Breast cancer after prophylactic bilateral mastectomy in women with a BRCA1 or BRCA2 mutation. Initial experiences of women from hereditary breast cancer families after bilateral prophylactic mastectomy: a retrospective study. Contralateral breast cancer in BRCA1 and BRCA2 mutation carriers. Contralateral prophylactic mastectomy. Predictors of significant histologic findings. Risk reduction of contralateral breast cancer and survival after contralateral prophylactic mastectomy in BRCA1 or BRCA2 mutation carriers. Efficacy of contralateral prophylactic mastectomy in women with a personal and family history of breast cancer. Complications leading to surgery after breast implantation. Patient regrets after bilateral prophylactic mastectomy. Efficacy of prophylactic mastectomy in women with unilateral breast cancer: a cancer research network project. Clinical experience of prophylactic mastectomy followed by immediate breast reconstruction in women at hereditary risk of breast cancer (HB(O)C) or a proven BRCA1 and BRCA2 germ-line mutation. Understanding the experience of prophylactic bilateral mastectomy: a qualitative study of ten women. The psychosocial impact of bilateral prophylactic mastectomy: prospective study using questionnaires and semistructured interviews. Predictors of quality of life in women with a bilateral prophylactic mastectomy. Efficacy of bilateral prophylactic mastectomy in women with a family history of breast cancer. Contralateral prophylactic mastectomy improves the outcome of selected patients undergoing mastectomy for breast cancer. Prevention in familial breast cancer: counseling and prophylactic mastectomy. Clinical follow-up after bilateral risk reducing ('prophylactic') mastectomy: mental health and body image outcomes. Bilateral prophylactic mastectomy reduces breast cancer risk in BRCA1 and BRCA2 mutation carriers: the PROSE Study Group. Long-term psychological impact of carrying a BRCA1/2 mutation and prophylactic surgery: a 5-year follow-up study. Subcutaneous mastectomy data: a final statistical analysis of 1500 patients. Reoperations after prophylactic mastectomy with or without implant reconstruction. One year follow-up of women opting for presymptomatic testing for BRCA1 and BRCA2: emotional impact of the test outcome and decisions on risk management (surveillance or prophylactic surgery). Satisfaction after contralateral prophylactic mastectomy: the significance of mastectomy type, reconstructive complications, and body appearance. Predictors of and satisfaction with bilateral prophylactic mastectomy. Satisfaction with prophylactic mastectomy and breast reconstruction in genetically predisposed women. Long-term satisfaction and psychological and social function following bilateral prophylactic mastectomy. Psychosocial functioning in women who have undergone bilateral prophylactic mastectomy. Efficacy of bilateral prophylactic mastectomy in BRCA1 and BRCA2 gene mutation carriers. Contentment with quality of life among breast cancer survivors with and without contralateral prophylactic mastectomy. A population-based study of bilateral prophylactic mastectomy efficacy in women at elevated risk for breast cancer in community practices. Postmastectomy reconstruction. Issues of regret in women with contralateral prophylactic mastectomies. Arguments against routine contralateral mastectomy or undirected biopsy for invasive lobular breast cancer. Utilisation of prophylactic mastectomy in 10 European centres. Complications following bilateral prophylactic mastectomy.
Women with a BRCA1 or BRCA2 mutation have a high risk of breast cancer and may choose to undergo prophylactic bilateral total mastectomy. We investigated the efficacy of this procedure in such women.
                We conducted a prospective study of 139 women with a pathogenic BRCA1 or BRCA2 mutation who were enrolled in a breast-cancer surveillance program at the Rotterdam Family Cancer Clinic. At the time of enrollment, none of the women had a history of breast cancer. Seventy-six of these women eventually underwent prophylactic mastectomy, and the other 63 remained under regular surveillance. The effect of mastectomy on the incidence of breast cancer was analyzed by the Cox proportional-hazards method in which mastectomy was modeled as a time-dependent covariate.
                No cases of breast cancer were observed after prophylactic mastectomy after a mean (+/-SE) follow-up of 2.9+/-1.4 years, whereas eight breast cancers developed in women under regular surveillance after a mean follow-up of 3.0+/-1.5 years (P=0.003; hazard ratio, 0; 95 percent confidence interval, 0 to 0.36). The actuarial mean five-year incidence of breast cancer among all women in the surveillance group was 17+/-7 percent. On the basis of an exponential model, the yearly incidence of breast cancer in this group was 2.5 percent. The observed number of breast cancers in the surveillance group was consistent with the expected number (ratio of observed to expected cases, 1.2; 95 percent confidence interval, 0.4 to 3.7; P=0.80).
                In women with a BRCA1 or BRCA2 mutation, prophylactic bilateral total mastectomy reduces the incidence of breast cancer at three years of follow-up. Women from families with breast and/or ovarian cancers seek advice and counselling for risk assessment, but they also want information about preventive measures that might reduce their risk of developing these neoplasms.
                This study was undertaken in order to assess 15 women's experience with the decision-making process prior to undergoing prophylactic bilateral mastectomy (PM) and immediate breast reconstruction (IBR). It was also designed to determine the degree of the women's satisfaction with the information delivered by the different caregivers, and whether the women felt that their need for psychosocial support was appropriately met. An additional goal was to learn about the patients> satisfaction with the operations.
                The women found it difficult to translate the genetic information transmitted to them, although they were satisfied by the way it was given. At some stage during the pre-operative and post-operative period nearly all women stated that they lacked psychological support from the different caregivers. No woman regretted her choice to undergo PM and IBR. By far, the most important issue was the actual risk reduction. However, the result exceeded all patients' initial expectations. When performing PM and IBR, a multidisciplinary team approach, including a psychologist, seems mandatory. It will facilitate the overall management of this group of women.
                Copyright 2000 Harcourt Publishers Ltd. To estimate the risk of contralateral breast cancer in BRCA1 and BRCA2 carriers after diagnosis and to determine which factors are predictive of the risk of a second primary breast cancer.
                Patients included 491 women with stage I or stage II breast cancer, for whom a BRCA1 or BRCA2 mutation had been identified in the family. Patients were followed from the initial diagnosis of cancer until contralateral mastectomy, contralateral breast cancer, death, or last follow-up.
