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This article was published in RN Magazine, February 2002

The Breast Cancer Information Gap

DIANA ZUCKERMAN, PhD

Breast cancer patients who are considering reconstructive surgery
following a mastectomy may not always receive the safety and
quality-of-life information they need to make a truly informed decision
about breast implants. This former Congressional investigator provides
the data you need to help fill that information gap.

Thanks to early detection, three out of four American women who are
newly diagnosed with breast cancer can safely choose breast-conserving
surgery rather than mastectomy.1 For those who choose a partial or
complete removal of a breast, many patients consider whether or not to
undergo breast reconstruction with implants.

In 1999, the most recent year for which statistics are available,
nearly 83,000 women underwent breast reconstruction.2 Although breast
implants often have the desirable effect of helping to improve a
woman's self-image and body symmetry, their safety remains
controversial. The potential complications include pain, breakage, and
a possible link to fibromyalgia and other diseases.

As a former Congressional investigator reviewing studies submitted
by implant manufacturers to the Food and Drug Administration (FDA), and
in my current work on health policy issues, I have studied firsthand
the research on the safety of breast implants and quality-of-life
issues surrounding them. Here I'll share with you a number of things
I've learned that you and your patients may not be aware of.

Safety issues patients may not fully grasp
There are two types of breast implants and they both have an outer
silicone shell; one type is filled with saline and the other with
silicone gel. Both were on the market for many years before the FDA
started regulating medical devices in 1976. When the agency began
reviewing safety data on medical devices, it gave priority to
lifesaving ones. As a result, the FDA didn't review the safety of
breast implants until 1991.

The FDA started with silicone-gel implants because of concerns that
silicone leakage could be harmful. In 1992, dissatisfied with the
safety data from the manufacturers of these products, the FDA
restricted the use of silicone implants to patients undergoing
reconstruction after mastectomy, women with breast deformities, and
those who had silicone implants that ruptured and wanted them
replaced.3 The FDA further stipulated that these implants had to be
used in ongoing clinical trials, which would enable the agency to track
patient data and evaluate implant safety over time.

In 1999, the FDA reviewed safety data from manufacturers of saline
implants, and, in 2000, approved several styles made by McGhan Medical
Corporation and Mentor Corporation (both in Santa Barbara, Calif.) for
breast reconstruction in women of all ages and breast augmentation in
women 18 years or older.

Although silicone gel implants feel more natural, saline implants
are generally considered safer in the event of rupture. Yet, patients
need to understand that saline implants also have risks.

According to studies the FDA received from manufacturers of saline
breast implants, seven out of ten reconstruction patients will
experience at least one serious complication within the first three
years of receiving an implant, such as pain, hardness, infection, or
rupture of the implant.4 The most common complication - experienced by
almost one-third of the women -- is a condition called capsular
contracture, in which scar tissue tightens around the implant, causing
the breast to become hard, misshapen, and painful.5 Patients who have
breastfed compare the sensation to being unable to nurse their baby for
many hours.

Capsular Contracture - Photos are courtesy of U.S. Food and Drug
Administration/Walter Peters, PHD, MD, FRCSC, University of Toronto

Capsular contracture occurs when the scar tissue, or capsule, that
normally forms around an implant tightens and squeezes the implant. The
Baker grades of capsular contracture range from I (breast is soft and
looks normal) to IV (breast is hard and painful and looks abnormal).
This 29-year old woman suffered a grade IV contracture in her right
breast seven years after placement of a silicone-filled implant.

Not guarantee to last a lifetime

Patients may also not be aware that a breast implants will break
eventually. A new FDA study shows that most implants break within 10-15
years, although some may break within just a few months.6 One in four
patients has an implant removed within three years because of this
complication and others.4

When the shell of a saline implant breaks, saline leaks out
quickly, or over several days. As a result, the implant gets smaller
and may lose its shape. Although the saline is absorbed by the body,
the deflated implant will need to be surgically removed.

Breast Implant Deflation - Photos are courtesy of U.S. Food and
Drug Administration/Walter Peters, PHD, MD, FRCSC, University of
Toronto

Deflation or rupture of a breast implant can be caused by
instruments during surgery, trauma or injury to the breast, excessive
compression during the mammography, or normal aging of the implant. The
left saline-filled implant in this 30-year-old woman defalted after
five months. The likely cause was the leaf-value design of the implant,
which is no longer being used by manufacturers.

Removing a ruptured silicone implant isn't so simple. Because
silicone gel is "sticky," it can be difficult, if not impossible, to
completely remove from surrounding tissue. When a silicone implant
ruptures, a woman may feel the reduction in size of her breast, bumps,
pain, tenderness, tingling, or numbness. Some women, however,
experience no symptoms at all. Even in these so-called "silent
ruptures," gel may slowly migrate to other parts of the body.

According to a recent FDA study of 344 women, 79% of the women who
had silicone implants for 11-15 years had at least one ruptured implant
but weren't aware of it.7 Their diagnosis was made by means of magnetic
resonance imaging (MRI), which also showed that silicone migrated away
from the broken implant in one in five women.

