Breast Implants - Case Notes

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Author - John Shepherd - Fall 1998

Teaching Notes I extended the Angell case so that in one complex social issue we would try to 'get to the bottom of it.'  I introduced the scientific literature as part of this case by having them each analyze one of the key papers from the primary literature, which added two days to the case.  I have copies of those articles in my office.  This made more sense to me than talking about journals in the abstract.   Before we did this case we did the Daubert Case which speaks to some of the issues in Chapter 5 of Angell. Below are the daily assignments I posted on the section web page.  I was scheduled for 50-minute class periods.

Assignment for Day 1. Read Chapters 1 and 2 in Marcia Angell, Science on Trial. Chapter 1 is an introduction to the rest of the book.  Familiarize yourself with this basic information.  In class we will spend some time talking about the issues in Chapter 2, especially the question of why women get breast implants.  As always, a quiz is possible in the first 10 minutes of class.

• Are breast implants a conscious or unconscious attempt to please males?
• Do they reflect a "cultural fetish" with large breasts?
• Are they a way to "stunt women's sexual capacity"?
• Does breast size affect a woman's attractiveness?
• Do you think you might treat large- and small-breasted women differently ? How?
• Do you think large- and small-breasted women are treated differently by men? by other women? How?

Assignment for Day 2. Read Chapters 3 and 4 in Marcia Angell, Science on Trial.  No written assignment, but a quiz is likely. Be able to answer the following questions when you come to class.

• Was the FDA ban on implant sale justified in 1992? Was the ban mostly a political act? a scientific judgement? a self-protecting legal decision?
• Does our tort system serve to protect consumers from the predatory and negligent behavior of other people? Does the structure of the tort system prevent reasoned, and reasonable, judgement from deciding the outcome of these cases? What product-related risks are (un)acceptable?
• Whatever your answers to these questions, be prepared to support them with evidence from the Angell book.

Assignment for Day 3. Read Chapters 5, 6, and 7 in Marcia Angell, Science on Trial.  These chapters will review material we have talked about in Carey and the Daubert case.  No written assignment, but a quiz is likely. Be able to answer the following questions when you come to class.

Chapter 5:

• What are Angell's "general principles of the scientific approach" (page 91)? How do these compare to what we learned from Carey?
• Why does Angell think that "risk factor" is a better description of the role of breast implants than "cause"?
• How do "case control" and "cohort" studies differ?
• What were the major findings of the Mayo Clinic study? the studies of scleroderma?
• According to Angell, what are the weaknesses of studies that purport to establish a causal link between implants and various diseases? (pages 103-108)

Chapter 6: Our Daubert case should make this chpater mostly familiar ground.

• In the product liability suits, what must plaintiff lawyers demonstrate in order to be successful?
• What does the phrase "preponderance of the evidence" mean when applied to questions of scientific evidence?
• How do courtroom conclusions differ from scientific conclusions?
• What is the role of "expert testimony" in a court case?

Chapter 7:

• Is it possible for our legal system to serve the public good in the area of product liability law?
• What is the role of the jury, the adversarial system of advocates (lawyers, compensatory and punitive damages, and the contingency fee in the effectiveness of the system overall?

Assignment for Day 4. The chapters you read for Monday examined the legal and scientific dimensions of the breast implant case.  Our earlier Daubert case should have made you familiar with some of the key legal questions.  Now we will delve a little deeper into the science.  According to Angell (pp 101-102) three scientific studies played a central role in the breast implant controversy.   Each discussion group will be required to read one of the articles as follows:

• Front Discussion Group: (Angell 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)
• Middle Discussion Group: (Angell Page 101. "the Women's Health Cohort Study") - Charles H, Hennekens, 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)
• Back Discussion Group: (Angell 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)

We will use these articles to expose you to the scientific 'archive' of peer-reviewed literature.  This will probably be challenging reading for you, but you are young, you are strong, you are intelligent, you can can do it! Before class on Wednesday, do the following:

• Get a copy of the article [I passed a few copies out in class, also in the MUSM library.].
• Examine its structure: Abstract, Introduction, Methods, Results, Discussion (or 'Comment').
• Read the Abstract to get the main ideas from each of the paper's sections.
• Read through the rest of the paper.  As you read, refer back to the abstract and to Angell.
• As you read, identify terms and passages that are not clear to you.
• Be prepared to describe the study's experimental design, results, conclusions, and limitations.

Assignment for Day 5. At the start of class on Friday, your group will have 5 minutes to collect itself.  Then we will begin your presentations.  Your presentation should do the following:

• Identify why the study was done.
• Identify the question the study was supposed to answer.
• Describe the experimental design and Methods. Compare the design to those we have studied in Carey.  Show how controls were introduced into the study. This description should show exactly how the design allowed the question to be answered.
• Describe the Results of the study. 
• Describe the Conclusions reached by the authors. How do they interpret the results?  Are they justified by the evidence presented? 
• What are the implications of their results?  What are the limitations of the study?  Are there inherent biases in the data or their interpretation? Are there flaws in the design or execution of the study?

Your talk should be 11-13 minutes long [I will take short talks as evidence of lack of depth and long talks as evidence of poor organization].   It needs to be well organized and comprehensive in its coverage.   Include sufficient detail that your audience (who hasn't read the paper) knows all the important facts.  Avoid reading from the paper and don't include unnecessary minutia.  You may want to make one or two transparencies to help you.   If you are already familiar with software like PowerPoint, you may use that in your presentation [you will have to arrange equipment with me ahead of class].   Your group needs to decide how to present, and who will present.  If you choose to use multiple presenters, you need to coordinate carefully so that transitions are smooth and changing styles are not disruptive or distracting.

Assignment for Day 6. Read Chapters 8, 9 and 10 in Marcia Angell, Science on Trial.

• Why does Angell think it important that we be skeptical but not cynical?
• Can you think of cases where the media has done a particularly good (or bad) job reporting a science issue?
• How can someone know what to do in the face on contradictory reports from the media?
• Why does Angell think that humanists, multiculturalists, some environmentlaists, and some feminists reject science as a source of answers?
• Does the "science establishment" reject the techniques of "alternative medicine" even when they work?
• What does Angell see as the dangers of rejecting science?
• Should the funding sources of all research projects have to be disclosed?
• If manufacturers contribute to the funding of a safety study, can the results of the study be trusted?
• "Are breast implants dangerous?"  Is it possible to know the answer to this question, or is it simply a matter of opinion and personal interpretation?

Assignment for Day 7. No written or reading assignment for our class meeting.  However, you are required to attend the panel discussion in the evening.  Before the evening meeting, write out at least two questions you can ask the panelists.  I will have a class roll attached to an orange clipboard at the front of the auditorium.  To get credit for attending, sign the roll next to your name.  You may sign the roll before the panel begins if you arrive early; otherwise you must wait until after the program concludes.  If you disrupt the proceedings to walk up and sign the roll, I'll reward you with 3 zeroes for quiz grades.

Assignment for Day 8. In class on Friday, we will finish our discussion of the Breast Implant case by talking about any unresolved issues from the video and the panel discussion.  Read the Afterword in Angell (pp 211- 221).  Think about things that would help avoid this type of controversy in the future.  Also read the final paper assignment and come to class with two or three vague ideas about topics you might choose.