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WOMEN’S IMPLANT SUPPORT NEWSLETTER

Founder: Myrl Jeffcoat
E-Mail:   myrl_jeffcoat@yahoo.com

February 23, 2000  

UP TO THE MINUTE STOCK QUOTES FOR ALL OF "OUR" MANUFACTURERS

See 'em all, by clicking here

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A MESSAGE FROM DIANA ZUCKERMAN, Ph.D.
 
Hi everyone!
We are compiling 3 lists:
1. The individuals and group leaders coming to the FDA meeting on saline
implants on March 1-3.

2. The individuals and group leaders who want to come to our workshop the
afternoon before the meeting, which will be on Feb. 29 in the same hotel as
the meeting.

3. The individuals and group leaders who are not coming but want to submit
testimony or a letter to the FDA on the topic.
Please let us know as soon as possible if you belong on any of these lists.
Even if you have already been in touch, please contact us again. We're
trying to keep track of everything, and also helping with logistics.
Sincerely,
Diana Zuckerman, Ph.D.
Executive Director
National Center for Policy Research for Women and Families
1444 Eye Street, NW
Suite 900
Washington, DC 20005
202 216-9507

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Immunology of Silicones, Vol. 210 
by: Michael Potter

The following book can be ordered through Barnes & Noble (hyperlink below).  It is not cheap ($197.00 + shipping and handling).

This volume contains 46 papers on a variety of topics relating to silicones. The chemistry of silicones and the composition of the commonly used silicone breast implants is described. It has been estimated that around 800,000 women in the U.S. have been recipients of silicone breast implants and there is much concern about the biological reaction to materials contained within these implants. Silicones interact with proteins and tissues, usually in a non-specific way. The question of whether silicone implants cause disease was not the subject of this book. It is generally accepted that under special circumstances silicone gels can induce a chronic inflammatory response and act as immunological adjuvants. The main benefit of this volume is the presentation of a balanced perspective of a field that is often clouded by controversy.

FROM THE BOOK

Table of Contents
Silica, Silicon and Silicones ... Unraveling the Mystery 3
Silicone Degradation Reactions 13
Chemical, Physical and Mechanical Analysis of Explanted Breast Implants 25
Silicon and Silicone Levels in Patients with Silicone Implants 39
Detection of Silicone Migration and Biodegration with NMR 49
Serum Silicon Levels are Elevated in Women with Silicone Gel Implants 59
The Development of an ELISA Method for the Detection of "Antibodies" to Silicone 69
The Adsorption of Proteins on a Polydimethylsiloxane Elastomer (PEP) and Their Antigenic Behavior 75
Aspecific Immunoglobin Binding to Hydrophobic Surfaces 85
Cytotoxicity and Membrane Damage in vitro by Inclusion Complexes Between y-cyclodextrin and Siloxanes 93
Induction of Type-II Collagen Arthritis in the DA Rat Using Silicone Gel as Adjuvant 103
The Adjuvancy of Silicones: Dependency on Compartmentalization 113
The Adjuvant Effect of Silicone Gel and Silicone Elastomer Particles in Rats 123
Silicone Gel and Octamethylcyclotetrasiloxane Potentiate Antibody Production to Bovine Serum Albumin in Mice 139
Fibrogenic and Other Biological Effects of Silica 147
Macrophages in Host Defense Mechanisms 159
Structure and Function of Natural Antibodies 167
Antibodies to Cholesterol: Biological Implications of Antibodies to Lipids 181
Silicone-Induced T-cell Proliferation in Mice 189
Silicone-induced Modulation of Natural Killer Cell Activity 199
HLA Typing in Women with and without Silicone Gel-filled Breast Implants 209
T Cell-Mediated Immune Response to Silica in Silicone Breast Implant Patients 227
Immunohistopathology and T-cell Receptor Gene Expression in Capsules Surrounding Silicone Breast Implants 237
Macrophage-Silicone Interactions in Women with Breast Prostheses 245
Microscopic Techniques and Histologic Finding in Silicone Mammary Implant Capsules and Regional Paranodal Tissues 253
Antinuclear Antibodies in Apparently Healthy Women with Breast Implants 265
Silicone Binding Immunoglobulins in Human Sera 269
Autoantibodies in Patients with Silicone Implants 277
Clinical and Laboratory Features of Patients with Scleroderma and Silicone Implants 283
Re-Evaluation of Autoantibodies and Clinical Overview of Silicone-Related Disorders 291
Development of Scleroderma-like Syndrome in Tsk/+ Mice is not Enhanced by Silicone Administration 299
Comparative Epitope Mapping of Antibodies to Collagen in Women with Silicone Breast Implants, Systemic Lupus Erythematosus and Rheumatoid Arthritis 307
The Prevalence of Autoantibodies in Symptomatic and Asymptomatic Patients with Breast Implants and Patients with Fibromyalgia 317
Monocyte/Macrophage Infiltrates in the Salivary Glands of Women with Silicone Breast Implants 323
Novel Anti-Silicone Surface-associated Antigen Antibodies (anti-SSAA(x)) may help Differentiate Symptomatic Patients with Silicone Breast Implants from Patients with Classical Rheumatological Disease 327
Laboratory Studies in Breast Implant Patients: ANA Positivity, Gammaglobulin Levels, and Other Autoantibodies 337
Is the Risk of Multiple Myeloma Increased in Patients with Silicone Implants? 357
Multiple Myeloma in Women with Silicone Breast Implants. Serum Immunoglobulin and Interleukin-6 Studies in Women at Risk 361
Silicone Gel Implants and Monoclonal Gammopathies: Three Cases of Multiple Myeloma and the Prevalence of Multiple Myeloma and Monoclonal Gammopathy of Undetermined Significance 367
Monoclonal Gammopathy of Undetermined Significance 375
The National Cancer Institute Silicone Implant/Multiple Myeloma Registry 385
The Epidemiology of Monoclonal Gammopathy of Unknown Significance: A Review 389
Plasmacytoma Development in Mice Injected with Silicone Gels 397
The Association of Augmentation Mammoplasty with Connective Tissue Disease, Including Systematic Sclerosis (Scleroderma): A Meta-Analysis 411
The Prevalence of Breast Implants Among Women in the United States 419
Epidemiology of Autoimmune and Immunological Diseases in Association with Silicone Implants: Is There an Excess of Clinical Disease or Antibody Response in Population-based or Other "Controlled" Studies? 427
ABOUT THE AUTHOR