                The actuarial risk of contralateral breast cancer was 29.5% at 10 years. Factors that were predictive of a reduced risk were the presence of a BRCA2 mutation (v BRCA1 mutation; hazard ratio [HR], 0.73; 95% CI, 0.47 to 1.15); age 50 years or older at first diagnosis (v <or= 49 years; HR, 0.63; 95% CI, 0.36 to 1.10); use of tamoxifen (HR, 0.59; 95% CI, 0.35 to 1.01); and history of oophorectomy (HR, 0.44; 95% CI, 0.21 to 0.91). The effect of oophorectomy was particularly strong in women first diagnosed prior to age 49 years (HR, 0.24; 95% CI, 0.07 to 0.77). For women who did not have an oophorectomy or take tamoxifen, the 10-year risk of contralateral cancer was 43.4% for BRCA1 carriers and 34.6% for BRCA2 carriers.
                The risk of contralateral breast cancer in women with a BRCA mutation is approximately 40% at 10 years, and is reduced in women who take tamoxifen or who undergo an oophorectomy. Women with unilateral breast carcinoma are at increased risk for developing contralateral breast carcinoma (CBC). The authors sought to identify predictors of malignant or moderate to high-risk histologic findings in contralateral prophylactic mastectomy (CPM) specimens, and to determine the efficacy of CPM.
                The authors performed a retrospective review of 239 patients with unilateral early-stage breast carcinoma who underwent CPM. The number of CBCs expected if the contralateral breast had been left intact was calculated based on CBC rates observed in the Surveillance, Epidemiology, and End Results (SEER) database and on life-table analysis by family history.
                In the current study, 11 patients (4.6%) had occult contralateral malignancies (4 invasive carcinomas and 7 ductal carcinomas in situ) and 44 (18.4%) patients had moderate to high-risk pathology (8 lobular carcinoma in situ, 11 atypical lobular hyperplasia, 25 atypical ductal hyperplasia). At 1846 patient-years of follow-up, only 1 patient (0.4%) developed a new CBC compared with 11 expected cancers based on SEER data. One CBC was observed among 140 patients with a family history of breast carcinoma, compared with 16 expected cancers based on life-table analysis adjusted for adjuvant therapy. The determinants of significant findings at CPM were invasive lobular histology, estrogen and progesterone receptor positivity, additional ipsilateral moderate to high-risk pathology, and age > 40 years at cancer diagnosis.
                CPM was associated with a low risk of subsequent development of breast carcinoma. Evaluation of histologic findings in the ipsilateral breast may help to predict the likelihood of significant disease in the contralateral breast and assist in risk stratification. The clinical outcome of contralateral prophylactic mastectomy (CPM) in women with a BRCA1 or BRCA2 mutation and a personal history of invasive breast cancer is unknown. We identified a cohort of 148 female BRCA1 or BRCA2 mutation carriers (115 and 33, respectively) who previously were treated for unilateral invasive breast cancer stages I-IIIa. In all, 79 women underwent a CPM, while the other women remained under intensive surveillance. The mean follow-up was 3.5 years and started at the time of CPM or at the date of mutation testing, whichever came last, that is, on average 5 years after diagnosis of the first breast cancer. One woman developed an invasive contralateral primary breast cancer after CPM, whereas six were observed in the surveillance group (P<0.001). Contralateral prophylactic mastectomy reduced the risk of contralateral breast cancer by 91%, independent of the effect of bilateral prophylactic oophorectomy (BPO). At 5 years follow-up, overall survival was 94% for the CPM group vs 77% for the surveillance group (P=0.03), but this was unexpectedly mostly due to higher mortality related with first breast cancer and ovarian cancer in the surveillance group. After adjustment for BPO in a multivariate Cox analysis, the CPM effect on overall survival was no longer significant. Our data show that CPM markedly reduces the risk of contralateral breast cancer among BRCA1 or BRCA2 mutation carriers with a history of breast cancer. Longer follow-up is needed to study the impact of CPM on contralateral breast cancer-specific survival. The choice for CPM is highly correlated with that for BPO, while only BPO leads to a significant improvement in overall survival so far. To estimate the efficacy of contralateral prophylactic mastectomy in women with a personal and family history of breast cancer.
                We followed the course of 745 women with a first breast cancer and a family history of breast and/or ovarian cancer who underwent contralateral prophylactic mastectomy at the Mayo Clinic between 1960 and 1993. Family history information and cancer follow-up information were obtained from the medical record, a study-specific questionnaire, and telephone follow-up. Life-tables for contralateral breast cancers, which consider age at first breast cancer, current age, and type of family history, were used to calculate the number of breast cancers expected in our cohort had they not had a prophylactic mastectomy.
                Of the 745 women in our cohort, 388 were premenopausal (age < 50 years) and 357 were post- menopausal. Eight women developed a contralateral breast cancer. Six events were observed among the premenopausal women, compared with 106.2 predicted, resulting in a risk reduction of 94.4% (95% confidence interval [CI], 87.7% to 97.9%). For the 357 postmenopausal women, 50.3 contralateral breast cancers were predicted, whereas only two were observed, representing a 96.0% risk reduction (95% CI, 85.6% to 99.5%).
                The incidence of contralateral breast cancer seems to be reduced significantly after contralateral prophylactic mastectomy in women with a personal and family history of breast cancer. Local complications that require additional surgical procedures are an important problem for women with breast implants.
                We studied 749 women who lived in Olmsted County, Minnesota, and received a first breast implant at the Mayo Clinic between 1964 and 1991. We identified complications that occurred after the initial procedure and after any subsequent implantation. A complication was defined as a surgical procedure performed for any of the following reasons: capsular contracture; rupture of the implant; hematoma or bleeding; infection or seroma of the wound; chronic pain; extrusion, leakage, or sweating of the implant; necrosis of the nipple, areola, or flap; malfunction of the filler port of a tissue expander; and wound dehiscence.
