Breast reconstruction with mentor anatomical implants and the risk of implant rotation: A retrospective study of 1134 women.

BACKGROUND: Implant rotation is a known complication to breast reconstruction using anatomical implants. However, there is a lack of large studies investigating the risk of implant rotation and potential predisposing risk factors. METHOD: We reviewed the medical records of all patients who underwent breast reconstruction with Mentor anatomical implants from 2010 to 2021 at two Danish hospitals. We compared the risk of implant rotation between one- and two-stage breast reconstruction using univariate logistic regression. We analyzed the effect of biological mesh, immediate versus delayed reconstruction, and use of a higher final expander volume than the permanent implant volume on the risk of implant rotation. Finally, we analyzed the success rate of revision surgery for implant rotation. RESULTS: In total, 1134 patients were enrolled. Patients who underwent two-stage breast reconstruction (n = 720) had a significantly higher risk of implant rotation than those who underwent one-stage breast reconstruction (n = 426; 11% vs. 5%, p < 0.01). There was no significant association between implant rotation and the use of biological mesh, immediate breast reconstruction, or use of a higher final expander volume than the permanent implant volume. The success rate of revision surgery after implant rotation was 73% (62/85 rotations). CONCLUSIONS: Two-stage breast reconstruction significantly increased the risk of implant rotation compared to one-stage breast reconstruction. The overall risk of implant rotation was low and success rate of revision surgery was high. These findings suggest that anatomical implants are safe to use for breast reconstruction. However, surgeons and patients should be aware of the increased risk of implant rotation after two-stage reconstruction.

Silicone Leakage from Breast Implants Is Determined by Silicone Cohesiveness: A Histological Study of 493 Patients.

BACKGROUND: Silicone leakage from breast implants is a concern with potential implications for patient health. This study aimed to quantify and model silicone leakage from implants to the breast implant capsule and to investigate whether silicone cohesiveness affected the silicone leakage rate. METHODS: Silicone content in the breast implant capsule was quantified histologically by measuring the area of silicone deposits. This was used to model silicone leakage over time based on the time of implantation. The effect of cohesiveness on silicone leakage was investigated across all implant brands with declared cohesiveness and in a subanalysis comparing only Mentor cohesive I implants with cohesive II and III implants. RESULTS: The study included 493 patients with 872 breasts and a median time of implantation of 13.0 years (range 0.4 to 51 years). The modeling of silicone leakage from intact implants showed that leakage and the acceleration of the leakage rate were significantly higher in low-cohesive implants than in highly cohesive implants (p<0.05). This was confirmed when analyzing only Mentor implants (p<0.05) and in the case of implant rupture (p<0.01) where low-cohesive implants also leaked significantly more than highly cohesive implants. CONCLUSIONS: Our results suggest that highly cohesive implants are superior to low-cohesive implants in preventing silicone leakage. Due to the accelerating rate of silicone leakage especially found in low-cohesive implants, we propose that exchange of low-cohesive implants could be discussed with patients 10 to 15 years after implantation to minimize silicone leakage even in the absence of implant rupture.

Antibiotic implant irrigation and deep infection: A retrospective study of 1508 patients undergoing breast reconstruction with implants.

BACKGROUND: Antibiotic implant irrigation is increasingly used to prevent deep infection after implant-based breast reconstruction. However, there is limited evidence of the clinical effect. In this study, we compare the risk of a deep infection in a Danish population of women who either received antibiotic implant irrigation with gentamycin or vancomycin, or no irrigation. METHODS: We retrospectively reviewed consecutive patients undergoing all types of breast reconstruction with implants at Rigshospitalet and Herlev Hospital, Denmark, in 2010-2019. Logistic regression was used to compare the risk of deep infection between no irrigation and irrigation with gentamicin or vancomycin, and to account for the difference in risk between patient subgroups and risk factors. RESULTS: We included 1508 patients who received antibiotic irrigation with gentamicin (500 patients), vancomycin (304 patients) or no irrigation (704 patients). The univariable risk analysis showed a significant decreased risk of deep infection using gentamicin irrigation compared with no irrigation (OR 0.58, p<0.05). However, when adjusting for risk factors for infection, there was no significant decrease in the risk of infection when using gentamicin (OR 0.90, p=0.71) or vancomycin (OR 1.0, p=0.99) compared with the control group. CONCLUSIONS: We found no significant effect of using antibiotic implant irrigation after isolating it from risk factors for deep infection. However, due to the limitations of the study, we cannot conclude that there is no effect of antibiotic implant irrigation. There is a need for a randomized, placebo-controlled trial to investigate the effect, and potential side-effects, of antibiotic implant irrigation.