Affiliation
Potter, Michael, MD(National Institutes of Health)
Rose, Noel R., MD, PhD(Johns Hopkins Univ)

The contributors represent the specialties of pathology, radiology, rheumatology, allergy, biology, chemistry, genetics, immunology, surgery, and biology. Most are from universities, companies, and medical institutes in the U.S. Institutions prominently represented include Dow Corning Corporation, Univ of Florida, Harvard Univ, UC Davis, Univ of Iowa, Rochester General Hospital, National Cancer Institute, National Health Institutes, Virginia Commonwealth Univ, and Johns Hopkins Univ.

Click here order from Barnes & Noble


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The importance of the LS422 Documents, comes from the "enlightenment" they give about the Chemicals and Compounds that were used in the manufacturer of various breast implants.
 
LS 422 documents
These image files were converted to text and sent to us by Pam Dowd. . .Thank you Pam.
January 29, 1980
 
TO:                  Barney Howard                - 113
                        Cec Svktich                      - 313
cc:                   Jackie Gant                      - S23
                        Gene Jakubczak              - S23
FROM:            Sue Peters                       - S23
SUBJECT:       LS422 QC
 
Barney, as per our conversation I’m sending a one pound sample of LS422, Lot FC109351 to your lab for analysis. This is the material now in-house and slated for the LS mammary envelope trial run.  The LS422 will have the medical number X7-2553. I’ve assigned the material medical experimental lot number HX8868. Will you please run the tests listed below and relay the results?
 
                                                                                      METHODS OF ANALYSIS
TEST                                                                             CTM    Sub      Compendia
1.                       Raw materials               Midland Certs                         
2.                       Specific Gravity, 25 1/4 C                                0022                ASTM D 972
3.                       Plasticity                                                           0166                ASTM D 926
 
Catalyze 100 parts base with 0.10 parts platinum II. To 3 separate portions add 1.8, 2.0, 2.2  XR6 3570 and 0.2 parts Ethynyl Cyclohexanol.  Mold o.075 inch ASTM slab for 10 + 5 minutes at 138 + 50 C(2800 F) and cure 4 + 0.25 hours at 177 + 50 C  (3500 F).
 
 
Durometer, Shore A
 
0099
ASTM D 2240
5.
*Tensile, Die C
 
0137A
ASTN D 412
6.
*Elongation
 
 
0137A
ASTM B 412
7.
*Modulus @100% E1ongation
 
 
0137A
ASTM B 412
8.
*Modulus @200% E1ongation
 
 
0137A
ASTM B 412
9•
* Modulus @300% E1ongation
 
 
0137A
ASTM B 412
10.
*Tear, Die B
 
 
0159A
ASTM B 624
 
 
*Report Minimum
11.   Rheometer                        Run curve for all XR63570 levels
0-000054
 
  2-
 
January 29, 1980
Page 2
 
 
 
I have also sent you a sample of LS422, Lot FC109351 which has 0.25 weight : (unable to read word) zinc stearate added.  The medical numbers for this material are X7-2550 Lot HX8869. Will you please run the test listed below and relay the results?
 
