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Myrl Jeffcoat myrlj@jps.net

3 mai, 2005 01:47

Susan Maharaj Testimony - FDA Panel Hearings - April 2005

DR. MAHARAJ: Good morning. I'm Dr. Susan Maharaj, and I am a professor of chemistry. I have no conflict of interest. Today I am presenting the results of Maharaj 2004, Maharaj and Lykissa 2004, and Lykissa and Maharaj 2005.

Next slide, please. Maharaj 2004. The results show that high levels of platinum are present in silicone breast implant gel, shells, and in the corresponding capsular tissue of women exposed to silicone breast implants. The gel and shell platinum values in this study are much higher than reported by manufacturers. Platinum tissue concentrations in women exposed to silicone breast implants are higher than in tissue samples of women not exposed to these devices. And, in fact, the values do not overlap.

Next slide, please. Maharaj and Lykissa 2004 and Lykissa and Maharaj 2005. Mean platinum concentration in whole blood and urine samples of women exposed to silicone breast implants was higher than in control subjects.

Mean platinum concentration in whole blood and urine samples of children conceived after their mothers were implanted was higher than in children conceived before their mothers were implanted.

Next slide, please. Mean platinum concentration in hair, nails, and sweat samples of women exposed to silicone breast implants and in children conceived after their mothers were implanted were higher than that of the general population and higher than in children conceived before their mothers were implanted.

Mean platinum concentration in breast milk samples of women exposed to silicone breast implants was much higher, about 100 times higher, than samples from women not exposed to these devices.

Next slide, please. Mean platinum oxidation states in explanted silicone breast implants occur mainly in the +2, +4, and +6 valence states. This is a very important point. Manufacturers are claiming and FDA believes that platinum is in the zero valence state. Mean platinum oxidation state in whole blood samples of controlled subjects was mainly in the zero oxidation state.

Next slide, please. Mean platinum oxidation states in whole blood and urine samples of exposed women were mainly in the +2, +4, and +6 oxidation states. Mean platinum oxidation state in whole blood samples of children conceived by mothers after implantation and in a brain tissue sample of an exposed individual were in the zero, +2, and +4 oxidation states.

Next slide, please. In conclusion, my main three points are as follows. Number one, the platinum concentration in gel and shell material of silicone breast implants is actually much higher than reported by manufacturers.

Number two, the platinum concentration in many different types of samples is consistently higher in women exposed to silicone breast implants than in non?exposed individuals and is higher in children conceived after implantation than in children conceived prior to implantation.

And, number three, silicone breast implants contain highly reactive forms of platinum.

Thank you very much.

 


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