Assessing the additional surgical risk of contralateral prophylactic mastectomy and immediate breast implant reconstruction.

INTRODUCTION: There has been a sharp rise in the rate of contralateral prophylactic mastectomy over the last decade, despite the low incidence of new primary cancers predicted for the contralateral breast. This study compares the postoperative complication rates between the diseased breast treated with mastectomy and the contralateral breast that underwent prophylactic mastectomy, followed by immediate bilateral breast implant reconstruction. We hypothesized that there will be no difference in postoperative outcomes between prophylactic and diseased groups, as the surgical approach would be comparable. METHODS: After IRB approval, a retrospective chart review identified consecutive unilateral breast cancer patients who underwent bilateral mastectomy and immediate breast reconstruction between May 2008 and May 2018 at a tertiary academic medical center. A paired sample t-test and a penalized logic regression model were constructed to identify relationships between breast laterality and outcomes. RESULTS: A total of 1117 patients with unilateral breast cancer who underwent bilateral mastectomy and immediate breast implant reconstruction were identified. Rates of capsular contracture and infection were significantly greater in the diseased breast, while rates of revision were significantly greater in the contralateral prophylactic breast. There were no statistically significant differences between breasts in rates of explant, skin flap necrosis or hematoma. When adjusted for confounding variables, a higher infection rate was observed in the diseased breast. CONCLUSION: This study detected significant differences in postoperative complication rates between the diseased and prophylactic breasts following bilateral mastectomy and immediate breast implant reconstruction. Postoperative complications occurred more frequently in the diseased breast compared with low rates of complications in the contralateral prophylactic breast. This information is helpful for preoperative decision making, as surgeons and patients carefully weigh the additional risks of contralateral prophylactic procedure.

Risk-reducing mastectomy: a case series of 124 procedures in Brazilian patients.

PURPOSE: Women with mutations in breast cancer predisposition genes have a significantly higher lifetime risk of developing breast cancer and can opt for risk-reducing mastectomy. Women with positive family history of cancer can also opt for prophylactic surgery as a preventive method in selected cases. Current studies showed reduced risk of developing breast cancer after prophylactic nipple-sparing mastectomy, however, despite the good clinical outcomes, one of the main concerns regarding nipple-sparing mastectomy (NSM) is the oncological safety of nipple-areola complex preservation. In this study, we aimed to evaluate the indications, complication rates, and unfavorable events of 62 Brazilian patients that underwent risk-reducing NSM from 2004 to 2018. METHODS: Patient data were reviewed retrospectively and descriptive statistics were utilized to summarize the findings. RESULTS: The mean patients age was 43.8 years. The main indication for risk-reducing NSM was the presence of pathogenic mutation (53.3%), followed by atypia or lobular carcinoma in situ (25.8), and family history of breast cancer and/or ovarian cancer (20.9%). There were four (3.2%) incidental diagnosis of ductal carcinoma in situ and one invasive ductal carcinoma (0.8%). From the 124 prophylactic NSM performed, two (1.6%) complications had occurred: one (0.8%) infection and one (0.8%) partial nipple necrosis. In a mean follow-up of 50 months, there was one (1.6%) newly diagnosed breast cancer in the 62 patients undergoing prophylactic NSM. CONCLUSIONS: Our findings demonstrated efficacy and safety to perform NSM as prophylactic surgery with good oncological outcomes and low complication rates in a case series of Brazilian patients.

Growing Trends of Contralateral Prophylactic Mastectomy and Reconstruction in Young Breast Cancer.

BACKGROUND: The aim of this study was to evaluate the trends of surgical treatments among young patients in T1N0-1M0 stage based on the Surveillance, Epidemiology, and End Results database. MATERIALS AND METHODS: Patients aged less than 40 y diagnosed between 1998 and 2015 were enrolled, with tumors in T1N0-1M0 stage and not located in the central area. Differences in clinical-pathological characteristics were evaluated using chi-square tests. Multivariate logistic regression was used to measure the various factors associated with contralateral prophylactic mastectomy (CPM). Independent prognostic factors were evaluated by Cox model. RESULTS: The total rate of breast-conserving surgery (BCS) was 51.6%, which declined from 64.5% in 1998 to 39.6% in 2015. The total rate of CPM was 22.7%, which increased from 3.7% in 1998 to 38.7% in 2014 despite a decline to 32.7% in 2015. Meanwhile, the rate of reconstruction increased in line with that of CPM, from 9.4% in 1998 to 35.0% in 2015. There was a trend of increasing use of implant-based reconstruction. Significant higher odds of CPM were found in recent year of diagnosis between 2010 and 2015 and in implant-based reconstruction. Patients undergoing CPM had similar survival outcomes compared with those undergoing BCS and unilateral mastectomy, whereas those undergoing BCS had better survival outcomes compared with those undergoing unilateral mastectomy. CONCLUSIONS: A trend of growing preference for CPM and reconstruction was observed among young patients in early stage in recent years without survival benefits. Efforts should be made to promote efficient communication and evidence-based decision-making.