                During follow-up (mean, 7.8 years; range, 0 to 25.8), 208 (27.8 percent) of the women underwent 450 additional implant-related surgical procedures. Ninety-one (20.2 percent) were anticipated, staged procedures or were done because the patient requested a size change or aesthetic improvement, and 359 procedures (79.8 percent) had at least one clinical indication (thus constituting a complication). Complications occurred in 178 (23.8 percent) of the 749 women and involved 274 (18.8 percent) of the 1454 breasts with implants and 321 (18.8 percent) of the 1703 implants. The most frequent problem was capsular contraction (272 cases), followed by rupture of the implant (60), hematoma (55), and wound infection (23). The rate of complications was significantly lower (P<0.001) among women with cosmetic implants (6.5 percent at one year, 12 percent at five years) than among women who underwent implantation after mastectomy for breast cancer (21.8 percent at one year, 34 percent at five years) or prophylactic mastectomy (17.3 percent at one year, 30.4 percent at five years).
                Women who have had breast implantation frequently experience local complications during the subsequent five years. Complications were significantly less frequent among patients who received implants for cosmetic reasons than among those who received implants after mastectomy for cancer or for cancer prophylaxis. The discovery of a cadre of breast cancer susceptibility genes has resulted in an increase in the number of women seeking information about prophylactic breast surgery, but virtually no large-scale prospective databases exist to assist women considering prophylactic mastectomy.
                The authors constructed a National Prophylactic Mastectomy Registry comprised of a volunteer population of 817 women from 43 states who have undergone prophylactic mastectomy.
                In the registry, 370 women had undergone bilateral prophylactic mastectomy. Twenty-one (5%) women expressed regrets about the procedure. The median follow-up was 14.6 years (mean 14.8 years; range 0.2-51 years). Those with regrets were subsetted into those with major (n = 10) or minor (n = 7) regrets. Regrets were more common in those women with whom discussion about prophylactic mastectomy was initiated by a physician (19/255), compared with patients who initiated the discussion themselves (2/108; P < .05).
                The overall satisfaction rate of 95% reported here may be explained by the voluntary nature of this registry. The most important factor that predicts an unfavorable outcome following bilateral prophylactic mastectomy is a physician-initiated discussion. We investigated the efficacy of contralateral prophylactic mastectomy (CPM) in reducing contralateral breast cancer incidence and breast cancer mortality among women who have already been diagnosed with breast cancer.
                This retrospective cohort study comprised approximately 50,000 women who were diagnosed with unilateral breast cancer during 1979 to 1999. Using computerized data confirmed by chart review, we identified 1,072 women (1.9%) who had CPM. We obtained covariate information for these women and for a sample of 317 women who did not undergo CPM.
                The median time from initial breast cancer diagnosis to the end of follow-up was 5.7 years. Contralateral breast cancer developed in 0.5% of women with CPM, metastatic disease developed in 10.5%, and subsequent breast cancer developed in 12.4%; 8.1% died from breast cancer. Contralateral breast cancer developed in 2.7% of women without CPM, and 11.7% died of breast cancer. After adjustment for initial breast cancer characteristics, treatment, and breast cancer risk factors, the hazard ratio (HR) for the occurrence of contralateral breast cancer after CPM was 0.03 (95% CI, 0.006 to 0.13). After adjustment for breast cancer characteristics and treatment, the HRs for the relationship of CPM with death from breast cancer, with death from other causes, and with all-cause mortality were 0.57 (95% CI, 0.45 to 0.72), 0.78 (95% CI, 0.57 to 1.06), and 0.60 (95% CI, 0.50 to 0.72), respectively.
                CPM seems to protect against the development of contralateral breast cancer, and although women who underwent CPM had relatively low all-cause mortality, CPM also was associated with decreased breast cancer mortality. Women with a proven BRCA1 or BRCA2 germ-line mutation or with a 50% risk of carrying the mutation, have an increased risk of breast cancer. Regular surveillance, chemoprevention or prophylactic mastectomy (PM) are options to detect breast cancer at an early stage or to reduce the risk. We describe the management of women who have opted for PM, the postoperative complications of PM, especially in combination with immediate breast reconstruction (IBR), and the oncological follow-up.
                The medical records of all women who underwent a PM from December 1993 to December 1999 have been reviewed with respect to management, patient characteristics, complications and oncological follow-up.
                During the study period 112 women with a median age of 38.8 years opted for a PM: 76 were germline mutation carriers. After PM, 79 women without breast or ovarian cancer in their medical history, were free of disease after 2.5 years (median). Before PM, 29 women had been treated for breast cancer, 3.9 years (median) previously; 5 of these women had developed metastatic disease by the last consultation. Before PM, 2 patients had been treated for DCIS and 2 patients for ovarian cancer. Four DCIS were found; none of these women had evidence of disease 4.0 years (median) after PM. In 59 women laparoscopic prophylactic bilateral oophorectomy (PBO) was performed; 36 simultaneously with PM and 23 separately. A total of 103 women (92%) opted for IBR. After PM, the complication rate for IBR was 21%: 11% within 6 weeks and 10% at long-term follow-up (median 3.5) after PM, including the removal of 10 prostheses.
                Women with an increased risk of breast cancer due to a genetic predisposition should be adequately informed about the different treatment options in the setting of a multidisciplinary approach. PM can simultaneously be combined with PBO and IBR. IBR can facilitate the decision to undergo a PM. PM followed by IBR has an acceptable complication rate. Prophylactic bilateral mastectomy represents a new and controversial cancer prevention strategy for women at high-risk of familial breast cancer, the psychosocial implications of which are yet to be fully explored. A qualitative methodology was therefore adopted to provide a discovery-orientated study of the perspectives of ten women who had undergone prophylactic mastectomy and the views of eight of their partners. Each participant was interviewed with the aim of exploring the personal experiences of surgery, factors associated with psychological adjustment and the impact on the family. Data were transcribed and systematically analysed using Grounded Theory. Themes emerging from participants' accounts formed seven significant categories that represented women's key experiences: (i) deciding; (ii) telling; (iii) experiencing surgery and recovering; (iv) maintaining womanliness; (v) processing the loss; and (vi) moving on. The importance of the social context in women's experience and difficulties of isolation/eliciting support were also highlighted: (vii) isolation and being supported. A core category of 'Suffering and countering multiple loss' considered central to women's experience, integrated the seven significant categories and provided further conceptualisation of women's experience. Implications for clinical practice are highlighted. To investigate the psychosocial impact of bilateral prophylactic mastectomy for women with increased risk of breast cancer and to identify, preoperatively, risk factors for postoperative distress.
