Implants, phony plastic hooters, do not equate "beauty," for starters,
so anybody who starts out with that rationale is already playing with
half a deck. That implants carry risk is no news to anybody. I
wouldn't even consider getting impants, if for no other reason than
they look silly and fake in addition to subjecting you to risk.
Everybody knows that surgery involves risk and that implants can
rupture and cause all kinds of problems.

Rosenthal is basically an irritating, spamming pain in the a.s who
doesn't do anything other than promote her tacky website that's
littered with silly flowers, fluttering butterflies, and "case
histories" funnelled into hideously poorly written Hallmark tripe.
That's fine.   But when she starts talking about "unecessary"
mastectomies for seriously at-risk women, without having ANY clue
whether or not these women would have died horrible agonizing deaths
instead of living on to fuss about implants, I get pissed off.  Note
that you took the time to address the issue; she didn't.

She must be talking about those women, or at least I hope she is,
because if there are other women out there being urged to chop off and
replace their breasts for purely cosmetic reasons, and do it, there's
no hope for them in any world.

I have a close friend who's 35, a doctor and the mother of 2 small
kids, with stage IV breast cancer. She may live another 6 months. Her
mother, sister, and aunt died before 40 of breast cancer.  She chose
not to remove her breasts.
Do you recognize the obscenity of suggesting that she's better off
this way than if she had to deal with implant leakage today?

There's no argument whatsoever about that. But honestly, do you know
of one single person who would take such a decision lightly?

For Doomers ...

You underestimate the power of marketing by the cancer and breast
implant industries and over estimate the truthfulness of their media.

www.BreastImplantAwareness.org/snake-oil.htm
They have merged their PR $$$$ with the vaccination and food &
chemical industries ... and work long, deep and wide to put out the
industry word as 'fact.'

Very intelligent, even brilliant women have been duped into believing
breast implants are safe ... so good is the industry PR.

http://ilenarose.blogspot.com
Health Lover, Ilena Rosenthal

http://www.center4research.org/health7.html

The Need to Improve Informed Consent for Breast Cancer Patients

Diana M. Zuckerman, PhD

Abstract

Many of the more than 182,000 women who will be newly diagnosed with
breast cancer this year will not have access to all the information
they need to make the surgical and treatment choices that are most
appropriate for them. Research clearly shows that lumpectomy and other
breast-conserving surgeries are just as safe as mastectomy for most
women with early stage disease, and yet approximately half will
undergo the more disfiguring procedures. Choices about breast implants
and autologous tissue reconstruction are based, at best, on a few
published studies that provide limited information about the long-term
safety of these procedures. Many healthy women who have strong family
histories of breast cancer consider prophylactic mastectomies, and
their decisions are also based on very limited information, because
there are few studies showing the effectiveness of that procedure.
This paper delineates how limited information and biased
recommendations can undermine breast cancer patients’ ability to make
informed choices. (Published in the Journal of the American Medical
Women’s Association, Fall 2000, 55: 285-289).

   Breast cancer is the most common malignancy in women in the United
States; more than 182,000 women will be newly diagnosed this year.1
Unlike previous generations, most of these women will have several
choices to make, including the type of surgery, whether to have
radiation, the type of adjuvant therapy (chemotherapy or hormonal
therapy), and the type of reconstruction, if any. However, many of
these women will not have access to all the information they need to
make the choices that are most appropriate for them.

   There is considerable research evidence that where a woman lives,
her income level and health insurance, the type of medical facility,
when her doctor was trained, and the doctor’s enthusiasm for
breast-conserving-surgery may have more impact on her surgical
treatment than her specific diagnosis. For example, research has
clearly shown that most women who are diagnosed with noninvasive or
early-stage breast cancer can be very safely and effectively treated
with breast-conserving surgery. And yet, so few women have this
surgery that it raises questions about whether they are objectively
informed about the advantages and disadvantages of their surgical
options.2,3,4,5 In addition, the lack of research on some prevention
and treatment options makes it impossible for many women to obtain the
information they need to make fully informed choices. The purpose of
this paper is to delineate how these and other choices made by many
breast cancer patients may be based on limited information and
sometimes biased recommendations, rather than the objective
information needed for informed consent.

