vessels. The proximity of the blood vessels to

the silicone particles, indicates that they were

transported elsewhere through the systemic

vasculature. Also of significance is the fact that the

internal zones as well as the surrounding areas of

mammary glands dislayed infiltrated silicone gel

particles.

Large clacified plates containing infiltrated silicone

particles were also noted in the tissue. Calcified

structures were formed in response to the deleterious

presence of metal in the silicone gel. These metals

migrate into the surrounding tissue from bleeding or

ruptured implants " .

In more medical records taken from a review of my

failed McGhan/ 3M implants states: " Both the inner

and outer shells had been ruptured for many years

prior to explanation. Highlights also include a MAJOR

PRODUCTION DEFECT on the left implant which CONSISTS

OF A DEBONDED GEL FILL HOLE SEAL. This defect confirms

that the devices which contains a DEGRADED FLUID GEL

DEVOID OF STABILITY AND SHAPE MEMORY WITH A LUMPY

DISPERSION. This type of presentation is typical of

incorrectly formulated filling substances. It should

be noted that Ms. sey received devices

manufactured by the same production facility and

embodying major production problems from the outset.

The capsules are noteworthy for deep infiltration with

oil and gel, as well as structural features such as

opening and fenestration. Contrary to opinions

occasionally expressed in some quarters, such capsules

amount to open structures that have no protective

value against the release of oils and gel impurities

into the user's system " .

Also in my records it states: " The patch workmanship

is very poor with evidence of errors in assembly and

improper use of adhesive for sealant as well as

PLATINUM EXCESSES AS EVIDENCED BY A BLACK

DISCOLORATION on the patch edge. The item was

defective from the outset as it shows an open gel fill

hole which was never correctly sealed. It leaks oil

grossly and has potential for severe adverse reaction.

Both implants are creditable with the release of large

quantities of mobile, invasive gel which deeply

penetrated tissues. The capsules are remarkable for

irregularities, fenestrations and the development for

granulomatous tissue. They reflect all the attributes

of periprosthetic tissue exposed to uncontained gel

for a long period of time. "

The records continue to state: " Her history is

further remarkable for use of electrosurgical

techniques in a OIL- CONTAMINATED FIELD. This

procedure has potential for long term sequelae. " (HAS

ANYONE BROUGHT UP THE USE OF THE BOVIE/ELECTROSURGICAL

TECHNIQUES WITH SILICONE GEL BREAST IMPLANTS? Because

it is not good to use a bovie and silicone gel breast

implants. Ask Dr. Blais from Canada. He can explain

why)

The records speak more of the platinum: " The gel

feill hole is exposed and the sealant is partly

debonded from the shell or alternately bonding never

took place. Platinum discoloration is visible on the

patch edge. This material is plartly detached from the

substrate. The valve stem is laden with fine debris

indicating leakage. The patch workmanship is poor with

irregular peripheral cutting. The gel is turbid and

has fluid characteristics consistent with an

improperly polymerized product.

Senator Enzi, I bet nobody addressed alot of these

concerns above (what I have brought up in my e-mail)

in the 2005 FDA Advisory Committee panel meeting and

in the PMA's reviewed at that meeting...but they

should have because this happens to many people...it

happened to me. If they failed to have addressed these

issues like what I have stated in my above e-mail then

they are failing to uphold their oath of First, do no

harm to that highest of high standard.

MY POOR CHILDREN. I exposed my children to this via

the placental barrier then I breastfed all of them

with this toxic soup (the adjuvant, the catalysts/

platinum) deemed breastmilk...and everyone in the

medical community thinks this is harmless? Well, what

one does not know will hurt someone! Staying in denial

like a drinker is not good, so I will not play the

enabler to the medical community and this is why my

voice needs to be heard. They need to fix this huge

problem THEY MADE for many as they have failed to

uphold their oath of First, do no harm to that highest

of high standard.

Suffer the little children? They did, they have and

will continue to suffer if silicone gel breast

implants are FDA approved.

Thank you for your time.

Fuchs-sey

915 Rustic Drive

Macon, Missouri 63552

phone: 660-385-4621

Fuchssey@...