Link to Stuyvesant High School People

Link to Leo Baeck Institute Family archive\

Link to Leo Baeck ancestral Collection




Robert Ira Lewy Distinguished Lecture Series in German Jewish History and NYU Skirball Department of 

Hebrew and Judaic Studies

Society of the Arch

Multiple  Myeloma Research Foundation Legacy  Society

NCBI Bibliography



Galaxy Society Manhattan School of Music Society

Enso Legacy New York Zen Center for Contemplative Care



Robert Ira Lewy, M.D., F.A.C.P  born October 16, 1943) is an American doctor who has conducted research on aspirin
therapy in heart disease and safety in recipients of silicone breast implants.  

Lewy graduated magna cum laude in 1964 

from Franklin and Marshall College in Lancaster, Pennsylvania, majoring in Biology after attending Stuyvesant High School in New York.. He was awarded the Roberts Prize in Biology, and was elected to the Phi Beta Kappa Society. He c

haired the Committee for Social Responsibility, welcomed Martin Luther King to the campus and arranged for collaboration with the Student Nonviolent Coordinating Committee (SNCC), at the time the leading pacifist desegregation voice in the South. He then matriculated at the University of Pennsylvania School of Medicine in Philadelphia, Pennsylvania. After one year, he took a leave of absence and was selected as a PhD candidate at the Princeton University Department of Graduate Studies doctoral program in Religion. There he was selected as a Woodrow Wilson scholar, and a William J. Fulbright Scholarship runner-up.

Returning to medical school, he graduated in 1971 from University of Pennsylvania School of Medicine in Philadelphia, Pennsylvania with a Doctor of Medicine degree. His Internship was served at the Philadelphia General Hospital, now defunct, in Philadelphia, and his Residency at the Mercy Catholic Medical Center in Philadelphia. He was then selected for a National Institute of Heart, Lung and Blood grant,[1] and began a two-year Clinical and Research Fellowship in Hematology at the Cardeza Foundation for Hematological Research of the Thomas Jefferson University of Philadelphia. His original research on the effect of aspirin on heart disease led to a period of prolific publishing in the scientific literature.[2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] He also held many hospital committee chairmanships, including Chairman, Infectious Disease and Pharmacy Review Committee of The Woman's Hospital of Texas, Chairman, Credentials Committee, Women’s Hospital of Texas and Chairman, Tissue and Therapeutics Committee, The Woman's Hospital of Texas. He holds two board certifications (board-certified by the American Board of Internal Medicine as an internist and sub-specialist from the American Board of Hematology); he is a member of the American Board of Forensic Examiners and a member of the American College of Rheumatology. He was accepted as a Fellow of the American College of Physicians in 1983.


Lewy practiced clinical hematology and oncology in Houston, Texas from 1979 until 2005, except for a brief period working for the Cancer Treatment Centers of America/Tulsa.[20] During this time he was Clinical Assistant Professor of Medicine at the University of Texas Health Science Center at Houston, and the Baylor College of Medicine in Houston. He served as a teaching physician at the St. Luke's Episcopal Hospital of Houston, where he was responsible for training interns, residents and fellows, and served the same function at the Ben Taub General Hospital in Houston on the Baylor College of Medicine Hematology service. During the early years of the AIDS epidemic (1979-1985) he was prominent in the evolution of diagnosis and treatment of hemophiliacs, post-cardiac bypass patients and the gay community of Houston. He was a staff member of the staffs of the Twelve Oaks Hospital ,the Hermann Hospital and founded the first AIDS only unit at Park Plaza Hospital..,He was a member of the Harris County Medical Society Committee on Public Health, the Board of the Harris County Blood Center and an Alternate Delegate to the Texas Medical .Association

His research on allergic aspects of silicone breast implants led to further scientific publications and book chapters during the mid-1990s as well as international scientific and governmental presentations,[21] and peer recognition.[22][23][24][25] On November 9, 2015, the Annals of Internal Medicine published a review on the safety of silicone breast

implants concluding that "further study is required to prove safety" (see Balk et al and Nannayakara et al below)[52]53]

His license remains in good standing in Texas, California, Pennsylvania and New York, although currently they are inactive due to his retirement in 2005. He remains registered with the American Board of Medical Specialties in Internal Medicine and Hematology. He published several papers regarding drug treatment of high grade brain cancers.[31][32][33]

Scientific 'whistleblowers' remain subject to selective legal and administrative retaliation.[34]


He is a member of the Steering Committee of the Multiple Myeloma Research Foundation. In 2006 he donated over $1 million to Stuyvesant High School, his high school alma mater for the establishment of the Dr. Robert Ira Lewy Multimedia Center, to serve as the high school’s central academic research facility.[35] In 2007 Lewy donated his personal library of 7000 books to the school[36] He established a proprietary family genealogy archive at the Leo Baeck Institute[37][38][39][40] and is listed as a Notable Graduate of Stuyvesant High School by the school[41] and the Stuyvesant Alumni Society for "pioneering work connecting hematology and cardiology".[42] In 2006 he wrote regarding guidelines for informing cancer patients[43] and topics in managed care .[44] In 2013 he commented for the New York Times regarding his previous work on aspirin use in heart disease.[45] and drug economics.[46] In December 2013, New York University honored him as a member of the Society of the Torch, which "honors alumni, faculty and friends of New York University who have recognized the importance of planning their philanthropy by providing to the University".[47] and in 2015 he became a member of the Society of the Arch, "established to recognize those benefactors who have supported NYU’s continued growth and reinvention with outright, six-figure commitments since September 1, 2010[48]"He continued publishing on tne management of multiple myeloma,[49] and published his photography.[50]

In late 2013 he made a bequest of $800,000 to New York University to establish the Dr Robert Ira Lewy Permanent Endowment in German Jewish History and Culture at the Skirball Department of Hebrew and Judaic Studies to establish the Dr Robert Ira Lewy Lecture Series In Jewish History and Culture and the Dr. Robert Ira Lewy Fellows In Jewish History and Culture.[51] He is a member of the Legacy Society of the Multiple Myeloma Research Foundation.