   The historical context is essential to understanding why
information may be inadequate. Many of today’s breast surgeons were
trained at a time when there were few choices in breast cancer
treatment, and tradition may still influence some doctors against
breast-conserving surgery.6 Halsted developed the radical mastectomy
in the 1890s; this procedure removed the breast, skin, nipple, areola,
pectoral muscles, and all the axillary lymph nodes on the same side.
Even more radical procedures were sometimes used, removing part of the
breastbone and ribs to get the internal mammary nodes. In the 1940s,
doctors in England developed the modified radical mastectomy, which
removed the breast and axillary lymph nodes, but left the chest
muscles intact. Although the reoccurrence rates seemed comparable to
those for the Halsted, the modified radical mastectomy did not become
more common than the Halsted procedure in most US hospitals until the
mid-1970s.7

   When researchers determined that many breast cancers grow slowly,
treatment decisions became less urgent, and clinical trials were
conducted to evaluate less radical procedures. In a study started in
1971, Fisher compared the survival of women who were randomized into
three treatment groups: radical mastectomy, simple mastectomy (which
removes only the breast and areola), and simple mastectomy with
radiation.8 After 15 years, the survival rate was the same for all
three groups. This study, published in 1985, was a turning point,
resulting in surgical choices for more women diagnosed with breast
cancer. Choices about radiation, chemotherapy, hormonal therapy, and
reconstruction also influence surgical decisions. Now that women have
so many choices to make, informed consent has become an important
issue for breast cancer patients.

   Informed consent relies on a patient receiving accurate
information and freely making a decision based on that information. If
objective information is not available on some aspects of breast
cancer treatment because of lack of research, then the patient should
be told that there is no research, or that existing research is
inconclusive. If physicians describe their own experiences to
patients, they should also explain the limitations of that information
compared to data from long-term, objective empirical research.9
Breast-Conserving Surgery

   In a landmark study comparing women with early-stage breast cancer
who received breast-conserving surgery followed by radiation with
those who had mastectomy, Fisher and his colleagues reported that
eight years after surgery, approximately 91% of the women in both
groups remained free of cancer.10 A consensus conference convened by
the National Institutes of Health (NIH) in 1991 concluded that
breast-conserving surgery with radiation was as effective as
mastectomy for the treatment of early-stage breast cancer.11 The
participants understood that breast-conserving surgery would not be
the choice of every woman who was eligible, and that the expense,
inconvenience, and fear of radiation would deter some women;
nevertheless, the consensus was that lumpectomy and other
breast-conserving surgery would be preferable for most patients.

   The NIH holds consensus conferences to help experts come to a
consensus about medical issues; the conferences also serve a public
education function because the NIH publicizes the conclusions to
physicians and patients across the country. The NIH consensus
conference on breast cancer surgery was intended to help
breast-conserving surgery gain wider acceptance by informing
physicians and the public that these procedures are as safe as more
radical surgery. In the decade since then, however, most of the women
who have been eligible for lumpectomies have undergone mastectomies
instead.

   Women who are poor and who live in certain parts of the country
are especially unlikely to have breast-conserving surgery. For
example, in a 1995-1996 study of patients at a large, urban,
university-affiliated Texas hospital serving primarily medically
indigent patients, only 16% of those eligible received
breast-conserving surgery.5 Although fear of breast cancer or
radiation may make some women reluctant to choose breast-conserving
surgery, one would expect that information clearly explaining that
they would live just as long with lumpectomies as with mastectomies
would reassure more than 16% of any group of women. Since
breast-conserving surgery was believed to be safest for women with
early-stage breast cancer, one would expect well-informed women with
stage I breast cancer to be significantly more likely to undergo
breast-conserving surgery than those with stage II breast cancer.
Instead, the vast majority of women in this study underwent
mastectomies regardless of stage, and the authors expressed concern
that the surgeons’ opinions and recommendations were the likely reason
for the high rate of mastectomy.

