Diana Zuckerman dz@center4research.org

Dear Friends,

This is the article on platinum in breast milk and other body fluids that was published online a few days ago, and will be published in the journal Analytical Chemistry on May 1. A simplified summary by CANDO is below.

At the FDA advisory panel meeting on silicone implants last April, several patients testified about platinum in their bodies from breast implants. When advisory panel members asked Inamed on April 12 about platinum in implants, they were assured by Dr. Brook (an Inamed consultant) that the platinum was in the "zero valent state" and therefore safe. Similarly, on April 13, Mentor’s Dr. Scott told the panel that the platinum "as far as we can tell" is 100 percent at the zero valent state. The transcripts are available online at

http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4101t2.DOC and at

http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4101t3.doc

However, this newly published peer-reviewed study finds that in women with silicone implants, there were very high levels of platinum in their breast milk, urine, hair and nails, and that the platinum was in the +2, +4, and +6 oxidation states, rather than 0. In contrast, the two women tested with saline breast implants did not have elevated platinum in their body fluids.

Since most women who get breast augmentation are reproductive age, and they are currently advised that implants do not interfere with breastfeeding, this is potentially very big news that should have an impact on FDA's approval process.

Please note that this does not mean that all women with breast implants have platinum in their bodies. It means that we need more information about how often this happens and what the health effects are.

The 2005 statistics of the American Society for Aesthetic Plastic Surgery estimates that 58,000 augmentation patients (not reconstruction patients) received silicone gel breast implants in the U.S. last year.

Congratulations to Marlene Keeling, Susan Maharaj, and Ernest Lykissa on this important research!

Best wishes,

Diana Zuckerman, Ph.D.

President

National Research Center for Women & Families

1701 K Street, NW, Ste. 700

Washington, DC 20006

(202) 223-4000

www.center4research.org

Summary of Research

Total Platinum Concentration and Platinum Oxidation States in

Body Fluids, Tissue, and Explants from Women Exposed

To Silicone and Saline Breast Implants by IC-ICP-MS

E.D. Lykissa and S.V.M. Maharaj

in

Analytical Chemistry, April 2006

Summary

Women exposed to silicone breast implants have platinum levels that exceed that of the general population, and the oxidation states of the platinum indicate that the exposure may be toxic.

Ion chromatography-inductively coupled plasma-mass spectrometry (IC-ICP-MS) was used to determine the total platinum (Pt) concentration and platinum oxidation states in samples from women exposed to silicone and saline breast implants. Samples included: whole blood, urine, hair, nails, sweat, brain tissue, breast milk, and explants.

Platinum in nine explanted silicone gel breast implants were mainly in the +2, +4, and +6 oxidation states. Platinum in seven whole blood and six breast milk samples from women implanted with silicone breast implants occurred mainly in the +2 and +4 oxidation states. In contrast, the fluid from the two saline breast explants tested did not contain detectable levels of Pt.

This peer-reviewed published study is the first to document the various platinum oxidation states in samples from women exposed to silicone breast implants. Positive oxidation states indicate risk.

Introduction

A complex platinum salt, hexachloroplatinate, has been used in silicone gel-filled breast implants as a catalyst in both the gel and envelope. Platinum salt exposure has been associated with a range of problems, from positive skin-patch tests (indicating an allergic reaction) and contact dermatitis, to more serious problems such as asthma, immunogenicity, and including potentially fatal reactions such as inhibitory effects on brain enzymes, neurotoxicity, mutagenicity, carcinogenicity, and allergic anaphylactic reactions.

Recent studies have shown that there are significant amounts of platinum in silicone breast implant gel and envelopes. Platinum has been shown to leak out of intact implants, and accumulate in the scar tissue and breast tissue of women exposed to silicone breast implants.

Platinum in compounds that occur in oxidation states other than zero (0) may be harmful to human health. In the compound hexachloroplatinate (used in silicone gel-filled breast implants), the oxidation state of platinum is +4. No previous study ever actually analyzed a breast implant or explant for the various forms of platinum.

Materials and Methods

The average amount of time the implants were in the women’s bodies was approximately fourteen years. The number of years the subjects were explanted before the analyses were conducted was six years.

The surgically explanted silicone implants in this study were all 2^nd generation implants, from the 1970s-1980’s, except for one more recent (3^rd generation), "low-bleed" silicone gel breast implant.

Questionnaires were completed to provide information regarding whether the women had been treated with platinum-based chemotherapy drugs; had worked in occupational settings where exposure to platinum may have occurred; or had dental amalgams that contained platinum.

Results and Discussion

The average platinum concentration in samples from women exposed to silicone breast implants was found to be the following when compared to samples from individuals with no known platinum exposure:

Hair samples 14 times higher

Nail samples 3 times higher

Breast Milk 100 times higher

Urine 60-1700 times higher

Our results indicate that platinum migrates from silicone implants via the lymphatic and blood systems into the urine, sweat, and breast milk, with deposits and accumulation in hair and nails. Platinum, including ionized forms of platinum, may persist years after the silicone gel breast implants have been removed.

The women did not have other platinum exposures that could explain the results.

All silicone envelopes used in silicone- and saline breast implants (and in testicular implants catalyzed with ionized platinum) would be expected to degrade and depolymerize as they age.

Silicone gel breast implants are the most likely source of the elevated total platinum levels, and the reactive forms of platinum in women