1.National Heart Lung Blood and Ischemia Investigator #5 T32 AM07084-04
2.Lewy, R.I., Kansu, E.: Prognostic Value of Platelet Counts in Idiopathic Sideroblastic Anemia; Blood; Sl:766-767; 1978.
3.Lewy, R.I., Smith, J.B., Silver, M.J., Wiener, L.J., Walinsky, P., & Saia, J.: Detection of Thromboxane B-2 in Peripheral Blood of Patients With Prinzmetal's Angina; Prostaglandins and Medicine; Vol. 2: 243-248; 1979.
4.Lewy, R.I., Smith, J.B., Silver, M.J., Saia, J., Walinsky, P., Wiener, L.: Detection of Thromboxane B2 in Peripheral Blood of Patients with Prinzmetal’s Angina. Clinical Research 27:462A, 1979.
5.Lewy, R.I., Wiener, L., Smith, J.B., Walinsky, P., Silver, M.J.: Intravenous Heparin Initiates In Vivo Synthesis Release of Thromboxane A-2 in Angina Pectoris; Lancet 2: 97; 1979
6.Wiener, L., Lewy, R.I., Walinsky, P., Lefer, A.M., Silver, M.J., Smith, J.B.: Thromboxane Release and Coronary Artery Disease Patients During Acute Myocardial Ischemia; Proceedings of the Florence International Conference on Myocardial Infarction; Vol. 1: 388-394; Excerpta Medica; Amsterdam; 1979 (Mason, D.T., Serneri, G.G., Oliver, M.F., Editors).
7.Lewy, R.I., Wiener, L., Smith, J.B., Walinsky, P., Silver, M.J., Saia, J.: Comparison of Plasma Concentrations of Thromboxane B-2 and Prinzmetal's Variant Angina and Classical Angina Pectoris; Clinical Cardiology; Vol. 2: 404-406; 1979.
8.Lewy, R.I., Wiener, L., Smith, J.B., Walinsky, P., Silver, M.J.: Measurements of Plasma Thromboxane in Peripheral Blood of Prinzmetal's Angina Patients; Circulation (Supp.) II: 248; 1979.(Presented November 15, 1979 at the Scientific Sessions of the American Heart Association, Anaheim, California).
9.Lewy, R.I., Kansu, E., Gabuzda, T.: Leukemia in Patients with Acquired Idiopathic Sideroblastic Anemia; An Evaluation of Prognostic Indicators; American Journal of Hematology; 6: 323-331; 1979.
10.Lewy, R.I., Bills, T.K., Dalton, J., Smith, J.B., Silver, M.J.: 19Hydroxyprostaglandin E and Infertility in Human Males; Prostaglandins and Medicine; 2: 367-372; 1979.
11.Lewy, R.I.: Thromboxane A-2 Release and the Injury-Spasm Hypothesis; Circulation; 62: 668; 1979(Letter).
12.Lewy, R.I., Effect of Elevated Free Fatty Acids on Thromboxane Release in Patients with Coronary Artery Disease.Hemostasis; 9:134-140; 1980.
13.Lewy, R.I., Wiener, L., Lefer, A.M., Silver, M.J., Smith, J.B., Thromboxane Release During Pacing-Induced Angina Pectoris; Possible Vaso-Constrictor Influence on the Coronary Vasculature; Circulation; Vol. 61: 1165-1171; 1980.
14.Michael L.H., Lewy R. I. et al. Thromboxane B2 in Dog Cardiac Lymph.Clinical Research 1980
15.Lewy, R.I., Thromboxane Release During Pacing-Induced Angina, (Author's Reply); Circulation;63: 237; 1981.
16.Lewy, R.I., Michael, L.H.: Transmyocardial Platelet Behavior in CAD (Author's Reply); Circulation; 63: 969; 1981.
17.Lewy, R.I. Thromboxane in Ischemic Heart Disease; New England Journal of Medicine (Letter);305: 106; 1981.
Lewy R.I. Role des thromboxanes dans l’angor spastique et dans l’angor occlusif. Proceedings of the International Symposium on Ischemia and Platelets. Editions de la Revue de Médecine. pp 57-60, 1982.
18.Lewy, R.I. Role of Thromboxanes in vasotonic versus vaso-occlusive angina. Archives des maladies du Coeur et des Vaisseaux. 76:13-16, 1983.
Davis, K. L., in The [Oklahoma City] Journal Record, August 4, 1999
19.Lewy, R.I. Laboratory Findings Reveal Potential Harm of Breast Implants. Texas Medicine. 89 (12), 1993
21.Preface, page x, Current Topics in Microbiology and Immunology 210: Immunology of Silicones, M. Potter and N.R. Rose, eds, pages 337-352, Springer Verlag 1996. ISBN 3-540-60272-0
22.Lewy, R.I Autoimmune Markers and Imaging Abnormalities in Silicone Breast Implant Users. Clinical Research, 42(2), 275A, 1994
23.Autoimmune Disease and Collagen Dermal Implants. Annals of Internal Medicine, 120(6), 524-525, 1994
24.Lewy RI. Antinuclear Antibodies, Lipid Disturbances and Central Nervous System Imaging Abnormalities in Silicone Breast Implant Users. Journal of Investigative Medicine 43:333A, 1995
Swartz M., Silicone City, Texas Monthly, August 1995.
31.Drugs R D vol 5,315-326,2004
32.Integrative Cancer Therapy, vol 3,157-261,2004
33.Drugs RD vol 4,91-101,2003
34.New York Times, "the Whistle-Blowers Quandary,
35.The Spectator, Volume XCVII, No 6, page 2, "Dedication Ceremony for the Lewy Multimedia Center Held".
"Stuy Alum Donates Library Books,The Spectator, Dec 2,2007
40.List of Stuyvesant High School people

42."View from the other side of the stethoscope" Oncology Times, vol 28 issue 16 2006
43.Evaluation of Anemia, American Journal,of Managed Care, vol 4, no 12, 1711, 1998
44. "Taking Aspirin at Night May Boost Heart Benefits",New York Times,December 19, 2013
45."Drug Makers donation to Co-pay Charity Face Scrutiny", New York Times, December 18, 2013
47."New York University Society of the Torch",
49.What Would the Hematologist Say"
51. "Dr Robert Ira Lewy Lecture Series",

52. Balk, Ethan M.; Earley, Amy; Avendano, Esther A.; Raman, Gowri (2 Feb 2016). "Long-term health outcomes in women with silicone gel breast implants: a systematic review". Ann Intern Med. 164 (3): 164–175. PMID 26550776. "The evidence remains inconclusive about any association between silicone gel implants and long-term health outcomes."