   Several studies indicate that physicians’ knowledge or attitudes
can deter women from choosing breast-conserving surgery. In a study of
157 hospitals in North Carolina, Kotwall et al found that patients
were more likely to undergo breast-conserving surgery if their
surgeons were trained after 1981 (by which time lumpectomies were
becoming more widely accepted).3 Attitudes may be more important than
knowledge; Tarbox et al reported that a substantial proportion of
surgeons who knew that lumpectomy was as safe as mastectomy
unknowingly influenced patients in favor of mastectomy with subtly
biased presentations.4 Similarly, Cady and Stone reported that the
surgeon’s "interest and enthusiasm" for breast-conserving surgery
increased the likelihood of patients choosing that treatment.12
Physician attitudes were also found to be influential in earlier
studies of breast-conserving surgery.13,14

   Lumpectomy with radiation is often more expensive than
mastectomy,12 so financial incentives may also contribute to
unnecessary mastectomies. Studies of low-income women indirectly
support concerns that breast cancer patients are making surgical
decisions that may not be based on informed choice. For example, the
study of Texas indigent patients mentioned above5 found that
mastectomy was more common among women with limited financial
resources. A study of 20,000 breast cancer patients in North Carolina
also reported lower lumpectomy rates among patients who did not have
private insurance.3 Economic incentives may be influential even among
Medicare patients, whose breast surgery is paid for by the federal
government. A study of Virginia Medicare patients treated in 1992 and
1993 found that only 26% of the women who would be considered good
candidates for breast-conserving surgery had such surgery, and this
choice was most likely if the hospital had radiation oncology
facilities on the grounds.15 Convenience was apparently not the only
reason; patients who underwent surgery in hospitals without on-site
radiation facilities were less likely to have breast-conserving
surgery whether radiation facilities were nearby or far away. These
findings suggest that economic incentives may influence surgeons’
discussion of treatment options or recommendations.

   Researchers believe that physician knowledge and attitudes are a
likely explanation for the dramatic regional differences they have
documented in breast-conserving surgery: in 1986, breast-conserving
surgery was more than twice as common in the Middle Atlantic states
and New England than in the South Central states.16 There were also
dramatic regional differences in a recent national study of ductal
carcinoma in situ; 58% of women in New Mexico received mastectomies
for this noninvasive breast cancer compared to only 29% in
Connecticut.17 In a study of 18 randomly selected hospitals in
Massachusetts and 30 in Minnesota, 75% of Massachusetts women who were
eligible for breast-conserving surgery made that choice, compared to
only half in Minnesota.2 Convenience of radiation facilities could
have been a factor, because Minnesota is more rural; however, informed
consent seemed to play an important role as well. More mastectomy
patients in Minnesota reported that their physicians did not discuss
breast-conserving surgery, and even when their physicians did discuss
the option, more Minnesota women reported choosing mastectomy because
their physicians recommended it.2 Patient compliance with physicians’
recommendations is a related issue; Kotwall et al found that
mastectomy patients were more likely to rely on the recommendations of
their physicians, whereas patients who had breast-conserving surgery
were more likely to obtain second opinions or to say they made the
decision themselves.18

   Differences in physician knowledge and attitudes could also
contribute to widely varying breast-conserving surgery rates within
states. For example, economic influences and hospital size or location
did not fully explain breast-conserving surgery rates that ranged from
0 to 44% among Virginia hospitals caring for more than 12 Medicare
breast cancer cases per year.15 Sometimes the difference in physician
or clinic attitudes is very explicit. For example, the Mayo Clinic,
which is the best-known medical facility in Minnesota, reported that
its eligibility criteria for lumpectomy was different from other
facilities, resulting in fewer women having breast-conserving
surgery.19

   Several states have laws aimed at improving informed consent by
requiring the disclosure of options for the treatment of breast
cancer.20 Research has shown the benefits and limitations of these
efforts: after passage of the state laws, breast-conserving surgery
rates increased by 9% in Michigan and 13% in Hawaii. The increases
were not maintained over time, however, and the authors speculated
that requiring physicians to provide objective information does not
necessarily change their recommendations.