TLR9 agonist MGN1703 enhances B cell differentiation and function in lymph nodes.

BACKGROUND: TLR9 agonists are being developed as immunotherapy against malignancies and infections. TLR9 is primarily expressed in B cells and plasmacytoid dendritic cells (pDCs). TLR9 signalling may be critically important for B cell activity in lymph nodes but little is known about the in vivo impact of TLR9 agonism on human lymph node B cells. As a pre-defined sub-study within our clinical trial investigating TLR9 agonist MGN1703 (lefitolimod) treatment in the context of developing HIV cure strategies (NCT02443935), we assessed TLR9 agonist-mediated effects in lymph nodes. METHODS: Participants received MGN1703 for 24 weeks concurrent with antiretroviral therapy. Seven participants completed the sub-study including lymph node resection at baseline and after 24 weeks of treatment. A variety of tissue-based immunologic and virologic parameters were assessed. FINDINGS: MGN1703 dosing increased B cell differentiation; activated pDCs, NK cells, and T cells; and induced a robust interferon response in lymph nodes. Expression of Activation-Induced cytidine Deaminase, an essential regulator of B cell diversification and somatic hypermutation, was highly elevated. During MGN1703 treatment IgG production increased and antibody glycosylation patterns were changed. INTERPRETATION: Our data present novel evidence that the TLR9 agonist MGN1703 modulates human lymph node B cells in vivo. These findings warrant further considerations in the development of TLR9 agonists as immunotherapy against cancers and infectious diseases. FUND: This work was supported by Aarhus University Research Foundation, the Danish Council for Independent Research and the NovoNordisk Foundation. Mologen AG provided study drug free of charge.

A Systematic Review and Meta-analysis of Functional Shoulder Impairment After Latissimus Dorsi Breast Reconstruction.

PURPOSE: The latissimus dorsi flap (LDF) is a very reliable flap and may be used for a multitude of reconstructive purposes. It is widely used for breast reconstruction when performed. It has few complications, except for a possible impact on shoulder function. The aims of this study were to evaluate the validity of the literature by investigating the level of evidence and to perform a meta-analysis. METHODS: A systematic literature search was conducted using the databases PubMed, Scopus, and Web of Science. Predictor variables were shoulder function after breast reconstruction with the LDF. Articles were chosen according to 4 different outcomes: shoulder range of motion (ROM), shoulder strength, DASH score, and subjective evaluation. RESULTS: Twenty-six articles were found, including 1045 patients: 8 level II, 16 level III, 1 level IV, and 1 level V articles. The meta-analysis showed that both ROMs for flexion and abduction are significantly impaired at less than or at 3 months of follow-up. CONCLUSIONS: There are several influencing factors, such as age, smoking, obesity, radiotherapy, and physiotherapy. Moreover, the impact on shoulder function seemed influenced by the type of thoracodorsal vessel-based flap. From the level of evidence analysis, there is a tendency that the LDF transfer does affect shoulder function. This limitation seems to be minimal, and few patients experience a major impact on shoulder function. However, the existing literature on total shoulder impairment after breast reconstruction with LDF is insufficient to draw any final conclusion. There is a need for future studies and current articles that suggest that the initial measurement should be performed preoperatively (preferably at the time of diagnosis or initial biopsy) and follow-ups with measurements at 6, 12, and 24 months (long-term effect) after surgery. We recommend measurements of both operated and nonoperated sides. Each measurement should be accompanied by a history with special emphasis on shoulder function. The methods of measuring outcomes of recommendation are DASH score, ROM with use of a goniometer preferably by a physiotherapist or a health care professional trained by a physiotherapist, and strength measured by, for example, a handheld dynamometer.

