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PART 8: ENDNOTES
1 Per agreement with Dow Corning Corporation, names have been changed. [back]
2 Franklin, Benjamin H., Annelin, Ronald B., "Subcutaneous Implants of Developmental Prosthetic Gels in Monkeys and Rats: Examination of Tissue Deposition and Urinary, Fecal, and Respiratory Elimination Routes," Dow Corning Corporation File Number 2726-1, Dow Corning Corporation, December 12, 1975. [back]
3 Carson, Steven, Ph.D., "Implantation Study in Rabbits with Four (4) Mammary Gels," Biometric Testing Inc., April 25, 1975. [back]
4 Carson, Steven, Ph.D., "Implantation Study in Rabbits with Four (4) Mammary Gels," Biometric Testing Inc., April 25, 1975. [back]
5 Franklin, Benjamin H., Annelin, Ronald B., "Subcutaneous Implants of Developmental Prosthetic Gels in Monkeys and Rats: Examination of Tissue Deposition and Urinary, Fecal, and Respiratory Elimination Routes," Dow Corning Corporation File Number 2726-1, Dow Corning Corporation, December 12, 1975, p.2.[back]
6 This section is based upon information from:
Eckroth, David; Graber, Eden; Klingsberg, Anna; Siegel, Paula M.;Editors: Kirk- Othmer Concise Encyclopedia of Chemical Technology John Wiley & Sons, New York: 1985.
Lane, T.H., Ph.D., "Silica, Silicon, and Silicones. . . Unraveling the Mystery", Dow Corning Corporation: 1995.
Rochow, Eugene G., Silicon and Silicones: About Stone-age Tools, Antique Pottery, Modern Ceramics, Computers, Space Materials and How They All Got That Way, Springer-Verlag Berlin Heidelberg: 1987.
Sax, N. Irving, & Lewis, Richard J., Sr., Hawley's Condensed Chemical Dictionary, Van Nostrand Reinhold Company, New York: 1987. [back]
7 Sax, N. Irving, & Lewis, Richard J., Sr., Hawley's Condensed ChemicalDictionary, Van Nostrand Reinhold Company, New York: 1987, p. 1038. [back]
8 Lane, T.H., Ph.D., "Silica, Silicon, and Silicones. . . Unraveling the Mystery", Dow Corning Corporation: 1995.
Rochow, Eugene G., Silicon and Silicones: About Stone-age Tools, Antique Pottery, Modern Ceramics, Computers, Space Materials and How They All Got That Way, Springer-Verlag Berlin Heidelberg: 1987.
This quotation comes from p.1 of the World Wide Web extract of their works. [back]
9 Lane, T.H., Ph.D., "Silica, Silicon, and Silicones. . . Unraveling the Mystery", Dow Corning Corporation: 1995.
Rochow, Eugene G., Silicon and Silicones: About Stone-age Tools, Antique Pottery, Modern Ceramics, Computers, Space Materials and How They All Got That Way, Springer-Verlag Berlin Heidelberg: 1987. This quotation comes from p.2 of the World Wide Web extract of their works. [back]
10 The New Lexicon Webster's Dictionary of the English Language, Lexicon Publications, Inc., New York, 1988.[back]
11 Sax, N. Irving, & Lewis, Richard J., Sr., Hawley's Condensed Chemical Dictionary, Van Nostrand Reinhold Company, New York: 1987, p.1004.[back]
12 Lane, T.H., Ph.D., "Silica, Silicon, and Silicones. . . Unraveling the Mystery", Dow Corning Corporation: 1995.
Rochow, Eugene G., Silicon and Silicones: About Stone-age Tools, Antique Pottery, Modern Ceramics, Computers, Space Materials and How They All Got That Way, Springer-Verlag Berlin Heidelberg: 1987.
This quotation comes from p.2 of the World Wide Web extract of their works. [back]
13 This section uses general historical information about the Dow Corning Corporation obtained from corporate literature, numerous other case studies, and interviews with members of the Dow Corning Corporation. [back]
14 Goggin, William C., "How the multidimensional structure works at Dow Corning," Harvard Business Review, 1976: p. 54-65. [back]
15 This section uses general historical information about the Dow Corning Corporation obtained from corporate literature, numerous other case studies, and interviews with members of the Dow Corning Corporation. [back]
16 The New Lexicon Webster's Dictionary of the English Language, Lexicon Publications, Inc., New York, 1988: p. 475.
17 Carrington, K.W. "Progress in the treatment of hydrocephalus," The Bulletin, Dow Corning Center for Aid to Medical Research (CAMR) newsletter, Volume 1, Number 1, October, 1959: p. 1:
For approximately, the last three years, Drs. Spitz and Nulsen have been successfully utilizing a valve designed by Mr. John Holter [a father of a hydrocephalus child in need of such a device]. Their results have not been published at this time, but certainly appear to be encouraging. . . Summary: 1. Fifty cases having ventriculo-venous shunts are reported. Follow-up periods ranged from two to eighteen months with 86 per-cent functioning well . . . 3. Sixty percent of the patients showed demonstrable physical or mental improvement following the shunt. In a paper delivered to the American Academy of Pediatrics meeting in New York City on October 9, 1956, Dr. E. B. Spitz reported on the first installations of the Silasticreg. tubes and valve designed by John Holter. During the 8 months following the first installation of this valve in February 1956, the same technique was employed in 68 cases. His procedure was successful in decompressing the brain in 57 cases, a feat he had previously achieved by other means in only 16 out of 122 cases. . . Holter valves are now being installed at a rate of more than 1200 a year. With about 4 million babies born per year in this country and an incidence of hydrocephalus in infants estimated at 1 in 500 per year among infants born in the United States.
