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Breast implants and breast cancer screening
Breast Implants and Breast Cancer Screening Stacy M. Smalley, CNM, MSN Concern about breast prostheses impairing breast cancer detection has become a priority issue. This article provides a review of the literature on the influence of implants on early detection methods of breast cancer, specifically breast self-examination (BSE), clinical breast examination (CBE), and mammography. Background information on implants is presented, including indications for surgery, types of prostheses, location of placement, and associated complications. Conclusions from the literature suggest that the presence of implants may facilitate BSE and CBE, yet challenge interpretation of mammography. However, there is no evidence that these women will have a later stage diagnosis or a poorer prognosis if diagnosed with breast cancer. J Midwifery Womens Health 2003;48:329 –337 © 2003 by the American College of NurseMidwives. keywords: breast implants, breast cancer, breast cancer screening
Nearly 2 million women in the United States have undergone augmentation mammoplasty, one of the most frequent plastic surgery procedures.1 In 2000, approximately 300,000 women in the United States had this surgery performed.2 A survey by the American Society for Aesthetic Plastic Surgery reported a 101% increase in breast augmentations between 1997 and 2000.3 Introduced in 1962, breast implants have received scientific scrutiny to assess short-term and long-term outcomes. The silicone component of the implants has been a particular subject of controversy. Silicone is a carbon-based polymer that appears throughout nature and can exist in various physical forms. Silicone can be found in many medical devices and implants including syringes, intravenous tubing, endotracheal tubes, and artificial heart valves. The U.S. Food and Drug Administration (FDA) was given authority to regulate such medical devices, including breast implants, by the enactment of the Medical Device Amendments in 1976. Devices in use before the 1976 law were allowed to stay on the market; however, evidence on their safety and effectiveness would eventually be required. In the late 1980s, allegations that silicone gel might be linked to generalized disease, including cancer, autoimmune disorders, and other systemic illnesses, were made in lawsuits that received media attention.4 The FDA gave breast implant manufacturers a 30-month deadline to submit safety data on their products. Because the data submitted were deemed insufficient to warrant a full review, the FDA removed breast implants from the market except as required for medical reconstruction.4 In 1992, following a brief moratorium on the use of silicone gel-filled implants, the FDA announced that these implants would be available for controlled clinical studies. Current FDA publications state there is insufficient evidence on which to base conclusions regarding a causal relationship between silicone and subsequent health problems.5 Despite the controversy about silicone implants in the
Address correspondence to Stacy M. Smalley, 2000 Holley Parkway, Apartment #2421, Roanoke, TX 76262.
Journal of Midwifery & Women’s Health • www.jmwh.org © 2003 by the American College of Nurse-Midwives Issued by Elsevier Inc.
media, the attention of professional health care providers has shifted to consideration of the possibility that any implant may interfere with conventional screening for breast cancer. It is estimated that in the United States in 2003, 267,000 women will be diagnosed with breast cancer, and 39,800 women will succumb to this disease.6 Early detection is a critical factor affecting breast cancer mortality. Due to the concern that implants may interfere with early detection of breast cancer, it is pertinent to evaluate the available data on breast implants and their possible effect on breast cancer detection. This article provides a review and synthesis of relevant, current literature on breast implants and their potential interference with breast cancer screening. BREAST IMPLANTS Indications for breast implant surgery are either aesthetic or reconstructive, with cosmetic incentive accounting for 80% of all implantation procedures.7 In aesthetic cases, implants are used to increase breast volume (augmentation) and/or correct ptosis, marked by sagging of the skin and breast parenchyma following postpartum involution. In reconstructive cases, implants are used to correct congenital breast asymmetry and to restore symmetry following mastectomy.8 Types of Breast Implants American manufacturers have created more than 240 different types of breast implants, most easily described in terms of shell surface characteristics, filler material, and number of lumina. Despite the controversy surrounding silicone gel as implant fill material, all implants have an external shell that contains silicone. Shells may be texturized or smooth, although it has been observed that recipients prefer smooth implants due to their diminished visibility and palpability.9,10 Historically, shells were also coated with polyurethane, but these were banned in 1989 by the FDA.5 This ban was prompted by a report from an in vitro experiment that found polyurethane biodegradation generated a carcinogenic by-product.5 Filler material within the shell may be silicone gel, saline, or oil. Despite the current lack of availability of 329 1526-9523/03/$30.00 • doi:10.1053/S1526-9523(03)00280-0
silicone gel outside of clinical trials, it constitutes the majority of implants in American women today because most were placed prior to the FDA’s 1992 moratorium.11 Since the moratorium, saline has become the major alternative fill for implants. In 2000, the FDA granted the first “approval” for the marketed use of a saline implant by two manufacturers. This approval was awarded following the submission of Pre-Market Approval applications (PMAs) from the makers that included their preclinical and clinical manufacturing data. On the basis of the data presented, the FDA found no evidence that saline-filled breast implants by these two manufacturers caused any major diseases and subsequently recommended approval. All other brands of saline implants remain “allowed” but are considered to be under investigation because their producers have not yet presented their own PMA data.12 Distributed empty, saline-filled implants are often referred to as “inflatable” implants. Compared with silicone gel-filled implants, which are available only as prefilled and sealed devices, saline-filled implants can be inserted through smaller incision sites and inflated to the desired size once placed. Common patient complaints about saline implants are they do not have a natural feel, they cause skin rippling if placed subglandularly, and the patients can hear and feel the saline sloshing within the implant when exercising.13 In an effort to avoid some of the disadvantages associated with saline as well as silicone gel, ideas for other implant filler material and implant construction have been explored. Biodegradable and radiolucent soybean and peanut oil-filled implants have been produced and are under clinical investigation in FDA-approved protocols. Although single-lumen implants are the only design available today, double- and triple-lumen implants have been used in the past. Of the multiple-lumen implants, double-lumen implants were more common and were fixed in volume or had the option for the adjustment of fill amount in either one or both lumens. Double-lumen implants had an inner silicone gel envelope with an outer saline bag, an inner saline envelope with an outer silicone gel layer, or silicone gel in both compartments. Placement of Breast Implants Implant location is typically subglandular or submuscular, and augmentation incision sites are periareolar, inframammary, or transaxillary. Subglandular augmentation involves positioning the implant posterior to the breast parenchyma and superficial to the pectoral muscle. With submuscular augmentation, the implant is placed under the pectoralis major muscle and over the pectoralis minor muscle. Data on which sites are chosen in practice are minimal. Gu-
Stacy M. Smalley, CNM, MSN, received her bachelor’s degree from the University of Arizona, Tucson, AZ, and her master of science degree specializing in nurse-midwifery from Yale University, New Haven, CT. Miss Smalley enjoys working with new families as a certified nurse-midwife.
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towski et al.11 conducted a retrospective, multicenter study that looked at outcome data from 509 women with salinefilled implants and found that placement was subpectoral in 50.3% of the cases and submammary in 49.7%. In another study14 of similar design that used data obtained from 450 patients with 882 saline-filled breast implants, 74% were placed submammary, 25.6% subpectorally, and 0.2% subcutaneously. Implant location affects current methods of detecting breast cancer, whereas incision site primarily affects success with breastfeeding.5,15 Complications Complications resulting from breast implantation are categorized by the timing of their onset and/or by association. Early-onset complications are related to the surgical procedures involved and include anesthesia effects, infection, swelling, erythema, bleeding, and decreased or absent nipple-areolar sensation.16 Late-onset complications are common and increase in incidence over time.12,13,16 The FDA’s informed consent booklet5 for implant consumers states that among long-term patients (beyond 3 years), 73% of women experience at least one of the more common complications such as capsular contracture, deflation, or rupture that require additional surgeries. Capsular contracture occurs most frequently in approximately 20% of recipients.11,14 Capsule contracture is a condition in which the periprosthetic capsule of scar tissue that envelops the implant hardens, compressing and distorting the implant to the point that it can cause the recipient discomfort or pain. It is thought that this pain is the result of nerve entrapment and/or interference with muscle motion.5 Little is known about the etiology behind capsular contracture; however, evidence suggests that texturized17,18 saline-filled13,17 implants placed submuscularly11,13,18 reduce the incidence of this adverse reaction. Other possible long-term problems are wrinkling or puckering of the overlying skin, which occurs in approximately 14% of recipients, worsening asymmetry, which occurs in approximately 10% of recipients due to a shifting implant with or without contracture, and calcium deposits in the tissue surrounding an implant, which occurs in 2% of recipients.5 BREAST CANCER SCREENING Knowledge that the two most influential risk factors for the development of breast cancer—age and family history—are nonmodifiable, coupled with the alarming fact that more than 75% of women with breast cancer have no identifiable risk factors, mandate the necessity of universal screening.19 –21 To reduce morbidity and mortality, efforts have focused primarily on early detection. The methods recommended for the early detection of breast cancer are breast self-examination (BSE), clinical breast examination (CBE), and mammographic imaging. Because the incidence of breast cancer is generally no greater,22–24 and in fact may Volume 48, No. 5, September/October 2003
Table 1. Breast Cancer Screening Guidelines of Select Professional Groups Organization
BSE
CBE
Mammography
United States Preventative Services Task Force (USPSTF) 2002 American College of Obstetricians and Gynecologists (ACOG) 2000
No recommendation for or against teaching or performing BSE Monthly for women 40 and older
Canadian Task Force on Preventive Health Care (CTFPHC) 2001
Not recommended for women 40– 69
American Cancer Society (ACS) 2003
Optional for women 20 and older; irregularity of screening acceptable
No recommendation for or against CBE screening alone Every 3 years for women 20–39; annually for women 40 and older No recommendation for or against for women 40–49; every 1–2 years for women 50–69 Every 3 years (minimum) for women 20–39; annually for women 40 and older
Annually for women 40–49; every other year for women 50–69 Every 1–2 years for women 40– 49; annually for women 50 and older No recommendation for or against for women 40–49; every 1–2 years for women 50–69 Annually for women 40 and older
actually be lower,7,25,26 in women with implants compared to those without, the guidelines for breast cancer screening are identical for all women.5 Table 1 presents the current recommendations for breast cancer screening promulgated by professional associations.27,28
strategies for raising the sensitivity and specificity of CBE, including standardizing the CBE and increasing its duration. Barton et al., among others, propose the MammaCare威 technique for the physical examination of breasts as a model for standardization.35
Breast Self-Examination
Mammography
Research on the effectiveness of breast self-examination (BSE) as a detection modality for breast cancer has been limited and the results contradictory.19,20,29 –31 As a result, BSE-screening guidelines issued by various professional societies vary. Of note is the large, recent RCT, involving 132,979 women,31 that found no improvement in breast cancer mortality or survival rates among women using BSE, as well as increased performance of benign biopsies. Despite the controversial benefit of BSE, there has been some agreement that BSE proficiency and thoroughness outweigh frequency and regularity in terms of improved cancer identification29,30,32 and that visual inspection needs to be included in BSE teaching.32,33
Screening mammography is performed as an attempt to detect breast cancer in asymptomatic women. Film-screen mammography is the best tool available for the early detection of breast cancer. Mammographic detection of breast malignancies has been shown to precede clinical detection by 2 to 4 years, and randomized controlled trials involving nearly 500,000 women on two continents have confirmed that screening mammography reduces breast cancer mortality.19,28,30,36 Recently, a group of Swedish researchers37 published results quantifying the impact of mammographic use in the screening of 247,000 women. They determined that mammography reduced the rate of death from breast cancer by 5% for women aged 50 through 54 and as much as 33% in the 60 through 69 age group. In accordance with these findings, screening guidelines suggested by various task forces, professional societies, and experts agree that annual mammograms should commence at 50 years of age at the latest.