Postoperative complications in combined gynecologic, plastic, and breast surgery: An analysis from National Surgical Quality Improvement Program.

Patients undergoing the addition of a contralateral prophylactic mastectomy with unilateral breast cancer have an increased and potentially doubled post-operative complication rate. One documented detriment from post-operative complications is the potential delay in initiating adjuvant therapy. To determine if the addition of a gynecologic and/or plastic reconstructive procedure to breast surgery results in an increased risk of postoperative complications and re-admissions, we evaluated outcomes in patients undergoing single vs multi-site surgery in a large national surgical database. We utilized the National Surgery Quality Improvement Program (NSQIP) database to identify patients who underwent breast surgery between 2011 and 2015. We extracted patients who underwent prophylactic oophorectomy with or without hysterectomy as a comparison group. Chi square analysis was used to assess postoperative outcomes including complications, readmission, and reoperation. All statistics were performed in SPSS v. 24. During the study timeframe, 77 030 patients had a solitary or combined breast surgical procedure and a second cohort of 124 patients underwent gynecologic surgery. Breast cancer patients who did not have a simultaneous reconstruction or gynecologic procedure were older with more comorbidities. Patients undergoing coordinated procedures had a significantly longer length of stay, higher complication, readmission, and reoperation rates (P < 0.001 for all) as compared with patients who underwent single site surgery. Patients with surgery for breast cancer, either with a plastic or gynecologic procedure, have greater postoperative complications. Higher complication rates for those with coordinated operations may lead to delays in adjuvant therapy and discussions regarding the indications for simultaneous surgery are recommended.

Trans-Vertical Mastectomy With Immediate Implant-Based Reconstruction: A Retrospective, Observational Study.

BACKGROUND: In women with large and ptotic breasts who require a mastectomy and immediate, implant-based reconstruction, long flaps pose a high risk for flap ischemia and necrosis. A new trans-vertical incision for skin-reducing mastectomy is described, which reduces the skin envelope and lifts the breast. OBJECTIVES: The authors sought to describe the new mastectomy access incision and assess its efficacy and safety when followed by immediate implant-based reconstruction. METHODS: This retrospective analysis included 70 consecutive patients (101 breasts) with large and ptotic breasts who underwent a unilateral (n = 39; 55.7%) or bilateral (n = 31; 44.3%), skin-reducing mastectomy utilizing the trans-vertical approach for either breast cancer or risk reduction. All received immediate one- (n = 86; 85.5%) or two-stage (n = 15; 14.5%), implant-based reconstruction utilizing acellular dermal matrix. RESULTS: Mean age was 50.1 years and mean body mass index was 25.6 kg/m2. After a median follow-up of 4.9 years, the number of breasts with minor and major complications was 21 (20.8%) and 26 (25.7%), respectively. The most common major complications were skin-flap necrosis (n = 12; 11.9%) and infection (n = 8; 7.9%). All occurred within 3 months postsurgically. There were 7 cases of capsular contracture (6.9%) and 5 reconstruction failures (5.0%). Higher body mass index (P < 0.01) and breast weight (P < 0.05) were associated with increased complication rates. According to BREAST-Q, 55/64 patients (85.9%) were somewhat or very satisfied with the aesthetic outcome. CONCLUSIONS: The trans-vertical approach is an effective, reproducible, and safe alternative to conventional skin-reducing mastectomy, with favorable aesthetic outcomes, in patients with large and ptotic breasts.

Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study.