18 "Silastic®" brand silicone is a trademark of the Dow Corning Corporation. [back]
19 Wallace, W. E., MD, "Prosthesis for dual defects," The Bulletin,
Dow Corning Center for Aid to Medical Research (CAMR) newsletter, Volume 2, Number 1, p. 1.[back]
20 Brown, James Barrett, MD, & Ohwiler, David A., MD, "Evaluation of silicones as tissue substitutes," The Bulletin, Dow Corning Center for Aid to Medical Research(CAMR) newsletter, Volume 2, Number 1, p. 1. [back]
21 Marzoni, F.A. Upchurch, S.E., and Lamvert, C.J., "An experimental study of silicone as a soft tissue substitute" , The Bulletin, Dow Corning Center for Aid to Medical Research (CAMR) newsletter, Volume 2, Number 1, p. 1 - 2. (Taken from Plastic and Reconstructive Surgery, 1959, 24(6): 600-608.) [back]
22 Braley, S.A., "Materials and Methods: Silicone treatment for cardiac catheters," The Bulletin, Dow Corning Center for Aid to Medical Research (CAMR) newsletter, Volume 2, Number 2, p. 4. [back]
23 Ames, R. H., MD, "Response to Silasticreg. Tubing," The Bulletin, Dow Corning Center for Aid to Medical Research(CAMR) newsletter, Volume 2, Number 4, p.1. [back]
24 McGregor, R.R., "Toxicology of the Silicones, Part I: Subcutaneous, intramuscular, and intraperitoneal injection and injection into the vitreous cavity," The Bulletin, Dow Corning Center for Aid to Medical Research(CAMR) newsletter, Volume 2, Number 4, p.15. [back]
25 Greatbatch, W., Chardack, W.M., & Gage, A.A., "Implantable pacemaker," The Bulletin, Dow Corning Center for Aid to Medical Research(CAMR) newsletter, Volume 3, Number 1, p.1. [back]
26 Cutting, Windsor C., MD, "Toxicity of Silicones," Stanford Medical Bulletin, Volume
10, Number 1, February 1952: p.25-26:
1. DC 200 Silicone produces renal tubular damage in rabbits, but not in rats, when fed in concentrations of one per cent, for three or four months.
2. DC Antifoam A Silicone produces widespread cellular infiltrations, particularly in the kidney and liver, when fed to rabbits in concentrations of .025 to one per cent for three or four months. Rats are spared these lesions.
3. The lower of these concentrations is 25 times that customarily used as an antifoaming agent in the preparation of foods and beverages.
This study was partially funded by a grant from Broemmel's Pharmaceuticals in San Francisco.
27 Russell, F.E. Simmers, M.H., Hirst, A.E., and Pudenz, R.H., "Tumors Associated With Embedded Polymers," Journal of the National Cancer Institute, Volume 23, Number 2, August 1959: p. 305 - 311.
This study was funded by the Volker Grant #1 from The Council on Drugs of the American Medical Association, and by a Neurosurgical Research Fund from the Institute of Medical Research at Huntington Memorial Hospital in Pasadena. [back]
28 Midland Silicones Ltd. was bought by Dow Corning in the early 1970's, several years after this study was published. [back]
29 Riley, I.H. and Winner, H.I., "A note on bacteriological tests of silicone rubbers for medical and pharmaceutical uses," The Bulletin, Dow Corning Center for Aid to Medical Research(CAMR)newsletter, Volume 3, Number 3, p.11. (Taken from the Journal of Pharmacy and Pharmacology)
30 Riley, I.H., and Winner, H.I., "A Note on Bacteriological Toxicity Tests of Silicone Rubbers for Medical and Pharmaceutical Uses," Journal of Pharmacy and Pharmacology, Volume 13, 1961; p. 111-114. [back]
Harris, Harold. I., MD, "Survey of Breast Implants from the Point of View of Carcinogenesis," Plastic and Reconstructive Surgery, Volume 28, 1961: p. 81 - 83.
This author mailed a questionnaire asking about the frequency of cancers seen in their implant patients to almost all U.S. certified plastics surgeons.
Conway, Herbert, MD, and Goulian, Dicran Jr., MD, D.D.S., "Experience with an Injectable Silasticreg. RTV as a Subcutaneous Prosthetic Material," Plastic and Reconstructive Surgery, Volume 32, Number 3, September, 1963: p. 294-302.
