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Keeling (281/444-0662)

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FDA'S NEW BREAST IMPLANT BOOKLET 2000

Houston, TX -- The FDA last week released on their

website (www.fda.gov/cdrh/breastimplants ) a new

consumer booklet on breast implants which includes

photographs of complications for the first time. This

is a victory for consumer advocates who have been

working to counter the plastic surgeons only showing

positive outcomes to women considering implants. One

look at what one woman's breasts look like after

implants were removed, should give all women second

thoughts about ever choosing to get implants in the

first place. For women who currently have ruptured,

leaking gel-filled implants and are thinking about

having them removed, it should be pointed out that

with a skilled surgeon and with a mastopexy, more

desirable results can be obtained. Women should be

warned it often costs twice or three times as much to

get implants removed, as it does to get them in the

beginning.

The FDA is once again allowing silicone gel-filled

breast implants for augmentation purposes, in spite of

the fact that no manufacturer has ever been able to

prove them to be either safe or effective. The FDA's

own research documents a 69% rupture rate with gel

found outside the scar capsule 21% of the time.

Women of child-bearing age should be aware of the

following statement found in the booklet, " It is not

known if a small amount of silicone may pass from the

shell of an implant into breast milk. If this occurs,

it is not known what effect it may have on the nursing

infant. "

The chemical companies and the manufacturers of

implants try to mislead the public, the FDA, and the

Institute of Medicine (IOM) into believing there are

no current methods for detecting silicone levels in

breast milk. Research published in 1998, paid for by

Dow Corning, the Plastic Surgery Education Foundation,

and the American Society of Plastic and Reconstructive

Surgeons, attempts to manipulate science by using

" silicon " (the second most abundant element on earth)

as a measurement in 15 lactating breast-implanted

women - to declare that breast feeding is not harmful.

When in fact, research published in 1997 by Baylor

College of Medicine establishes the ability of new

high powered equipment (GC/AED and GC/MS) to detect

silicones in the nanogram range. Additional research

in 1997, found platinum (used as a catalyst in the

preparation of silicone gels) was leaking from

gel-filled implants and could be measured by using

ICP-MS.

In Western Europe, but not the United States, women

with silicone breast implants are advised not to

breast feed. It has been stated that one of the exits

for fat-soluble chemicals in women's breast tissue is

through lactation, perhaps explaining why women who

have not nursed infants are at higher risk for breast

cancer. But are we unloading toxic contaminants into

the bodies of our babies?

Chemically Associated Neurological Disorders (CANDO)

has been granted a meeting with the Office of Device

Evaluation at the FDA on September 11th, to present

preliminary data from research done by ExperTox, Inc.

Indicating the platinum released from gel-filled

implants is in a highly reactive toxic form. The

chemical companies and manufacturers of implants have

previously misled the FDA and the IOM into believing

the platinum released was harmless.

Symptoms of exposure to toxic platinum can include

fatigue (a non-specific condition frequently

associated with impaired oxygen exchange ability),

sicca symptoms (dry eyes, mouth, joint inflammation,

etc.), mental confusion (neurotoxicity/CNS

involvement), pulmonary symptoms (cough, shortness of

breath, pleuiritic chest pain, or abnormal pulmonary

function test results), hair loss, and rash.

________________________________________________________________

To receive a copy of the FDA breast implant handbook

2000, readers can call the FDA at 1-888-463-6332. When

prompted, press 1, press 2, press 1, press 6, and then

press 2 to leave your address and have the handbook

mailed to you.

Keeling, is President of Chemically Associated

Neurological Disorders, a nonprofit organization

dedicated to education and research on the effects of

various types of implants on the human body.

Keeling, President and Founding Director

Chemically Associated Neurological Disorders

P.O. Box 682633

Houston, Tx. 77268-2633