53.Nanayakkara, Prabath W.B.; de Blok, Christel J.M. (2 Feb 2016). "Silicone gel breast implants: what we know about safety after all these years working toward a solution: the unanswered questions about silicone gel breast implants". Ann Intern Med. (editorial) 164 (3): 199–200. doi:10.7326/M15-2427.

Plaintiff's Exhibit List for Daubert Hearing Merlin vs. 3M/McGhan




1. Investigation at Dow Corning into use of silicones as pesticides: in1968, found that Dow Corning 360 fluid both attracted and killedcockroaches; also repelled mites and mealy bugs; killed and repelledaphids. Plaintiffs' Exhibit 705)

2. Dow Corning Report, 'Histopathological Findings In Animals of VariousSpecies from Experiments Conducted by Thomas D. Rees", 4/22/68.Plaintiffs' Exhibit 548)

Silicone injected into various animals produced organ damage includingchronic inflammation of liver, kidneys and occasional pancreas and gonadabnormalities seen in mice; similar but less prevalent organ damage inrats; and liver abnormalities and chronic kidney inflammation in guineapigs. Additionally, holes in cytoplasm of cells commonly observed in allspecies.

3. Dow Corning Research: Immunological Enhancing Activities ofOrganosilicon Compounds and non-functional fluids, 10/2/74. (Plaintiffs'Exhibit 120)

Study carried out to determine if certain silicone oils could act asadjuvants in experimental animals. An adjuvant is a chemical that willenhance or prolong the immune response when given mixed with a foreignprotein (antigen). Study concluded that nine of the forty-nine adjuvantstested showe6 adjuvant activity similar to that of known adjuvant (CFA).

CONCLUSION: Silicone oils can act as adjuvants to enhance the antibodyresponse to a standard antigen in experimental animals.


4. "Summary of Histopathological Findings in Primates", 3/21/67 DowCorning Document. (Plaintiffs' Exhibit 774)

Twelve monkeys injected with silicone fluids in both breasts and leftcheek. Animals sacrificed at two years after first injection; findingsincluded holes in cells (vacyated cells) in lungs, cheeks and breasts;abnormal adrenal glands and chronic kidney inflammation.

These tests signal potential immunological impact of long term presenceofpolysiloxane in primate fluids in primates.

5. Structure-Activity Relationships of Oral Organosiloxanes on the MaleReproductive System. by D.R. Bennett, S.J. Gorzinsid, and J.E. LeBeau.Toxicology and Applied Pharmacology. 21, 55-67 (1972). (Plaintiffs'Exhibit 545)

Oral organosiloxanes depressed male reproductive function in the mouse,rat and rabbit.

6. Local & Systemic Effects of Dimethylpolysiloxane Fluid In Mice. ByN.Ben-Hur, M.D., Donald BaBantyne, Jr., Ph.D., Thomas Rees, M.D. and @gSeidman, M.D. Plastic & Reconstructive Surgery. Aprfl 1967. pp.423-426.(Plaintiffs' Exhibit 544)

Mice and rats injected subcutaneously with silicone fluid; on autopsy,silicone found in the vital organs and lymph nodes. Phagocytes ingestedsilicone fluid and caused granuloma-like lesions; silicone also engulfedby wandering histiocytes and transported to lymph nodes and throughoutthereticuloendothelial system to liver, spleen and other organs.

7. Changes In the Lung Following Injections of Silicone Gel. by MarcusCastro Ferreira, M.D., Victor Spina, M.D. and Kyoshi Iriya, M.D. BritishJournal of Plastic & Reconstructive Surgery. pp.173-176. 1975.(Plaintiffs' Exhibit 546)

Injections of silicone gel in 38 MI. rats produced findings of siliconegels in lungs on autopsy, the result of phagocytosis of the silicone bymacrophages, carried to the lungs in blood stream or through lymphatics.Authors conclude that silicone gel behaves like silicone fluid and is notso inert as solid silicone as was previously supposed.

8. Dow Corning Corp Research Dept Report# 3977. Authors: Joseph LeBeau &Stanley J. Gorzinski DMPS fluid (Dow Corning 360 Medical Fluid)distribution and disposition in rats following subcutaneous injection.(Plaintiffs' Exhibit 687)

Dow Corning 360 medical grade silicone administered to rats. Withassistance from radioactive labeling, silicone fluid found in expiredair,urine and feces as well as in times and organs. Migration of siliconethrough lymphatic system confirmed.

9. Dow Corning Report # 3323 Project # 464 by Ruth M. Lacefield, et al.Biological Distributions of DMPS. (Plaintiffs' Exhibit 688) Radioactivelabeled medical grade 360 fluid traced to determine biologicaldistribution in test animal; silicone found in brain, blood, bile,internal organs.

10. 2, 6-cis-Diphenylhexamethyl - cyclotetrasiloxane Chemistry AnalyticalChemistry, Biological Effects and Excretion. By Bennett, Don R. Aborg,Bertfl. Editors ACTA, Pharmacological et To;dcologir-al. Vol. 36,Supp-III, 1975. (Plaintiffs' Exlubit 553)

2, 6-cis being evaluated as an estrogen by Dow, noted to produce changesin male genital organs of rabbits and dogs.

11. Structure Activity Relationships of Organosiloxanes and the FemaleReproductive System. by James F. Hayden & Sue A. Barlow. To7dcology andApplied Pharmacology. Vol.21, 1972 pp.68-79. (Plaintiffs' Exhibit 689) 2,6-cis is biologically active in the female rat and produced estrogen-likeeffect.

12. Investigation of the Toxicologic Properties of aPhenylmethylcyclosiloxane by R.J. Palazzolo et al. Toxicology and AppliedPharmacology. Vol.21, 1972. pp.15-28. (Plaintiffs' Exhibit 691)

Experiments by oral ingestion and by skin applications on various speciesshowed silicone material to be biologically active by mouth in monkeysleading to testicular atrophy and decrease or absence of seminal fluid.

13. Peritoneal Response To Silicone Fluid. A Histologic Study. Brody,Gerald L., M.D. and Frey, Charles F., M.D. Arch Surg. Vol. 96, February1968, PP 237-241. (Plaintiffs' Exhibit 586)

Injection of silicone fluid into rats produced histiocytic granulomas.Fact that granulomas exist and that silicone is transported to draininglymph nodes indicates that silicone is not inert.

