Chemically Associated Neurological Disorders

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http://www.humanticsfoundation.com/cando.htm

Chemically Associated Neurological Disorders

(CANDO)

Research Project #2

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Since the CANDO funded research abstract Platinum and

platinum species in explanted silicone gel breast

prosthetic devices using IC-ICP-MS was presented by

S.V.M Maharaj, Ph.D., at the August 2004 American

Chemical Society meeting, many breast implanted women

have contacted either Dr. Maharaj, ExperTox, or CANDO

asking about platinum testing. In response to many

requests for information, I am putting this

comprehensive letter together to try and respond to

many of your questions.

In 1994 I had my ruptured double-lumen silicone

gel-filled breast implants removed because of hardened

capsules, fatigue, memory loss, hair loss, depression,

peripheral and demyelinating neuropathy (damage to my

nerves). In networking with many breast-implanted

women, I discovered they had similar symptoms and

diagnoses including chronic inflammatory demyelinating

neuropathy. As a result, in 1996 I along with others

founded Chemically Associated Neurological Disorders

(CANDO). We organized a charity golf tournament and

raised funds for education and research.

First let me assure you that I have worked on this

issue for ten years as a volunteer (I have received no

money or compensation for my time and have no

financial ties to ExperTox). I met Dr. Lykissa, an

expert forensic toxicologist, in 1997 when we both

spoke at an FDA meeting regarding what we believed to

be the harmful effects of gel-filled breast implants.

While employed at Baylor College of Medicine in

Houston, Dr. Lykissa and others published the

following research:

Detection and Characterization of

Poly(dimethylsiloxane)s in Biological Tissues by

GC/AED and GC/MS. Anal. Chem. 1997, 69: 1267-1271

Release of Low Molecular Weight Silicones and Platinum

from Silicone Breast Implants. Anal. Chem. 1997, 69,

23: 4912-4916

Low Molecular Weight Silicones Are Widely Distributed

after a Single Subcutaneous Injection in Mice. Am J

Pathol. 1998, 152: 645-649

Cyclosiloxanes Produce Fatal Liver and Lung Damage in

Mice. Environ Health Perspect. 1999, 107: 161-165

I filed, with the support of many other organizations,

a Citizen’s Petition in 1997 requesting that the FDA

revoke permission granted to manufacturers to make

silicone gel-filled breast implants available to women

with breast cancer (who already had a weakened immune

system) and women who previously had implants (who

probably already had high levels of silicone and

platinum). The FDA denied this petition.

In 1997 the Department of Health and Human Services

asked the Institute of Medicine (IOM) to conduct a

review of all research regarding the safety of

silicone breast implants. In 1998, the FDA completed a

study to assess the rupture rate of silicone

gel-filled implants.

The IOM released their report on June 22, 1999 titled

“Safety of Silicone Breast Implants” with the

following recommendations:

“Reliable techniques for the measuring of silicone

concentration in body fluids and tissues are needed to

provide established, agreed-upon values and ranges of

silicone concentrations in body fluids and tissues

with or without exposure to silicone from an implanted

medical device. Such developments could improve the

study of silicones and silicone distribution in

humans, could help with regulatory requirements, and

might in some circumstances resolve questions by

providing quantitative data on the presence or absence

of silicones.

Ongoing surveillance of recipients of silicone breast

implants should be carried out for representative

groups of women, including long-term outcomes and

local complication, with attention to, or definition

of the following:

Implant physical and chemical characteristics,

Tracking identified individual implants,

Using appropriate, standardized, and validated

technologies for detecting and defining outcomes,

Carrying out associated toxicology studies by

standards consistent with accepted toxicological

standards for other devices; and

Ensuring representative samples, appropriate controls

and randomization in any specific studies, as required

by good experimental design.

The development of a national model of informed

consent for women undergoing breast implantation

should be encouraged, and the continuing effectiveness

of such a model should be monitored.”

I helped work on the Citizen’s Petition filed in 1999

by Anne Stansell, a breast cancer survivor, requesting

the FDA ban the use of silicone gel-filled breast

implants due to independent research documenting

extremely high rupture rates (70% or more in some

cases). The FDA denied this petition.

From my work with the FDA and the recommendations by

the IOM, I came to understand that published research

of the testing of implants, the tissues and fluids of

breast implanted women was perhaps the only way to

convince the FDA to make regulatory changes. In

2000, CANDO funded a small study concentrating on

platinum release from explants and in the blood,

sweat, hair, nails, and urine of breast implanted

women and their children born after implantation

(children born prior to implantation and women without

implants were used as controls). Breast-milk from

nursing breast- implanted mothers was also tested.