Loss of E-cadherin as Part of a Migratory Phenotype in Melanoma Is Associated With Ulceration.

It has been suggested that embryogenic properties of migratory cells are reactivated during wound healing and metastasis in adults. This might explain the association between wound-induced inflammation and poor survival in patients with ulcerated melanoma. Linking inflammation with a migratory phenotype, we characterize the infiltration of innate inflammatory cells, loss of cell-to-cell adhesion (E-cadherin), factors associated with extracellular matrix degradation [matrix metalloproteinase-9 (MMP-9), and neutrophil elastase (NE)], and spindle-shaped cell morphology, between ulcerated (n = 179) and nonulcerated (n = 206) melanoma. In addition, the presence of "extravascular migratory metastasis" (angiotropism) and tumor-vessel density were evaluated as important factors for tumor cell dispersal in ulcerated melanoma. We showed a correlation between expression of the granulocyte marker cd66b+ and the expression of NE and MMP-9, reflecting activated neutrophils. Ulcerated melanoma correlated with a low global E-cadherin score (P = 0.041) and weak-spot score (P = 0.0004). Thus, 28% of the nonulcerated, 42% of the minimally/moderately ulcerated melanoma, and 53% of the excessively ulcerated melanoma presented low scores as opposed to a high E-cadherin score. In addition, the presence of ulceration was correlated with angiotropism (P < 0.0001) and spindle-shaped morphology (P = 0.021). There were no differences in MMP-9 expression or intratumoral vessel density between the ulcerated and nonulcerated group. In conclusion, expression of migratory cell properties showed a highly heterogeneous pattern, which was associated with ulcerated areas and inflammatory cells, in general and with neutrophils in particular. We, therefore, suggest that wound-associated inflammation may be involved in the induction of migratory cell transition and tumor cell dispersal in ulcerated melanoma.

Unilateral breast reconstruction after mastectomy - patient satisfaction, aesthetic outcome and quality of life.

BACKGROUND: An increasing number of women undergo a breast reconstruction (BR) after treatment for breast cancer. The aim of the present study was to evaluate patient-reported esthetic satisfaction, quality of life (QoL), and the association between these, following different types of BR. MATERIALS AND METHODS: All women who underwent unilateral BR in Central Denmark Region between January 2005 and July 2011 were included. Participants were sent a questionnaire package, which included the Body Image Scale, The Beck Depression Inventory, the Impact of Event Scale, and a study-specific patient-reported esthetic satisfaction scale. Additionally, patients were asked if they experienced a change in QoL owing to the BR. Based on reconstructive method and timing, participants were divided into four groups, three delayed: an abdominal flap group, a latissimus dorsi flap group, an implant ± thoracodorsal flap group; and one immediate BR group. RESULTS: Of 166 eligible participants, a total of 144 women (87%) completed the questionnaire. The mean follow-up was 3.8 years. Esthetic satisfaction differed significantly between groups [F(3,139) = 8.55; p < 0.001], with abdominal flap recipients reporting the highest levels of esthetic satisfaction. No between-group differences were observed for the remaining psychosocial measures. Higher satisfaction with esthetic outcome was associated with reporting higher QoL owing to the BR (odds ratio 1.10, p<0.001; 95% CI 1.06-1.15). CONCLUSIONS: Abdominal flap recipients expressed higher satisfaction with their esthetic outcome, compared to the remaining BR types. Higher esthetic satisfaction was strongly associated with reporting an experience of higher QoL.