Clinical Breast Examination With a sensitivity of 55% to 60% and specificity approximately 94%, the precision and accuracy of clinical breast examination (CBE) are acceptable, but whether it reduces breast cancer mortality remains uncertain.32 Consequently, current recommendations for CBE as a routine, breast cancer screening tool are mixed. However, it is encouraging that CBE is able to detect 15% of cancers in women who are mammographically occult, primarily in women under the age of 50.28,30,34 Because CBE can detect some malignancies missed by screening mammograms, the combination of CBE and mammography yields a greater sensitivity than that of mammography alone.28,32,34 Barton et al.32 did a meta-analysis of randomized trials and case control studies that assessed the use of CBE for testing. These authors concluded that specificity may improve with the combination of CBE and mammography, which may lower breast cancer mortality rates. The authors explore various Journal of Midwifery & Women’s Health • www.jmwh.org
IMPLANTS AND BREAST CANCER SCREENING Physical examination of an implanted breast should include a traditional breast evaluation, with the possible additional assessment of capsular contracture, if present, using the Baker system of classification.13,16,38 Cady et al.,20 McCool et al.,21 Barton et al.,32 and Pennypacker et al.35 include detailed instructions in their articles on how to perform a thorough breast examination on a non-augmented breast. An example of an examination technique is the MammaCare威 method described by Barton et al.32 and Pennypacker et al.35 Easily remembered for its theme of the number 3, MammaCare威 advises the use of a vertical strip pattern to cover all the breast tissue, making circular motions 331
Table 2. Baker’s Classification of Capsular Contracture Grade I (Absent)
Grade II (Minimal)
Grade III (Moderate)
Grade IV (Severe)
The breast is soft with no palpable capsule and looks natural.
The breast is a little firm with a palpable capsule but looks normal.
The breast is firm with an easily palpated capsule and is visually abnormal.
The breast is hard, cold, painful, and markedly distorted.
with the pads of the middle three fingers, and applying three different levels of pressure to each area being palpated. Three minutes or more should be spent on each breast. If capsular contracture is evident, the degree to which this complication has progressed can be graded by Baker’s classification scale,38 as depicted in Table 2. As mentioned previously, significant contracture usually requires additional surgery to remove capsule tissue or the implant itself with possible implant replacement. The effect of mammary prostheses on the sensitivity and specificity of BSE and CBE has been sorely lacking.39 Eklund and Cardenosa40 state that the presence of an implant does not compromise physical assessment of the breast and that, in fact, it facilitates it. The smooth anterior surface of the implant can be used as a backdrop (especially if it is in the subglandular position), and the thinning of the breast tissue over the implant heightens palpation sensitivity. In a 1993 retrospective, cohort-controlled study comparing 33 augmented patients with 1,735 non-augmented patients, Clark et al.39 found that not only did BSE and CBE detect more cancers than mammography (70% versus 58%), but also the tumors were smaller and there was a lower incidence of axillary metastasis compared with the control group (22% versus 58%). Although the data could suggest that physical examination is more sensitive in the augmented breast, the authors point out that there may be other contributing factors among this population, such as an increased body awareness and practice of BSE, the use of breast massage in an effort to prevent capsular contracture, and/or the enhanced postsurgical interaction with their surgeons that typically entail physical evaluation. Given that the success of physical examination of the implanted breasts in the above study was due to improved sensitivity, clinical evaluation can still be challenging. There are numerous similarities between the physical presentation of breast cancer and the physical characteristics of implants and implant complications. For example, breast asymmetry can be due to tumor formation,14 capsular contracture,5,14 silicone gel bleed or rupture,5 or saline leakage or deflation.5 Breast lumps or nodules may be malignancy,20 an implant valve,41 periprosthetic calcifications,5 or silicone gel from a ruptured implant.41 Axillary adenopathy could be invasive cancer or free silicone that has migrated into nodal tissue.5 Finally, wrinkling or rippling of the skin may be the “orange peel” sign associated with cancer or a consequence of subglandular place332
ment of an implant.5,13 Most likely, the ability to correctly differentiate the true cause in the previous scenarios comes with experience, and practitioners not familiar with augmented breasts should refer abnormal findings to a plastic surgeon.20 Mammography There is widespread recognition that the presence of breast implants increases the difficulty in the performance of mammography as well as the interpretation of mammographic films.5 There are multiple mechanisms by which this occurs, the first being that all implants appear radiopaque on film, albeit to varying degrees.42– 44 Several studies have calculated the amount of parenchymal tissue obscured by an implant to be between 22% and 83%.25,45,46 In addition to the opacity of the implant, breast tissue that is displaced and condensed by the prosthesis hinders the detection of small cancers, which include microcalcifications, architectural distortions, and occult masses.16,41 Implants are less compliant than breast tissue, thus achieving the level of compression required during mammography for optimal visualization of the parenchyma is nearly impossible.42– 44 Finally, the production of implant-related artifact that appears on film can confuse its interpretation with carcinoma. Periprosthetic calcifications and scarring of breast parenchyma can mimic the presentation of cancer.45 To increase the amount of breast tissue imaged and to improve clarity without risking the integrity of the implant, Eklund and colleagues43,44 developed certain displacement and compression techniques specific for women with breast prostheses. Intended to supplement the standard craniocaudal (CC) and mediolateral oblique (MLO) views, the modified techniques involve two additional CC and MLO views, plus an optional fifth 90° lateral view, in which the implant is pushed back against the chest wall and the breast tissue pulled forward. With the implant displaced posteriorly, compression can then be applied to the tissue anterior to the implant. Although the Eklund views enhance imaging of the tissue in front of the prosthesis, standard views provide better imaging of breast tissue behind and underneath the implant, as well as the lower axillary area. With the Eklund method, women with implants experience longer examination times, increased exposure to radiation, and an increased risk of implant rupture.5,43 Because of the complicated nature of mammographic evaluation of these Volume 48, No. 5, September/October 2003
women, the American Society of Reconstructive and Plastic Surgery and the FDA encourage providers to refer patients with breast implants to skilled mammographers experienced with the Eklund views.5 The quantity and quality of breast tissue imaged around implants in the standard and Eklund views depend on a number of factors. Breast size, glandularity, and fat content, as well as implant size, position, and associated complications all affect mammographic success.16,42 Of these, implant position and capsular contracture have the greatest effect. Submuscular implantation affords nearly twice the amount of breast tissue visualized compared with that of subglandular augmentation, and severe encapsulation (Baker grade 3 or 4), which does not permit implant displacement, has been reported to reduce visualized areas by up to 50%.42 Eklund and Cardenosa40 recommend using the fifth modified view whenever capsular contracture is evident. The extent to which the Eklund views enhance mammography has been disputed. In their initial publication describing their modified techniques, Eklund et al.44 estimated that the use of these techniques improved mammographic evaluation in 92% of patients. However, subsequent data by Handel et al.42 showed that the displacement views increased the area visualized above that obtained by standard compression by less than 5%. Similarly, Silverstein et al.46 found that even with the Eklund technique, 39% of breast tissue in subglandular implants and 9% in subpectoral implants remained obscured. Eklund and Cardenosa40 eventually responded to these reports with the statement that their calculations were flawed and that an accurate method that quantifies the amount of tissue imaged in an augmented breast is not available. On review of this data, in 1991 the American College of Radiology stated that adequate mammographic examination of women with breast augmentation is possible.47 Imaging an augmented breast frequently requires tailored supplemental implant displacement views, or ancillary studies such as ultrasonography, to achieve optimal visualization of breast tissue.40 Besides altering mammographic practice, experimental work with new substances to fill breast implants is being conducted in hope of circumventing some of the identified adverse effects on mammography. As mentioned previously, oil-filled implants are being evaluated for potential use due to their organic constitution and radiolucency on film. GarciaTutor et al.48 assessed whether triglyceride-filled implants allow mammographic visualization of benign and malignant lesions in mastectomy specimens. They found that although the implant did not interfere with the imaging of microscopic and macroscopic calcifications, the implants required a higher kilovoltage and milliamperage compared with the specimens alone. Thus, exposure to increased levels of radiation would be necessary to thoroughly evaluate a breast with an oil-filled implant. More research on the use of oil and other materials as alternatives to saline is needed. Journal of Midwifery & Women’s Health • www.jmwh.org