TEST
METHODS OF ANALYSIS
CTM SUB CO~ENDIA
1.       Color                                                                                                  0063
2.       Specific Gravity, 25°C                                                                        0022              ASTM D 972
3.       Plasticity                                                                                             0166              ASTM D 926
  Catalyze 100 parts Q7-2420 base with 0.128 platinum II.  To 4 separate portions, add 0.8, 0.9, 1.0, 1.1, XR6-3570 and 0.1 parts Ethynyl Cyclonexanol.
Mold 0.075 inch ASTM slab for 10 + 5 C (2800F) and cure 4 + -/25 hours at 177 + hours at 177 + 50 C (3500F).
 
 
Durometer, Shore A
0099
ASTM D 2240
5.  *Tensile, Die C
0137A
ASTM D 412
6.  *Elongation
0137A
ASTM D 412
7.  *Modulus @ 100% Elongation
0137A
ASTM D 412
8.  *Modulus @ 200% Elongation
0137A
ASTM D 412
9.  *Modulus @ 300% Elongation
0137A
ASTM D 412
10.*Tear, Die B
0159A
ASTM D 624

                                               
*Report Minimum
 
11. Rheometer              Run curve for all XR6-3570 levels
 
12. Zinc Stearate                                                          0571
 
 
Thanks in advance. If there are any questions, please call at ext. 432.
Regards,
 
Sue Peters
sfc
                                                                                                                                                 D-000055
- - - - - - - - - - - - - - - - - - - - - - - -


. . . .and another'n. . . .

October 7, 1983

TO: BILL BOLEY

CC: TONY BARTOLO
        GENE JAXUBCZAK
        MIKE HEATON
        FRANK CYBALA
       JIM MATHERLY

FROM: TOM BROWN

SUBJECT: LS 422 LOT FA101435 

Bill, as we discussed, the following is the situation regarding lot FA101435 of Silastic® LS 422 flurosilicone base:

1.  Original test results from Midland indicated this lot was acceptable.

2.  Testing in Hemlock to criteria specified for Q7—2553 (flurosilicone base) determined that the level of sodium present in this material was excessive by approximately 4ppm. All other criteria were acceptable.

3.  Lot FA101435 has exceeded its original shelf life. Samples of this lot are being submitted to Midland Elastomers QA for re-testing lot acceptance require­ments as LS 422.

4.  Enclosed please find a copy of the test reports on LS 422 lot FA101435, and Q7-2553 lot HH093006 (the Medical Products nomenclature for LS 422 lot FA101435)

As I understand it, from a biological standpoint you see no problems in using this lot of material as the base for preparing Silastic® II rotocoating dispersion. In order to secure a waiver of the emission specifications, your favorable opinion will be required. For your convenience, if you agree that this material may be used for the pro­duction of Silastic II Mammary Prostheses, please sign and date the blank on the attached page.

 

Regards,

Thomas E. Brown

I _________ PRODUCED BY DCC & DCW

SILASTIC® LS 422 LOT FA101435 (Q7—2553 LOT H093006) MAY BE USED FOR THE PRODUCTION OF SILASTIC® II MAMMARY  PROSTHESES. THE EXCESS SOLIUM DETECTED IN EMISSIONS TESTING SHOULD POSE NO PROBLEM FROM A BIOLOGICAL STANDPOINT.

 

SIGNED __________________

William F. Boley
DATE

* SOLIUM is a mistype on the actual document.  They are referring to SODIUM

 
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OTHER SILICONE RELATED RESOURCES ARE AVAILABLE THROUGH
THE SILICONE WEBRING

http://www.homestead.com/siliconecity /webring

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WHERE THERE’S SMOKE THERE’S FIRE ~ On The Net
The following websites have the “Where There’s Smoke There’s Fire” documents:

http://implants.clic.net/tony/Smoke/index.html

http://www.homestead.com/siliconecity/index.html

http://implants.clic.net/tony/Smoke/index.html

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Dow Docs - Online

http://www.info-implants.com/

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LOOKING FOR BACK ISSUES OF THE WOMEN’S IMPLANT SUPPORT NEWSLETTER?
Back issues of our Newsletters are archived and available on the Tony and Micheline Lambert’s website, “Canadian Connection.”

http://implants.clic.net/tony/Myrl/index.html

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HUMOR

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THOUGHT FOR THE DAY
Sent to us by Edna. . .Thank you Edna

       ~Snowflakes are some of nature's most fragile things, 
              but just look what happens when they stick together.

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   Women's Implant Support Website

    http://www.homestead.com/siliconecity 




Women’s Implant Support Newsletter

http://www.webstarmagic.com/wisletter.htm

E-Mail Myrl
myrl_jeffcoat@yahoo.com
Women's Implant Support Newsletter




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