Remote ischemic perconditioning attenuates acute inflammation of experimental musculocutaneous flaps following ischemia-reperfusion injury.

BACKGROUND: In free flap reconstruction and replantation surgery, prolonged ischemia time may lead to flap or replantation failure. The aim of the study was to investigate the effects of hypothermic flap ischemia or remote ischemic perconditioning (RIPER) during normothermic ischemia on acute inflammation of musculocutaneous flaps subjected to ischemia-reperfusion injury. MATERIALS AND METHODS: In 24 pigs, a musculocutaneous latissimus dorsi flap was dissected and subjected to 4 hours of arterial ischemia and 7 hours of reperfusion. The animals were allocated into two experimental groups: hypothermic flap ischemia at 4°C (n = 8) or normothermic flap ischemia with RIPER (n = 8), and one control group with normothermic flap ischemia (n = 8). The hypothermic ischemic flaps were cooled in a basin with fresh water and ice. RIPER was initiated 1 hour before reperfusion, by inducing three 10 min cycles of hind limb ischemia with a tourniquet, each separated by 10 min of reperfusion. Acute inflammation was described by inflammatory cytokine secretion (IL-1ß, IL-6, IL-10, IL-12p40, and TNF-α) from the flap during reperfusion, and by quantitative determination of macrophages in flap biopsies of dermis, subcutaneous tissue, and skeletal muscle following reperfusion. RESULTS: No significant differences were found between normothermic and hypothermic flap ischemia in inflammatory cytokine secretion. However, the IL-6 secretion was significantly reduced in the RIPER group compared with the control group at 5 hours of reperfusion (P = 0.036), and in the RIPER group compared with the hypothermic ischemia group at 3 (P = 0 0.0063), 5 (P = 0.0026), and 7 hours of reperfusion (P = 0.028). The IL-12p40 secretion was significantly reduced in the RIPER group compared with the control group (P = 0.0054) as well as the hypothermic ischemia group (P = 0.028) at 5 hours of reperfusion. No significant difference was found among groups in macrophage infiltration. CONCLUSION: RIPER reduced IL-6 and IL-12p40 secretion during reperfusion of porcine musculocutaneous flaps, when compared with hypothermic ischemic flaps and normothermic ischemic flaps without RIPER. © 2016 Wiley Periodicals, Inc. Microsurgery 37:148-155, 2017.

Fat grafting for alleviating persistent pain after breast cancer treatment: A randomized controlled trial.

BACKGROUND: Persistent pain is a common side effect of breast cancer treatment, affecting 24-52% of women after mastectomy. Recent studies have described analgesic effects of fat grafting in various settings. We aimed to investigate whether fat grafting had an analgesic effect on persistent pain after mastectomy and whether fat grafting had a remodeling effect on the mastectomy scar. METHODS: This study was conducted as a randomized controlled trial. Patients were randomized to either receive fat grafting to the pain-afflicted area around the missing breast or a control group without any intervention. A total of 18 unilaterally mastectomized women with persistent pain ≥3 on the numerical rating scale were enrolled. Patients were examined at the baseline and at 3 and 6 months by using the DoloTest(®), visual analog scale (VAS) pain score, neuropathic pain symptom inventory, and patient and observer scar assessment scale. RESULTS: A total of 15 patients were analyzed (fat grafted n = 8, control n = 7). The average amount of grafted fat was 71 ± 24.6 mL. Fat grafting showed a significant improvement in the pain as measured on the VAS pain scale (p = 0.001) with an average reduction of 54.9% and as measured on the neuropathic pain symptom inventory (p = 0.002). Furthermore, a significant improvement was observed in health-related quality of life (p = 0.007) and the quality of the scar (p < 0.001). CONCLUSION: This is the first randomized controlled trial evaluating the analgesic effect of fat grafting. Fat grafting is a safe and effective technique for alleviating persistent pain after mastectomy.

Consumption of the epidermis: a suggested precursor of ulceration associated with increased proliferation of melanoma cells.