                Prospective study using interviews and questionnaire assessments.
                Participants' homes throughout the United Kingdom.
                143 women with increased risk of developing breast cancer who were offered bilateral prophylactic mastectomy and who accepted or declined the surgery; a further 11 were offered surgery but deferred making a decision.
                Psychological and sexual morbidity.
                Psychological morbidity decreased significantly over time for the 79 women who chose to have surgery (accepters): 58% (41/71) preoperatively v 41% (29/71) 6 months postoperatively (difference in percentages 17%, 95% confidence interval 2% to 32%; P=0.04) and 60% (39/65) preoperatively v 29% (19/65) 18 months postoperatively (31%, 15% to 47%; P<0.001). Psychological morbidity in the 64 women who declined surgery (decliners) did not decrease significantly: 57% (31/54) at baseline v 43% (23/54) at 6 months (14%, 0% to 29%; P=0.08) and 57% (29/52) at baseline v 41% (21/52) at 18 months (16%; -2% to 33%; P=0.11). Greater than normal proneness to anxiety was more common in the decliners than in the accepters: 78% (45/58) v 56% (41/73) (22%, 6% to 38%; P=0.006). Accepters were more likely than decliners to believe it inevitable that they would develop breast cancer (32% (24/74) v 10% (6/58) (difference in percentages 22%, 9% to 35%; P=0.003)), and decliners were more likely to believe that screening could help (92% (55/60) v 74% (55/74) (18%, 5% to 31%; P=0.007)). Level of sexual discomfort and degree of sexual pleasure did not change significantly over time in either of the two groups.
                Bilateral prophylactic mastectomy may provide psychological benefits in women with a high risk of developing breast cancer. The purpose of this study was to assess the quality of life in women who had previously undergone a bilateral prophylactic mastectomy and to determine what factors predict quality of life in this population. Women in Ontario who had undergone prophylactic mastectomy between 1991 and 2000 were asked to complete several questionnaires that assessed current psychosocial functioning, including the Quality of Life Index (QLI). The mean score for the QLI was 23.34 (range 9.53-30.00). QLI scores were negatively correlated with cancer-related distress, body image difficulties, and psychological distress. Conversely, QLI scores were positively correlated with social support. Significant predictors of quality of life included psychological distress and one subscale of body image (vulnerability). Vulnerability and psychological distress are important predictors of quality of life in women who have previously undergone bilateral prophylactic mastectomy. Options for women at high risk for breast cancer include surveillance, chemoprevention, and prophylactic mastectomy. The data on the outcomes for surveillance and prophylactic mastectomy are incomplete.
                We conducted a retrospective study of all women with a family history of breast cancer who underwent bilateral prophylactic mastectomy at the Mayo Clinic between 1960 and 1993. The women were divided into two groups - high risk and moderate risk - on the basis of family history. A control study of the sisters of the high-risk probands and the Gail model were used to predict the number of breast cancers expected in these two groups in the absence of prophylactic mastectomy.
                We identified 639 women with a family history of breast cancer who had undergone bilateral prophylactic mastectomy: 214 at high risk and 425 at moderate risk. The median length of follow-up was 14 years. The median age at prophylactic mastectomy was 42 years. According to the Gall model, 37.4 breast cancers were expected in the moderate-risk group; 4 breast cancers occurred (reduction in risk, 89.5 percent; P<0.001). We compared the numbers of breast cancers among the 214 high-risk probands with the numbers among their 403 sisters who had not undergone prophylactic mastectomy. Of these sisters, 38.7 percent (156) had been given a diagnosis of breast cancer (115 cases were diagnosed before the respective proband's prophylactic mastectomy, 38 were diagnosed afterward, and the time of the diagnosis was unknown in 3 cases). By contrast, breast cancer was diagnosed in 1.4 percent (3 of 214) of the probands. Thus, prophylactic mastectomy was associated with a reduction in the incidence of breast cancer of at least 90 percent.
                In women with a high risk of breast cancer on the basis of family history, prophylactic mastectomy can significantly reduce the incidence of breast cancer. Risk factors for contralateral breast cancer (CBC) may indicate a benefit for contralateral prophylactic mastectomy (CPM) at the time of unilateral mastectomy for breast cancer. The purpose of this study is to evaluate the efficacy of CPM in preventing CBC.
                sixty-four patients undergoing CPM and a control group of 182 patients not undergoing CPM and matched for age, stage, surgery, chemotherapy, and hormonal therapy were retrospectively compared for CBC rate, disease-free survival, and overall survival.
                Thirty-six CBCs occurred in the control group. In the CPM group, 3 CBCs were found at the time of prophylactic mastectomy, but none occurred subsequently (P = 0.005). Disease-free survival at 15 years in the CPM group was 55% (95% confidence interval [CI] 38% to 69%) versus 28% (95% CI 19% to 36%) in the control group (P = 0.01). Overall survival at 15 years was 64% (95% CI 45% to 78%) CPM versus 48% (95% CI 39% to 58%) in controls (P = 0.26).
                CPM prevented CBC and significantly prolonged disease-free survival. Future studies will need to address risk assessment and contralateral breast cancer prevention in patients treated for early breast cancer. nan In Manchester, approximately 120 women at > or = 1:4 lifetime risk of breast cancer have considered preventative surgery since 1992. Women treated within the Manchester protocol receive two genetic counselling sessions, a psychological assessment and a surgical consultation pre-operatively and annual follow-up post-operatively. The vast majority of women have breast reconstruction.
                Since 1996, mental health and body image have been assessed in women attending annual follow-up using self-report questionnaires: the 28-item General Health Questionnaire (GHQ) and 10-item Body Image Scale (BIS). Women with high scores are assessed by clinical interview together with a proportion who have no significant problems.
