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

www.BreastImplantAwareness.org/cando.htm

FDA PANEL HEARINGS October 15, 2003

MS. KEELING: My name is Marlene Keeling. I paid my own way here and I have no conflicts of interest. I chose to get double-lumen breast implants in 1978 after my plastic surgeon assured me only 2 percent 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 demyelating neuropathy. Since removing my implants, 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 affected by exposure to silicone gel."

Inamed data has revealed the 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 and are involved in control of infection?

In networking with other silicone-implanted women, I realize that many were being diagnosed with chronic inflammatory demyelating 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.

German research by Flasseck et al., published 2003, found higher platinum levels in the fat tissue of breast-implanted patients when compared to control patients without implants. The 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.

This becomes important because the Dow-funded Semple, et al., study on breast milk from implanted women used 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 researchers, could you comment on whether you believe that elemental silicon is an appropriate measurement for breast milk from implanted women to determine safety. Their response was, of course not.

How can this panel vote to approve devices for augmentation and revision of young women of childbearing age without a properly designed breast-milk study for safety of children born after implantation.

I have one final point. Two years ago, McGhan Medical, now Inamed, filed a patent which makes the statement, "Silicone oil is not biocompatible with other human tissues. Therefore, the use of silicone-based filler material has been discontinued in the industry."

How can this panel approve a device that harms human tissue, leaks silicone and heavy metals through the shell, ruptures at an underascertained 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.

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 must say no to corporate greed. I don't have a Ph.D. in suicide risk, but I can tell you, in networking with thousands of breast-implanted women, many do not have the money to have their ruptured and leaking implants removed.

Many have constant pain. Many have declining health. Many have lost their health insurance or have been denied coverage. Many have children born after implantation with similar health problems and suffer guilt. Many are now no longer able to take care of their families and do not want to be a burden.

Thank you.