It has recently been demonstrated that the extent of ulceration and the presence of epidermal involvement that theoretically precede ulceration (consumption of epidermis, COE) or seen subsequent to inflammation (reactive epidermal hyperplasia or re-epithelialization) allowed better prognostic stratification of ulcerated melanoma. Understanding why these histopathologic markers have prognostic potential is important, not least because accurate consensual assessment of ulceration lies at the root of proper staging and clinical management. The authors therefore performed immunohistochemical analyses of tumor cell proliferation (Melan-A/Ki67) and infiltration of inflammatory cells (CD66b neutrophils and CD163 macrophages) to better understand the biology of the epidermal changes described. Tumors with a COE configuration showed 37% (95% CI: 4-54, P = 0.0046) increased tumor cell proliferation compared with tumors of normal epidermal configuration. COE is therefore suggested a precursor of ulceration associated with increased proliferation of melanoma cells. There was no observed correlation between COE and an increased inflammatory response (CD163 macrophages or CD66b neutrophils), which supports that the proliferation drive is noninflammatory. In contrast, the presence of re-epithelialization and/or reactive epidermal hyperplasia demonstrated an 18% (95% CI: 6-53, P = 0.0021) increased density of neutrophils compared with tumor with no evidence of these possibly prolonged late-stage or resolved ulcerations. These results further support the relevance of including these epidermal changes into the definition of ulceration and to define ulceration of a primary melanoma as loss of epidermis with evidence of a host response (infiltration of neutrophils or fibrin deposition) and thinning, effacement, or reactive hyperplasia of the surrounding epidermis.

Socio-demographic, clinical, and health-related factors associated with breast reconstruction - A nationwide cohort study.

We collected registry- and questionnaire-based data on socio-economic and health status, tumor- and treatment-related variables, and explored associations with receipt of reconstruction and information about treatment options in a nationwide cohort of Danish women, treated for primary breast cancer. A total of 594 women were available for analysis, 240 (40%) of these received reconstruction. Multivariate analyses showed that receipt of reconstruction was associated with 1) younger age at time of primary surgery (<36 years: OR = 10.04, [3.80-26.50], p < 0.001 and 36-49 years: OR = 2.48, [1.73-3.56], p < 0.001, compared to 50-60 year olds), 2) having received radiotherapy (OR = 0.57, [0.40-0.81], p = 0.002), 3) high income (Second quartile: OR = 1.74, [1.05-2.90], p = 0.033 and fourth quartile: OR = 2.18, [1.31-3.62], p = 0.003, compared with the lowest income quartile), and 4) ethnicity other than Danish (OR = 6.32, [1.58-25.36], p = 0.009). Health-related factors at the time of primary surgery (physical functioning, body mass index, smoking, use of alcohol, and comorbidity) were not associated with reconstruction. Odds of having received information about the option of reconstruction decreased by 8% per year of age in the multivariate analysis (OR = 0.92, [0.87-0.97], p = 0.003). In conclusion, younger age and not having been treated with radiotherapy was independently associated with reconstruction. In addition, higher income was also found to be associated with reconstruction despite free and equal access to reconstruction and healthcare in Denmark. Healthrelated factors were not associated with the use of reconstruction following mastectomy. Our findings underscore the need for physicians to ensure optimal level of information and accessibility to reconstruction for all women regardless of age, treatment, and socio-economic status.

MelanA-negative spindle-cell associated melanoma, a distinct inflammatory phenotype correlated with dense infiltration of CD163 macrophages and loss of E-cadherin.