14. Biocompatibility of Silicone Implants. by Heggers, John P. Ph.D.,etal., Reprinted Annals of Plastic Surgery. Vol. 11, No. 1, July 1983, PP37. (Plaintiffs' Exhibit 592)

Silicone is capable of eliciting a cellular immune response. This mayindicate that silicone acts like an incomplete antigen.


15. The Adjuvant Effect Of Silicone-Gel On Antibody Formation In Rats. ByNaim, John 0. Lanzafame, Raymond J. Oss, Carl J. The University ofRochester School of Medicine and Dentistry, Rochester, New York.(Plainiffs' Exhibit 604)

Silicone gel is a potent, immunological adjuvant and may also be able tomediate an auto-immune reaction.

16. The Effect of Silicone Gel on the Immune Response. by Naim, John 0.Lanzafame, Raymond J. Oss, Car] J. Journal of Biomaterials Scienceaccepted 2/10/94.

Silicone gel is capable of eliciting auto-antibodies in the series ofanimal experiments; silicone gel from McGhan commercial breast implantbehaves both as a potent humoral adjuvant and relatively weakcellular-mediated immunity adjuvant. Silicone gel also capable ofinducingauto-antibodies in the rat.


17. Antibodies To Silicone Elastomers and Reactions ToVentriculoperitoneal Shunts. Goldblum, Randall M. Ronald P., et al., TheLancet, Vol. 340: August 29, 1992. PP 510-513. (Plantiffs' Exhibit 595)

Severe immune reactions seen in patients with silicone elastomer(shunts).

18. "Antinuclear Autoantibodies In Women with Silicone Breast Implants".11/28/92, Press RI et al. Lancet 340: pp.1304-1307.

Antinuclear Autoantibodies (ANAS) found in women with silicone breastimplants; some of the ANAs similar to those found in idiopathicauto-immune disorders but some other putative antigens could not beidentified and may represent novel auto-antibody/autoantigen systems.

19. "A Clinical and Immunologic Evaluation of Women with SBI and Symptomsof Rheumatic Disease". 6/15/1993 Bridges A.B et al. Annals Int. Med. 11812): 929-936.

Physical exams and lab work conducted on 156 women with silicone breastimplants and rheumatic disease complaints; controls for lab studies were12 women with silicone implants and no rheumatic symptoms and 174 withfibromyalgia without silicone implants.

Findings suggest that most women with SBI and rheumatic disease symptomsdo not have classical connective tissue diseases; however possibilitythatatypical auto-immune illness, may be associated with silicone exposure insmall number of women exists.

20. Immunopathologic Effects of Silicone Breast Implants. Suzanne S.Teuber, M.D., Steven H. Yoshida, Ph.D. and Eric Gershwin, M.D. WesternJournal of Medicine, Vol.162, No.5, May 1995. pp.418-425. (Plaintiffs'Exhibit 516)

This review of studies on silicone and immunity concluded that siliconesare neither biologically nor chemically inert and that there is clinicaland theoretical reason for concern.


21. Immunological Reactions to Silicone Implants: Risk and Management.Robert F. Spiera, et al. Clinic Immunother 1 (6) 1994, pp.406-411.(Plaintiffs' Exhibit 517)

Scleroderma-like illnesses are markedly over-represented in women withsilicone implants and identifiable connective tissue disease, mimickingthe earlier reported Japanese experience with injectable silicones.Although authors clinically recommend to their patients removal ofimplants if symptomatic, some patients with scleroderma-like illness mayhave a progression of disease and even death despite explantation perhapsdue to migration of silicone distantly in the host and the consequentinability to remove the substance entirely. Exposure may thus initiate aself-perpetuating disease process no longer requiring the presence of theinitial silicone stimulus.

22. "Surface Dependent Antigens Identified by High Binding Affinity ofSerum Antibodies in a Subpopulation of Patients with Breast Prosthesis".12/93 Kossovsky, Nir et al. Journal of Applied Biomaterials 4 (33):pp.1-(Plaintiffs' Exhibit 538)

Silicones found to function as human adjuvants by denaturing nativemacromolecules. Hypothesis tested by two assays of sera from threegroups:249 with SBI, 47 non-implanted age-matched healthy women; 39non-implantedwomen with various known rheumatological diseases. Conclusion is thatsilicone may function as an adjuvant by inducing changes in theconfirmation of native molecules.

23. Silicon and Silicones Theoretical and Clinical Implications of BreastImplants. by Steven H. Yoshida et al. in Regulatory Toxicology andPharmacology. Vol.17, 1993, pp.3-18.

Authors review the element silicon, the chemistry of silicone, theimmunogenicity of silicone, and the know biological functions of siliconeto demonstrate how silicone might promote auto-immune disease inpre-disposed individuals. Review of case reports of 27 people withimmunological reactions as well as literature on silicone exposures inanimal studies leads authors to conclude that silicone can generateinflammatory and immune responses despite its long standing and incorrectrepresentation as a chemically and biologically inert substance.


24. Autoantibodies In Patients with Silicone Breast Implants. by Alan J.Bridges. Seminars in Arthritis & Rheumatism, Vol.24, No.1, Supp.1, Aug.1994, pp.54-60. (Plaintiffs' Exhibit 488)

Review of literature as well as 1992 American College of Rheumatologyabstracts from annual meeting show differences in the clinical andserological features of patients with connective tissue diseaseassociatedwith silicone implants compared with patients with idiopathic connectivetissue disease.

25. Multiple Autoantibodies In Patients with Silicone Breast Implants, E.Bar-Meir, S.S. Teuber, et al. Journal of Autoimmunity, 8, 1995,pp.267-277. (Plaintiffs' Exhibit 509)

Sera from 250 patients tested blindly (116 women with SBI and 134controls) to analyze twenty auto-antibodies. Chief complaints ofimplantedpatient group included polyarthralgias, fatigue, myalgias, morningstiffness and decreased memory.

Statistically significant greater frequency of auto-antibodies in womenwith implants for fifteen of the twenty auto-antigens. The association ofauto-antibodies in implants suggests an adjuvant action ofsilicon/silicone by products.

26. Detection of Lymphocyte Simulation by Silicon Dioxide, by David L.Smalley, Douglas R. Shanklin, Mary F. Hall and Michael V. Stevens inInternational Journal of Occupational Medicine and Toxicology Vol. 4,No.1, pp.63-70. (Plaintiffs' Exhibit 594)

In the continuing work investigating the immune response to silicone, theauthors adapted standard mitogen testing which demonstrated cell-mediatedimmune responses of T-lymphocytes to purified silicon dioxide or silicainthe implanted patients.