IMPLANTS AND BREAST CANCER DIAGNOSIS/PROGNOSIS Recognizing potential barriers of mammary prostheses on the efficacy of breast cancer screening, investigators have sought to identify outcomes associated with implants. If the presence of implants indeed hinders the early detection of breast malignancies, diagnosis would likely occur at a more advanced stage, thereby decreasing overall survival. Numerous clinical studies of various designs and methodologies have investigated this matter (Appendices A–C). Three prospective, cohort studies and one retrospective chart review44 – 46,49 have suggested that the sensitivity of mammography is reduced when implants are present and that women with implants present with more advanced cancer, as demonstrated by more frequent axillary nodal metastases at the time of diagnosis. Contradicting these findings are population-based case-control and chart review investigations reporting the stage of cancer at presentation in women with implants as similar to that of women without implants.26,50 Another retrospective casecontrolled study found that the average stage of cancer detected in women with implants was less advanced than the stage of cancer in patients without implants.39 However, interpretation of these results is clouded by the small sample sizes, known referral bias, and design flaws such as the failure to obtain preaugmentation baseline mammograms.1,23,49 Two large cohort studies conducted in Los Angeles, California, and Alberta, Canada, attempted to address these issues. Deapen et al.7,51 have been following 3,182 women over a 14-year period who underwent cosmetic augmentation and have not observed a delay in diagnosis (based on stage at the time of diagnosis), compared with breast cancer patients without breast implants in the Los Angeles County area; in fact, their 5-year survival rates were similar to those that would be predicted by the National Cancer Institute’s (NCI) Surveillance, Epidemiology, and End Results (SEER) rates.52 Birdsell et al.53 studied the cancer stage at detection and the survival experience of 41 women who developed breast cancer following breast augmentation. Compared with all other patients diagnosed with breast cancer in the province of Alberta from 1973 to 1990, the subjects’ tumors were smaller at the time of diagnosis, and they survived as long as the women without implants. In 1999, the Institute of Medicine of the National Academy of Sciences released its final report following a 2-year investigation on the safety of silicone. No studies of women with breast implants have shown increases in cancer deaths because of mammographic diagnostic delay; however, the committee believes this deserves further study.12 Similar to the research that has been performed in Los Angeles and Canada, additional populationbased studies with large sample sizes and sound methodologies are needed to solidify this conclusion. In the meantime, women with implants should be assured that in 333
the event that they develop breast cancer, they should not experience a less-favorable outcome as a result of having the implants. Acknowledging the limitations of mammographic screening in women who have undergone augmentation mammaplasty, what could explain similar stages at diagnosis and survival rates compared with women without implants? It has been suggested that women who receive implants are more health conscious of their bodies and better educated about breast cancer screening.39,53 Strom et al.15 studied the credibility of this postulation in a patient survey of 292 women and discovered that the frequency of use of screening mammography and BSE was high; 91% of the study participants between the ages of 40 and 49 and 94% of those aged 50 or older reported having had at least one mammogram. Sixty-one percent of the women who practiced BSE performed it at monthly intervals. The results for mammogram frequency were then compared with data on the screening mammogram practices of women without breast prostheses published by the Behavioral Risk Factor Surveillance System, revealing a 28% increase in having at least one mammogram among women with implants in the 40 to 49 age category and a 27% increase among women aged 50 to 69. The authors attribute this behavior to the emphasis plastic surgeons and primary care providers place on breast cancer screening. SUMMARY
reported problems with their breast implants to the Food and Drug Administration. Plast Reconstr Surg 2002;109(6):2043–51. 3. Shons A. Breast cancer and augmentation mammaplasty: The preoperative consultation. Plast Reconstr Surg 2002;109(1):383–5. 4. Angell M. Do breast implants cause systemic disease? Science in the courtroom. N Engl J Med 1994;330(24):1748 –9. 5. United States Food and Drug Administration-Center for Devices and Radiologic Health. Breast implants: An information update 2000. [cited June 2003] Available from: www.fda.gov/cdrh/ breastimplants. 6. American Cancer Society. Cancer facts and figures 2003. [cited June 2003] Available from: www.caonline.amcancersoc.org. 7. Deapen D, Bernstein L, Brody GS. Are breast implants anticarcinogenic? A 14-year follow-up of the Los Angeles study. Plast Reconst Surg 1997;99(5):1346 –53. 8. Bostwick J. Breast reconstruction following mastectomy. CA Cancer J Clin 1995;45(5):289 –304. 9. Rohrich RJ, Kenkel JM, Adams WP. Preventing capsular contracture in breast augmentation: In search of the Holy Grail. Plast Reconstr Surg 1999;103(6):1759 –60. 10. Burkhardt BR. Capsular contracture: Hard breasts, soft data. Clin Plast Surg 1988;15:521–32. 11. Gutowski KA, Mesna GT, Cunningham BL. Saline-filled breast implants: A Plastic Surgery Educational Foundation multicenter outcomes study. Plast Reconstr Surg 1997;100(4):1019 –27. 12. Rohrich RJ. The FDA approves saline-filled breast implants: What does this mean for our patients? Plast Reconstr Surg 2000; 106(4):903–5.
Detectability of breast cancer in patients with augmentation implants primarily depends on the following: (1) appropriate selection of implant size relative to the amount of native breast tissue, (2) vigilance in obtaining annual physical examination by an experienced examiner, (3) proper instruction in doing monthly BSE, (4) immediate attention to clinical concerns, and (5) properly done mammographic studies at appropriate intervals with on-site supervision of an experienced radiologist.40 Adhering to these recommendations should improve outcomes of breast cancer occurring in women with breast implants, including the promotion of breast cancer mortality rates at a level comparable with the general population.
14. Cunningham BL, Lokeh A, Gutowski KA. Saline-filled breast implant safety and efficacy: A multicenter retrospective review. Plast Reconstr Surg 2000;105(6):2143–9.
This article was written in partial fulfillment of the requirements for the degree Master of Science in Nursing at Yale University. The author gratefully acknowledges the contributions and expert editing provided by Tish Knobf, RN, PhD, FAAN, AOCN.
17. Burkhardt BR, Demas CP. The effect of Siltex texturizing and povidone-iodine irrigation on capsular contracture around saline inflatable breast implants. Plast Reconstr Surg 1994;93(1):123–8.
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46. Silverstein MJ, Handel N, Gamagami P, Gierson ED, Furmaski M, Collins AR, et al. Breast cancer diagnosis and prognosis in women following augmentation with silicone gel-filled prostheses. Eur J Cancer 1992;28(2):635–40.
30. Thomas DB, Gao DL, Ray RM, Wang WN, Allison CJ, Chen FL, et al. Randomized trial of breast self-examination in Shanghai: Final results. J Natl Cancer Inst 2002;94:1445–57. 31. Sirovich BE, Sox HC. Breast cancer management: Breast cancer screening. Surg Clin North Am 1999;79(5):961–90. 32. Barton MB, Harris R, Fletcher SW. Does this patient have breast cancer? The screening clinical breast examination: Should it be done? How? J Am Med Assoc 1999;282(13):1270 –80. 33. Harvey BJ, Miller AB, Baines CJ, Corey PN. Effect of breast self-examination techniques on the risk of death from breast cancer. Can Med Assoc J 1997;157(9):1205–12. 34. Park BY, Kim SI, Kim MH, Kim EK, Park SH, Lee KS. Clinical breast examination for screening of asymptomatic women: The importance of clinical breast examination for breast cancer detection. Yonsei Med J 2000;41(3):312–8.
47. Eklund GW. Statement for American College of Radiology at FDA Advisory Panel for General or Plastic Surgical Devices, Gaithersburg, MD, November 12, 1991. Rockville (MD): Food and Drug Administration, November 12, 1991. 48. Garcia-Tutor F, Hontanilla B, Agreda J, Bazan A. Radiotransparency of the triglyceride mammary prosthesis: A quantitative analysis with mastectomy specimens. Plast Reconstr Surg 1999;104(3): 681–6. 49. Fajardo LL, Harvey JA, McAleese KA, Roberts CC, Granstrom P. Breast cancer diagnosis in women with subglandular silicone gel-filled augmentation implants. Radiology 1995;194(3):859 –62. 50. Carlson GW, Curley SA, Martin JE, Fornage BD, Ames FC. The detection of breast cancer after augmentation mammoplasty. Plast Reconstr Surg 1992;91(5):837–40.
