Writing Assignment 2: Breast Implants
Due: Sunday
Directions: Read the following case study: “Breast Implants” (Case 6.1, pp. 229-231 in
your textbook). Once you have finished reading the article, write a 2 page paper in which
you answer question #4 under “Discussion Questions” on p. 252: Was it irresponsible of
the manufacturers of breast implants to have marketed them without first conclusively
proving that they were safe? If you were on the jury, would you have found Dow Corning
or its parent company liable for the illnesses suffered by women who have had breast
implants? In answering the second part of the question, make sure that you explain why
you, as a member of the jury, would reason the way that you did. Refer to the material in
the chapter of strict liability when you are writing your paper.
It is all right if you slightly exceed the 2-page limit. However, no paper should be more
than 5 pages in length. Do not waste space retyping the question or summarizing the
article. Use the space allotted to answer the question.
This paper should be written entirely in your own words. If you must quote from the
article, quotations should be kept short (no more than 10 words in length). There should
not be more than two quotations in this paper. Quoted language must be placed in
quotation marks and followed by a citation. Failure to do so is plagiarism. Plagiarized
assignments will receive a 0.
No outside sources of any kind may be used when writing this paper. People using
outside sources will receive not receive credit for this assignment. All the
information that you need to answer the question is contained in your textbook and
class notes.
Papers should be double-spaced with standard margins. Use 12-point Times New Roman
type (the same size and font used in these directions). Pages should be numbered.
Make sure that your last name is included as part of the document name before
submitting it. All papers must be submitted via the dropbox. Upload the paper. Do not
copy and paste the paper in the dropbox window unless you absolutely cannot upload it.
Do not email papers to me. No late papers will be accepted.
CASE 6.1
Breast Implants
IN THE LAST FEW DECADES, SILICONE HAS
become a crucial industrial product, playing a role in the
manufacture of thousands of products, from lubricants to
adhesive labels to Silly Putty. One of its medical uses, how-
ever, has been controversial-namely, as the gel used for
breast implants. Dow Corning, which was founded in 1943
to produce silicones for commercial purposes, invented
mammary prostheses in the 1960s. Since then a million
American women have had bags of silicone gel implanted
in their breasts. For many of them, silicone implants are
part of reconstructive surgery after breast cancer or other
operations. However, by 1990 four out of five implants were
for the cosmetic augmentation of normal, healthy breasts-
a procedure that became increasingly popular in the 1980s
as celebrities such as Cher and Jenny Jones spoke openly of
their surgically enhanced breasts.
Today, however, what used to be a common elective
operation is rarely performed.103 The reason dates from the
1980s, when women with silicone breast implants first began
reporting certain patterns of illness. There were stories of
ruptured or leaky bags, although the estimates of the propor-
tion of women affected ranged from 1-5 percent to 32 per-
cent. And there were allegations that the silicone implants
were responsible for various autoimmune disorders—such
as rheumatoid arthritis, lupus erythematosus, and sclero-
derma—in which the body's immune system attacks its own
connective tissue. Then, in 1991, a jury heard the case of
Mariann Hopkins, who claimed that her implants had rup-
tured and released silicone gel, causing severe joint and
muscle pain, weight loss, and fatigue. On the basis of docu-
ments suggesting that Dow Corning knew of the dangers of
leaky bags, a San Francisco jury found the company guilty of
negligence and fraud and awarded Hopkins $7.3 million.
When Dow Corning first sold breast implants in 1965,
they were subject to no specific government regulations. In
1978 the Food and Drug Administration (FDA) classified them
as “Class Il” devices, meaning that they did not need testing
to remain on the market. In 1989, however, as worries about
the dangers of silicone implants increased, the FDA reclassi-
fied them as “Class Il devices and in 1991 required all
manufacturers to submit safety and effectiveness data.
Although some FDA staff members were scathingly critical of
the poor and inconclusive documentation submitted by the
manufacturers, the FDA's advisory panel ruled that the implants
were not a major threat to health. Based on public need, it
voted to keep them on the market.
After the Hopkins case, however, David A. Kessler, the FDA's
new chairman, called for a moratorium on breast implants. He
asked doctors to stop performing the operation, but he told
women who had already had the operation not to have the bags
removed. Still, the moratorium terrified the women who had had
breast implants, a few of whom tried in desperation to carve
them out themselves, and it galvanized a political movement led
by women who were upset about having been used, yet again, as
guinea pigs for an unsafe medical procedure. For them, it was
just one more episode in a long history of the mistreatment of
women by a medical, scientific, and industrial establishment that
refused to treat them as persons and take their needs seriously.