BACKGROUND: Robotic nipple-sparing mastectomy (RNSM) could be a significant advancement in the treatment of breast cancers and prophylaxis because the mastectomy is performed without leaving any scar on the breast. The aim of this study was to assess the feasibility and the safety of RNSM with immediate prosthetic breast reconstruction (IPBR). METHODS: In this prospective study, RNSM with IPBR was offered to patients with breast cup size A, B or C and ptosis grade ≤ 2. In case of oncologic surgery, RNSM was proposed only if the tumor was located more than 2 cm away from the nipple-areola complex (NAC) and if postoperative radiation was not indicated. In case of prophylactic surgery, RNSM was proposed only if a high-risk genetic mutation had been identified. The primary endpoint was the rate of skin or NAC necrosis. The rate of conversion to open technique, the duration of the procedure, and postoperative complications were also analyzed. RESULTS: Sixty-three RNSM with IPBR were performed in 33 patients. There were no cases of mastectomy skin flap or NAC necrosis. We had to convert to an open technique in one case (1.6%). Three infections occurred (4.8%), one leading to implant loss (1.6%). No other major complications were observed. CONCLUSIONS: Preliminary data attest to the feasibility, the reproducibility, and the safety of this approach. However, long-term data are needed to confirm the oncological safety and the esthetic stability of the result. Trial registration identifier NCT02673268.

Risk-reducing mastectomy for the prevention of primary breast cancer.

BACKGROUND: Recent progress in understanding the genetic basis of breast cancer and widely publicized reports of celebrities undergoing risk-reducing mastectomy (RRM) have increased interest in RRM as a method of preventing breast cancer. This is an update of a Cochrane Review first published in 2004 and previously updated in 2006 and 2010. OBJECTIVES: (i) To determine whether risk-reducing mastectomy reduces death rates from any cause in women who have never had breast cancer and in women who have a history of breast cancer in one breast, and (ii) to examine the effect of risk-reducing mastectomy on other endpoints, including breast cancer incidence, breast cancer mortality, disease-free survival, physical morbidity, and psychosocial outcomes. SEARCH METHODS: For this Review update, we searched Cochrane Breast Cancer's Specialized Register, MEDLINE, Embase and the WHO International Clinical Trials Registry Platform (ICTRP) on 9 July 2016. We included studies in English. SELECTION CRITERIA: Participants included women at risk for breast cancer in at least one breast. Interventions included all types of mastectomy performed for the purpose of preventing breast cancer. DATA COLLECTION AND ANALYSIS: At least two review authors independently abstracted data from each report. We summarized data descriptively; quantitative meta-analysis was not feasible due to heterogeneity of study designs and insufficient reporting. We analyzed data separately for bilateral risk-reducing mastectomy (BRRM) and contralateral risk-reducing mastectomy (CRRM). Four review authors assessed the methodological quality to determine whether or not the methods used sufficiently minimized selection bias, performance bias, detection bias, and attrition bias. MAIN RESULTS: All 61 included studies were observational studies with some methodological limitations; randomized trials were absent. The studies presented data on 15,077 women with a wide range of risk factors for breast cancer, who underwent RRM.Twenty-one BRRM studies looking at the incidence of breast cancer or disease-specific mortality, or both, reported reductions after BRRM, particularly for those women with BRCA1/2 mutations. Twenty-six CRRM studies consistently reported reductions in incidence of contralateral breast cancer but were inconsistent about improvements in disease-specific survival. Seven studies attempted to control for multiple differences between intervention groups and showed no overall survival advantage for CRRM. Another study showed significantly improved survival following CRRM, but after adjusting for bilateral risk-reducing salpingo-oophorectomy (BRRSO), the CRRM effect on all-cause mortality was no longer significant.Twenty studies assessed psychosocial measures; most reported high levels of satisfaction with the decision to have RRM but greater variation in satisfaction with cosmetic results. Worry over breast cancer was significantly reduced after BRRM when compared both to baseline worry levels and to the groups who opted for surveillance rather than BRRM, but there was diminished satisfaction with body image and sexual feelings.Seventeen case series reporting on adverse events from RRM with or without reconstruction reported rates of unanticipated reoperations from 4% in those without reconstruction to 64% in participants with reconstruction.In women who have had cancer in one breast, removing the other breast may reduce the incidence of cancer in that other breast, but there is insufficient evidence that this improves survival because of the continuing risk of recurrence or metastases from the original cancer. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention, when considering RRM. AUTHORS' CONCLUSIONS: While published observational studies demonstrated that BRRM was effective in reducing both the incidence of, and death from, breast cancer, more rigorous prospective studies are suggested. BRRM should be considered only among those at high risk of disease, for example, BRCA1/2 carriers. CRRM was shown to reduce the incidence of contralateral breast cancer, but there is insufficient evidence that CRRM improves survival, and studies that control for multiple confounding variables are recommended. It is possible that selection bias in terms of healthier, younger women being recommended for or choosing CRRM produces better overall survival numbers for CRRM. Given the number of women who may be over-treated with BRRM/CRRM, it is critical that women and clinicians understand the true risk for each individual woman before considering surgery. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention when considering RRM.

