The Breast Cancer Information Gap

Diana Zuckerman, PhD, National Center for Health Research, RN Magazine: February, 2002

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.

capsular1Capsular 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 guaranteed 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.

deflate2Deflation 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 sex 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.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

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.
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. 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. www.fda.gov/cdrh/breastimplants/labeling/mcghan_patient_labeling_5900.html [5 Nov. 2001].

5 US Food and Drug Administration. “Breast implant risks.” 2000. 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. www.fda.gov/cdrh/breastimplants/studies/birupture.htm. [5 Nov. 2001].

8 U.S. Food and Drug Administration. “Breast Implants: Other illnesses.” 2000. 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.