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Breast Implant Chemical List
As we review the CD evidence gained through discovery with the MDL 926, we will be posting
chemicals known to be used in the processing of breast implants or in the sterilization process. They will be identified by
manufacturer, description of usage, and the disk and file where the information was obtained. If you have documentation of
any chemical, please contact me for posting. Documentation would be evidence that has been actually entered into evidence
during a trial or negotiations. Unverifiable lists cannot be posted on this site.
Cleansing/Sterilization Chemicals
Ethylene oxide--McGhan--Ethylene oxide was used in the sterilization of the medical devices it made including breast prostheses.
--MCG901/62993/04/8418 The use of this chemical was called into question by a physician in California in a letter dated July
17, 1981, in which the doctor states that "ethylene oxide is "very, very irritating to tissues and is impossible
to thoroughly get out of implants, so that may be a major cause of constrictive fibrosis." --MCG901/62993/04/8416
Trichloroethane--McGhan--All products were cleaned with 1,1,1 Trichloroethane solvent, in accordance with ASTM Standard
F703--MCG901/62993/06/4495
Silicone Barriers--Double Lumens
Dimethyldiphenyl-- McGhan--Dimethyldiphenyl was used
in all INTRASHIEL products which came with a smooth or BIOCELL (textured) surface--MCG901/62993/06/4495
Dimethyl/Trifluoropropylmethyl--McGhan--
Dimethyl/Trifluoropropylmethyl was used in all UHP (Ultra-High Performance) products. These products also came with either
a smooth or BIOCELL surface.--MCG901/62993/06/4495
Silicone Polymers
methyl chloride to give a mixture of methylchlorosilanes--BAX
104/121792/17/Z-06351.002
(see technical note below)
dimethyldichlorosilane, (CH3)2SiCl2. Reaction of (CH3)2SiCl2
with water results in the formation of polydimethylisiloxane prepolymers-- BAX 104/121792/17/Z-06351.002
methylvinylsiloxane--
BAX 104/121792/17/Z-06351.002-- prepolymer
polydimethylsiloxane-- BAX 104/121792/17/Z-06351.002 The swelling agent
is a high viscosity polydimethylsiloxane
polymethylvinylsiloxane and polymethylhydrogensiloxane are present in lesser
amounts.-- BAX 104/121792/17/Z-06351.002
Platinum as a catalyst
August 8, 1975--memo from Tom Powell to Bill
Masuda
Note on document indicates "gel mammary shell"
Subject: Platinum Solution--expecting a new supply
of platinum solution from General Electric BAX406/030393/10/83635
September 3, 1976-- Letter from Department of Health,
714 P Street, Sacramento, CA to Mr. James Rudy concerning "leakage of liquid silicone into body tissue" as a "serious
hazard to health." Also concerned that corporate policy on "defective manufacture would seem to discourage accurate
reporting of failure circumstances by your customers." Signed by Victor Asch, PHD, Biomedical Engineer BAX406/030393/08/8277
Toulene
Toluene--mentioned in numerous manufacturers' documents, toluene can cause, according to OSHA documents,
many difficulties with the mucus system and the digestive system of the body. This document will be available soon on the
internet.
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