These test were run on 50 symptomatic patients with SBI and 50 normal agematched female controls without implants or symptoms. T-lymphocytes wereharvested from each group. This test method distinguishes the immunedisorders found in mammary implant patients due to sensitization tosilicon dioxide (silica) from other altered immune disorders unrelated toimplants.

27. Quantitative Aspects of Cellular Responses to Silicone by Douglas R.Shanklin and David L. Smalley, International Journal of OccupationalMedicine and Toxicology Vol. 4, No.1, 1995 pp.99-111. (Plaintiffs'Exhibit762)

A study of pathology slides from 100 consecutive but random patientconsultations and mammary capsular tissue surrounding which hadsurroundedSBI. Cellular responses occur in women with mammary, as seen inhistopathological examination. Lymphocytic response with resultingformation of granulomas and macrophages.

28. Immunologic Markers In Silicone Breast Implant Recipients, by DavidSmalley, Mary F. Hall, Douglas R. Shanklin and NCchael Stevens inInternational Journal of Occupational Medicine and Toxicology Vol. 4, No.1, 1995 pp.147-153. (Plaintiffs' Exhibit 763)

The presence of various autoantibodies and the significant number ofsymptomatic implantation is taken as evidence for a range Atypical Immuneresponsiveness consistent with a primary cellular immune response. Thename - silicone associated disease - is understood as an inclusive termfota new form of autoimmunity caused by an alien material (silicones andrelated substances) which mimic known and better defined autoimmunediseases.

29. Immunologic Stimulation of T-lymphocytes by Silica After Use ofSilicone Implants. by David L. Smalley, Douglas R. Shanklin, Mazy F.Hall,Michael V. Stevens and Aram Hanissian. The FASEB Journal, Vol. 9,Mar.1995,pp.424-427. (Plaintiffs' Exhibit 504)

Standard lymphocyte stimulation test performed on 70 implant patients, 76normal controls without implants or symptoms, and 18 patients withclassicrheumatic disorders without a history of SBI. Lymphocytes harvested fromall groups. Results show implant patients with increased stimulationindexcompared to controls in those with rheumatic disorders. Follow-up studywith 220 normal controls, no SBI, 942 implants with symptoms, and 34implant patients without symptoms.

CONCLUSION: Silicone Implant patients respond immunologically to thesilicone dioxide (silica) contained in mammary prostheses.

30. Affidavit of Douglas R. Shanklin, M.D. (Plaintiffs' Exhibit 764)

Dr. Shanklin, a Board Certified pathologist, discusses the sixindependentreports by six independent labs, each documenting silcone/silica memory TLymphocytes.

31. Curriculum Vitae of Douglas R. Shanklin, M.D. (Plaintiffs' Exhibit765)

32. Affidavit of Donard S. Dwyer, Ph.D. (Plaintiffs' Exhibit 766)

Dr. Dwyer, former Director of Immunology at Procept (owned byBristol-Myers Squibb), managed the research program on T-cell receptorsfunded by Bristol-Myers Squibb, a former manufacturer of silicone breastimplants. The Smalley/Shanklin laboratory data was evaluated by Dr. Dwyerand found to be based on the standard and acceptable method for measuringT-cell proliferation which has been reproduced and is consistent in theProcept laboratory.

Thus, the conclusions that patients with SBI have a T-cell mediatedImmuneresponse to silicon dioxide (silica) is justified.

33. Curriculum Vitae Donard S. Dwyer, Ph.d. ((Plaintiffs' Exhibit 767)

34. Antinuclear Antibodies in Breast Implant Patients are

Exposure-Duration Dependent But Not Age Dependent. Robert Ira Lewy, M.D.,FACP; Edward Ezraffson, Ph.D. Departments of Medicine, Baylor College ofMedicine and University of Texas Health Science Center of Houston,Houston, TX. Immunology of Silicones Workshop. March 13-14, 1995.NationalInstitute of Health, M.D. (Plaintiffs' Exhibit 495)

35. Autoantibodies In Sera from Patients with L-Tryptophan-AssociatedEosinophilia-Myalgia Syndrome. by Leed D. Kaufman, John Varga, Juan J.Gomez-Reino, Sergio Jimenez, and Iran N. Targoff, Clinical Immunology andImmunopathology, Vol.76, No.2, August, pp.115-119, 1995.(Plaintiffs'Exhibit


Study found unique auto-antibodies in sera from patients with EMS(Eosinophilia-Myalgia Syndrome) associated with exposure of L-Tryptophan.These auto antibodies were clearly distinct from the aut-antibodiescommonly recognized in systemic auto-immune conditions.

36. Silicone Breast Implants: Immunotoxic and Epidemiologic Issues. BySteven H. Yoshida, Shanna Swan, Suzanne Teuber and M. Eric Gershwin, LifeSciences Vol. 56, No. 16, pp.1299-1310, 1995. (Plaintiffs' Exhibit 695)

Discussion of adverse immune effects from silicone from literatureanalysis including local responses in animals, systemic responses inanimals, inflammatory responses in humans and autoimmune disease inhumans. Discussion of limitations of epidemiological studies of siliconerelated diseases to date, including Mayo Clinic Study, Wells and Englert.

37. Repeated Exposure to Silicone Gel Can Induce DelayedHypersensitivity.Phillip P. Narini, M.D., et al. Plastic & Reconstructive Surgery, Vol.96,No.2. August 1995. pp.371-380. (Plaintiffs' Exhibit 519)

Study performed to investigate a possible cell-mediated immune responsetosilicone gel. Authors demonstrated an antigen-specificlymphocyte-mediatedresponse in the animals primed only with silicone gel. A delayed typehypersensitivity to silicone gel was induced.

38. Antinuclear Antibodies and Breast Implants. Henry Claman, M.D. andAlastair D. Robertson, Ph.D. The Western Journal of Medicine. Vol. 160,No.3. March 1994. pp.225-228. (Plaintiffs' Exhibit 513)

Antinuclear antibodies tested in the sera of four groups of women. Fourgroups studied:

Group 0 = 19 women without SBI, healthy;

Group I = 38 women with SBI, healthy and pleased with implants;

Group II = 82 women with SBI with various symptoms but no definite

diagnosis of autoimmune connective tissue disease;

Group III= 11 women with SBI with overt connective tissue diseases.

