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Breast Milk Silicone

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DCC017001517

WEST COAST ANALYTICAL SERVICES

November 2O, 1992

BRODY, M.D. INC. GARRY S

hire Medical Building #504

11411 hire Avenue

Downey, California 90241

Attn:

Dr. Garry Brody

JOB NO. 22488

LABORATORY REPORT

Samples Received: One (1) Breast Milk Sample

Date Received: 9-30-92

Purchase Order No: COD

The sample was analyzed as follows:

Samples Analyzed Analysis Results

One (1) Breast Milk Silicone by GC/FID Table 1

The sample was analyzed using modification of the

procedure developed by Dow Chemical for silicon.

(po1ydimethy1silaxane) in water. The sample is

reacted with hydrochloric acid to hydrolyze the

silicone to dimethyldisilanol, than with

hexamethyldisiloxane (HMDS) to generate

dimethoxydimethlsilane (D). This compound is then

determined by gas chromatography (GC).

The sample results are shown in Table 1. The detection

limit is high because of an interference in the method

blank which was shown to be due to D in the reagents.

This was shown using both QC and gas

chromatography-mass spectrometry (GCMS). Attempts to

eliminate this interference by distilling the HMDS

failed. No other interferences from the matrix were

observed.

Bettina Oelke

Senior Chemist

Shelton

Technical Director

This report to be reproduced in its entirety.

=============================================

GARRY S. BRODY, M.D., INC. Job # 22488

Dr. Garry Brady November 20, 1992

LABORATORY REPORT

The chemical used in this procedure for calibration is

dichlorodimethylsilane (DCDS). The silicone gel used

in implants could not be dissolved in any solvent, so

calibration solutions could not be made from the gel.

An attempt to disperse the gel in both homogenized

milk and whole cream using ultrasonication also

failed. A sample of the gel, unweighed, was taken

successfully through the analytical procedure showing

that the test method is valid.

In conclusion, the method appears to work, but it

appears that it is impossible to disperse or dissolve

the silicone gel in body fluids in high enough

concentrations to be measured. Dow developed the

original test for low molecular weight silicones, used

as anti-foams-and surfactants in water treatment,

forms that are-water soluble. Perhaps the test could

be applied to tissues, however the presence of

silicone in tissues may be obvious from the situation.

Since silicone gel is not soluble in body fluids

above 5ppm it may be unlikely to metabolize fast

enough to show an elemental silicon. The rate of

elimination is probably faster than the rate of

metabolization.

While these results are negative, do you have any

suggestions for further research or where and how

these results could be published?

===============================

WEST COAST ANALYTICAL SYSTEMS

GARRY S. BRODY, M.D. * INC

Dr. Carry Brady

LABORATORY REPORT

Job #22488

November 20, 1992

Table 1

Silicone by GC/FID

Sample ID Parts per million (mg/l)

Breast Milk, Chase D. L. N. D.

Detection Limit

*High detection limit due to an interference in blank.

Date extracted: 10/2/92

Date Analyzed: 10/6/92

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