                Between 1995 and 1999, 76 women completed surgery. Ten were awaiting post-operative review and 60 (91%) attended for follow-up of whom 45 (75%) were interviewed. Questionnaire data were available for 52 (79%) women, mean age 40.8 years (range 27-58). Six women were gene mutation carriers and of these three had had breast cancer. One additional patient was affected but had not been genetically tested. Eight (17%) of 47 women with assessments in the first post-operative year scored in the 'caseness' range on the GHQ: the mean GHQ score was 3.8 (S.D. 6.7), range 0-25. Results were comparable with those for women attending the Family History Clinic for risk assessment. The mean score on the BIS was 5.1 (S.D. 5.5), range 0-25, comparable with scores for women undergoing conservative surgery for breast cancer. Twenty-one percent of women reported no negative change in body image following surgery (i.e. zero questionnaire summary scores) and the majority of changes reported were of minor degree (item scores 0 or 1). The most frequently reported changes were in sexual attractiveness (55%), feeling less physically attractive (53%) and self-consciousness about appearance (53%): a third of women felt less feminine to a minimal degree. These results appeared stable over time. A minority of women had more serious psychological or body image concerns, usually in relation to surgical complications: they received further psychiatric intervention.
                For the majority of women there is no evidence of significant mental health or body image problems in the first 3 years following Bilateral Prophylactic Mastectomy (BPM), but women who have complications warrant additional psychological help. Careful pre-operative preparation and long-term monitoring are advocated in this new field of cancer prevention. Data on the efficacy of bilateral prophylactic mastectomy for breast cancer risk reduction in women with BRCA1 and BRCA2 (BRCA1/2) mutations are limited, despite the clinical use of this risk-management strategy. Thus, we estimated the degree of breast cancer risk reduction after surgery in women who carry these mutations.
                Four hundred eighty-three women with disease-associated germline BRCA1/2 mutations were studied for the occurrence of breast cancer. Cases were mutation carriers who underwent bilateral prophylactic mastectomy and who were followed prospectively from the time of their center ascertainment and their surgery, with analyses performed for both follow-up periods. Controls were BRCA1/2 mutation carriers with no history of bilateral prophylactic mastectomy matched to cases on gene, center, and year of birth. Both cases and controls were excluded for previous or concurrent diagnosis of breast cancer. Analyses were adjusted for duration of endogenous ovarian hormone exposure, including age at bilateral prophylactic oophorectomy if applicable.
                Breast cancer was diagnosed in two (1.9%) of 105 women who had bilateral prophylactic mastectomy and in 184 (48.7%) of 378 matched controls who did not have the procedure, with a mean follow-up of 6.4 years. Bilateral prophylactic mastectomy reduced the risk of breast cancer by approximately 95% in women with prior or concurrent bilateral prophylactic oophorectomy and by approximately 90% in women with intact ovaries.
                Bilateral prophylactic mastectomy reduces the risk of breast cancer in women with BRCA1/2 mutations by approximately 90%. To explore long-term psychosocial consequences of carrying a BRCA1/2 mutation and to identify possible risk factors for long-term psychological distress.
                Five years after genetic test disclosure, 65 female participants (23 carriers, 42 noncarriers) of our psychological follow-up study completed a questionnaire and 51 participants were interviewed. We assessed general and hereditary cancer-related distress, risk perception, openness to discuss the test result with relatives, body image and sexual functioning.
                Carriers did not differ from noncarriers on several distress measures and both groups showed a significant increase in anxiety and depression from 1 to 5 years follow-up. Carriers having undergone prophylactic surgery (21 of 23 carriers) had a less favorable body image than noncarriers and 70% reported changes in the sexual relationship. A major psychological benefit of prophylactic surgery was a reduction in the fear of developing cancer. Predictors of long-term distress were hereditary cancer-related distress at blood sampling, having young children, and having lost a relative to breast/ovarian cancer. Long-term distress was also associated with less open communication about the test result within the family, changes in relationships with relatives, doubting about the validity of the test result, and higher risk perception.
                Our findings support the emerging consensus that genetic predisposition testing for BRCA1/2 does not pose major mental health risks, but our findings also show that the impact of prophylactic surgery on aspects such as body image and sexuality should not be underestimated, and that some women are at risk for high distress, and as a result, need more attentive care. A statistical analysis of 1500 patients who underwent subcutaneous mastectomy is presented. Their data suggest that most patients who were treated by subcutaneous mastectomy had proliferative fibrocystic disease or macrocystic disease, among other high risk factors. The data also suggest that a thoroughly performed subcutaneous mastectomy is an effective means of providing prophylaxis in women who are at high risk for breast cancer. Conclusions were confirmed by many unsolicited comments of patients who underwent the procedure and were grateful to their doctors who performed it. The authors characterized the unanticipated reoperations after prophylactic mastectomy, with or without implant reconstruction.
                The surgical cohort was comprised of 1417 women with a family history of breast carcinoma. The women received a prophylactic mastectomy with (bilateral, n = 593; contralateral, n = 506) or without reconstruction (n = 318) at the Mayo Clinic (Rochester, MN) between 1960 and 1993. Reoperations and indications for reoperation were compiled from medical records and a patient survey.
                Three hundred eighteen women received a bilateral (n = 39) or contralateral (n = 279) prophylactic mastectomy without reconstruction. With a median follow-up of 15 years, 18 women (6%) required reoperation. Most of these reoperations occurred within the first year after prophylactic mastectomy. Five hundred ninety-three women had reconstruction with implants following bilateral prophylactic mastectomy. Approximately one-half of the women (52%) required at least 1 unanticipated reoperation during a median follow-up of 14 years. Approximately 39% of all reoperations occurred within 1 year of breast reconstruction and 69% within 5 years. Implant-related issues were the most common cause for reoperation. Some women with breast carcinoma elected to receive contralateral prophylactic mastectomy with therapeutic mastectomy for the affected breast. Five hundred six women received reconstruction with implants. During a median follow-up of 8.8 years, 189 women (37%) required unanticipated reoperation. The most common indication was implant-related issues. The time course of reoperations was similar to that for women in the bilateral group.
                Surgical reoperations were fairly common among women who received prophylactic mastectomy with implant reconstruction. Most of the reoperations were implant related. Reoperations were fairly uncommon after prophylactic mastectomy without reconstruction.