Results: no positive ANA tests in Group 0.

Significant positive ANA tests in higher than expected frequency (18%) ofGroup I women, healthy women with SBI.

Many women have a variety of complaints and also have positive ANA tests(26%).

In women with breast implants with later connective tissue disease,scleroderma was far more prevalent than rheumatoid arthritis or SLE.

39. Self-Reported Signs & Symptoms In Breast Implant Patients with NovelAntibodies to Silicone Surface Associated Antigens [anti-SSAA(x)]. NirKossovsky, Journal of Applied Biomaterials, Vol.6, 1995, pp.153-160.(Plaintiffs' Exhibit 520)

Previous sera studies that had shown statistically significant levels ofantibodies to Silicone Surface Association Antigens were correlated tosymptoms by clinical survey sent to sera positive SBI women. Results

Showed statistically significant differences in 3 symptoms of anti-SSAApositive patients.

40. Immune Functional Abnormalities In Patients With ChemicalAbnormalities and Silicone Breast Implants. by Campbell, Andrew W., M.D.Vojdani, Aristo, Ph.D., Brautbar, Nachman, M.D. (Plaintiffs' Exhibit 587)

Forty patients with SBI and forty healthy sex and age-matched controlsselected for study including physical examination, history and laboratorytests.

Many immunological abnormalities are found in individuals with SBI;conclusion is mechanism of fime injury causing auto-immune diseases orsyndromes.

41. A Pathophysiological Examination of the Biophysics and Bioreactivityof silicone Breast Implants. by Nir Kossovsky and John Stassi. SeminarsinArthritis & Rheumatism, Vol.24, No.1, Supp.1, Aug. 1994, pp.18-21.(Plaintiffs' Exhibit 573)

Biological responses to implanted silicone are initiated by surfaceadsorption of native proteins to the implant. Proteins then undergoconformational changes and denature on complexing silicone. Bioreactivityis thus surface dependant and affected by characteristics such as surfacearea, shape, charge in chemistry. Biological response occurs withpossibleimmunological activation.

42. Silicone Toxicology, by Harris Busch. Seminars in Arthritis &Rheumatism, Vol.24, No.1, Supp.1, Aug. 1994, pp.11-17. (Plaintiffs'Exhibit 572)

Silicone is not inert; silicone and/or the multiple chemical contaminantswithin elicit foreign body reactions associated with granulomatousinflammation and fibrosis and have potential for significant toxicity inthe implanted recipient.

43. Abstracts and Presentations from the Workshop on Immunologies ofSilicones Sponsored by National Institute for Health, NCI and DCBDC heldMarch 13, 1995. (Plaintiffs' Exhibit 772)

44. Silicone-Specific Blood Lymphocyte Response in Women with SiliconeBreast Implants, by Emmanuel A. Ojo-Amaize, Victor Conte, Hun-Chi Lin,Robert Brocker, Milcon Agopian and James Peter. COIN. Giagn Lab. Immunol.Nov. 1994, pp. 689-695. Vol. 1, No.6. (Plaintiffs' Exhibit 621)

Blinded cross-sectional study with 99 women, 44 with SBI. SBI groupdivided into asymptomatic, symptomatic and implanted women andsymptomaticexplanted women. Control was 55 healthy volunteer women without SBI.

Conclusion: Silicon specific T-cell responses observed in twice as manysymptomatic as asymptomatic women exposed to SBI, sugggesting cellmediated immunogenicity plays a role In the development of abnormalimmunereactions associated with silicone. This provides a new apparentlyspecificscreening blood test.

45. Human Immune Response to Polydimethylsilaxe (silicone): ScreeningStudies in a Breast Implant Population. Wolf, Lappe, Peterson andEzrailson. Vol. 7, Oct. 1993, FASBE Journal, pp. 1265-1268. (Plaintiffs'Exhibit 622)


46. Portions of Lot History from 3M Implants - Lot # S04-19747 implantedin Mildred Merlin showing silica as component material.

47. Report from the Instructional Course of the Int'l Society ofAestheticPlastic Surgery, Uppsala, Sweden, March 16-18, 1993. in Memorandum fromCurt Sahlgren, 3M Sweden to: Bruno Lowinger, 3M Europe. March 18, 1983.(Plaintiffs' Exhibit 483)

3M acknowledges that recent investigations have shown that gel bleed froman intact implant leaves "...particles of elemental silica and organicsilicone within the systemic organism of the body with not yet knownadverse effects."

48. Adjuvant Effects of Amorphous Silica on the Immune Response toVariousAntigens in Guinea Pigs., by D. Mancino and N. Bevilacqua Int. ARchs.Allergy appl. Immun. S31 97-103 (1977). (Plaintiffs' Exhibit 480)

Amorphous silica is able to enhance the humoral immune response tovariousantigens, widely differing in molecular weight.

Silica has been shown to influence the immune response with eitherdepressive or stimulators effects depending on the type and amount ofsubstance used.

49. Pathological Effects of Inhaledled Amorphous Silicas in Animals, byDavid H. Groth, M.D., Choudari Kommieni, D.V.M., Ph.D., William J.Moorman, Lloyd E. Stettler, Ph.D., William D. Wagner. Presented at ASTMInternational Symposium on Health Effects of Synthetic SilicaParticulates, Torremolinos, Spain 6 November 1979. (Plaintiffs' Exhibit479)

Exposure by inhalation to monkeys of amorphous, fumed silica producedfindings of large quantities of silica in macrophages in lungs andtracheal lymph nodes of monkeys and early nodular fibrosis in the lungsofmonkeys.

50. The Biological Action of Degussa Submicron Amorphous Silica Dust (DowCorning Silica). Inhalation Studies on Rats. by Gerrit Schepers, M.D.,D.Sc., Thomas M. Durkan, M.E., Anthony B. Delahant; Francis T. CreedonAMAARCH. of IND. Health. Vol.16. Aug. 1957. pp.125-146. (Plaintiffs' Exhibit484)

Inhalation studies on rats exposed to amorphous silica dust from DowCorning silica died from pulmonary vascular obstruction coupled withpulmonary insufficiency and emphysema.