MelanA is a known melanocyte marker and is important in melanoma diagnostics. Some tumours, however, show loss of MelanA expression and may therefore be difficult to distinguish from tumours of mesenchymal origin. Pure spindle-cell melanoma is a rare event, and little is known about its biological background and prognosis. However, morphological changes towards a more mesenchymal shape and cellular dedifferentiation may correlate with reactivation of important developmental programmes (epithelial-to-mesenchymal transition) and disseminative tumour cell properties. Inflammation and CD163+ macrophages have been shown to be important inducers of E-cadherin and cell-to-cell adhesion loss, a pivotal and final event of epithelial-to-mesenchymal transition. In a cohort of 385 patients with melanoma, we located nine tumours with a clonal MelanA expression, defined as a tumour section with a distinct MelanA-negative clone next to a MelanA-positive clone. Interestingly, MelanA-negative clones correlated significantly with an augmented inflammatory response of tumour-infiltrating macrophages (CD163+), complete loss of E-cadherin and a spindle-shaped morphology, irrespective of ulcerated status. These cases show the inflammatory heterogeneity of melanoma, which may have important diagnostic, prognostic and therapeutic implications for the patients. We show that melanomas harbour cell clones that bear strong resemblance to tumour-associated macrophages, a pivotal player in a tumour-supporting microenvironment. Interestingly, this distinct inflammatory phenotype is associated with loss of MelanA expression, the presence of spindle-shape morphology and complete loss of E-cadherin, considered as possible markers of poorly differentiated and more invasive tumour cells.

Prognostic stratification of ulcerated melanoma: not only the extent matters.

OBJECTIVES: For patients with melanoma, ulceration is an important prognostic marker and interestingly also a predictive marker for the response of adjuvant interferon. A consensual definition and accurate assessment of ulceration are therefore crucial for proper staging and clinical management. We evaluated the prognostic impact of the extent and type of ulceration and the epidermal involvement theoretically preceding it (consumption of epidermis and cleft formation) or seen subsequent to the inflammation (reepithelialization and reactive epidermal hyperplasia), aiming for better prognostic stratification of ulcerated lesions. METHODS: From H&E-stained sections, the status (presence vs absence), extent (percentage of the total tumor length), and type (infiltrative vs attenuative) of ulceration and epidermal involvement were evaluated from 385 patients with cutaneous melanoma. RESULTS: The presence of ulceration (hazard ratio [HR], 1.83), an attenuative type of ulceration (HR, 3.02), and excessive ulceration (HR, 3.57) were independent predictors of poor melanoma-specific survival. Further subdivision of minimal/moderate ulceration showed independent prognostic value only for lesions with epidermal involvement of the surrounding epidermis (HR, 1.78). CONCLUSION: The extent and type of ulceration and involvement of the surrounding epidermis provided more accurate prognostic information than the mere absence or presence and may be useful markers allowing better stratification of ulcerated lesions.

Identification and characterization of locus-specific methylation patterns within novel loci undergoing hypermethylation during breast cancer pathogenesis.

INTRODUCTION: Despite similar clinical and pathological features, large numbers of breast cancer patients experience different outcomes of the disease. This, together with the fact that the incidence of breast cancer is growing worldwide, emphasizes an urgent need for identification of new biomarkers for early cancer detection and stratification of patients. METHODS: We used ultrahigh-resolution microarrays to compare genomewide methylation patterns of breast carcinomas (n = 20) and nonmalignant breast tissue (n = 5). Biomarker properties of a subset of discovered differentially methylated regions (DMRs) were validated using methylation-sensitive high-resolution melting (MS-HRM) in a case-control study on a panel of breast carcinomas (n = 275) and non-malignant controls (n = 74). RESULTS: On the basis of microarray results, we selected 19 DMRs for large-scale screening of cases and controls. Analysis of the screening results showed that all DMRs tested displayed significant gains of methylation in the cancer tissue compared to the levels in control tissue. Interestingly, we observed two types of locus-specific methylation, with loci undergoing either predominantly full or heterogeneous methylation during carcinogenesis. Almost all tested DMRs (17 of 19) displayed low-level methylation in nonmalignant breast tissue, independently of locus-specific methylation patterns in cases. CONCLUSIONS: Specific loci can undergo either heterogeneous or full methylation during carcinogenesis, and loci hypermethylated in cancer frequently show low-level methylation in nonmalignant tissue.