                Copyright 2003 American Cancer Society. Genetic testing enables women at risk for hereditary breast and/or ovarian cancer to find out whether they have inherited the gene mutation (BRCA1/BRCA2), and if so, to opt for frequent surveillance and/or prophylactic surgery (bilateral mastectomy and/or oophorectomy). Here, a follow-up is described for 63 healthy women at 50% risk of being a BRCA1/BRCA2 mutation carrier who underwent genetic testing. The course of distress and problems regarding body image and sexuality up to 1 year after disclosure of the test-outcome were described separately for mutation carriers undergoing mastectomy (n = 14), for mutation carriers opting for surveillance (n = 12) and for non-mutation carriers (n = 37). Furthermore, we analyzed whether women opting for prophylactic mastectomy differed from those opting for close surveillance with respect to biographical characteristics, experiences with cancer in relatives and personality. Women opting for prophylactic mastectomy had significantly higher distress levels than mutation carriers who opted for surveillance, and the non-mutation carriers. This difference in levels of distress was highest at pre- and post-test and had almost disappeared at 1-year follow-up. Besides, mutation carriers opting for prophylactic mastectomy were more often in their thirties, more often had young children and had a longer awareness of the genetic nature of cancer in the family than those opting for regular surveillance. Adverse effects were observed in women who underwent prophylactic mastectomy (mostly in combination with immediate breast reconstruction) regarding the perception of how their breast region looked like and felt, the intimate relationship and physical wellbeing whereas women opting for prophylactic mastectomy reported more distress than the other women in the study, their distress levels had significantly decreased 6 months or longer after surgery, possibly due to the significant risk reduction of developing breast cancer. This might explain, why most women who underwent prophylactic mastectomy were satisfied with this decision, despite a perceived negative impact on body image, the intimate relationship and physical wellbeing. Contralateral prophylactic mastectomy (CPM) is one option for reducing the risk of a second breast cancer in women with a personal and family history of breast cancer. Few data are available regarding satisfaction, psychological, and social function after CPM. The purpose of this research is to evaluate women's long-term satisfaction with CPM, factors influencing satisfaction, and psychological and social function after CPM.
                This was a descriptive study of all women with a family history of breast cancer, known to be alive, who elected CPM at Mayo Clinic (Rochester, MN) between 1960 and 1993 (n = 621). Ninety-four percent of the women (n = 583) completed a study-specific questionnaire.
                A mean of 10.3 years after the procedure, the majority of women (83%) were satisfied with their CPM. A smaller number were neutral (8%) or dissatisfied (9%). Women who had a subcutaneous mastectomy had more problems with reconstruction, and fewer of these women were satisfied than women with simple mastectomy. Decreased satisfaction with CPM was associated with decreased satisfaction with appearance, complications with reconstruction, reconstruction after CPM, and increased level of stress in life. The majority of women experienced no change or favorable effects in self-esteem (83%), level of stress in life (83%), and emotional stability (88%). Satisfaction with body appearance, feelings of femininity, and sexual relationships were the most adversely affected with 33%, 26%, and 23% of the women responding negatively.
                Although most women are satisfied with CPM, each woman should weigh the benefits alongside the potential adverse effects. Women with a first-degree relative with breast cancer are at increased risk of developing this disease. The optimal medical management of these women is unclear, with options including close breast cancer screening, bilateral prophylactic mastectomy, or participation in chemoprevention trials. Among women who undergo prophylactic bilateral mastectomy, very little is known about satisfaction with this surgery. Also, we know very little about variables related to prophylactic mastectomy decision making.
                Participants were women at increased risk of breast cancer due to family history. These women were categorized by self-report as not interested in prophylactic mastectomy (n = 58), interested but deciding against surgery (n = 92), or subsequently having a bilateral prophylactic mastectomy (n = 14). Information on screening practices, risk perception, level of depression, and cancer-related worry was collected. Women completing prophylactic mastectomy reported on their satisfaction with the surgery and breast reconstruction.
                Women selecting surgery reported more breast cancer worry. The group expressing no interest in surgery reported fewer biopsies and lower risk estimates. Women completing surgery were satisfied with their decision, although satisfaction with reconstruction was mixed.
                Factors influencing surgical decision making may include breast-cancer-related worry, biopsy history, and subjective breast cancer risk. Prophylactic mastectomy with breast reconstruction is a risk-reducing strategy for women at increased risk of breast cancer. It remains a very radical intervention, and long-term data on satisfaction are insufficiently available. In the present follow-up study, the authors assess satisfaction with prophylactic mastectomy and breast reconstruction and its impact on sexual relationships.
                The authors conducted a retrospective study using a short self-report questionnaire administered to 114 genetically predisposed women who underwent prophylactic mastectomy and breast reconstruction mainly by subpectorally implanted silicone prostheses performed at one institution.
                The median follow-up time between prophylactic mastectomy/breast reconstruction and completion of the questionnaire was 3 years. Sixty percent of all participants were satisfied with the result of prophylactic mastectomy/breast reconstruction. Satisfaction was significantly and negatively correlated with perceived lack of information, experienced complications, ongoing complaints, whether or not the reconstructed breasts feel "like your own," and not choosing this type of breast reconstruction again. Adverse effects in the patient's sexual relationship were strongly correlated with perceived lack of information, discrepant expectations, ongoing complaints and limitations, whether or not the reconstructed breasts feel "like your own," altered feelings of femininity, partner's negative perception on femininity and sexuality, and not choosing this type of breast reconstruction again.
                A majority of women would choose the procedure again, but adverse effects and untoward changes in the perception of the sexual relationship need to be addressed in the counselling of women at high risk, to optimize an informed choice and enable adequate adjustment postoperatively. Prophylactic mastectomy is a preventive option for women who wish to reduce their risk of breast cancer. There has been concern about possible negative psychological sequelae following this procedure. However, few data are available regarding long-term satisfaction and psychological and social function following this procedure.
                To evaluate patients' long-term satisfaction and psychological and social function following prophylactic mastectomy.
                Descriptive study of all women known to be alive (n = 609) who had a family history of breast cancer and elected to undergo bilateral prophylactic mastectomy at a large, tertiary US health care clinic between 1960 and 1993, 94% (n = 572) of whom completed a study questionnaire.
                Satisfaction with procedure and effects on psychological and social function, based on responses to the study-specific questionnaire.