51. Myoflbroblasts and Free Silicon Around Breast Implants. by RossRudolph, MD Jerrold Abraham, M.D., Thomas Vecchione, M.D., Steven Guber,M.D. and Marilyn Woodward. Plastic And Reconstructive Surgery. Vol.62.No.2. Aug. 1978. pp.185-196. (Plaintiffs' Exhibit 485)

Breast tissue and capsules (scar tissue) explanted from women duringexplantation surgery revealed presence of the element silicon viascanningelectron microscopic technique. Such a technique cannot identify silica.Such a technique must be developed because silica in tissue can causesilicosis, a fibrotic disease.

52. The Association of Progressive Systemic Sclerosis (Scleroderma) withCoal Miner's Pneumoconiosis & other Forms of Silicosis. Gerald Rodnan,M.D. et al. Annals of Internal Medicine. Vol. 66, No.2 February 1967,pp.323-334. (Plaintiffs' Exhibit 602)

Silica exposure is a hazard of coal mining; the authors describe anassociation of progressive systemic sclerosis (scleroderma) within coalminers or in other occupations marked by heavy exposure to silica dust

53. Health Effects of Synthetic Silica Particulates. A Symposiumsponsoredby ASTM Committee E-34 on Occupational Health and Safety and theIndustrialHealth Foundation Benalmadena-Costa (Torremolinos), Spain 5-6 No. 1979.ASTM STP 732. D.D. DUNNOM, Ed., American Society for Testing andMaterials, 1981, pp.82-93. (Plaintiffs' Exhibit 478)

Chapter by Robert Burrell "Immunological Aspects of Silica".

54. Effects of a Crystalline Silica on Antibody Production to T-Dependentand T-Independent Antigens In Balb/c mice. by D. Mancino, M.L. Viotte, M.Minucci. Int. ARchs Allergy appl. Immun. 73:10-13 (1984). (Plaintiffs'Exhibit 481)

55. Adjuvant Effects of Silica (Tridymite) on Antibody Production, byBenvenuto Pernis and Florenzo Paronetto (Introduced by Hans Popper). Deptof Experimental Pathology, Institute of Industrial Medicine, UniversityofMilan, Italy. Received 12 April, 1962. PSEBM, 1962, v.110. (Plaintiffs'Exhibit 482)

56. Endothelial Metaplasia of the Alveolar Capillaries In ExperimentalSilicosis of Rats. by Mochimura H., Kawanami O., Kudoh S., Niitani H.Japanese Journal of Thoracic Diseases. 33(3):268-74, 1995 Mar.Plaintiffs'Exhibit 672)

Silicosis induced in rats by administration of silica particles.

57. Mortality Study of Gold Miners Exposed to Silica and NonasbestiformAmphibole Minerals: An Update with 14 More Years of Follow-up. BySteenland K, and Brown D. American Journal of Industrial Medicine. 27(2):217-29, 1995 Feb. (Plaintiffs' Exhibit 673)

Follow-up study of over 3,000 gold miners reveals significant excesses ofarthritis, muscular skeletal diseases including systemic lupus andsclerosis and skin conditions including scleroderma and lupus, alldiseases of auto-immune origin which have been associated with silicaexposure.

58. Silicosis in Brazilian pit diggers: relationship between dustexposureand radiologic findings. by Holanda NM, Holanda NM, Martins MP.,FelisminoPH., and Pinheiro VG. American Journal of Industrial Medicine.27(3):367-78, 1995 Mar. (Plaintiffs' Exhibit 674)

59. Detection of anti-topoisomerase I antibodies using a full lengthhumantopoisomerase I recombinant protein purified from baculovirus expressionsystem. by Whyte J., Earnshaw WC., Champoux JJ., Parker LH., Stewart L.,Hall ND., and McHugh NJ. Clinical & Experimental Immunology.100(2):214-8,1995 May. (Plaintiffs' Exhibit 675)

60. Occupational silicosis-Ohio, 1989-1994 [published erratum appears inMMWR Morb Mortal Wkly Rept 1995 Apr 28;44(16):325]. by Anonymous.Morbidity & Mortality Weekly Report. 44(4):61-4, 1995 Feb.3. (Plaintiffs'Exhibit 676)

61. Shedding of Silicone Particulates From Inflated Breast Implants. ByAlex Vargas, M.D. Plastic & Reconstructive Surgery. Vol.34, No.2.pp.252-253. Aug. 1979. (Plaintiffs' Exhibit 486)

Explantation of a saline implant showed collections of "sand" on thesurface; on infrared spectroscopy, demonstrated the silicon-carbon bond.

62. Silica Exposure In Auto-Immune Disease. by Steenland, Kyle, Ph.d. andGoldsmith, David, MSPH, Ph.d. American Journal of Industrial Medicine28:603-608 (1995). (Plainfiffi' Exhibit 489)

Authors summarize the evidence of association of silica exposure to avariety of auto-immune diseases including systemic sclerosis, rheumatoidarthritis, lupus and chronic renal disease. Authors posit the linkbetweensilicone exposure and auto-immune disease, and whether silicone breastimplants have same causal relationship with auto-immune disease.

63. Silica-Induced Scleroderma, Haustein, Ziegler, Hurrmann. Panel of theAmerican Academy of Dermatology., 1990; 22:444-8 (Plaintiffs' Exhibit507).


64. Silicone in the Liver. Possible Late Effects. By J. Hunt, M.J.G.Farthing, L.R.I. Baker, P.R. Crocker, D.A. Levison. Gut. 1989, 30,239-242. (Plaintiffs' Exhibit 540)

Silicone identified in liver of two patients that had abnormal liverfunction and liver scarring. 'nese patients had been on dialysis prior torenal transplant and siliconized blood pump insert had liberated siliconeinto liver.

65. Migration and Chemical Modification of Silicone In Women w/BreastProstheses. by Lencio Garrido, MRM Vol.31, 1994, pp.328-330. (Plaintiffs'Exhibit 692)

NMR (Nuclearmacnetic resonance) spectroscopy performed on women with SBIand 3 without implants revealed silicone and other silicon compounds inboth blood and liver of implanted women, whether or not implants wereclinically ruptured; however total concentration was lower when implantsappear to be intact.

66. Migration and Accumulation of Silicone In the Liver of Women withSilicone Gel-Filled Breast Implants. Bettina Pfleiderer & LeonicioGarrido. Magnetic Resonance in Medicine Jan. 1995 33(l): pp.8-17 (Plainfiffi' Exhibit 664)

Authors formed NMR spectroscopy in liver of human volunteers withimplantsand results clearly reveal presence of silicone in the liver. Prior workbysame authors on rat model demonstrated a considerable amount of freesilicone migrates from gel-filled implants and that silicone is notchemically inert but undergoes chemical degradation.