35. Pennypacker HS, Naylor L, Sander AA, Goldstein MK. Why can’t we do better breast examinations? Nurse Pract Forum 1999; 10(3):122–8.
51. Deapen D, Hamilton A, Bernstein L, Brody GS. Breast cancer stage at diagnosis and survival among patients with prior breast implants. Plast Reconstr Surg 2000;105(2):535–40.
36. Schapira DV, Levine RB. Breast cancer screening and compliance and evaluation of lesions. Med Clin North Am 1996;80(1):15–26.
52. National Cancer Institute. Sureveillance, epidemiology, and end results (SEER). [cited June 2003] Available from: www.seer. cancer.gov.
37. Nystrom L, Andersson I, Bjurstam N, Frisell J, Nordenskjold B, Rutqvist LE. Long-term effects of mammography screening: Updated overview of the Swedish randomised trials. Lancet 2002;359: 909 –19.
Journal of Midwifery & Women’s Health • www.jmwh.org
53. Birdsell DC, Jenkins H, Berkel H. Breast cancer diagnosis and survival in women with and without breast implants. Plast Reconstr Surg 1992;92(5):795–800.
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Appendix A. Clinical Studies That Indicate Detection of Breast Cancer Is Delayed in Women With Breast Implants Authors
Aim and Design
Sample
Results
Eklund et al.
A prospective cohort study that tested whether augmented women could be adequately assessed with mammography using modified methods.
50 Consecutive women with breast augmentations.
Hayes et al.45
A prospective, case-control study that aimed to quantify the effect of breast implants on mammography. A prospective cohort study that followed women with augmentation implants to assess cancer outcomes.
6 Women without palpable abnormalities.
With standard compression views: “high rate of missing “significant” lesions in 59% of cases, “moderate” rate in 40% of cases; with “moderate to marked” improvement in compression in 99% of cases, increase in compression by 2–3 cm, no cases of prosthetic rupture. Ratings were assigned as an average of observations by two radiologists. Average of 38.1% of glandular tissue is obscured, with a range of 22–83%.
A chart review study that retrospectively investigated the effect of mammary implants on mammography.
1,968 Women with breast augmentation prostheses were identified between 1985 and 1992; 18 were diagnosed with breast carcinoma.
44
Silverstein et al.46
Fajardo et al.49
Original cohort source and size not stated; 42 who subsequently developed breast cancer between 1981 and 1990.
Compared with data from the LA County Surveillance Program (LACSP) (5,876 women with breast cancer aged 45–54 years between 1972 and 1985): Average tumor size measured 2.3 cm in diameter in study subjects vs. 2.7 cm LACSP; non-invasive lesions occurred in 10% of subjects vs. 7% LACSP; invasive lesion with metastases to axillary nodes or other distant sites occurred in 45% of subjects vs. 43% LACSP. 95% of subjects’ tumors were palpable; 40% false-negative rate with mammography (14 of 35). Data from this study were not compared with similar statistics of non-augmented women in the same time frame: 89% (16 of 18) of the subjects had palpable abnormalities; standard mammographic views detected cancer in 6% of cases (1 of 18); additional Eklund views detected cancer in 67% of cases (12 of 18); 21% (16 of 18) had non-invasive carcinoma; 39% (7 of 18) had invasive carcinoma with axillary node metastases.
Appendix B. Clinical Studies That Indicate the Detection of Breast Cancer in Women With Implants Is Not Delayed or Improved Authors
Aim and Design
Brinton et al.
26
Clark et al.39
Carlson et al.50
336
Sample
Results
Population-based case-control study 2,174 Cases diagnosed with breast cancer Rates of breast implants within each tumor-stage group on breast cancer risk associated in two metropolitan areas with 2,009 were compared within the entire control group: with breast enlargement and controls; 36 (1.7%) of the cases vs. 44 statistically significant reduced risk for in situ tumors reduction. (2.2%) controls reported having prior (RR, 0.2: 95% CI, 0.0 to 0.8) reduced risk (although breast enlargement. not statistically significant for localized (RR, 0.8: 95% CI, 0.5–1.4) and invasive tumors (RR, 0.8: 95% CI, 0.4–1.5). Various factors among the study group were compared 1,735 Participants selected from the A retrospective case-controlled with the controls: 19% vs. 41% of axillary Registry of the Komen Breast Cancer at study that examined the initial metastases (P ⫽ .006; 82% vs. 63% had ⬍2 cm Baylor University Medical Center during diagnostic and prognostic tumors (P ⫽ .016); 24% vs. 42% the period 1982 through 1991; 33 features of breast cancer in mammographically detected cancer (P ⫽ .064); subjects with breast cancer and women who had undergone 70% vs. 58% cancers detected by physical implants. augmentation mammoplasty. examination (P ⫽ .064). A chart review study that explores 35 Patients with 37 cases of breast Results are compared with those “of previous reports and whether breast implants interfere cancer selected from 1975 to 1990. the general population” (see p. 839 for citations); 8% with the mammographic (3 cases) rate of intraductal carcinoma, 49% (18 detection of potentially curable cases) rate of invasive carcinoma confined to the breast cancers. breast, 46% (16 cases) rate of metastatic breast cancer in axillary nodes or other sites.
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Appendix C. Epidemiological Studies That Indicate Detection of Breast Cancer Is Not Delayed in Women With Breast Implants Authors
Aim and Design
Sample
Results
Deapen et al.
A record linkage cohort study that examined breast cancer risk and detection issues among patients with breast implants.
3,182 Non-Spanish-surnamed caucasian women in Los Angeles County who received breast implants between 1953 and 1980; 31 cases of breast cancer.
Deapen et al.51
A follow-up to their previous article (7), survival rates among women with breast cancer and breast implants were studied.
Same cohort as for (7); 37 cases of breast cancer.
Birdsell et al.53
A non-concurrent cohort linkage study that evaluated breast cancer stage at diagnosis and survival experience among a group of women with augmentation implants.
13,246 Women diagnosed with breast cancer in the prov ince of Alberta from 1973 to 1990; 41 subjects who developed breast cancer after breast augmentation.
Compared with data from the Los Angeles County Cancer Surveillance Program (LACCSP) (non-Spanishsurnamed caucasian women aged 35–74 years from 1976 to 1991): 10% rate of in situ cancer in the study group vs. 8.7% rate among the controls, 49.6% rate of local cancer vs. 52.6%, and 40.4% rate of non-local cancer vs. 38.7%. Database in which results were compared is identical to (7): 10.4% rate of in situ cancer in the study group vs. 8.7% rate in the control group, 50.1% rate of local cancers vs. 52.6%, and 39.5% rate of non-local stages of cancer at presentation; compared with 5year survival rates established by NCI’s SEER: inclusive of all stages of cancer, 88.5% study group vs. 84.1% general population (95% CI, 77.8–99.1). Compared with the control cohort: 12.2% of the study subjects vs. 6.2% of the control group had Stage 0 cancer (carcinoma in situ, no axillary or distant metastases, 36.6% vs. 22.5% had Stage I (tumor 2 cm or less in greatest dimension, no axillary or distant metastases), 36.5% vs. 45.5 had stage 2 (multiple definitions—see p. 796), 4.9% vs. 17.8% had stage 3 (multiple definitions—see p. 796), and 4.9% vs. 3.0% had stage 4 (axillary and distant metastases); using the Kaplan-Meir method, the 5- and 10-year survival rates were 83% and 74%, respectively, for the subjects vs. 74% and 62% for the controls (not statistically significant).
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Nearly 2 million women in the United States have undergone augmentation mammoplasty, one of the most frequent plastic surgery procedures.1 In 2000, approximately 300,000 women in the United States had this surgery performed.2 A survey by the American Society for Aesthetic Plastic Surgery reported a 101% increase in breast augmentations between 1997 and 2000.3 Introduced in 1962, breast implants have received scientific scrutiny to assess short-term and long-term outcomes. The silicone component of the implants has been a particular subject of controversy. Silicone is a carbon-based polymer that appears throughout nature and can exist in various physical forms. Silicone can be found in many medical devices and implants including syringes, intravenous tubing, endotracheal tubes, and artificial heart valves. The U.S. Food and Drug Administration (FDA) was given authority to regulate such medical devices, including breast implants, by the enactment of the Medical Device Amendments in 1976. Devices in use before the 1976 law were allowed to stay on the market; however, evidence on their safety and effectiveness would eventually be required. In the late 1980s, allegations that silicone gel might be linked to generalized disease, including cancer, autoimmune disorders, and other systemic illnesses, were made in lawsuits that received media attention.4 The FDA gave breast implant manufacturers a 30-month deadline to submit safety data on their products. Because the data submitted were deemed insufficient to warrant a full review, the FDA removed breast implants from the market except as required for medical reconstruction.4 In 1992, following a brief moratorium on the use of silicone gel-filled implants, the FDA announced that these implants would be available for controlled clinical studies. Current FDA publications state there is insufficient evidence on which to base conclusions regarding a causal relationship between silicone and subsequent health problems.5 Despite the controversy about silicone implants in the
Address correspondence to Stacy M. Smalley, 2000 Holley Parkway, Apartment #2421, Roanoke, TX 76262.