                Mean time from prophylactic mastectomy to last follow-up was 14.5 years. Most women (70%) were satisfied with the procedure; 11% were neutral; and 19% were dissatisfied. Among the psychological and social variables, the most striking finding was that 74% reported a diminished level of emotional concern about developing breast cancer. The majority of women reported no change/favorable effects in levels of emotional stability (68%/23%), level of stress (58%/28%), self-esteem (69%/13%), sexual relationships (73%/4%), and feelings of femininity (67%/8%). Forty-eight percent reported no change in their level of satisfaction with body appearance; 16% reported favorable effects. However, 9%, 14%, 18%, 23%, 25%, and 36% reported negative effects in these 6 variables, respectively.
                This study suggests that positive outcomes following prophylactic mastectomy include decreased emotional concern about developing breast cancer and generally favorable psychological and social outcomes. These must be weighed against the irreversibility of the decision, potential problems with implants and reconstructive surgery, and occurrence of adverse psychological and social outcomes in some women. JAMA. 2000;284:319-324 The purpose of this study was to determine the current psychosocial functioning of women who had previously had a bilateral prophylactic mastectomy. Women in the province of Ontario who had undergone prophylactic mastectomy between 1991 and 2000 were asked to complete questionnaires that assessed psychological distress, sexual activity, overall satisfaction with decision to have a prophylactic mastectomy, and body image. Ninety-seven percent of the women were satisfied with their decision to have a prophylactic mastectomy, but young women (<50 years) were less likely to report satisfaction than older women (p=0.001). Women with a strong family history of breast cancer or a BRCA1 or BRCA2 mutation experienced more cancer-related distress than those with a limited family history. Women who had reconstruction following mastectomy reported higher levels of satisfaction with general body shape and appearance than those without reconstruction. In conclusion, the majority of women were satisfied with their decision to undergo prophylactic mastectomy and were not experiencing abnormal levels of psychological distress, low levels of sexual activity, or difficulties with body image.
                Copyright 2003 John Wiley & Sons, Ltd. In women with a family history of breast cancer, bilateral prophylactic mastectomy is associated with a decreased risk of subsequent breast cancer of approximately 90%. We examined the association between bilateral prophylactic mastectomy and breast cancer risk in women at high risk for breast cancer who also had mutations in BRCA1 and BRCA2 genes.
                We obtained blood samples from 176 of the 214 high-risk women who participated in our previous retrospective cohort study of bilateral prophylactic mastectomy. We used conformation-sensitive gel electrophoresis and direct sequence analysis of the blood specimens to identify women with mutations in BRCA1 and BRCA2. The carriers' probabilities of developing breast cancer were estimated from two different penetrance models.
                We identified 26 women with an alteration in BRCA1 or BRCA2. Eighteen of the mutations were considered to be deleterious and eight to be of uncertain clinical significance. None of the 26 women has developed breast cancer after a median of 13.4 years of follow-up (range, 5.8-28.5 years). Three of the 214 women are known to have developed a breast cancer after prophylactic mastectomy. For two of these women, BRCA1 and BRCA2 screening was negative, and no blood specimen was available for the third. Estimations of the effectiveness of prophylactic mastectomy were performed, considering this woman as both a mutation carrier and a noncarrier. These calculations predicted that six to nine breast cancers should have developed among the mutation carriers, which translates into a risk reduction, after bilateral prophylactic mastectomy, of 89.5%-100% (95% confidence interval = 41.4% to 100%).
                Prophylactic mastectomy is associated with a substantial reduction in the incidence of subsequent breast cancer not only in women identified as being at high risk on the basis of a family history of breast cancer but also in known BRCA1 or BRCA2 mutation carriers. To understand psychosocial outcomes after prophylactic removal of the contralateral breast in women with unilateral breast cancer.
                We mailed surveys to women with contralateral prophylactic mastectomy after breast cancer diagnosis between 1979 and 1999 at six health care delivery systems, and to a smaller random sample of women with breast cancer without the procedure. Measures were modeled on instruments developed to assess contentment with quality of life, body image, sexual satisfaction, breast cancer concern, depression, and health perception. We examined associations between quality of life and the other domains using logistic regression.
                The response rate was 72.6%. Among 519 women who underwent contralateral prophylactic mastectomy, 86.5% were satisfied with their decision; 76.3% reported high contentment with quality of life compared with 75.4% of 61 women who did not undergo the procedure (P = .88). Among all case subjects, less contentment with quality of life was not associated with contralateral prophylactic mastectomy or demographic characteristics, but was associated with poor or fair general health perception (odds ratio [OR], 7.0; 95% CI, 3.4 to 14.1); possible depression (OR, 5.4; 95% CI, 3.1 to 9.2); dissatisfaction with appearance when dressed (OR, 3.5; 95% CI, 2.0 to 6.0); self-consciousness about appearance (OR, 2.0; 95% CI, 1.1 to 3.7); and avoiding thoughts about breast cancer (modest: OR, 2.2; 95% CI, 1.1 to 4.5; highest: OR, 1.7; 95% CI, 0.9 to 3.2).
                Most women undergoing contralateral prophylactic mastectomy report satisfaction with their decision and experience psychosocial outcomes similar to breast cancer survivors without the procedure. Findings from several studies suggest that bilateral prophylactic mastectomy reduces breast cancer incidence by 90% or more, but the studies used highly selected patients from referral centers, and the comparison groups were not population based. We studied the efficacy of bilateral prophylactic mastectomy in women with elevated breast cancer risk cared for in community practices.
                We conducted a retrospective case-cohort study of women aged 18 to 80 years with 1 or more breast cancer risk factors (family history of breast cancer, history of atypical hyperplasia, or > or =1 breast biopsies with benign findings). Using computerized data and medical records, we identified 276 women with bilateral prophylactic mastectomy and a stratified random sample of 196 women representing an underlying cohort of 666 800 women with elevated breast cancer risk without prophylactic mastectomy, and then we determined who developed breast cancer.
                Breast cancer developed in 1 woman (0.4%) after bilateral prophylactic mastectomy vs 26 800 women (4.0%) without prophylactic mastectomy. Stratifying by birth year, the hazard ratio for breast cancer occurrence after bilateral prophylactic mastectomy was 0.005 (95% confidence interval, 0.001-0.044). No woman with bilateral prophylactic mastectomy died of breast cancer vs a calculated 0.2% of women without prophylactic mastectomy.