Long-term evaluation of postmastectomy breast reconstruction with the pedicled transverse rectus abdominis musculocutaneous flap.

The transverse rectus abdominis musculocutaneus (TRAM) flap is ideal for unilateral breast reconstruction. It can produce a breast with a lasting natural look, soft feeling, and good resemblance to the opposite breast. The aim was to evaluate long-term results of the TRAM flap reconstruction in an homogenous study population and to examine the impact on abdominal competence, appearance, and function relative to patient satisfaction. The study included 123 women from the cohort of patients undergoing a postmastectomy breast reconstruction in the period from 1992-2005. Data was collected from patient charts, a study-specific questionnaire, and a clinical follow-up visit. The response to the questionnaire was 81% (100/123), and 78 of them participated in a clinical follow-up visit. Eighty-four per cent were satisfied with the overall results of their breast reconstruction, and the majority of the women were pleased with the overall appearance of their abdomen. A significant correlation existed between satisfaction with the abdominal appearance and donor site complications (p = 0.01). No association was determined between complications in the breast area and smoking. A BMI above 25 increased the risk of complications. Radiation therapy (RT) significantly increased the risk of severe complications (p = 0.04) and of an inferior aesthetic result (p = 0.03). In conclusion, after a median of 6 years, women reconstructed with a TRAM flap were pleased with the overall result, with the appearance and strength of their abdomen including the umbilicus. Breast reconstruction with the pedicled TRAM flap results in lasting good results and pleased patients.

Long-term follow-up of late morbidity, cosmetic outcome and body image after breast conserving therapy. A study from the Danish Breast Cancer Cooperative Group (DBCG).

UNLABELLED: The Danish Breast Cancer Cooperative Group (DBCG) introduced BCT as a standard treatment in Denmark in 1990. The aim of this study was to investigate late morbidity, cosmetic outcome, and body image after BCT and to associate these outcome variables with patient, tumor, and treatment characteristics. MATERIAL AND METHODS: A total of 214 patients treated with BCT from 1989-2002 participated in a long-term follow-up visit comprising an interview, clinical examination, photos of the breast region and completion of a questionnaire on Body Image. RESULTS: Median follow-up time was 12 years (range 7-20). Moderate to severe fibrosis was found in 23% of patients and was associated with chemotherapy [OR 2.6, CI (1.1; 5.9), p = 0.02], large breast size [OR 3.2, CI (1.6; 6.4), p = 0.001], and smoking [OR 2.4, CI (1.1; 4.9), p = 0.02]. Patients with a satisfactory cosmetic outcome, when assessed by a clinician, were characterized by small tumors [OR 3.2, CI (1.5; 6.8), p = 0.003] and small to medium sized breasts [OR 2.0, CI (1.1; 3.5), p = 0.002]. Fifty percent of patients scored good or excellent when assessed by a clinician compared to 88% when reported by the patients themselves. Patients satisfied with their own cosmetic outcome were the younger patients [< 50 years; OR 3.2, CI (1.1; 8.6), p = 0.03] with no postoperative complications [OR 3.3, CI (1.2; 9.2), p = 0.02]. Regarding body image 15% felt less feminine, 25% felt less sexually attractive, and 28% of patients had changed their clothing habits as a result of the disease or treatment. CONCLUSION: The majority of patients were satisfied with their cosmetic outcome after BCT, whereas only half of the patients were found to have a good or excellent cosmetic outcome when assessed by the clinician. Body image was found to be only minimally disturbed in the majority of patients. The level of moderate to severe fibrosis was acceptable compared to both national and international studies with similar patient compositions.

Immediate breast reconstruction: a retrospective study with emphasis on complications and risk factors.