Journal of Midwifery & Women’s Health • www.jmwh.org © 2003 by the American College of Nurse-Midwives Issued by Elsevier Inc.
media, the attention of professional health care providers has shifted to consideration of the possibility that any implant may interfere with conventional screening for breast cancer. It is estimated that in the United States in 2003, 267,000 women will be diagnosed with breast cancer, and 39,800 women will succumb to this disease.6 Early detection is a critical factor affecting breast cancer mortality. Due to the concern that implants may interfere with early detection of breast cancer, it is pertinent to evaluate the available data on breast implants and their possible effect on breast cancer detection. This article provides a review and synthesis of relevant, current literature on breast implants and their potential interference with breast cancer screening. BREAST IMPLANTS Indications for breast implant surgery are either aesthetic or reconstructive, with cosmetic incentive accounting for 80% of all implantation procedures.7 In aesthetic cases, implants are used to increase breast volume (augmentation) and/or correct ptosis, marked by sagging of the skin and breast parenchyma following postpartum involution. In reconstructive cases, implants are used to correct congenital breast asymmetry and to restore symmetry following mastectomy.8 Types of Breast Implants American manufacturers have created more than 240 different types of breast implants, most easily described in terms of shell surface characteristics, filler material, and number of lumina. Despite the controversy surrounding silicone gel as implant fill material, all implants have an external shell that contains silicone. Shells may be texturized or smooth, although it has been observed that recipients prefer smooth implants due to their diminished visibility and palpability.9,10 Historically, shells were also coated with polyurethane, but these were banned in 1989 by the FDA.5 This ban was prompted by a report from an in vitro experiment that found polyurethane biodegradation generated a carcinogenic by-product.5 Filler material within the shell may be silicone gel, saline, or oil. Despite the current lack of availability of 329 1526-9523/03/$30.00 • doi:10.1053/S1526-9523(03)00280-0
silicone gel outside of clinical trials, it constitutes the majority of implants in American women today because most were placed prior to the FDA’s 1992 moratorium.11 Since the moratorium, saline has become the major alternative fill for implants. In 2000, the FDA granted the first “approval” for the marketed use of a saline implant by two manufacturers. This approval was awarded following the submission of Pre-Market Approval applications (PMAs) from the makers that included their preclinical and clinical manufacturing data. On the basis of the data presented, the FDA found no evidence that saline-filled breast implants by these two manufacturers caused any major diseases and subsequently recommended approval. All other brands of saline implants remain “allowed” but are considered to be under investigation because their producers have not yet presented their own PMA data.12 Distributed empty, saline-filled implants are often referred to as “inflatable” implants. Compared with silicone gel-filled implants, which are available only as prefilled and sealed devices, saline-filled implants can be inserted through smaller incision sites and inflated to the desired size once placed. Common patient complaints about saline implants are they do not have a natural feel, they cause skin rippling if placed subglandularly, and the patients can hear and feel the saline sloshing within the implant when exercising.13 In an effort to avoid some of the disadvantages associated with saline as well as silicone gel, ideas for other implant filler material and implant construction have been explored. Biodegradable and radiolucent soybean and peanut oil-filled implants have been produced and are under clinical investigation in FDA-approved protocols. Although single-lumen implants are the only design available today, double- and triple-lumen implants have been used in the past. Of the multiple-lumen implants, double-lumen implants were more common and were fixed in volume or had the option for the adjustment of fill amount in either one or both lumens. Double-lumen implants had an inner silicone gel envelope with an outer saline bag, an inner saline envelope with an outer silicone gel layer, or silicone gel in both compartments. Placement of Breast Implants Implant location is typically subglandular or submuscular, and augmentation incision sites are periareolar, inframammary, or transaxillary. Subglandular augmentation involves positioning the implant posterior to the breast parenchyma and superficial to the pectoral muscle. With submuscular augmentation, the implant is placed under the pectoralis major muscle and over the pectoralis minor muscle. Data on which sites are chosen in practice are minimal. Gu-
Stacy M. Smalley, CNM, MSN, received her bachelor’s degree from the University of Arizona, Tucson, AZ, and her master of science degree specializing in nurse-midwifery from Yale University, New Haven, CT. Miss Smalley enjoys working with new families as a certified nurse-midwife.
330
towski et al.11 conducted a retrospective, multicenter study that looked at outcome data from 509 women with salinefilled implants and found that placement was subpectoral in 50.3% of the cases and submammary in 49.7%. In another study14 of similar design that used data obtained from 450 patients with 882 saline-filled breast implants, 74% were placed submammary, 25.6% subpectorally, and 0.2% subcutaneously. Implant location affects current methods of detecting breast cancer, whereas incision site primarily affects success with breastfeeding.5,15 Complications Complications resulting from breast implantation are categorized by the timing of their onset and/or by association. Early-onset complications are related to the surgical procedures involved and include anesthesia effects, infection, swelling, erythema, bleeding, and decreased or absent nipple-areolar sensation.16 Late-onset complications are common and increase in incidence over time.12,13,16 The FDA’s informed consent booklet5 for implant consumers states that among long-term patients (beyond 3 years), 73% of women experience at least one of the more common complications such as capsular contracture, deflation, or rupture that require additional surgeries. Capsular contracture occurs most frequently in approximately 20% of recipients.11,14 Capsule contracture is a condition in which the periprosthetic capsule of scar tissue that envelops the implant hardens, compressing and distorting the implant to the point that it can cause the recipient discomfort or pain. It is thought that this pain is the result of nerve entrapment and/or interference with muscle motion.5 Little is known about the etiology behind capsular contracture; however, evidence suggests that texturized17,18 saline-filled13,17 implants placed submuscularly11,13,18 reduce the incidence of this adverse reaction. Other possible long-term problems are wrinkling or puckering of the overlying skin, which occurs in approximately 14% of recipients, worsening asymmetry, which occurs in approximately 10% of recipients due to a shifting implant with or without contracture, and calcium deposits in the tissue surrounding an implant, which occurs in 2% of recipients.5 BREAST CANCER SCREENING Knowledge that the two most influential risk factors for the development of breast cancer—age and family history—are nonmodifiable, coupled with the alarming fact that more than 75% of women with breast cancer have no identifiable risk factors, mandate the necessity of universal screening.19 –21 To reduce morbidity and mortality, efforts have focused primarily on early detection. The methods recommended for the early detection of breast cancer are breast self-examination (BSE), clinical breast examination (CBE), and mammographic imaging. Because the incidence of breast cancer is generally no greater,22–24 and in fact may Volume 48, No. 5, September/October 2003
Table 1. Breast Cancer Screening Guidelines of Select Professional Groups Organization
BSE
CBE
Mammography
United States Preventative Services Task Force (USPSTF) 2002 American College of Obstetricians and Gynecologists (ACOG) 2000
No recommendation for or against teaching or performing BSE Monthly for women 40 and older
Canadian Task Force on Preventive Health Care (CTFPHC) 2001
Not recommended for women 40– 69
American Cancer Society (ACS) 2003
Optional for women 20 and older; irregularity of screening acceptable
No recommendation for or against CBE screening alone Every 3 years for women 20–39; annually for women 40 and older No recommendation for or against for women 40–49; every 1–2 years for women 50–69 Every 3 years (minimum) for women 20–39; annually for women 40 and older
Annually for women 40–49; every other year for women 50–69 Every 1–2 years for women 40– 49; annually for women 50 and older No recommendation for or against for women 40–49; every 1–2 years for women 50–69 Annually for women 40 and older
actually be lower,7,25,26 in women with implants compared to those without, the guidelines for breast cancer screening are identical for all women.5 Table 1 presents the current recommendations for breast cancer screening promulgated by professional associations.27,28
strategies for raising the sensitivity and specificity of CBE, including standardizing the CBE and increasing its duration. Barton et al., among others, propose the MammaCare威 technique for the physical examination of breasts as a model for standardization.35
Breast Self-Examination
Mammography
Research on the effectiveness of breast self-examination (BSE) as a detection modality for breast cancer has been limited and the results contradictory.19,20,29 –31 As a result, BSE-screening guidelines issued by various professional societies vary. Of note is the large, recent RCT, involving 132,979 women,31 that found no improvement in breast cancer mortality or survival rates among women using BSE, as well as increased performance of benign biopsies. Despite the controversial benefit of BSE, there has been some agreement that BSE proficiency and thoroughness outweigh frequency and regularity in terms of improved cancer identification29,30,32 and that visual inspection needs to be included in BSE teaching.32,33
Screening mammography is performed as an attempt to detect breast cancer in asymptomatic women. Film-screen mammography is the best tool available for the early detection of breast cancer. Mammographic detection of breast malignancies has been shown to precede clinical detection by 2 to 4 years, and randomized controlled trials involving nearly 500,000 women on two continents have confirmed that screening mammography reduces breast cancer mortality.19,28,30,36 Recently, a group of Swedish researchers37 published results quantifying the impact of mammographic use in the screening of 247,000 women. They determined that mammography reduced the rate of death from breast cancer by 5% for women aged 50 through 54 and as much as 33% in the 60 through 69 age group. In accordance with these findings, screening guidelines suggested by various task forces, professional societies, and experts agree that annual mammograms should commence at 50 years of age at the latest.
