Myrl Jeffcoat myrlj@jps.net

MS. KEELING: My name is Marlene Keeling. I am President and founding Director of Chemically Associated Neurological Disorders, or CANDO. I have paid my own way here because of my concern over toxic and hypersensitizing chemicals that I am convinced are leaking or bleeding from implants into not only the bodies of women but, even more worrisome, their children born after implantation.

I was implanted with McGhan double lumen breast implants in 1978. I had my ruptured implants removed in 1994, after I became convinced that my implants were causing my swollen lymph nodes, hair loss, memory loss, overwhelming fatigue, peripheral and demyelinating neuropathy. I was perfectly healthy before I got implants, got sick, had my implants and scar capsule removed in block and not replaced, got better.

When tested for platinum six years after explantation, my urine was found to contain 36 parts per billion per liter of urine. Platinum was found to leak from my implants. And platinum was also found in my hair, nails, sweat, and blood.

The ionization or speciation of my platinum was +2 and +4. Dr. Joseph Bubinak, a board?certified hematologist and medical oncologist, testified before a breast implant advisory board in 2002 regarding his experience with the chemotherapy agent cisplatin.

Dr. Bubinak reported that he was astounded to learn that the catalyst used to manufacture the silicone for breast implants was platinum chloride, a highly reactive molecule and precursor to the chemotherapy agent cisplatin. He 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.

Dr. Bubinak stated that the migration of reactive platinum alone could explain capsule formation and tells the world that the chemicals in breast implants are not inert.

Can you go to C? Dr. Maharaj has presented data from CANDO's research project number 1 here today. Based on this research, it was determined that urine was the least invasive, best method to test for platinum levels in the body.

CANDO's research project number 2 has now tested the urine of over 50 breast?implanted women and their children born prior to and after implantation. I have copies of this raw data, which I can give to the panel today.

Previously in a written submission, I gave the panel 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.

To quickly recap, the results of the raw data presented today, one child born after implantation tested over 300 parts per billion. One woman tested over 200 parts per billion 11 years after explantation. And nine women and one child tested over 100 parts per billion.

The panel was also given a copy of Dow?Corning's 1996 letter notifying the EPA of substantial risk to their platinum catalyst used in breast implants. Ionized platinum is on the list as being a suspected neurotoxicant and immunotoxicant.

Mentor's most recent FDA-approved product insert makes the following statement, "Toxicity studies are currently in progress by various research facilities, universities, government agencies, the medical community, and the medical device industry. Some of these studies are conducted in animal models to determine potential immunotoxicity and autoimmune issues related to silicone materials. There is the potential that in the animal models being studied, immunotoxicity may result."

I submit it is not safe enough for the FDA to simply say it is not known if a small amount of silicone may pass from the silicone shell of an implant into breast milk. If this occurs, it is not known what effect it may have on the nursing infant. We must protect our future generation, who cannot make a choice.

Thank you.