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 BAX 406/030393/10/83635

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 BAX 406/030393/08/8277

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.

Bristol Meyer Chemical List as introduced into court in Minnesota
FDA Chemical Confirmation

Bristol Meyer Squibb-Surgitek chemical list: introduced into U.S.Dist. Court of MN.

4th Division, Judge David S. Doty, in May 1992. Dow entered a permanent order to preserve evidence at that time. The breast implant examined for this case was used in a 1989 surgery.

INVENTORY OF PRODUCTION SAMPLE

  • EXHIBIT B–

    • (intermediate materials)

    Name Description
    SGM-26 GUM
    SGM-33 GUM
    SGM-35 GUM
    MDF-0069 CATALYST
    DC2—FLUID O.65CST FLUID
    LS 422 BASE
    DC 1107 FLUID
    Q1-0043 FLUID
    F1-0049 FLUID
    Q1-2287 ME VI CYOLLOS
    3-8015 PLATINUM II
    Q4-2782 FLUID
    Q4-2826 PR FLLUID
    Q4-2839 PL FLUID
    6-3570 CL FLUID
    7-2046A ELASTOMER
    7-2046B ELASTOMER
    Q7-2127 BASE STOCK
    Q7-2146 GEL FLUID
    Q7-2150 GEL FLUID
    Q7-2151 FIRM GEL
    Q7-2159A STANDARD GEL
    Q7-2167 GEL FLUID
    Q7-2168 GEL FLUID
    Q7-2317 1000CST FLUID
    Q7-2420 BASE
    Q7-2424A BASE
    Q7-2424B
    BASE
    Q7-2553 BASE

    (RAW MATERIALS):

    ACETONE ACS REAGENT SOLVENT
    ALUMINA, ACTIVATED FILLER
    CAB-O-SIL S-170 SILICA-BAG FILLER
    CHLORETHENE-BULK SOLVENT
    CHLORETHENE-DRUM SOLVENT
    CHLOROPLATINIC ACID 0.4% PLATINUM
    DIETHYLENE BLYCOL MBE ACETATE SOLVENT
    MEDICAL ADHESIVE A.MISC. ADHESIVE
    ETCH ETHYNYL CYCLOHEXANOL PROCESS AID
    ZINC STEARATE SURFACTANT

    2

    INVENTORY OF PRODUCTION SAMPLES

  • EXHIBIT B–

    • FINISHED PRODUCTS (in sterile packaging):

    NAME QUALITY TO BE RETAINED
    IC II-LOW PROFILE ROUND 50
    SILASTIC II-HIGH PROFILE ROUND 50
    SILASTIC II-TEARDROP 50
    SILASTIC II-GEL/SALINE 50
    SILASTIC MSI-LOW PROFILE ROUND 50
    SILASTIC MSI-HIGH PROFILE ROUND 50
    SILASTIC MSI-MODERATE PROFILE ROUND 50
    SILASTIC MSI-GEL/SALINE 50
                                                                                                                                                                            TOTOL 400


    MATERIALS USED EXCLUSIVELY IN THE MANUFACTURE OF BREAST IMPLANTS:

    (Intermediate materials):

    NAME DESCRIPTION
    Q7-2198 ADHESIVE
    Q7-2373 SHEETING
    Q7-2423 DISPERSION
    Q7-2551 DISPERSION
    Q7-2868 SHEETING
    Q7-2869 SHEETING
    Q7-2503 INFILTRATION VALVE
    Q7-2517 FILL TUBE ASSEMBLY
    Q7-2316 MAMMARY ENVELOPE, LPR
    Q7-2595 MAMMARY ENVELOPE, TDP
    Q7-3062 MAMMARY ENVELOPE, HPR
    Q7-3063 MAMMARY ENVELOPE, TDP-UPE
    Q7-3024 MAMMARY ENVELOPE, LPE-UPE
    Q7-3028 MAMMARY ENVELOPE, TEX INNER
    8-0102 MAMMARY ENVELOPE, MSI-UPE
    8-0104 FILL TUBE ASSEMBLY
    FILL TUBE NOZZLE COMPONENT
    SLS CONNECTOR COMPONENT
    SLS NEEDLE COMPONENT
    TUBING, MDF-0108 COMPONENT

    Bristol Meyer Chemical List as introduced into court in Minnesota FDA Chemical Confirmation

    What the FDA has to say about chemicals in breast implants.




    From: Rhodes, Stephen SPR@CDRH.FDA.GOV
    To: NAME WITHHELD
    Cc: Nearing, Toni M TMN@CDRH.FDA.GOV; Arepalli, Sambasiva
    SRA@CDRH.FDA.GOV; Allen, Samie Niver SXN@CDRH.FDA.GOV
    Date: Sunday, December 05, 1999 10:20 AM
    Subject: McGhan Implants

    Ms. ,

    Your e-mail dated November 25 regarding McGhan Medical breast implants was forwarded to me. You had two inquiries: when your implants were manufactured and what are the material constituents. For the former, FDA does not have information on the date of manufacture of implants based on lot numbers. For this you can contact McGhan Medical in Santa Barbara, CA, 1-800-624-4261. Regarding the materials, this style of implant has a silicone rubber shell and is filled with silicone gel. The silicone rubber contains the following substances:

    1. small amounts (parts per million) of various smaller silicones
    2. small amounts (50 - 100 parts per million) of metals like tin and platinum and very trace amounts of other metals
    3. trace amounts of volatile materials like xylene and other organic compounds
    4. considerable amounts (approximately 20 parts per hundred) of finely powdered silica that is tightly bound to silicone rubber pouch

    The filler material contains silicone oil and silicone gel in addition to the four materials (chemicals) listed above.

    I hope this answers your questions.

    Sincerely,

    Stephen Rhodes
    Chief, Plastic and Reconstructive Surgery Devices

    http://www.ccohs.ca/oshanswers/chemicals/chem_profiles/xylene/health_xyl.html

    Bristol Meyer Chemical List as introduced into court in Minnesota
    Chemical List from Evidence collected by MDL 926