Clinical Breast Examination With a sensitivity of 55% to 60% and specificity approximately 94%, the precision and accuracy of clinical breast examination (CBE) are acceptable, but whether it reduces breast cancer mortality remains uncertain.32 Consequently, current recommendations for CBE as a routine, breast cancer screening tool are mixed. However, it is encouraging that CBE is able to detect 15% of cancers in women who are mammographically occult, primarily in women under the age of 50.28,30,34 Because CBE can detect some malignancies missed by screening mammograms, the combination of CBE and mammography yields a greater sensitivity than that of mammography alone.28,32,34 Barton et al.32 did a meta-analysis of randomized trials and case control studies that assessed the use of CBE for testing. These authors concluded that specificity may improve with the combination of CBE and mammography, which may lower breast cancer mortality rates. The authors explore various Journal of Midwifery & Women’s Health • www.jmwh.org
IMPLANTS AND BREAST CANCER SCREENING Physical examination of an implanted breast should include a traditional breast evaluation, with the possible additional assessment of capsular contracture, if present, using the Baker system of classification.13,16,38 Cady et al.,20 McCool et al.,21 Barton et al.,32 and Pennypacker et al.35 include detailed instructions in their articles on how to perform a thorough breast examination on a non-augmented breast. An example of an examination technique is the MammaCare威 method described by Barton et al.32 and Pennypacker et al.35 Easily remembered for its theme of the number 3, MammaCare威 advises the use of a vertical strip pattern to cover all the breast tissue, making circular motions 331
Table 2. Baker’s Classification of Capsular Contracture Grade I (Absent)
Grade II (Minimal)
Grade III (Moderate)
Grade IV (Severe)
The breast is soft with no palpable capsule and looks natural.
The breast is a little firm with a palpable capsule but looks normal.
The breast is firm with an easily palpated capsule and is visually abnormal.
The breast is hard, cold, painful, and markedly distorted.
with the pads of the middle three fingers, and applying three different levels of pressure to each area being palpated. Three minutes or more should be spent on each breast. If capsular contracture is evident, the degree to which this complication has progressed can be graded by Baker’s classification scale,38 as depicted in Table 2. As mentioned previously, significant contracture usually requires additional surgery to remove capsule tissue or the implant itself with possible implant replacement. The effect of mammary prostheses on the sensitivity and specificity of BSE and CBE has been sorely lacking.39 Eklund and Cardenosa40 state that the presence of an implant does not compromise physical assessment of the breast and that, in fact, it facilitates it. The smooth anterior surface of the implant can be used as a backdrop (especially if it is in the subglandular position), and the thinning of the breast tissue over the implant heightens palpation sensitivity. In a 1993 retrospective, cohort-controlled study comparing 33 augmented patients with 1,735 non-augmented patients, Clark et al.39 found that not only did BSE and CBE detect more cancers than mammography (70% versus 58%), but also the tumors were smaller and there was a lower incidence of axillary metastasis compared with the control group (22% versus 58%). Although the data could suggest that physical examination is more sensitive in the augmented breast, the authors point out that there may be other contributing factors among this population, such as an increased body awareness and practice of BSE, the use of breast massage in an effort to prevent capsular contracture, and/or the enhanced postsurgical interaction with their surgeons that typically entail physical evaluation. Given that the success of physical examination of the implanted breasts in the above study was due to improved sensitivity, clinical evaluation can still be challenging. There are numerous similarities between the physical presentation of breast cancer and the physical characteristics of implants and implant complications. For example, breast asymmetry can be due to tumor formation,14 capsular contracture,5,14 silicone gel bleed or rupture,5 or saline leakage or deflation.5 Breast lumps or nodules may be malignancy,20 an implant valve,41 periprosthetic calcifications,5 or silicone gel from a ruptured implant.41 Axillary adenopathy could be invasive cancer or free silicone that has migrated into nodal tissue.5 Finally, wrinkling or rippling of the skin may be the “orange peel” sign associated with cancer or a consequence of subglandular place332
ment of an implant.5,13 Most likely, the ability to correctly differentiate the true cause in the previous scenarios comes with experience, and practitioners not familiar with augmented breasts should refer abnormal findings to a plastic surgeon.20 Mammography There is widespread recognition that the presence of breast implants increases the difficulty in the performance of mammography as well as the interpretation of mammographic films.5 There are multiple mechanisms by which this occurs, the first being that all implants appear radiopaque on film, albeit to varying degrees.42– 44 Several studies have calculated the amount of parenchymal tissue obscured by an implant to be between 22% and 83%.25,45,46 In addition to the opacity of the implant, breast tissue that is displaced and condensed by the prosthesis hinders the detection of small cancers, which include microcalcifications, architectural distortions, and occult masses.16,41 Implants are less compliant than breast tissue, thus achieving the level of compression required during mammography for optimal visualization of the parenchyma is nearly impossible.42– 44 Finally, the production of implant-related artifact that appears on film can confuse its interpretation with carcinoma. Periprosthetic calcifications and scarring of breast parenchyma can mimic the presentation of cancer.45 To increase the amount of breast tissue imaged and to improve clarity without risking the integrity of the implant, Eklund and colleagues43,44 developed certain displacement and compression techniques specific for women with breast prostheses. Intended to supplement the standard craniocaudal (CC) and mediolateral oblique (MLO) views, the modified techniques involve two additional CC and MLO views, plus an optional fifth 90° lateral view, in which the implant is pushed back against the chest wall and the breast tissue pulled forward. With the implant displaced posteriorly, compression can then be applied to the tissue anterior to the implant. Although the Eklund views enhance imaging of the tissue in front of the prosthesis, standard views provide better imaging of breast tissue behind and underneath the implant, as well as the lower axillary area. With the Eklund method, women with implants experience longer examination times, increased exposure to radiation, and an increased risk of implant rupture.5,43 Because of the complicated nature of mammographic evaluation of these Volume 48, No. 5, September/October 2003
women, the American Society of Reconstructive and Plastic Surgery and the FDA encourage providers to refer patients with breast implants to skilled mammographers experienced with the Eklund views.5 The quantity and quality of breast tissue imaged around implants in the standard and Eklund views depend on a number of factors. Breast size, glandularity, and fat content, as well as implant size, position, and associated complications all affect mammographic success.16,42 Of these, implant position and capsular contracture have the greatest effect. Submuscular implantation affords nearly twice the amount of breast tissue visualized compared with that of subglandular augmentation, and severe encapsulation (Baker grade 3 or 4), which does not permit implant displacement, has been reported to reduce visualized areas by up to 50%.42 Eklund and Cardenosa40 recommend using the fifth modified view whenever capsular contracture is evident. The extent to which the Eklund views enhance mammography has been disputed. In their initial publication describing their modified techniques, Eklund et al.44 estimated that the use of these techniques improved mammographic evaluation in 92% of patients. However, subsequent data by Handel et al.42 showed that the displacement views increased the area visualized above that obtained by standard compression by less than 5%. Similarly, Silverstein et al.46 found that even with the Eklund technique, 39% of breast tissue in subglandular implants and 9% in subpectoral implants remained obscured. Eklund and Cardenosa40 eventually responded to these reports with the statement that their calculations were flawed and that an accurate method that quantifies the amount of tissue imaged in an augmented breast is not available. On review of this data, in 1991 the American College of Radiology stated that adequate mammographic examination of women with breast augmentation is possible.47 Imaging an augmented breast frequently requires tailored supplemental implant displacement views, or ancillary studies such as ultrasonography, to achieve optimal visualization of breast tissue.40 Besides altering mammographic practice, experimental work with new substances to fill breast implants is being conducted in hope of circumventing some of the identified adverse effects on mammography. As mentioned previously, oil-filled implants are being evaluated for potential use due to their organic constitution and radiolucency on film. GarciaTutor et al.48 assessed whether triglyceride-filled implants allow mammographic visualization of benign and malignant lesions in mastectomy specimens. They found that although the implant did not interfere with the imaging of microscopic and macroscopic calcifications, the implants required a higher kilovoltage and milliamperage compared with the specimens alone. Thus, exposure to increased levels of radiation would be necessary to thoroughly evaluate a breast with an oil-filled implant. More research on the use of oil and other materials as alternatives to saline is needed. Journal of Midwifery & Women’s Health • www.jmwh.org
