Breast Implants - Reference List SCI Home | SCI Faculty Page | Cover Sheet | Case Notes | Users Notes

Last Revised: June 06, 2000

Author - John Shepherd - Summer 1998

• Marcia Angell. 1997. Science on Trial: The clash of medical evidence and the law in the breast implant case. W.W. Norton. 0-393-31672-6
• Chapter 3. David Kessler's justification of the 1992 FDA Ban and Angell's criticism of it. See pages 62-62.
  • David Kessler. 1992. The Basis of the FDA's decision on Breast Implants. N Engl J Med 326(25):1713-1715
  • Marcia Angell. 1992. Breast Implants- Protection or Paternalism? N Engl J Med 326(25):1695-1696
• Chapter 5. Scientific Evidence.
  • Marcia Angell. 1990. The Interpretation of Epidemiologic Studies. N Engl J Med 323(12):823-825
  • Ralph Keeney. 1994. Decisions about Life-Threatening Risks. N Engl J Med 331(3):193-196.
  • Page 101. "the Mayo Clinic Study" - Sherine E, Gabriel, W. Michael O'fallon, Leonard T. Kurland, C. Mary Beard, John E. Woods, And L. Joseph Melton, 1994. Risk Of Connective-Tissue Diseases And Other Disorders After Breast Implantation. N Engl J Med 330:1697-1702 (abstract on line at PBS site)
  • Page 101. "the Women's Health Cohort Study" - Charles H, Hennekens, , DRPH; I-Min Lee, , Nancy R. Cook,; Patricia R. Hebert,Elizabeth W. Karlson,; Fran LaMotte; JoAnn E. Manson, Julie E. Buring, 1996. Self-reported Breast Implants and Connective Tissue Diseases in Female Health Professionals. A Retrospective Cohort Study. JAMA 275(8):616-621. (abstract on line at PBS site)
  • Page 102. "the Nurses' Health Study" - J. Sanchez-Geurrero, G. Colditz, E. Karlson, D. Hunter, F. Speizer, and M. Laing. 1995. Silicone breast implants and the risk of connective tissue diseases and symptoms. New England Journal of Medicine 332:1666-1670.(abstract on line at PBS site)
  • Page 104. The results of injecting silicone directly into the breast - Yasuo Kumagai, Yuichi Shiokawa. Thomas A. Medsger. Jr.. And Gerald P. Rodnan. 1984. Clinical Spectrum Of Connective Tissue Disease After Cosmetic Surgery. Observations on Eighteen Patients and a Review of the Japanese Literature. Arthritis and Rheumatism, Vol. 27, No. I pp 1-12.
  • Page 104, the first report of CTD connected to implants - Sheryl A. Van Nunen, Paul A. Gatenby, And Antony Basten. 1982. Post-Mammoplasty Connective Tissue Disease. Arthritis and Rheumatism, Vol. 25, No. 6 pp694-697

