ilena

Marlene Keeling

My name is Marlene Keeling. I chose to get double-lumen breast
implants in 1978 after my plastic surgeon assured me only 2% of his
patients ever had problems and he could fix anything that happened.

My health problems did not start until about seven years after my
surgery. I developed weakness, fatigue, periodic swollen lymph nodes
in my neck, depression, memory loss, peripheral and demyelinating
neuropathy. Since removing my ruptured implants in 1994 all of my
symptoms have slowly improved. However, the last time I had my
natural killer cells counted they were low. This is consistent with a
finding of the Institute of Medicine report that states "Consistent
with animal toxicology studies it appears that natural killer cells
might be effected by exposure to silicone gel." Inamed data has
revealed a loss of natural killer activity in their immunotoxicity
research. How can this panel approve a device for breast cancer
survivors that compromises the immune system by lowering natural
killer cells which are the cornerstone of the immune system, are
responsible for controlling tumor cell growth, are involved in control
of infection, and have immunoregulatory properties?

In networking with other silicone implanted women, I realized that
many were also being diagnosed with chronic inflammatory demyelinating
polyneuropathy and had memory problems or depression. In 1996, I
became a Founding Director of Chemically Associated Neurological
Disorders, which is dedicated to information and research. We funded
a research project conducted by Ernest Lykissa, Ph.D., a forensic
toxicologist as the principal investigator. In September 2000 we
submitted the results to the FDA. Eight out of the first eight
gel-filled breast implants Dr. Lykissa tested (including mine)
released significant platinum in a reactive valence. If platinum is
in a free highly oxidizing form, the higher the valence the more toxic
and hypersensitizing the platinum becomes. Five out of the first
eight implants tested released platinum as high as 6+. Fortunately
for me, mine only released platinum as high as 4+. However platinum
with a valence of 2+ and 4+ render the platinum easily transportable
across the blood brain barrier.

German research by Flassbeck et al published 2003 found higher
platinum levels in the fibrin layer and fat tissue of breast implanted
patients when compared to control patients without implants. These
same researchers report "the data of this work clearly show that the
use of elemental silicon as an indicator of migration…from breast
implants to the surrounding tissue is not appropriate." The Dow
funded Semple et al study on breast-milk from implanted women uses the
inappropriate measurement of elemental silicon in an attempt to imply
that breast-feeding by implanted mothers is safe. In an e-mail I
asked the German researcher "Could you comment on whether you believe
that elemental silicon is an appropriate measure for breast-milk from
implanted women to determine safety?" Their response was "Of course
not". How can this panel vote to approve these devices for
augmentation and revision of young women of child bearing age, without
a properly designed breast-milk study for safety of children born
after implantation?

Inamed states: "A woman with breast implants who has questions about
risks while pregnant or breast feeding should consult her physician."
Since the chemicals and heavy metals including platinum contained in
breast implants are proprietary information known only to the
manufacturers and the FDA, how can a physician provide useful advice?

Platinum salts inhibits brain enzymes and causes structural damage to
brain cells, according to Dr. Michael Harbut, Chief, Center for
Occupational and Environmental Medicine at Wayne State. Dr. Harbut
has treated over 1,000 breast implant patients. I have court stamped
documents indicating that platinum salts and chloroplatinic acid were
used in making breast implants. Dow advised the EPA in 1996 of
substantial risk to Dow Intermediate Platinum #2 used as a catalyst in
making breast implants. Chloroplatinic acid is one of the most
hyper-sensitizing agents known to man.

I have one final point. Two years ago, McGhan Medical (now Inamed)
filed a patent which makes the statement "adverse medical consequences
have recently become associated with the use of silicone gel filled
implants because it has been discovered that the silicone oil can
migrate through the implant shell and the silicone oil is not
biocompatible with other human tissues. Therefore, the use of
silicone based filler materials has been discontinued in the
industry."

My point is that Inamed, in their patent, stated that silicone oil is
harmful to human tissues – and yet their research shows silicone and
most likely platinum are released through the shell. How can this
panel approve a device that harms human tissue, leaks silicone and
heavy metals through the shell, ruptures at an "under ascertained"
rate and the rupture may be silent? There is no way to remove all of
the toxic and hypersensitizing chemicals once they leak into the
tissues.

I submit the Nuremberg code states "the voluntary consent of the human
subject is absolutely essential". It goes on to say that the person
involved should have sufficient knowledge and comprehension of the
element of the subject matter involved as to enable ‘her' to make an
understanding and enlightened decision." Women with breast implants
have not had informed consent. I say loud and clear "You are the
scientists in charge who must stop this experimentation on women and
our future generations and just say no to corporate greed."

ilena

Marlene Keeling

My name is Marlene Keeling. I chose to get double-lumen breast
implants in 1978 after my plastic surgeon assured me only 2% of his
patients ever had problems and he could fix anything that happened.