The authors were plastic surgeons from Cornell Medical Center in New York. They acknowledge "the interest and cooperation of the Dow Corning Center for Aid to Medical Research . . . in particular Mr. Silas Braley. . . "
Demergian, Vaughn, MD, "Experiences with the Newer Subcutaneous Implant Materials," The Surgical Clinics of North America, Volume 43, Number 5, October, 1963: p.1313-1321.
Demergian was part of the Department of Plastic and Reconstructive Surgery at Jackson Clinic in Madison, Wisconsin, at the time. [back]
32 Little, K. and Parkhouse, James, "Tissue Reactions to Polymers," The Lancet, October 27, 1962: p. 857-861. A Professor J. Trueta provided facilities, and the chemical manufacturers supplied samples and information about their samples.[back]
33 This section uses general historical information about the Dow Corning Corporation obtained from corporate literature, numerous other case studies, and interviews with members of the Dow Corning Corporation. [back]
34 Bassett, C. Andrew L., MD, & Campbell, James B., MD, "Keeping Silastic sterile," The Bulletin, Dow Corning Center for Aid to Medical research (CAMR) newsletter, Volume 2, Number 2, p.1. [back]
35 Greatbatch, W., Chardack, W.M., & Gage, A.A., "Implantable pacemaker," The Bulletin, Dow Corning Center for Aid to Medical Research(CAMR) newsletter, Volume 3, Number 1, p.1. [back]
36 Dow Corning Corporation's response to the University of St. Thomas Case Study series, p. 1.[back]
37 Leninger, R. I., Mirkovitch, V., Peters, A. & Hawks, W.A., "Change in Properties of Plastics During Implantation.", Trans. Amer. Soci. Artif. Int. Organs, Volume 10, 1964, p. 320-321. [back]
38 Leninger, R. I., Mirkovitch, V., Peters, A. & Hawks, W.A., "Change in Properties of Plastics During Implantation.", Trans. Amer. Soci. Artif. Int. Organs, Volume 10, 1964, p.320. [back]
39 Park, Joon B. and Lakes, Roderic S., "Tissue Response to Implants," Biomaterials: An Introduction, Second Edition, Plenum Press, New York: 1992, p.223-225.
With respect to breast implants, encapsulation of the implant can cause discomfort from the hardness and aesthetic displeasure , according to a Dow Corning scientist with experience in the medical implant area. [back]
40 The Random House College Dictionary, Revised Edition, Random House, Inc., 1975: p.628.[back]
41 Carson, Steven, Ph.D., "Chronic Implantation Studies of Polysiloxanes In Dogs," November 29, 1968, p. 1.[back]
42 Carson, Steven, Ph.D., "Chronic Implantation Studies of Polysiloxanes In Dogs," November 29, 1968, p. 1.[back]
43 Carson, Steven, Ph.D., "Chronic Implantation Studies of Polysiloxanes In Dogs,"
November 29, 1968:
In view of the large number of implants placed in some of these dogs, they all showed remarkable recoveries, and were singularly unaffected during the extended period when these foreign materials remained implanted. Behavior and appearance were normal in all . . . Generally, no untoward chronic tissue reactions were noted with any of the implant materials. Systemic tissue responses were not observed at 24 or 36 months. There was no evidence of tumorigenesis, with any of the samples or at any of the sites of implantations over a 3-year period of testing in dogs. . . The prosthetic breast samples [made of material numbered 372] . . . revealed no untoward tissue reactions . -p.11 [back]
44 This information is closely based on an interview with a Dow Corning employee, and The Dow Corning Product Staging System: A Product Management Tool: Dow Corning Corporation: p. 3 - 7. [back]
45 Taken from The Dow Corning Product Staging System Introduction, p. 3-4.oration: p. 3 - 7.[back]
46 This section uses information obtained from members of the Dow Corning Corporation.[back]
47 Dow Corning, "Position Statement on: Dow Corning Mammary Task Force"-p.2. [back]
48 A Dow Corning Employee [back]
49 Franklin, Benjamin H., Annelin, Ronald B., "Subcutaneous Implants of Developmental Prosthetic Gels in Monkeys and Rats: Examination of Tissue Deposition and Urinary, Fecal, and Respiratory Elimination Routes," Dow Corning Corporation File Number 2726-1, Dow Corning Corporation, December 12, 1975, in the summary section. [back]
50 Franklin, Benjamin H., Annelin, Ronald B., "Subcutaneous Implants of Developmental Prosthetic Gels in Monkeys and Rats: Examination of Tissue Deposition and Urinary, Fecal, and Respiratory Elimination Routes," Dow Corning Corporation File Number 2726-1, Dow Corning Corporation, December 12, 1975, in the summary section. [back]
51 Carson, Steven, Ph.D., "Implantation Study in Rabbits with Four (4) Mammary Gels," Biometric Testing Inc., April 25, 1975, p. 4-5. [back]
52 Carson, Steven, Ph.D., "Implantation Study in Rabbits with Four (4) Mammary Gels," Biometric Testing Inc., April 25, 1975, p. 4. [back]
Go on to Part 9 (Appendix 1)