• Chapter 6. Science in the Courtroom
  • The Daubert v Merrell Dow case examines the evidentiary issues in detail.  Parts of this case can be used to supplement Angell's chapters.
  • Frye v United States - 1923 US Supreme Court Decision was the basis of the Frye rule, which was made obsolete by the Daubert decision.  The Frye rule is a convenient starting point for issues of social interaction and peer critique.  By this rule expert testimony is admissible if it is "generally accepted" in the appropriate scientific community.
  • The were over 20 'friends of the court' briefs (an extraordinarily high number) filed before the court.  The six on the Daubert case reference list make contradictory persuasive arguments about the need for peer review and general acceptance as measures of reliability in scientific evidence.  They are greatly edited for brevity and clarity.
• Gary Taubes. 1995. Epidemiology Faces its Limits. Science 269:164-169.
• The AMA statement on breast implants and a critical response by David Kessler.
  • Council on Scientific Affairs, American Medical Association. 1993. Silicone Gel Breast Implants. JAMA 270:2602-2606
  • D. Kessler. R. Merkatz, and R. Schapiro. 1993. A call for higher standards for breast implants. JAMA 270:2607-2608
• The Journal of Clinical Epidemiology published a special section of breast implant articles in 1995 (vol 48 number 4, starting page number given below), which contained the following articles:
  • W.O. Spitzer. Editor's note: a special section of breast implants and the health of women. 503
  • R.D. Mann. Guest editorial: Breast implants: the tyranny of the anecdote. p 504
  • Steven Lamm. Silicone breast implants and long-term health effects: when are data adequate? p 507
  • R. LeVier, M. Harrison, R. Cook & T. Lane. What is silicone? p 513
  • Ralph R. Cook, Robert.R.Delongchamp, MaryAnn Woodbury, Laura Perkins. and Myron C. Harrison The prevalence of women with breast implants in the United States-1989.p 519
  • Sherine E. Gabriel, W, Michael O'Fallon, C. Mary Beard, Leonard T. Kurland, John E. Woods and L. Joseph Melton, III Trends in the utilization of silicone breast implants, 1964-1991, and methodology for a population-based study of outcomes. p 527
  • Arnold Engel, Steven H. Lamm and Shenghan H. Lai. Human breast sarcoma and human breast implantation: a time trend analysis based on SEER data (1973-1990) p 539
  • Robert W. Morgan and Maryellen Elcock. Artificial implants and soft tissue sarcomas p 545
  • Dennis M. Deapen and Carry S. Brody Augmentation mammaplasty and breast cancer: a five year update of the Los Angeles study p 551
  • Louise A. Brinton, Paolo Toniolo and Bernard S. Pasternack Epidemiologic follow-up studies of breast augmentation patients p 557
  • Marc C. Hochberg, Robyn Miller and Fredrick M. Wigley Frequency of augmentation mammoplasty in patients with systemic sclerosis Maryland Scleroderma Center: data from the Johns Hopkins-University of Maryland Scleroderma Center p 565
  • John A. Goldman, Jesse Greenblatt, -Ron Joines, Leslie White, Bruce Aylward and Steven H. Lamm Breast implants, rheumatoid arthritis, and connective tissue diseases in a clinical practice p 571
  • David Schottenfeld, Carol J. Burns, Brenda W. Gillespie, Timothy J. Laing, Maureen D. Nlayes, Steven G. Heerings and Kirsten H. Alcser The design of a population-based case-control study of systemic sclerosis (scleroderma): commentary on the University of Michigan studv p 583

Breast Implants on Trial - PBS web site

• Breast Implant Chronology
• Videotapes (FRONTLINE program, "Breast Implants on Trial" is available in the Mercer Media Center and 26-page verbatim Transcript of the show is on line.
• Corporate Resources and perspectives
  • Dow-Corning Implant Package Inserts
  • History/Chemistry of Silicone
  • Products with Silicone
• Legal Issues and perspectives
  • Gladys Laas Case - She was awarded $5.2 million by a jury in 1994.
    • Plaintiff Closing Argument
    • Defense (Dow-Corning) Closing Argument
  • Readings
    • Epidemiology article "(A good backgrounder on theories of causation, relative risk, statistical significance and, on what epidemiology can and can't tell you.)"
    • Defense Journal "(This describes the Federal Rules of Evidence 702 and 703 pertaining to specialized knowledge of a witness. No less influential in this area are the Supreme Court precedents described in Frye vs. U.S. (1923) and Daubert vs. Merrill Dow (1993) which shaped rules on admitting scientific evidence. These cases created heated debate about judges' role as 'gatekeepers.')"
    • Mass Tort article "Courts know how to treat individual cases. What's new is the explosion in mass-tort litigation and growing concern about the courts' ability to cope."
    • Cardozo Law Review "Taking Daubert's "Focus" Seriously: The Methodology/Conclusion Distinction"
• Medical Resources
  • Do Breast implants cause systemic disease?
    • Doctors who say yes (a long list of WWW sources)
    • Studies that say no (a list of abstracted primary articles reprinted on-line, including those linked above)
  • Medicine and Law - Guidelines for Judges at Federal Judicial Center, which also has an up-to-date information on implant litigation.