There is only one study of the health effects of ruptured silicone
implants, and the results, though not conclusive, are disturbing.6 When
the silicone migrated from the broken implant, those women were more
likely to be diagnosed with fibromyalgia or several other painful and
debilitating autoimmune diseases, compared to the other women with
implants. In addition, some women have developed symptoms of lupus,
rheumatoid arthritis, scleroderma, or other connective tissue diseases
that they attribute to their implants. Although most of these concerns
center around silicone implants, similar symptoms have been reported
anecdotally among women with saline implants, where the silicone shell
may "leak" small amounts of silicone.8

Even more disturbing, two recent studies by the National Cancer
Institute found that women with silicone or saline breast implants were
more likely to develop cancer than other women their age, and more
likely to die from brain cancer, lung cancer or other lung disease, or
suicide, compared with other plastic surgery patients.9,10 These
studies, however, didn't include reconstruction patients, and more
research is needed before conclusions can be drawn. Meanwhile, a
connection between breast implants and serious diseases can't be ruled
out.8

Women who have a saline or silicone implant removed but not
replaced may describe the experience as "losing their breast twice,"
but this decision is appropriate for women who want to avoid future
complications.

Talking with patients about their options

An important part of counseling patients is listening without
making assumptions about what patients need or want. Many of us might
assume, for example, that breast reconstruction improves the quality of
women's lives. Yet the most recent research by the National Cancer
Institute concludes that women who undergo mastectomies report the same
levels of satisfaction with their lives whether or not they undergo
reconstruction (with implants or autologous tissue transfers such as
TRAM--transverse rectus abdominus myocutaneous-flaps).11 In fact,
mastectomy patients who underwent reconstruction were more likely to
report that breast cancer had a negative impact on their *** lives than
women who didn't have reconstruction.

Such findings remind us that we can't predict what is best for
patients. What we should do is provide them with options and support
their choices.

Patients who decide to undergo breast reconstruction with implants
may ask your advice about the timing of the surgery. It can take place
at the time of tumor removal or months or years afterwards. Immediate
reconstruction may reduce costs by combining mastectomy and
implantation, although patients may face a longer operation and
recuperation. Other patients may prefer to delay reconstruction so that
they have more time to consider their options or to complete chemo- or
radiation therapy. (For details on nursing care for breast
reconstruction patients, see "Oncology Today: Breast reconstruction,"
RN, April 2000.)

Regardless of the timing of surgery, additional procedures are
often needed to complete the reconstruction. Breast reconstruction with
silicone gel is a one-stage procedure. With a saline implant, the
surgeon must first insert a tissue expander, and, over several weeks,
inject more saline into the expander so that it gradually stretches the
muscle and skin. Eventually, the expander is surgically replaced with a
saline implant.

With either type of implant, at a later point, the patient may want
a skin graft to create a new nipple or may undergo surgery on her other
breast to make the two breasts look more similar in shape and size. So
even if there are no complications, many women undergo several
surgeries.

Breast implant patients should be encouraged to report any pain,
bumps, loss of size or shape, or other symptoms of a problem. Because
the implant can interfere with the detection of a tumor during
mammography, the patient should insist on having a specially trained
technician conduct that test. The technician needs to take precautions
to avoid rupturing the implant during compression and take special
views of the breast to detect tumors that might be obscured by the
implant.

Patients deserve to be given information about what is known and
not known about the safety of breast implants. When they know the risks
and benefits, they will be more satisfied with the decisions they make.
For more information on the safety of breast implants, visit the FDA
website and key in "breast implants" in the search box. The Web site of
the National Center for Policy Research for Women & Families provides
additional links to women's health research. With your help, patients
can make the decision that's best for them.

REFERENCES

1 Zuckerman, D.M. [2000]. The need to improve informed consent for
breast cancer patients. J Am Med Wom Assoc, 55[5], 285.
2 American Society of Plastic Surgeons. "1999 Plastic Surgery
Procedural Statistics." 2000.
http://www.plasticsurgery.org/mediactr/totalrec99a.htm [5 Nov. 2001].
3 U.S. Food and Drug Administration. "Saline breast implants stays
on market as experts warn about risks." 2000.
http://www.fda.gov/fdac/features/2000/400_implant.html [26 Oct 2001].
4 U.S Food and Drug Administration. "Saline-filled breast implant
surgery: Making an informed decision." 2000.
http://www.fda.gov/cdrh/breastimplants/labeling/mcghan_patient_labeling_5900.html
[5 Nov. 2001].
5 US Food and Drug Administration. "Breast implant risks." 2000.
http://www.fda.gov/cdrh/breastimplants/birisk.html [5 Nov. 2001].
6 Brown, S., Penello, G., et al. [2001]. Silicone gel breast
implant rupture, extracapsular silicone, and health status in a
population of women. J Rheumatol, 28[5], 996.
7 U.S Food and Drug Administration. "Study of rupture of silicone
gel-filled breast implants [MRI component]." 2000.
http://www.fda.gov/cdrh/breastimplants/studies/birupture.htm. [5 Nov. 2001].
8 U.S. Food and Drug Administration. "Breast Implants: Other
illnesses." 2000. http://www.fda.gov/cdrh/breastimplants/biill.html [26 Oct.
2001].
9 Brinton, L. A., Lubin, J. H., et al. [2001]. Mortality among
augmentation mammoplasty patients. Epidemiology 12[3], 321.
10 Brinton, L. A., Lubin J. H., et al. [2001]. Cancer risk sites
other than the breat following augmentation mammoplasty. Ann Epidemiol,
11[4], 248.
11 Rowland, J. H., Desmond, K. A., et al. [2000]. Role of breast
reconstructive surgery in physical and emotional outcomes among breast
cancer survivors. J Natl Cancer Inst, 92[17], 1375.


Photos are courtesy of U.S. Food and Drug Administration/Walter
Peters, PHD, MD, FRCSC, University of Toronto.

The article published in RN magazine contained a few errors that
have been corrected in this web version.

http://www.center4research.org/health9.html