   The statistical associations between mastectomy rates and
financial incentives and physician characteristics do not prove that
women are not receiving accurate information. However, five studies
explicitly examined how physicians’ attitudes influenced their
patients’ decisions and found that they either directly or indirectly
influenced informed consent.2,4,12,13,14 A sixth study found that
doctors trained in the era before lumpectomies were proven equally
safe were less likely to perform them.3 A seventh study found that
women who had mastectomies were more likely to have relied on their
physicians for advice, and women with breast-conserving surgery were
more likely to have sought second opinions or relied on themselves for
the decision.18 When considered together, these studies and those
documenting different rates associated with geographic, insurance,
socioeconomic, and other factors strongly suggest that physician
attitudes and recommendations, most likely influenced by knowledge,
training, and financial incentives, affected the information that
patients received or the way they interpreted that information. In
addition, the steady increase in lumpectomy rates during the last
eight years, despite no new research regarding its safety, suggests
substantial changes in the information that women are receiving, from
their physicians or elsewhere.
Prophylactic Mastectomy

   As women have become more aware of the risk factors for breast
cancer, including family history and gene mutations, healthy women who
are concerned about their risk of cancer are deciding whether to
undergo prophylactic mastectomies. This raises informed consent issues
in two ways: Are women receiving accurate and understandable
information about their risk of breast cancer? And are they
appropriately informed about the risks and benefits of prophylactic
mastectomy?

   The fact that women were willing to undergo prophylactic
mastectomies even before research indicated that the surgery
significantly reduces the risk of cancer indicates the level of fear
associated with the disease. Statistics warning that one of every
eight women will get breast cancer are often quoted in the media, but
it is less widely understood that the lifetime risk is much higher
than the risk for women under age 50 and exponentially higher than the
risk that a woman of any age will get cancer in the next five years.
The first step in informed consent for women considering prophylactic
mastectomies should be to clarify the differences between lifetime
risk and short-term risk, and to emphasize that estimates about the
risks associated with genetic factors are very preliminary.

   Informed consent for prophylactic mastectomy is limited by the
paucity of research. One recent study indicated that prophylactic
mastectomy reduced the rate of breast cancer in women with strong
family histories of the disease.21 Those results were described on
television and radio and published in major newspapers across the
country, including The New York Times, The Washington Post, USA Today,
and the Chicago Tribune. Two letters to the editor of the medical
journal that published the study, however, pointed out that the risk
of undergoing a mastectomy unnecessarily is also high. Hamm et al
estimated that 13 women at moderate risk would lose their breasts
unnecessarily for every prophylactic mastectomy that actually
prevented one woman at moderate risk from getting breast cancer, and
that 42 women at moderate risk of breast cancer or 25 women at high
risk would have to have prophylactic mastectomies in order to prevent
one death from breast cancer.22 Ernster estimated that 98% of women at
moderate risk of breast cancer would not benefit from prophylactic
mastectomy in terms of reduced mortality.23 According to a Lexis-Nexis
search, the information from the letters was not widely published in
the mass media and is therefore probably less available to women
considering prophylactic mastectomy.
Reconstruction Options

   If a woman has a mastectomy, she must also decide whether to
undergo reconstruction and what kind of reconstruction, and her
decision about mastectomy may be influenced by her views on the safety
of reconstruction. Therefore, accurate, unbiased information regarding
reconstruction is essential even before a woman decides to have a
mastectomy.

   The first breast implants were developed in the early 1960s for
augmentation, not reconstruction. Halsted opposed reconstruction, and
radical mastectomies left little tissue for it. With the increased
popularity of modified radical mastectomies and simple mastectomies,
however, plastic surgeons began to recommend the use of implants,
urging that breast cancer patients had the "right" to replace breasts
lost to cancer.24

   At the time breast implants were first sold in the 1960s, the US
Food and Drug Administration (FDA) did not regulate medical devices
and therefore did not evaluate implant safety. When the FDA was given
that authority in 1976, breast implants and many other devices were
"grandfathered" and therefore allowed to stay on the market at least
temporarily. Although there were warnings on the package inserts in
the box containing breast implants, including the risk of breast
hardening, rupture and gel leakage, infection, hematoma, swelling,
pain, and necrosis,25 the package insert is enclosed in a sealed box
that is not opened until surgery in order to keep the implant sterile.
Implant patients are therefore dependent on their doctors for safety
information. A pamphlet developed and widely distributed by the
American Society of Plastic and Reconstructive Surgeons described
implants as safe and did not mention that there were no empirical
studies of long-term health effects.25

   In 1991, the FDA required implant manufacturers to submit data
proving that silicone gel breast implants were safe and effective, but
the studies submitted were deemed too poorly designed to prove safety
or effectiveness.26 In an almost unprecedented decision, however, the
FDA allowed continued sale of silicone implants to mastectomy patients
and women who wanted implant replacements, to meet a "public health
need." In 1992, the FDA approved a large-scale "clinical trial" to be
conducted by one implant manufacturer, which was open to virtually any
mastectomy patient; no data from that trial have yet been published or
reviewed by the FDA.