My health problems did not start until about seven years after my
surgery. I developed weakness, fatigue, periodic swollen lymph nodes
in my neck, depression, memory loss, peripheral and demyelinating
neuropathy. Since removing my ruptured implants in 1994 all of my
symptoms have slowly improved. However, the last time I had my
natural killer cells counted they were low. This is consistent with a
finding of the Institute of Medicine report that states "Consistent
with animal toxicology studies it appears that natural killer cells
might be effected by exposure to silicone gel." Inamed data has
revealed a loss of natural killer activity in their immunotoxicity
research. How can this panel approve a device for breast cancer
survivors that compromises the immune system by lowering natural
killer cells which are the cornerstone of the immune system, are
responsible for controlling tumor cell growth, are involved in control
of infection, and have immunoregulatory properties?

In networking with other silicone implanted women, I realized that
many were also being diagnosed with chronic inflammatory demyelinating
polyneuropathy and had memory problems or depression. In 1996, I
became a Founding Director of Chemically Associated Neurological
Disorders, which is dedicated to information and research. We funded
a research project conducted by Ernest Lykissa, Ph.D., a forensic
toxicologist as the principal investigator. In September 2000 we
submitted the results to the FDA. Eight out of the first eight
gel-filled breast implants Dr. Lykissa tested (including mine)
released significant platinum in a reactive valence. If platinum is
in a free highly oxidizing form, the higher the valence the more toxic
and hypersensitizing the platinum becomes. Five out of the first
eight implants tested released platinum as high as 6+. Fortunately
for me, mine only released platinum as high as 4+. However platinum
with a valence of 2+ and 4+ render the platinum easily transportable
across the blood brain barrier.

German research by Flassbeck et al published 2003 found higher
platinum levels in the fibrin layer and fat tissue of breast implanted
patients when compared to control patients without implants. These
same researchers report "the data of this work clearly show that the
use of elemental silicon as an indicator of migration…from breast
implants to the surrounding tissue is not appropriate." The Dow
funded Semple et al study on breast-milk from implanted women uses the
inappropriate measurement of elemental silicon in an attempt to imply
that breast-feeding by implanted mothers is safe. In an e-mail I
asked the German researcher "Could you comment on whether you believe
that elemental silicon is an appropriate measure for breast-milk from
implanted women to determine safety?" Their response was "Of course
not". How can this panel vote to approve these devices for
augmentation and revision of young women of child bearing age, without
a properly designed breast-milk study for safety of children born
after implantation?

Inamed states: "A woman with breast implants who has questions about
risks while pregnant or breast feeding should consult her physician."
Since the chemicals and heavy metals including platinum contained in
breast implants are proprietary information known only to the
manufacturers and the FDA, how can a physician provide useful advice?

Platinum salts inhibits brain enzymes and causes structural damage to
brain cells, according to Dr. Michael Harbut, Chief, Center for
Occupational and Environmental Medicine at Wayne State. Dr. Harbut
has treated over 1,000 breast implant patients. I have court stamped
documents indicating that platinum salts and chloroplatinic acid were
used in making breast implants. Dow advised the EPA in 1996 of
substantial risk to Dow Intermediate Platinum #2 used as a catalyst in
making breast implants. Chloroplatinic acid is one of the most
hyper-sensitizing agents known to man.

I have one final point. Two years ago, McGhan Medical (now Inamed)
filed a patent which makes the statement "adverse medical consequences
have recently become associated with the use of silicone gel filled
implants because it has been discovered that the silicone oil can
migrate through the implant shell and the silicone oil is not
biocompatible with other human tissues. Therefore, the use of
silicone based filler materials has been discontinued in the
industry."

My point is that Inamed, in their patent, stated that silicone oil is
harmful to human tissues – and yet their research shows silicone and
most likely platinum are released through the shell. How can this
panel approve a device that harms human tissue, leaks silicone and
heavy metals through the shell, ruptures at an "under ascertained"
rate and the rupture may be silent? There is no way to remove all of
the toxic and hypersensitizing chemicals once they leak into the
tissues.

I submit the Nuremberg code states "the voluntary consent of the human
subject is absolutely essential". It goes on to say that the person
involved should have sufficient knowledge and comprehension of the
element of the subject matter involved as to enable ‘her' to make an
understanding and enlightened decision." Women with breast implants
have not had informed consent. I say loud and clear "You are the
scientists in charge who must stop this experimentation on women and
our future generations and just say no to corporate greed."