Tradeoffs Associated With Contralateral Prophylactic Mastectomy in Women Choosing Breast Reconstruction: Results of a Prospective Multicenter Cohort.

OBJECTIVE: Assess postoperative morbidity and patient-reported outcomes after unilateral and bilateral breast reconstruction in patients with unilateral breast cancer. BACKGROUND: Relatively little is known about the morbidity associated with and changes in quality of life experienced by patients who undergo contralateral prophylactic mastectomy (CPM) and breast reconstruction. This information would be valuable for decision making in patients with unilateral breast cancer. METHODS: Women undergoing mastectomy and breast reconstruction for unilateral breast cancer were recruited for this prospective observational study. Postoperative complications after implant and autologous breast reconstruction in patients undergoing unilateral or bilateral mastectomy were recorded. Preoperative and 1 year patient-reported outcomes were measured. Univariate tests and logistic regression analyses were performed, studying the effects of reconstructive method, laterality, and risk factors on surgical complication rates, patient satisfaction, and anxiety. RESULTS: We identified 1144 women who underwent either unilateral (47.2%) or bilateral (52.8%) mastectomies with reconstruction. Bilateral autologous (odds ratio 1.73, 95% confidence interval 1.07-2.81) and implant reconstructions (odds ratio 1.73, 95% confidence interval 1.22-2.47) were associated with a higher risk of complications compared with unilateral reconstructions. Baseline anxiety was greater in women who chose bilateral compared with unilateral implant reconstructions (P = 0.001). There was no difference in anxiety levels between groups postoperatively. Postoperatively, women who chose CPM with implant reconstructions were more satisfied with their breasts than women with unilateral reconstructions (P = 0.034). CONCLUSIONS: Although higher postoperative complications were observed after CPM and reconstruction, these procedures were associated with decreased anxiety levels and improved satisfaction with breasts for women who underwent implant reconstructions.

The financial impact and drivers of hospital charges in contralateral prophylactic mastectomy and reconstruction: a Nationwide Inpatient Sample hospital analysis.

PURPOSE: Rates of contralateral prophylactic mastectomy (CPM) have increased over the last decade; it is important for surgeons and hospital systems to understand the economic drivers of increased costs in these patients. This study aims to identify factors affecting charges in those undergoing CPM and reconstruction. METHODS: Analysis of the Healthcare Cost and Utilization Project National Inpatient Sample was undertaken (2009-2012), identifying women aged ≥18 with unilateral breast cancer undergoing unilateral mastectomy with CPM and immediate breast reconstruction (IBR) (CPM group), in addition to unilateral mastectomy and IBR alone (UM group). Generalized linear modeling with gamma regression and a log-link function provided mean marginal hospital charge (MMHC) estimates associated with the presence or absence of patient, hospital and operative characteristics, postoperative complications, and length of stay (LOS). RESULTS: Overall, 70,695 women underwent mastectomy and reconstruction for unilateral breast cancer; 36,691 (51.9%) in the CPM group, incurring additional MMHCs of $20,775 compared to those in the UM group (p < 0.001). In the CPM group, MMHCs were reduced in those aged >60 years (p < 0.001), while African American or Hispanic origin increased MMHCs (p < 0.001). Diabetes, depression, and obesity increased MMHCs (p < 0.001). MMHCs increased with larger (p < 0.001) hospitals, Western location (p < 0.001), greater household income (p < 0.001), complications (p < 0.001), and increasing LOS (p < 0.001). MMHCs decreased in urban teaching hospitals and Midwest or Southern regions (p < 0.001). CONCLUSION: There are many patient and hospital factors affecting charges; this study provides surgeons and hospital systems with transparent, quantitative charge data in patients undergoing contralateral prophylactic mastectomy and immediate breast reconstruction.

Trends in Sexual Function After Breast Cancer Surgery.