   Because of the lack of research on any kind of breast implants and
concern about the almost one million women who already had them,
Congress passed legislation in 1992 requiring the National Institutes
of Health (NIH) to study the safety of breast implants. The NIH
director refused to include mastectomy patients in this study of more
than 13,000 implant patients, explaining to members of Congress that
it would complicate the study design.26 There are, therefore, no
epidemiological safety studies of mastectomy patients with implants
funded by the federal government. Very few studies have examined even
the short-term health outcome for mastectomy patients.27,28 Some
studies of mastectomy patients have reported substantial
complications, but their results are not widely disseminated and
therefore are not available to most doctors or patients. For example,
a five-year prospective study of silicone gel implants conducted by
one implant manufacturer indicated that 24% of the mastectomy patients
underwent at least one implant-related additional surgery within the
first year, and 24% underwent surgery to remove at least one implant
within the first two years (McGhan Medical Corporation, unpublished
data, 1998). This unpublished study is available only on request from
the Institute of Medicine (IOM) Library in Washington, DC.

   Saline-filled breast implants have had a similar history. The FDA
reviewed safety data provided by two manufacturers in March 2000 and
approved the implants despite evidence that approximately
three-fourths of the mastectomy patients studied had had serious
complications in the first three years, including pain, implant
rupture, additional surgery, hardness, or the need to have the implant
removed.9,29 The FDA required the two implant manufacturers to add new
warnings to their package inserts, but these warnings are, as before,
provided to the surgeons in the sealed implant box rather than to the
patients.

   Women considering mastectomy and reconstruction should be informed
of the lack of peer-reviewed research on implants for mastectomy
patients and the high rupture, resurgery, and complication rates
reported in unpublished studies. They should also be advised that no
studies of the health risks of a saline implant with bacteria or mold
breaking inside the body have been conducted. Patients will not have
the information needed to make informed decisions if neither they nor
their doctors have access to objective, peer-reviewed research
conducted on mastectomy patients. Representatives of the American
Society of Plastic and Reconstructive Surgeons provided testimony to
the FDA that breast implants are very safe and that serious
complications are rare.9 In contrast, a review of research conducted
by FDA scientists reported that rupture was common, and a recent FDA
study found that more than 79% of patients had at least one broken
implant within 11 to 15 years.30,31

   In the last decade, alternative breast reconstruction techniques
have become increasingly available, using muscle and fat from the
abdomen or back. Published studies on the safety and effectiveness of
these types of breast reconstruction are limited; most are small case
series of plastic surgeons’ own patients, which clearly raises
questions about generalizability and objectivity. Even so, the
articles raise concerns about skin or fat necrosis,32 especially among
smokers;33 problems with inexperienced physicians,30 high complication
rates,31,34 burns on reconstructed breasts due to impaired
thermoregulatory capacity of transplanted tissue;35 and death.36

   These surgeries are lengthy, complicated procedures, and the
researchers warn that success rates vary greatly depending on the
skill of the surgeon; it is therefore unlikely that the results from
one practice are generalizable to most patients. In the absence of
large multicenter clinical trials or empirical studies of a doctor’s
own patients it is not possible for most doctors to provide good
estimates of the risks associated with these procedures to their
patients, thus greatly limiting informed consent.
Improving Informed Consent for Breast Cancer Patients

   Informed consent for breast-conserving surgery, prophylactic
mastectomy, and reconstructive surgery is limited partly because
physicians themselves lack the information they need to appropriately
inform their patients. In all these situations, informed consent
should focus on what is not known about long-term risks in addition to
what is known about failure rates and local complications. Physicians
should provide as much objective information as possible, including
long-term follow-up data from their own patients. We do not know if
most doctors inform women of the lack of research, but there is clear
evidence that at least one medical association is providing women with
overly optimistic statements about the safety of implants. The ASPS
website currently has an article stating that "Recent scientific
studies have absolved silicone gel breast implants of causing health
problems in women." This statement is apparently based on studies
showing no increased risks of autoimmune disease or cancer, but it
ignores the IOM and FDA conclusions that implants can cause such
serious health problems as pain, infection, and the need for multiple
surgeries.