IMPLANTS AND BREAST CANCER DIAGNOSIS/PROGNOSIS Recognizing potential barriers of mammary prostheses on the efficacy of breast cancer screening, investigators have sought to identify outcomes associated with implants. If the presence of implants indeed hinders the early detection of breast malignancies, diagnosis would likely occur at a more advanced stage, thereby decreasing overall survival. Numerous clinical studies of various designs and methodologies have investigated this matter (Appendices A–C). Three prospective, cohort studies and one retrospective chart review44 – 46,49 have suggested that the sensitivity of mammography is reduced when implants are present and that women with implants present with more advanced cancer, as demonstrated by more frequent axillary nodal metastases at the time of diagnosis. Contradicting these findings are population-based case-control and chart review investigations reporting the stage of cancer at presentation in women with implants as similar to that of women without implants.26,50 Another retrospective casecontrolled study found that the average stage of cancer detected in women with implants was less advanced than the stage of cancer in patients without implants.39 However, interpretation of these results is clouded by the small sample sizes, known referral bias, and design flaws such as the failure to obtain preaugmentation baseline mammograms.1,23,49 Two large cohort studies conducted in Los Angeles, California, and Alberta, Canada, attempted to address these issues. Deapen et al.7,51 have been following 3,182 women over a 14-year period who underwent cosmetic augmentation and have not observed a delay in diagnosis (based on stage at the time of diagnosis), compared with breast cancer patients without breast implants in the Los Angeles County area; in fact, their 5-year survival rates were similar to those that would be predicted by the National Cancer Institute’s (NCI) Surveillance, Epidemiology, and End Results (SEER) rates.52 Birdsell et al.53 studied the cancer stage at detection and the survival experience of 41 women who developed breast cancer following breast augmentation. Compared with all other patients diagnosed with breast cancer in the province of Alberta from 1973 to 1990, the subjects’ tumors were smaller at the time of diagnosis, and they survived as long as the women without implants. In 1999, the Institute of Medicine of the National Academy of Sciences released its final report following a 2-year investigation on the safety of silicone. No studies of women with breast implants have shown increases in cancer deaths because of mammographic diagnostic delay; however, the committee believes this deserves further study.12 Similar to the research that has been performed in Los Angeles and Canada, additional populationbased studies with large sample sizes and sound methodologies are needed to solidify this conclusion. In the meantime, women with implants should be assured that in 333
the event that they develop breast cancer, they should not experience a less-favorable outcome as a result of having the implants. Acknowledging the limitations of mammographic screening in women who have undergone augmentation mammaplasty, what could explain similar stages at diagnosis and survival rates compared with women without implants? It has been suggested that women who receive implants are more health conscious of their bodies and better educated about breast cancer screening.39,53 Strom et al.15 studied the credibility of this postulation in a patient survey of 292 women and discovered that the frequency of use of screening mammography and BSE was high; 91% of the study participants between the ages of 40 and 49 and 94% of those aged 50 or older reported having had at least one mammogram. Sixty-one percent of the women who practiced BSE performed it at monthly intervals. The results for mammogram frequency were then compared with data on the screening mammogram practices of women without breast prostheses published by the Behavioral Risk Factor Surveillance System, revealing a 28% increase in having at least one mammogram among women with implants in the 40 to 49 age category and a 27% increase among women aged 50 to 69. The authors attribute this behavior to the emphasis plastic surgeons and primary care providers place on breast cancer screening. SUMMARY
reported problems with their breast implants to the Food and Drug Administration. Plast Reconstr Surg 2002;109(6):2043–51. 3. Shons A. Breast cancer and augmentation mammaplasty: The preoperative consultation. Plast Reconstr Surg 2002;109(1):383–5. 4. Angell M. Do breast implants cause systemic disease? Science in the courtroom. N Engl J Med 1994;330(24):1748 –9. 5. United States Food and Drug Administration-Center for Devices and Radiologic Health. Breast implants: An information update 2000. [cited June 2003] Available from: www.fda.gov/cdrh/ breastimplants. 6. American Cancer Society. Cancer facts and figures 2003. [cited June 2003] Available from: www.caonline.amcancersoc.org. 7. Deapen D, Bernstein L, Brody GS. Are breast implants anticarcinogenic? A 14-year follow-up of the Los Angeles study. Plast Reconst Surg 1997;99(5):1346 –53. 8. Bostwick J. Breast reconstruction following mastectomy. CA Cancer J Clin 1995;45(5):289 –304. 9. Rohrich RJ, Kenkel JM, Adams WP. Preventing capsular contracture in breast augmentation: In search of the Holy Grail. Plast Reconstr Surg 1999;103(6):1759 –60. 10. Burkhardt BR. Capsular contracture: Hard breasts, soft data. Clin Plast Surg 1988;15:521–32. 11. Gutowski KA, Mesna GT, Cunningham BL. Saline-filled breast implants: A Plastic Surgery Educational Foundation multicenter outcomes study. Plast Reconstr Surg 1997;100(4):1019 –27. 12. Rohrich RJ. The FDA approves saline-filled breast implants: What does this mean for our patients? Plast Reconstr Surg 2000; 106(4):903–5.
Detectability of breast cancer in patients with augmentation implants primarily depends on the following: (1) appropriate selection of implant size relative to the amount of native breast tissue, (2) vigilance in obtaining annual physical examination by an experienced examiner, (3) proper instruction in doing monthly BSE, (4) immediate attention to clinical concerns, and (5) properly done mammographic studies at appropriate intervals with on-site supervision of an experienced radiologist.40 Adhering to these recommendations should improve outcomes of breast cancer occurring in women with breast implants, including the promotion of breast cancer mortality rates at a level comparable with the general population.
14. Cunningham BL, Lokeh A, Gutowski KA. Saline-filled breast implant safety and efficacy: A multicenter retrospective review. Plast Reconstr Surg 2000;105(6):2143–9.
This article was written in partial fulfillment of the requirements for the degree Master of Science in Nursing at Yale University. The author gratefully acknowledges the contributions and expert editing provided by Tish Knobf, RN, PhD, FAAN, AOCN.
17. Burkhardt BR, Demas CP. The effect of Siltex texturizing and povidone-iodine irrigation on capsular contracture around saline inflatable breast implants. Plast Reconstr Surg 1994;93(1):123–8.
REFERENCES 1. Edelman DA, Grant S, van Os WA. Breast cancer risk among women using silicone gel breast implants. Int J Fertil 1995;40(5):274 – 80. 2. Coon SK, Burris R, Coleman EA, Lemon SJ. An analysis of telephone interview data collected in 1992 from 820 women who
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13. Watson J, Shaw W, Ahn C. Surgical approaches to breast augmentation and implant removal: Procedures, clinical evaluations, and complications. In Gorczyca DP, Brenner RJ. The Augmented Breast: Radiologic and Clinical Perspectives. New York: Thieme, 1997:17–27.
15. Strom SS, Baldwin BJ, Sigurdson MS, Schusterman MA. Cosmetic saline breast implants: A survey of satisfaction, breast-feeding experience, cancer screening, and health. Plast Reconst Surg 1997; 100(6):1553–7. 16. Schumann D. Health risks for women with breast implants. Nurs Pract 1994;19(7):19 –30.
18. Asplund O, Gylbert L, Jurell G, Ward C. Textured or smooth implants for submuscular augmentation: A controlled study. Plast Reconstr Surg 1996;97(6):1200 –6. 19. Melkinow J, Nuovo J. Cancer prevention and screening in women. Prim Care 1997;24(1):15–26. 20. Cady B, Steele GD, Morrow M, Gardner B, Smith BL, Lee NC, et al. Evaluation of common breast problems: Guidance for primary care providers. CA Cancer J Clin 1998;48(1):49 –63.
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21. McCool WF, Stone-Condry M, Bradford HM. Breast health care: A review. J Nurse Midwifery 1998;43(6):406 –30. 22. Bryant H, Brasher P. Breast implants and breast cancer— Reanalysis of a linkage study. N Engl J Med 1995;332(23):1535–9. 23. Brinton LA, Brown SL. Breast implants and cancer. J Natl Cancer Inst 1997;89(18):1341–9. 24. McLaughlin JK, Nyren O, Blot WJ, Yin L, Josefsson S, Fraumeni JF, et al. Cancer risk among women with cosmetic breast implants: A population-based cohort study in Sweden. J Natl Cancer Inst 1998;90(2):156 –8. 25. Berkel H, Birdsell DC, Jenkins H. Breast augmentation: A risk factor for breast cancer? N Engl J Med 1992;326:1649 –53. 26. Brinton LA, Malone KE, Coates RJ, Schoenberg JB, Swanson CA, Daling JR, et al. Breast enlargement and reduction: Results from a breast cancer case-control study. Plast Reconstr Surg 1996;97(2): 269 –74. 27. United States Preventive Services Task Force. Screening for breast cancer: Recommendations and rationale. Ann Intern Med 2002;137:344 –6.
38. Baker JL, Bartels RJ, Douglas WM. Closed compression techniques for rupturing a contracted capsule around a breast implant. Plast Reconstr Surg 1976;58:137–41. 39. Clark CP, Peters GN, O’Brien KM. Cancer in the augmented breast. Cancer 1993;72(7):2170 –4. 40. Eklund GW, Cardenosa G. Mammographic evaluation of the augmented breast. In Gorczyca DP, Brenner RJ. The Augmented Breast: Radiologic and Clinical Perspectives. New York: Thieme, 1997:45–55. 41. Brenner RJ. Tumor detection in the augmented breast. In Gorczyca DP, Brenner RJ. The Augmented Breast: Radiologic and Clinical Perspectives. New York: Thieme, 1997:154 –69. 42. Handel N, Silverstein MJ, Gamagami P, Jensen JA, Collins A. Factors affecting mammographic visualization of the breast after augmentation mammaplasty. J Am Med Assoc 1992;268(14):1913–7. 43. Eklund GW. Mammographic imaging of the augmented breast. Admin Radiol 1988;12:42–3. 44. Eklund GW, Busby RC, Miller SH, Job JS. Improved imaging of the augmented breast. AJR 1988;151:469 –73.
28. Smith RA, Saslow D, Sawyer KA, Burke W, Evans WP, Foster RS, et al. American Cancer Society guidelines for breast cancer screening: Update 2003. CA Cancer J Clin 2003;53:141–69.