My explant was tested in this initial research and

found to release significant amounts of ionized

platinum in the 2+ and 4+ ionization state. On

September 11, 2000 the initial results of my explant

testing along with the other explants tested in this

small CANDO research project was presented to the FDA.

On November 7, 2000 I filed, along with the support

of many other organizations, a Citizen’s Petition

requesting that the FDA revoke the implantation of

silicone gel-filled breast implants for any reason in

light of new research documenting the release of

platinum in a reactive valence from intact implants.

The FDA denied this petition.

Note that on December 27, 1996 Dow Corning sent a

notification of substantial risk to the Office of

Pollution Prevention and Toxics at the Environmental

Protection Agency regarding their 3-8015 Intermediate

(Platinum #2). Dow Mammary Implant Material

Formulation documents that 3-8015 INT (PLATNM2)

Chloroplatinic Acid was used as a catalyst in the

making of silicone gel-filled breast implants.

The FDA issued new guidance for breast implant

manufacturers on August 13, 2001 that required for the

first time that they provide qualitative and

quantitative analysis for heavy metals and residues of

catalysts including the valence status of any heavy

metal.

Platinum was found in my hair, blood, nails, sweat,

and my urine contained 36.0 ug/L (parts per billion

per liter of urine). Two studies done by the CDC in

1999 show that for the sample of the general U.S.

population (2465 people) ages 6 and over no platinum

(ionized or elemental) was found in their urine.

These initial research findings along with the other

participants (no names were revealed only patient

numbers) were given to the FDA in a teleconference on

11/26/01.

German research Determination of Siloxanes, Silicon,

and Platinum in Tissues of Women with Silicone

Gel-filled Implants was published in 2003 documenting

for the first time platinum in the tissues of breast

implanted women.

After the FDA panel hearing in 2003 I filed, along

with the support of others, a Citizen’s Petition

asking that the FDA delay the approval of gel-filled

breast implants until additional valid long-term

scientific data was collected. The FDA denied my

petition.

S.V.M. Maharaj, Ph.D. published research in 2004

titled Platinum concentration in silicone breast

implant material and capsular tissue by ICP-MS

documenting significant amounts of platinum in the

capsular tissue and breast implants of fifteen women.

Dr. Maharaj agreed to collaborate free of charge with

ExperTox to help get the CANDO Research Project #1

published.

Please forgive the length of this letter documenting

the history of CANDO but I felt it was necessary

because I have recently become aware that I was being

accused of a for-profit motive and being part of

groups that are interconnected on a non-scientific

basis.

While I do admit that I do not have a scientific or

medical background, I do have common sense. I have

used my small settlement from the manufacturer of my

defective implants to try and learn the truth about

the health risks of chemicals implanted in the body.

Women need accurate information on the risks to make

an informed decision or give informed consent.

ExperTox must charge a fee to test for toxic

chemicals. Other wise they would go bankrupt and we

would have one less independent lab (not owned by the

chemical companies). From the initial CANDO research

project it was determined that the urine was the least

invasive best method to test for platinum in the body

(confirmed by the CDC study done of the general U.S.).

To make it as simple as possible and at the lowest

cost, we have made the protocol to include collection

in your own home with instructions to ship it

overnight to ExperTox. CANDO is out of funds.

However, I am expanding the research to be called

CANDO Research Project #2 by inviting all interested

breast implanted women and their children to

participate. ExperTox has agreed to do this platinum

urine testing for the reduced fee of $150 per person

for anyone willing to fill out a questionnaire. The

questionnaire is necessary to try and rule out any

other significant sources of platinum you might have

been exposed to in your environment.

Our purpose in expanding the research is to try and

determine why we find platinum in the urine of some

breast implanted women and not others. Does length

of implantation make a difference? Does type of

implant and manufacturer make a difference? We need

your results even if they are non-detect to try and

answer these questions. Does length of time after

explantation before testing is done make a difference?

We hope to force the FDA to do some independent

testing or require the manufacturers of implants to

test explants in a retrieval study. As many of you

told the IOM, we are the “evidence”. Test our fluids

and tissues. This was not done in the Mayo study,

the Harvard study, or the NIH study – only medical

records were reviewed or questionnaires filled out.

I am helping to collect the questionnaires and data to

get this important research published. If you have

already had your urine tested, please let me know so

that we can include your results. If you don’t know

what your levels of platinum might be and would like

to participate in this project, please contact me and

I will either e-mail or send by mail the protocol and

questionnaire. Together we can make a difference.

Sincerely,

Keeling, President

Chemically Associated Neurological Disorders

P.O. Box 682633

Houston, Texas 77268-2633

281-444-0662

keeling.m@...

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