   Signed consent forms provide liability protection and meet
research requirements by giving detailed descriptions of the risks,
known and unknown. In contrast, health professionals’ oral
explanations of risks and benefits may be inconsistent with their own
written materials. To improve informed consent for breast cancer
patients, we need more information about the process of decision
making. It is certainly likely that some women who are accurately and
persuasively told that lumpectomies are as safe as mastectomies will
choose mastectomies, and that some women who have mastectomies will
choose reconstruction even if told that there are serious short-term
risks and that the long-term risks are unknown. However, it is likely
that better information will change the current pattern of high rates
of unnecessary mastectomies followed by reconstruction.

   In summary, more long-term safety data are needed on
reconstruction options, better research is needed on the efficacy of
prophylactic mastectomy, and many physicians need better access to the
most accurate, unbiased information already available on breast cancer
surgical outcomes. In addition, research is needed to better
understand why the rate for breast-conserving surgery is so low, and
what programs and policies would be most effective in ensuring that
breast cancer patients receive objective information in ways that
enable them to make the best possible medical and surgical choices.
The bottom line is that many patients do not have the information they
need to make informed choices, and patient advocates and policy makers
need to support objective research and develop new strategies to
ensure better informed consent for breast cancer patients.

References

1 Cancer Facts and Figures 2000. Atlanta, Ga: American Cancer Society;
2000.

2 Guadagnoli E, Weeks JC, Shapiro CL, Gurwitz JH, Borbas C, Soumerai
SB. Use of breast-conserving surgery for treatment of stage I and
stage II breast cancer. J Clin Oncol. 1998; 16:101-106.

3 Kotwall CA, Covington DL, Rutledge R, Churchill MP, Meyer AA.
Patient, hospital, and surgeon factors associated with breast
conservation surgery: A statewide analysis in North Carolina. Ann Surg
1996;224:419-426.

4 Tarbox BB, Rockwood JK, Abernathy CM. Are modified radical
mastectomies done for T1 breast cancers because of surgeon’s advice or
patient’s choice? Am J Surg. 1992;164:417-420.

5 Dolan JT, Granchi TS. Low rate of breast conservation surgery in a
large urban hospital serving the medically indigent. Am J Surg.
1998;176:520-524.

6 Treatment of early-stage Breast Cancer. NIH Consensus Statement
Online. 1990;8:1-19.
http://odp.od.nih.gov/consensus/cons/081/081_statement.htm.

7 Love SM. Dr. Susan Love's Breast Book. 2nd ed. Reading, Mass:
Addison-Wesley; 1995.

8 Fisher B, Redmond CB, Fisher E, et al. Ten-year results of
randomized clinical trials comparing radical mastectomy and total
mastectomy with or without radiation. N Engl J Med. 1985;312:674.

9 Testimony before the Food and Drug Administration Meeting on Saline
Breast Implants, March 1, 2000. http://www.fda.gov.

10 Fisher B, Anderson S, Redmond CK, Wolmark N, Wickerham DL, Cronin
WM. Reanalysis and results after 12 years of follow-up in a randomized
clinical trial comparing total mastectomy with lumpectomy with or
without irradiation in the treatment of breast cancer. N Engl J Med.
1995;1456-1461.

11 NIH Consensus Conference. NIH Consensus Conference: Treatment of
early stage breast cancer. JAMA. 1991;265:391-395.

12 Cady B, Stone, MD. Selection of breast-preservation therapy for
primary invasive breast carcinoma. Surg Clin North Am.
1990;70:1047-1049.

13 Ward S, Heidrick S, Wolberg W. Factors women take into account when
deciding upon type of surgery for breast cancer. Cancer Nurs.
1989;12:344-351.

14 Liberati A, Apolone G, Nicolucci A, et al. The role of attitudes,
beliefs, and personal characteristics of Italian physicians in the
surgical treatment of early breast cancer. Am J Public Health.
1990;81:38.