PURPOSE: Sexual dysfunction is assumed to be common, but understudied, in breast cancer patients. Herein, we use the validated female sexual functioning index (FSFI) to evaluate changes in female sexual function after breast cancer surgery. METHODS: The FSFI assesses sexual function in six domains (desire, arousal, lubrication, orgasm, satisfaction, pain) on a 36-point scale, with scores >26.6 indicating better sexual function. We identified 226 women with unilateral breast cancer undergoing surgery at our institution from June 2010-January 2015. All completed the FSFI preoperatively and at a median of 13 months postoperatively. We quantified declines in FSFI scores and considered p-values <0.05 statistically significant. RESULTS: Overall, 119 women had breast-conserving surgery (BCS), 40 had unilateral mastectomy (UM), and 67 had UM plus contralateral prophylactic mastectomy (CPM). All women had similar baseline FSFI scores (medians: BCS, 26.3; UM, 25.2; UM+CPM, 23.7; p = 0.23). At follow-up, sexual function had declined significantly in BCS (23.5; p < 0.001) and UM (17.4; p = 0.010), but was unchanged in UM+CPM (22.8; p = 0.74) women. Interestingly, all women maintained their desire for sex (p = 0.17). BCS and UM women demonstrated significant declines in all other subscale domains (all p < 0.045). UM+CPM women demonstrated no decline in any subscale domain, yet did not exhibit superior sexual function to those having UM or BCS (medians: BCS, 23.5; UM, 17.4; UM+CPM, 22.8; p = 0.21). CONCLUSIONS: Baseline sexual dysfunction exists in women diagnosed with breast cancer. Surgery negatively impacts sexual function. Patients who choose mastectomy do not exhibit superior sexual function over those having BCS at 13 months following surgery.

Symmetric Breast Surgery: Balancing Procedures versus Prophylactic Mastectomy and Immediate Reconstruction.

BACKGROUND: Various techniques for management of the contralateral breast exist in patients with unilateral breast cancer, including contralateral prophylactic mastectomy with immediate breast reconstruction (PMIBR), and symmetrization techniques including augmentation, reduction, or mastopexy. The purpose of this prospective cohort study was to evaluate and compare complications and patient-reported satisfaction of patients with contralateral PMIBR versus having symmetrization procedures. METHODS: A 7-year, single-institution, prospectively maintained database was reviewed. Patient-reported BREAST-Q scores were obtained at baseline, 3 months, and 12 months prospectively. Postoperative complications, oncologic outcomes, and BREAST-Q scores were compared. RESULTS: A total of 249 patients were included, 93 (37%) of whom underwent contralateral PMIBR and 156 (63%) of whom underwent contralateral symmetrization. The patients who underwent PMIBR were younger and had less comorbidities compared with patients with symmetrization. Rates of major and minor complications were similar, apart from higher rates of minor wound dehiscence in the PMIBR group. When comparing mean change at 12-month follow-up to preoperative results, there was a significant decrease in physical well-being of the chest in the symmetrization compared with the PMIBR group (2.94 versus -5.69; P = 0.042). There were no significant differences in mean breast satisfaction and psychosocial well-being, and nonsignificant decreases in sexual well-being between groups. CONCLUSIONS: Patients with unilateral breast cancer who underwent immediate contralateral breast management, with either contralateral PMIBR or symmetrization techniques, demonstrated similar profiles of major complications and good overall satisfaction except for one physical well-being domain. Management of the contralateral breast with symmetrization may provide similar outcomes compared with PMIBR, which often is considered not necessary in patients without specific indications. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Contralateral prophylactic mastectomy: Weighing the risks of delayed chemotherapy, radiotherapy, and hormonal therapy.