The use of skin-sparing mastectomy (SSM) with immediate reconstruction is preferred, as it has cosmetic and psychological advantages, and comprises one operation. We retrospectively reviewed the complication rate after SSM and immediate reconstruction with implants in 141 consecutive patients with 208 reconstructions. Risk factors were related to both patients and the procedure. The overall morbidity was 42/208 (20%) with one or more minor or major complications including epidermolysis, skin necrosis, or infection. The overall explantation rate was 26/208 (13%). Smoking was a significant risk factor for infection and explantation, and tended to increase risk of necrosis (p = 0.05). Preoperative radiation did not increase the risk of explantation. Age above the median of 44 (range 25-67) years implied a significantly increased risk of epidermolysis, infection, and explantation. Women who had a one-stage procedure with implantation of fixed-sized implant experienced explantation four times more often than women who had a two-stage procedure with tissue expander (p = 0.001). In conclusion, SSM with immediate reconstruction yields a low complication rate when patients are carefully selected. SSM with immediate reconstruction should be done for younger women who have had no previous radiation. Patients should stop smoking to ensure optimal outcome.

Delayed breast implant reconstruction: a 10-year prospective study.

Studies of complications following reconstructive surgery with implants among women with breast cancer are needed. As the, to our knowledge, first prospective long-term study we evaluated the occurrence of complications following delayed breast reconstruction separately for one- and two-stage procedures. From the Danish Registry for Plastic Surgery of the Breast, which has prospectively registered data for women undergoing breast implantations since 1999, we identified 559 women without a history of radiation therapy undergoing 592 delayed breast reconstructions following breast cancer during the period 1999 to 2006; 239 one-stage procedures and 353 two-stage procedures. The postoperative course through November 2009 was evaluated by cumulative incidence adjusting for competing risks for the selected outcomes; hematoma, infection, seroma, implant rupture, severe capsular contracture (modified Baker III and IV), extrusion of the implant, asymmetry/displacement of the implant, any complication, and reoperation. These analyses were performed both overall and separately according to type of procedure (one- or two-stage). The overall 10-year risk estimates were 68.1% for any complication, 7.7% for severe capsular contracture, 32.3% for displacement/asymmetry of the implant and 38.6% for reoperation. When comparing one- and two-stage procedures, we observed significantly higher risk estimates for infection, seroma and extrusion of the implant following two-stage procedures, whereas the risk of reoperation was significantly higher following the one-stage procedure. For both procedures, the majority of reoperations were due to asymmetry or displacement of the implant. In conclusion, non-radiated one- and two-stage delayed breast implant reconstructions are associated with substantial risks of complications and reoperation which should be taken into consideration in the planning of breast reconstruction.

The clinical course of immediate breast implant reconstruction after breast cancer.

BACKGROUND: The number of women suitable for breast conserving treatment as well as immediate reconstruction after breast cancer has been increasing, and studies of complications hereafter are needed. MATERIAL AND METHODS: The cohort was identified in the prospective database of the Danish Registry for Plastic Surgery of the Breast during the period 1999 to 2006; 167 women with 189 immediate breast reconstructions (40 one-stage and 149 two-stage procedures) after breast cancer without a history of radiation therapy. The women were followed for complications until November 2009. Cumulative incidence risks were computed for infection, hematoma, seroma, severe capsular contracture (modified Baker III and IV), extrusion of the implant, implant rupture, asymmetry/displacement of the implant, any complication, and reoperation. In addition, we compared the postoperative course of immediate two-stage procedures with delayed two-stage procedures. RESULTS: The overall eight-year risk estimates for the immediate procedures were 76.4% for any complication, 5.3% for severe capsular contracture, 29.5% for displacement/asymmetry of the implant and 40.6% for reoperation. Significantly higher risk for reoperation was observed after immediate one-stage than after two-stage procedures. For immediate two-stage procedures acute complications such as infection, seroma and hematoma were higher in the expansion period than after the second planned surgery. Higher risks for acute complications were observed after immediate than after delayed two-stage procedures. CONCLUSION: Immediate breast implant reconstruction was found to have substantial risks of complications in non-radiated women, which should be considered in the guidance of breast cancer patients before choosing reconstructive procedure.