FDA Advisory Meeting - from Marlene Keeling

[Guest guest]

FDA Advisory Meeting

April 11 – 13, 2005

CANDO wants to thank everyone who traveled to or sent

written testimony to be read into the official record

during the public comment period of the recent FDA

advisory meeting. We had approximately fourteen who

had been tested for platinum who testified.

We owe a huge debt of gratitude to V.M. Maharaj,

Ph.D., a professor of chemistry at American

University, who testified regarding her published 2004

research on platinum and the results from CANDO

Research Project #1. I presented raw data from CANDO

Research Project #2 which found one child born after

implantation tested over 300 parts per billion, one

woman tested aver 200 parts per billion eleven years

after explantation, and nine women and one child

tested over 100 parts per billion. Previously in a

written submission to the FDA and panel members, I

sent a copy of the CDC’s platinum urine study in the

general U. S. population of over 1,000 people and not

one of them had over the level of detection of <0.04

parts per billion per liter of urine.

Harbut, M.D., board certified in Occupational

Medicine who has limited his practice to the diagnosis

and treatment of diseases caused by occupational and

environmental toxins, provided testimony read into the

record regarding platinum. , M.D.,

board certified in Internal Medicine and in Allergy

and Immunology, spoke about her research regarding

Toxicant Induced Loss of Tolerance or TILT. This may

explain why many breast implant patients now have a

low tolerance to many chemicals in the environment.

The FDA transcript on April 13, 2005 quotes Sam

Arrepali, Ph.D. Chemist at the FDA as saying " While

saline-filled breast implants contain only tin, the

gel-filled breast implants contain both platinum and

trace amounts of tin as both these catalysts are used

in the manufacture of gel-filled breast implants. "

Ionized platinum is one of the most hypersensitizing

agents known to man. Oxidized platinum also is on the

suspected list as being a neurotoxicant,

immunotoxicant, sense organ toxicant, and respiratory

toxicant. Some of the recognized symptoms and

diagnoses of people exposed to ionized platinum

include the following: asthma, rhinorrhea, tinnitus,

conjunctivitis, urticaria (hives), fatigue syndromes

secondary to impaired oxygen exchange, neurotoxicity,

sicca syndrome, and macular rashes.

Ionized platinum is capable of crossing the placental

barrier and brain barrier. The World Health

Organization (WHO) states there is no data available

to assess the carcinogenic risk of platinum or its

salts to humans. NIH research has documented that

breast-implanted women have a two fold increased risk

of brain cancer, a three-fold increase of respiratory

tract cancer, and a four fold increased rate of

suicide. WHO also states that the acute toxic effects

of platinum are dependent on metal speciation and

further studies are required in particular on the

speciation of platinum in the environment. Mentor

drops a woman from their clinical trials if she has

her implants removed because of health concerns and

elects not to be re-implanted. Independent FDA

research found an increased incidence of fibromyalgia

in breast-implanted women. It is not surprising that

research funded by the pro-implant lobby group finds

no link to systemic disease.

Dr. ph Bubinak, a board-certified oncologist,

testified before a breast implant advisory board in

2002 regarding his experience with the chemotherapy

agent cisplatin which is mutagenic, carcinogenic,

leukemogenic and teratogenic. Dr. Bubinak stated that

some breast-implanted patients have the same systemic

complaints and side effects as cisplatin treated

patients including fatigue, hair loss, loss of short

term memory, rash and other allergic reactions,

respiratory system problems, and peripheral neuropathy

which is sometimes disabling. He further stated that

migration of reactive platinum alone could explain

capsule formation and tells the world that the

chemicals in breast implants are not inert.

The advisory panel asked many questions regarding

platinum. Inamed’s platinum data showing no release

of platinum from their implants was deemed irrelevant

by the panel because they used inappropriate disks.

Mentor did admit to platinum release from their

implants but stated it was in the zero valence or

harmless (they did not use state of the art equipment

such as IC-IC-PMS).

CANDO’S Research Project #1 found significant levels

of platinum is released by gel-filled breast implants

and is in an ionized form. CANDO’S research also

found significant amounts of platinum in breast-milk

from implanted mothers and ionized platinum is being

found in the urine of children born after

implantation. Both Inamed and Mentor stated that they

do not plan on doing research or gathering information

on second-generation effects.

CANDO has the funds to test a limited number of women

and their children born after implantation free of

charge. We are specifically looking for women

implanted after 1988 with Mentor third-generation

silicone gel-filled breast implants. We are uncertain

if the silicone shell of saline implants contains tin

or platinum as the catalyst. Therefore we will be

unable to include saline implanted women in the free

testing program at this time.

If you have or know of anyone who has 1988 or later

Mentor gel-filled implants please contact me

immediately by e-mail keeling.m@... or by phone

281/444-0662. If you know of anyone who was enrolled

in the Mentor clinical trials especially the core

trials after 1992 but were either dropped or not

followed up by a plastic surgeon, please also have

them contact CANDO.

If you have children born after implantation with the

following symptoms or diagnoses we are interested in

hearing from you: (1) year round atypical allergies

(2) asthma (even atypical with no wheezing) (3)

unusual rashes, hives, or atypical eczema (4) lowered

tolerance to everyday chemicals (5) peripheral or

demyelinating neuropathy (6) bone pain (7) esophageal

motility (swallowing) problems or esophagitis (8)

learning disabilities or other neurological disorders

(9) autoimmune or connective tissue symptoms or

diagnoses (10) tinnitus or other hearing problems (11)

bladder problems (especially frequency).

Keeling

Chemically Associated Neurological Disorders

P. O. Box 682633

Houston, Texas 77268-2633

281/444-0662

281/444-5468 FAX

keeling.m@...