                Bilateral prophylactic mastectomy reduced breast cancer incidence in women at elevated risk for breast cancer cared for in community-based practices. However, the absolute risk of breast cancer incidence and death in women who did not undergo the procedure in these settings was relatively low. Reconstructive surgery following mastectomy has had an increased acceptability with improved techniques and prostheses. Plastic reconstructive procedures following prophylactic mastectomy were performed in 104 patients and following mastectomy for cancer in 88 patients. Capsular contractions have not occurred with the use of a subpectoral pocket and detection of recurrent cancer is not hampered by the materials now used. Patients with a history of carcinoma of one breast have an estimated risk of 0.5% to 0.75% per year of developing a contralateral breast cancer. This risk prompts many women to consider contralateral prophylactic mastectomy (CPM) as a preventive measure. Virtually nothing is known about patient acceptance following CPM. We have developed a National Prophylactic Mastectomy Registry comprised of a volunteer population of 817 women from 43 states who have undergone prophylactic (unilateral or bilateral) mastectomy.
                Of the 346 women with CPM who responded to national notices, 296 women returned detailed questionnaires. The information obtained included patient demographics, family history, reproductive history, ipsilateral breast cancer staging and treatment, as well as issues involving the CPM.
                At median follow-up of 4.9 years, the respondents were primarily married (79%), white (97%) women who had some level of college education or above (81%). These women cited the following reasons for choosing CPM: (1) physician advice regarding the high risk of developing contralateral breast cancer (30%); (2) fear of developing more breast cancer (14%); (3) desire for cosmetic symmetry (10%); (4) family history (7%); (5) fibrocystic breast disease (4%); (6) a combination of all of these reasons (32%); (7) other (2%); and (8) unknown (1%). Eighteen of the 296 women (6%) expressed regrets regarding their decision to undergo CPM. Unlike women with bilateral prophylactic mastectomies, regrets tended to be less common in the women with whom the discussion of CPM had been initiated by their physician (5%) than in the women who had initiated the discussion themselves (8%) (P = ns). Family history and stage of index lesion had no impact on regret status. The reasons for regret included: (1) poor cosmetic result, either of the CPM or of the reconstruction (39%); (2) diminished sense of sexuality (22%); (3) lack of education regarding alternative surveillance methods or CPM efficacy (22%); and (4) other reasons (17%).
                To minimize the risk of regrets in women contemplating CPM, it is imperative that these women be counseled regarding an estimation of contralateral breast cancer risk, the alternatives to CPM, and the efficacy of CPM. In addition, these women should have realistic expectations of the cosmetic outcomes of surgery and understand the potential impact on their body image. Management of the contralateral normal-appearing breast in a patient with ipsilateral invasive lobular carcinoma (ILC) is controversial.
                The case histories of patients with histologically proven ILC who underwent definitive surgery at our institution from 1978 to 1991 were retrospectively reviewed.
                Of the 419 women with ILC, 36 (8.6%) had bilateral cancer, with a cumulative risk of 10% at 10 years. Twenty-five (69%) of these cancers were suspected before operation. From 105 contralateral prophylactic surgical procedures, seven (64%) in-situ and four (36%) invasive cancers were detected. The age at presentation and multifocality of the index cancer were significantly different between patients with unilateral and those with bilateral cancers. No survival difference was noted between patients whose contralateral cancers were suspected clinically and those whose cancers were detected prophylactically. Survival rates between patients with unilateral versus bilateral cancers were also not different. However, patients with contralateral prophylactic surgery had a better prognosis than those with unilateral tumors and no prophylaxis.
                Ten percent of patients with ILC experienced bilateral cancers during a period of 10 years. Survival was not influenced by the development of a second cancer, but it improved with surgical prophylaxis. Increasingly women at high risk of breast cancer are opting for prophylactic surgery to reduce their risks. Data from 10 European centres that offer a risk counselling and screening service to women at risk show different approaches to the option of preventive surgery, although most centres adhere to a protocol including at least two risk counselling sessions and a psychological assessment. Thus far the combined centres have data on 174 women who have undergone prophylactic mastectomy with in excess of 400 women years of follow up. Operations were carried out on women with lifetime risks of 25-80%, with an average annual expected incidence rate of 1% per women. No breast cancers have occurred in this cohort. Long term follow up on an extended group of women will be necessary to truly address the risk of subsequent breast cancer and the psychological sequelae. Bilateral prophylactic mastectomy significantly decreases breast cancer risk, but complications of the procedure have only been described in single-site studies. We describe the frequency and type of complications in women who underwent bilateral prophylactic mastectomy in a multisite community-based cohort.
                Women aged 18-80 years undergoing bilateral prophylactic mastectomy without a personal history of breast cancer at one of six health plans were eligible. We identified women from automated data sources, then reviewed hospital data, ambulatory notes, and other chart elements to confirm eligibility and obtain all charted information about complications and surgeries performed after prophylactic mastectomy, including reconstructive procedures. Reconstructions were characterized by type (implant vs. tissue graft). Complications were noted for a 1-year period after any surgical procedure.
                We identified 269 women with prophylactic mastectomy who were followed for a mean of 7.4 years. Their mean age was 44.9 years. Nearly 80% undertook reconstruction, most with prosthetic implants. One or more complications occurred in 64%. The most common complications were pain (35% of women), infection (17%), and seroma (17%). Women with no reconstruction had fewer complications (mean of .93) than women who had implant (2.0) or tissue graft (2.4) reconstruction procedures (differences from no reconstruction: 1.07 [95% confidence interval = 0.36 to 1.77] and 1.50 [95% confidence interval = 0.44 to 2.56] respectively). Delay of reconstruction after mastectomy was associated with a borderline-significant higher risk of complications (80.6%) compared to simultaneous reconstruction (64.0%, P = .055).
                We found that almost two-thirds of women undergoing bilateral prophylactic mastectomy had at least one complication following surgery. Further work should be done to minimize and to understand the effect of complications of bilateral prophylactic mastectomy.
Sixteen studies have been published since the last version of the review, without altering our conclusions. While published observational studies demonstrated that BPM was effective in reducing both the incidence of, and death from, breast cancer, more rigorous prospective studies (ideally randomized trials) are needed. BPM should be considered only among those at very high risk of disease. There is insufficient evidence that CPM improves survival and studies that control for multiple confounding variables are needed.