45. Hayes H, Vandergrift J, Diner WC. Mammography and breast implants. Plast Reconstr Surg 1988;82:1–6.
29. Hislop G. Is breast self-examination still necessary? Can Med Assoc J 1997;157(9):1225–6.
46. Silverstein MJ, Handel N, Gamagami P, Gierson ED, Furmaski M, Collins AR, et al. Breast cancer diagnosis and prognosis in women following augmentation with silicone gel-filled prostheses. Eur J Cancer 1992;28(2):635–40.
30. Thomas DB, Gao DL, Ray RM, Wang WN, Allison CJ, Chen FL, et al. Randomized trial of breast self-examination in Shanghai: Final results. J Natl Cancer Inst 2002;94:1445–57. 31. Sirovich BE, Sox HC. Breast cancer management: Breast cancer screening. Surg Clin North Am 1999;79(5):961–90. 32. Barton MB, Harris R, Fletcher SW. Does this patient have breast cancer? The screening clinical breast examination: Should it be done? How? J Am Med Assoc 1999;282(13):1270 –80. 33. Harvey BJ, Miller AB, Baines CJ, Corey PN. Effect of breast self-examination techniques on the risk of death from breast cancer. Can Med Assoc J 1997;157(9):1205–12. 34. Park BY, Kim SI, Kim MH, Kim EK, Park SH, Lee KS. Clinical breast examination for screening of asymptomatic women: The importance of clinical breast examination for breast cancer detection. Yonsei Med J 2000;41(3):312–8.
47. Eklund GW. Statement for American College of Radiology at FDA Advisory Panel for General or Plastic Surgical Devices, Gaithersburg, MD, November 12, 1991. Rockville (MD): Food and Drug Administration, November 12, 1991. 48. Garcia-Tutor F, Hontanilla B, Agreda J, Bazan A. Radiotransparency of the triglyceride mammary prosthesis: A quantitative analysis with mastectomy specimens. Plast Reconstr Surg 1999;104(3): 681–6. 49. Fajardo LL, Harvey JA, McAleese KA, Roberts CC, Granstrom P. Breast cancer diagnosis in women with subglandular silicone gel-filled augmentation implants. Radiology 1995;194(3):859 –62. 50. Carlson GW, Curley SA, Martin JE, Fornage BD, Ames FC. The detection of breast cancer after augmentation mammoplasty. Plast Reconstr Surg 1992;91(5):837–40.
35. Pennypacker HS, Naylor L, Sander AA, Goldstein MK. Why can’t we do better breast examinations? Nurse Pract Forum 1999; 10(3):122–8.
51. Deapen D, Hamilton A, Bernstein L, Brody GS. Breast cancer stage at diagnosis and survival among patients with prior breast implants. Plast Reconstr Surg 2000;105(2):535–40.
36. Schapira DV, Levine RB. Breast cancer screening and compliance and evaluation of lesions. Med Clin North Am 1996;80(1):15–26.
52. National Cancer Institute. Sureveillance, epidemiology, and end results (SEER). [cited June 2003] Available from: www.seer. cancer.gov.
37. Nystrom L, Andersson I, Bjurstam N, Frisell J, Nordenskjold B, Rutqvist LE. Long-term effects of mammography screening: Updated overview of the Swedish randomised trials. Lancet 2002;359: 909 –19.
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Appendix A. Clinical Studies That Indicate Detection of Breast Cancer Is Delayed in Women With Breast Implants Authors
Aim and Design
Sample
Results
Eklund et al.
A prospective cohort study that tested whether augmented women could be adequately assessed with mammography using modified methods.
50 Consecutive women with breast augmentations.
Hayes et al.45
A prospective, case-control study that aimed to quantify the effect of breast implants on mammography. A prospective cohort study that followed women with augmentation implants to assess cancer outcomes.
6 Women without palpable abnormalities.
With standard compression views: “high rate of missing “significant” lesions in 59% of cases, “moderate” rate in 40% of cases; with “moderate to marked” improvement in compression in 99% of cases, increase in compression by 2–3 cm, no cases of prosthetic rupture. Ratings were assigned as an average of observations by two radiologists. Average of 38.1% of glandular tissue is obscured, with a range of 22–83%.
A chart review study that retrospectively investigated the effect of mammary implants on mammography.
1,968 Women with breast augmentation prostheses were identified between 1985 and 1992; 18 were diagnosed with breast carcinoma.
44
Silverstein et al.46
Fajardo et al.49
Original cohort source and size not stated; 42 who subsequently developed breast cancer between 1981 and 1990.
Compared with data from the LA County Surveillance Program (LACSP) (5,876 women with breast cancer aged 45–54 years between 1972 and 1985): Average tumor size measured 2.3 cm in diameter in study subjects vs. 2.7 cm LACSP; non-invasive lesions occurred in 10% of subjects vs. 7% LACSP; invasive lesion with metastases to axillary nodes or other distant sites occurred in 45% of subjects vs. 43% LACSP. 95% of subjects’ tumors were palpable; 40% false-negative rate with mammography (14 of 35). Data from this study were not compared with similar statistics of non-augmented women in the same time frame: 89% (16 of 18) of the subjects had palpable abnormalities; standard mammographic views detected cancer in 6% of cases (1 of 18); additional Eklund views detected cancer in 67% of cases (12 of 18); 21% (16 of 18) had non-invasive carcinoma; 39% (7 of 18) had invasive carcinoma with axillary node metastases.
Appendix B. Clinical Studies That Indicate the Detection of Breast Cancer in Women With Implants Is Not Delayed or Improved Authors
Aim and Design
Brinton et al.
26
Clark et al.39
Carlson et al.50
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Sample
Results
Population-based case-control study 2,174 Cases diagnosed with breast cancer Rates of breast implants within each tumor-stage group on breast cancer risk associated in two metropolitan areas with 2,009 were compared within the entire control group: with breast enlargement and controls; 36 (1.7%) of the cases vs. 44 statistically significant reduced risk for in situ tumors reduction. (2.2%) controls reported having prior (RR, 0.2: 95% CI, 0.0 to 0.8) reduced risk (although breast enlargement. not statistically significant for localized (RR, 0.8: 95% CI, 0.5–1.4) and invasive tumors (RR, 0.8: 95% CI, 0.4–1.5). Various factors among the study group were compared 1,735 Participants selected from the A retrospective case-controlled with the controls: 19% vs. 41% of axillary Registry of the Komen Breast Cancer at study that examined the initial metastases (P ⫽ .006; 82% vs. 63% had ⬍2 cm Baylor University Medical Center during diagnostic and prognostic tumors (P ⫽ .016); 24% vs. 42% the period 1982 through 1991; 33 features of breast cancer in mammographically detected cancer (P ⫽ .064); subjects with breast cancer and women who had undergone 70% vs. 58% cancers detected by physical implants. augmentation mammoplasty. examination (P ⫽ .064). A chart review study that explores 35 Patients with 37 cases of breast Results are compared with those “of previous reports and whether breast implants interfere cancer selected from 1975 to 1990. the general population” (see p. 839 for citations); 8% with the mammographic (3 cases) rate of intraductal carcinoma, 49% (18 detection of potentially curable cases) rate of invasive carcinoma confined to the breast cancers. breast, 46% (16 cases) rate of metastatic breast cancer in axillary nodes or other sites.
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Appendix C. Epidemiological Studies That Indicate Detection of Breast Cancer Is Not Delayed in Women With Breast Implants Authors
Aim and Design
Sample
Results
Deapen et al.
A record linkage cohort study that examined breast cancer risk and detection issues among patients with breast implants.
3,182 Non-Spanish-surnamed caucasian women in Los Angeles County who received breast implants between 1953 and 1980; 31 cases of breast cancer.
Deapen et al.51
A follow-up to their previous article (7), survival rates among women with breast cancer and breast implants were studied.
Same cohort as for (7); 37 cases of breast cancer.
Birdsell et al.53
A non-concurrent cohort linkage study that evaluated breast cancer stage at diagnosis and survival experience among a group of women with augmentation implants.
13,246 Women diagnosed with breast cancer in the prov ince of Alberta from 1973 to 1990; 41 subjects who developed breast cancer after breast augmentation.
Compared with data from the Los Angeles County Cancer Surveillance Program (LACCSP) (non-Spanishsurnamed caucasian women aged 35–74 years from 1976 to 1991): 10% rate of in situ cancer in the study group vs. 8.7% rate among the controls, 49.6% rate of local cancer vs. 52.6%, and 40.4% rate of non-local cancer vs. 38.7%. Database in which results were compared is identical to (7): 10.4% rate of in situ cancer in the study group vs. 8.7% rate in the control group, 50.1% rate of local cancers vs. 52.6%, and 39.5% rate of non-local stages of cancer at presentation; compared with 5year survival rates established by NCI’s SEER: inclusive of all stages of cancer, 88.5% study group vs. 84.1% general population (95% CI, 77.8–99.1). Compared with the control cohort: 12.2% of the study subjects vs. 6.2% of the control group had Stage 0 cancer (carcinoma in situ, no axillary or distant metastases, 36.6% vs. 22.5% had Stage I (tumor 2 cm or less in greatest dimension, no axillary or distant metastases), 36.5% vs. 45.5 had stage 2 (multiple definitions—see p. 796), 4.9% vs. 17.8% had stage 3 (multiple definitions—see p. 796), and 4.9% vs. 3.0% had stage 4 (axillary and distant metastases); using the Kaplan-Meir method, the 5- and 10-year survival rates were 83% and 74%, respectively, for the subjects vs. 74% and 62% for the controls (not statistically significant).
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