The FDA moratorium also galvanized the legal forces marshaled
against the manufacturers of silicone bags. By 1994, some
twenty thousand lawsuits had been filed against Dow Corning
alone. Entrepreneurial lawyers organized most of these actions
This reasoning, and the skepticism toward science and
statistics that it represents, has swayed jurors. After Dow
Corning filed bankruptcy in 1995, which brought to a halt the
lawsuits against it, new lawsuits were filed against its parent
company, Dow Chemical. The first of these resulted in a
$14.1 million verdict against the company, despite the lack
of scientific evidence. Disregarding the New England Journal
of Medicine study, the jurors were convinced that this par-
ticular plaintiff's suffering somehow stemmed from her Dow-
manufactured breast implant. A few years later, the women
who said their silicone breast implants made them ill agreed
to settle their claims against Dow Corning for $3.2 billion.
The settlement is part of its bankruptcy reorganization plan
and is similar to a settlement entered into earlier by 3M,
Bristol-Myers Squibb, and other manufacturers of breast
implants.
into a few large class-action suits so that their pooled legal
resources would be more than a match for the manufacturers.
Meanwhile, Kessler instructed the FDA's advisory panel to
re-study the breast implant question. Presented with a series
of anecdotal reports about diseases that are not rare, the
panel complained about the lack of hard scientific data. From
the scientific point of view, the problem was how to distinguish
coincidence from causation. For example, if connective-tissue
disease strikes 1 percent of all women and if 1 million women
have implants, then statistically one should expect that 10,000
women will have both implants and connective-tissue disease.
So if a woman develops the disease, can it correctly be said
that it was caused by her breast implants? Moreover, not only
does silicone appear to be chemically inert, but silicone from a
ruptured breast implant will remain trapped inside a fibrous
capsule of scar tissue. Nevertheless, on the basis of the panel's
recommendation, the FDA ruled that silicone may be used only
for reconstruction and that cosmetic breast augmentation must
be done only with saline packs.
At that point the gulf between science, on the one hand,
and the FDA and public opinion, on the other, began to widen
further. A Mayo Clinic study published in the prestigious New
England Journal of Medicine in June 1994 showed that there
was no difference between women with breast implants and
other women with respect to incidence of connective-tissue
disease; by the summer of 1995 two larger studies had con-
firmed the Mayo Clinic's report. On top of that, the FBI and other
investigators exposed several labs that were selling to lawyers
and victims fraudulent test results purporting to show the pres-
ence of silicone in the blood of women with breast implants.
Lawyers and other advocates for the women with implants
repudiate those studies, contending that the women have a
new disease. To this contention scientists respond that the
description of the symptoms of this supposed disease keeps
changing. Some say it looks like fibromyalgia, which is
included in their studies. Many feminist activist groups dis-
trust science; they believe that we should pay less attention
to statistics and medical studies and greater attention to the
women who have suffered. These women know what their
bodies have been through, and they are convinced that their
implants are responsible.
Update
By now, more than twenty reputable scientific studies have
been conducted on implant safety. Three European govern-
ments have convened scientific panels. The American College
of Rheumatology, the American Academy of Neurology, the
Institute of Medicine, and the American Medical Association
have all published reviews of the evidence, as has an inde-
pendent scientific panel appointed by a federal court. The
conclusion is unanimous and unequivocal: There is no evi-
dence that breast implants cause disease of any kind. 104
In light of these findings and the recommendations of a
federal advisory panel, in 2006 the FDA gave conditional
approval to Mentor Corporation's application to produce sili-
cone breast implants, thus effectively ending a thirteen-year
ban on the use of silicone for cosmetic breast enhancements.
DISCUSSION QUESTIONS
1. What does the breast implant controversy reveal about
society's attitudes toward product safety, about the legal
liability of manufacturers, and about the role of regulatory
agencies like the FDA in protecting consumers? Is our
society too cautious about product safety or not cautious
enough?
2. Was the FDA justified in placing a moratorium on silicone
breast implants and then halting them altogether for
cosmetic purposes?
3. Is the agency too concerned with public opinion? Should
it pay greater attention to scientific evidence or to the
individual women who have suffered?
4. Was it irresponsible of the manufacturers of breast
implants to have marketed them without first conclusively
proving they were safe? If you were on the jury, would
you have found Dow Corning or its parent company liable
for the illnesses suffered by women who have had breast
implants?
5. On safety matters, should the FDA or any regulatory
agency err on the side of overprotection or underprotec-
tion? Has the FDA's stance on breast implants been
fair to women who would like breast augmentation but
cannot get it? Some people disapprove of cosmetic
augmentation or believe it to be a frivolous operation.
Do you think that attitudes like this played a role in the
controversy over the safety of breast implants?
6. Some argue that in the case of new drugs or medical pro-
cedures in which the dangers are uncertain, consumers
should be free to decide for themselves whether they wish
to run the health risks associated with these products or
services. Assess this argument.
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