CONCLUSION: Migration of free material from silicone implants to localanddistant sites occurs through lymphatic or hematogenous pathway.

67. Rheumatic Disease Among 1167 Women Reporting Local Implant andSystemic Problems After Breast Implant Surgery. Elizabeth Ann Coleman,R.N.P., Ph.D., et al. Journal of Women's Health, Vol.3, No.3, 1994.pp.165-177.

(Plaintiffs' Exhibit 518)

National Cancer Institute (NCI) investigators contacted 1,167 women whohad had breast implant surgery and who had reported local implant orsystemic problems to the FDA. Out of the 820 women interviewed,statistically significant associations that were found included breastimplant type with scleroderma, breast implant manufacturer with systemiclupus.

68. Siliconosis: A Spectrum of Illness, by David Borenstein. Seminars inArthritis & Rheumatism, Vol.24, No.1, Supp.1, Aug. 1994, pp.1-7.(Plaintiffs' Exhibit 632)

This, and ensuing papers published in Seminars in Arthritis andRheumatism, emanated from a symposium held in 1992 at George WashingtonUniversity Medical Center. Information reported at the symposiumpresentedinitial data supporting the notion that patients with exposure tosiliconegel are experiencing a new illness, previously described as "humanadjuvant disease" or chronic silicone arthropathy. Symposium presentersused terms such as siliconosis or silicone implant syndrome.

Conclusion: Siliconosis is a musculoskeletal pain syndrome characterizedby overwhelming fatigue, arthraigias and myalgias. Additionally,alopecia,fever, sleep disturbances, Sjogren's-like Syndrome, lymphadenopathy andarthritis have also been identified.

69. Clinical Findings In Symptomatic Women with Silicone Breast Implants.By Frank B. Vasey, Deborah L. Havice, Thomas S. Boranegra, Mitchel J.Seleznick, Paul H. Bridgeford, Pindaro Martinex-Osuna, and Luis R.Espinoza.

Seminars in Arthritis & Rheumatism, Vol.24, No.1, Supp.1, Aug. 1994,pp.22-28. (Plaintiffs' Exhibit 633)

Fifty women seen in clinic between 1977 and 1991 with SBI were followed.The most common clinical findings included chronic fatigue, muscle pain,joint pain, joint swelling and lymphadenopathy. 33 women underwentexplantation: 24 of them improved clinically, 8 did not change and oneworsened. Authors believe that this case series supports the relationshipbetween SBI and rheumatic disease signs and symptoms.

70. A Clinical and Laboratory Profile of Symptomatic Women with SiliconeBreast Implants. by Gary Solomon. Seminars in Arthritis & Rheumatism,Vol.24, No.1, Supp.1, Aug. 1994, pp. 29-37. (Plaintiffs' Exhibit 634) 276patients with SBI evaluated to describe frequency of various symptoms insymptomatic patients.

Conclusion: siliconosis Is a novel systemic disease with symptoms ofchronic fatigue, cognitive disfunction, sicca syndrome and arthralgiaoccurring in women with longstanding implants who have antecedent localpathology in the form of capsular contracture and/or implant ruptue.

71. Epidemiology of Silicone Related Disease. by Shanna Swan. Seminars inArthritis & Rheumatism, Vol.24, No.1, Supp.1, Aug. 1994, pp.38-43.(Plaintiffs' Exhibit 635)

Author discusses problems inherent in epidemiology of silicone relateddiseases, especially due to atypical nature of the dise ase, whichcomplicates disease definition and renders study of classic diseaseunlikely

to check risks of silicone exposure. The report addresses the mostimportant study design issues -- disease and exposure definitions, bias,confounding and power -- in the context of studies of silicone relateddisorder.

72. A Profile of Symptomatic Patients with Silicone Breast Implants; ASjogren's-like Syndr-ome. by Bruce Freundlich, Charles Atman, et al.Seminars in Arthritis & Rheumatism, Vol.24, No.1, Supp.1, Aug. 1994, pp.44-53. (Plaintiffs' Exhibit 636)

Prospective non-controlled study on first fifty consecutive women withSBIat the Graduate Hospital of Rheumatology revealed the most prominentcomplaints to be fatigue, generalized stiffness, poor sleep andarthalgias. Other problems included Raynaud's phenomenon, alopecia,adenopathy, night sweats and frequent soar throats. Fifty percent of thewomen complained of dry eyes and dry mouth. Positive ANA or rheumatoidfactors in 38% of patients.

Conclusion: Findings indicate the presence of a unique syndromeassociatedwith silicone breast implants characterized by musculoskeletal pain andauto-immune features.

73. Scleroderma After Silicone Augmentation Mammoplasty, by Spiera, H.,JAMA 260: 236-238, 198838 (Plaintiffs' Exhibit 773)

Case-control study showed a much higher incidence of prior siliconeimplantation in scleroderma patients when compared with patients withrheumatoid arthritis.

74. Case Report- Scleroderma, Primary Bilary Cirrhosis and Sjogren'sSyndrome After Cosmetic Breast Augmentation with Silicone Injections: Acase Report of Possible Human Adjuvant Disease. Y. Okano et al. Annal ofthe Rheumatic Diseases, 43, pp.520-522, 1984 (Plaintiffs' Exhibit 599)

A 52 year old women developed scleroderma, liver disease and sjogren'ssyndrome after cosmetic injections with silicone.

75. Silicone Implants and Rheumatic Diseases. by John S. Sergent, et al.Textbook of Rheumatology, Update 4. 1993 pp.1-12. (Plaintiffs' Exhibit623)

This chapter in Kelly's Rheumatology disc

page 790/10 - 795/17

page 796/5 - 811/20

page 813/25 - 830/2

Dr. Gershwin, Board Certified in Internal Medicine, Rheumatology andImmunology, a Professor at U.C. Davis for the past twenty years, formerlyof NIH, Editor in Chief of Clinic Reviews in Allergy and Immunology, hassix to eight articles relating to silicone exposure and disease inpeer-reviewed journals, testified in this case against 3M that there is anew, unique disease in which women have a constellation of symptoms thatare not ordinarily seen in other circumstances, but which experience hasoccurred in the past from other exposures such as drugs or environmentalagents such as silica.