15 Elward KS, Penberthy LT, Bear H, Swartz DM , Boudreau RM, Cook SS.
Variation in the use of breast-conserving therapy for Medicare
beneficiaries in Virginia: Clinical, geographic, and hospital
characteristics. Clin Perform Qual Health Care. 1998;6:63-69.

16 Nattinger AB, Gottlieb MS, Veum J, et al. Geographic variation in
the use of breast-conserving treatment for breast cancer. N Engl J
Med. 1992;3326:1102-1107.

17 Ernster VL, Barclay J, Kerlikowske K, et al. Incidence of and
treatment for ductal carcinoma in situ of the breast. JAMA.
1996;275:913-918.

18 Kotwall CA, Maxwell JG, Covington DL, Churhill P, Smith SE, Covan
EK. Clinicopathologic factors and patient perceptions associated with
surgical breast-conserving treatment. Ann Surg Oncol. 1996;3:169-175.

19 Grant CS. Changes in the treatment of early breast cancer at the
Mayo Clinic: 1988-1992.Eur J Surg. 1996;162:93-96.

20 Nattinger AB, Hoffman RG, Shapiro R, Gottlieb MS, Goodwin JS. The
effect of legislative requirements on the use of breast-conserving
surgery. N Engl J Med. 1996;335:1035-1040.

21 Hartmann LC, Schaid DJ, Woods JE, et al. Efficacy of bilateral
prophylactic mastectomy in women with a family history of breast
cancer. N Engl J Med. 1999;340:77-84.

22 Hamm RM, Lawler F, Scheid, D. Prophylactic mastectomy in women with
a family history of breast cancer. N Engl J Med. 1999;340:1837-38.
Letter.

23 Ernster VL. . Prophylactic mastectomy in women with a family
history of breast cancer. N Engl J Med. 1999;340:1838. Letter.

24 Jacobson N. The socially constructed breast: Breast implants and
the medical construction of need. Am J Public Health.
1998;88:1254-1261.

25 Is the FDA Protecting Patients From the Dangers of Silicone Breast
Implants? Hearing before the Human Resources and Intergovernmental
Relations Subcommittee of the Committee on Government Operations, U.S.
House of Representatives. Washington, DC: US Government Printing
Office; 1991: 179-185, 278-370.

26 The FDA’s Regulation of Silicone Breast Implants: Staff Report for
the Human Resources and Intergovernmental Relations Subcommittee of
the Committee on Government Operations, U.S. House of Representatives.
Washington, DC: US Government Printing Office; 1993.

27 Safety of Silicone Breast Implants. Washington, DC: Institute of
Medicine; 1999.

28 Zuckerman D. Summary of Studies of Saline Implants and Connective
Tissue Diseases. http://www.cpr4womenandfamilies.org/implant.html.

29 Local Complications of Saline Breast Implants.
http://www.cpr4womenandfamilies.org/implant.html.

30 Brown SL, Silverman BG, Berg W. Rupture of silicone-gel breast
implants: Causes, sequelae, and diagnosis. Lancet. 1997;
350:1531-1537.

31 Brown SL, Middleton MS, Berg WA, Soo MS, Pennello G. Prevalence of
rupture of silicone gel breast implants in a population of women in
Birmingham, Alabama. Am J Roentgenol 2000; 175: 1057-1064.

32 Baldwin BJ, Schusterman MA, Miller MJ, et al. Bilateral breast
reconstruction: Conventional versus free TRAM. Plast Reconstr Surg.
1994;93:1410-1416.

33 Schusterman MA, Kroll SS, Miller MJ, et al. The free transverse
rectus abdominis musculocutaneous flap for breast reconstruction: One
center’s experience with 211 consecutive cases. Ann Plast Surg.
1994;32:234-241.

34 Delay E, Gounot N, Bouillot A, et al. Autologous latissimus breast
reconstruction: A 3-year clinical experience with 100 patients. Plast
Reconstr Surg. 1998;102:1461-1478.

35 Nahabedian MY, McGibbon BM. Thermal injuries in autogenous tissue
breast reconstruction. Br J Plast Surg. 1998; 51:599-602.

36 Hamdi M, Weiler-Mithoff EM, Webster MH. Deep inferior epigastric
perforator flap in breast reconstruction: Experience with the first 50
flaps. Plast Reconstr Surg. 1999;103:86-95.