BACKGROUND: Many patients with unilateral breast cancer opt for contralateral prophylactic mastectomy (CPM) at the time of therapeutic mastectomy (immediate CPM) or following completion of adjuvant therapy. Studies show that immediate CPM increases the risk of surgical complications related to unilateral mastectomy (UM) alone, which may lead to delays in adjuvant therapy initiation. However, it is unclear if these complications cause clinically significant delays in initiating adjuvant chemotherapy, radiotherapy, or hormonal therapy. METHODS: A retrospective chart review was conducted on patients with breast cancer who underwent immediate CPM versus UM alone at Columbia University Medical Center from January 2000 to December 2020. Patient demographic and oncologic characteristics; complications; and timing of adjuvant chemotherapy, radiotherapy, and/or hormonal therapy relative to therapeutic mastectomy were collected. RESULTS: In this study, 239 UM alone patients were propensity score matched to 239 immediate CPM patients. No significant difference in complication rates was found between the index and contralateral breasts in CPM patients. A similar percentage of CPM and UM patients experienced postoperative complications (19% vs. 17%, p = 0.64). No significant difference in time to adjuvant chemotherapy, radiotherapy, or hormonal therapy was found between CPM patients with complications and all CPM patients or all UM patients. CONCLUSIONS: There is a lack of clear guidance for clinical decision-making regarding timing of CPM relative to adjuvant therapy. Our study suggests that immediate CPM does not significantly increase the risks of postoperative complications or complication-related delays in the initiation of adjuvant chemotherapy, radiotherapy, or hormonal therapy. This information may help patients and providers to plan, select, and schedule breast cancer treatment options.

Preserving choice in breast cancer treatment: A different perspective on contralateral prophylactic mastectomy.

Contralateral prophylactic mastectomy is the removal of both breasts when only one is affected by cancer. Rates of this controversial cancer treatment have been increasing since the late 1990s, even among women who do not have the kind of family history or known genetic mutation that would put them at high-risk for another breast cancer. Citing contralateral prophylactic mastectomy's lack of oncologic benefit and increased risk of surgical complications, the American Society of Breast Surgeons discourages contralateral prophylactic mastectomy for average-risk women with unilateral cancer, as does most of the medical literature on this topic. Within this literature, desire for contralateral prophylactic mastectomy is often painted as the product of an emotional overreaction to a cancer diagnosis and misunderstanding of breast cancer risk. Drawing on the personal experience of a breast cancer survivor, as well as relevant medical literature on breast cancer screening and surgery, this article offers a different perspective on the ongoing popularity of contralateral prophylactic mastectomy, one that focuses on practical experiences and logical deliberations about those experiences. Specifically, it calls attention to two features of the contralateral prophylactic mastectomy decision-making situation that have been inadequately covered in the medical literature: (1) the way that breast cancer screening after a breast cancer diagnosis can become a kind of radiological overtreatment, even for "average-risk" women; and (2) how desire for bodily symmetry after breast cancer, which can best be achieved through bilateral reconstruction or no reconstruction, drives interest in contralateral prophylactic mastectomy. The goal of this article is not to suggest that all women who want contralateral prophylactic mastectomy should have the surgery. In some cases, it is not advisable. But many "average-risk" women with unilateral cancer have good reasons for wanting contralateral prophylactic mastectomy, and we believe their right to choose it should be protected.

Complications Associated with Contralateral Prophylactic Mastectomy: A Systematic Review and Meta-Analysis.

BACKGROUND: No meta-analysis has examined whether contralateral prophylactic mastectomy increases complication risk for unilateral breast cancer patients undergoing unilateral mastectomy. METHODS: Fifteen studies on complications of unilateral mastectomy plus contralateral prophylactic mastectomy met inclusion criteria. Meta-analyses compared complications of (1) diseased versus contralateral breasts in unilateral plus contralateral prophylactic mastectomy patients and (2) patients undergoing unilateral plus contralateral prophylactic mastectomy versus unilateral alone when grouped by reconstructive method. RESULTS: For all unilateral plus contralateral prophylactic mastectomy patients, the diseased breast was significantly more prone to complications versus the contralateral breast (relative risk, 1.24; p = 0.03). In studies that stratified by reconstructive method, the complication risk was significantly higher for unilateral plus contralateral prophylactic mastectomy versus unilateral mastectomy alone for patients with no reconstruction (relative risk, 2.03; p = 0.0003), prosthetic-based reconstruction (relative risk,1.42; p = 0.003), and autologous reconstruction (relative risk, 1.32; p = 0.005). The only prospective trial showed similar results, including for more severe complications. Smaller retrospective studies without stratification by reconstructive method showed similar complications for unilateral plus contralateral prophylactic mastectomy versus unilateral mastectomy alone (relative risk, 1.06; p = 0.70). These groups had similar incidences of complication-related delay in adjuvant therapy, as demonstrated by one study. CONCLUSIONS: After unilateral plus contralateral prophylactic mastectomy, diseased breasts are at higher risk for complications. Stronger evidence supports higher complication risk for unilateral plus contralateral prophylactic mastectomy than unilateral alone. More work is needed to determine the effect of complications on timing of adjuvant therapy.