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Background: Recently, old concerns linking silicone breast implants (SBIs) with breast cancer have resurfaced. These concerns apply specifically to the risk of breast cancer recurrence in patients who received breast reconstructions with macro-textured SBIs. In this study, the authors investigated the effect of breast reconstruction with macro-textured SBIs on long-term oncologic outcomes of breast cancer patients., Materials and Methods: The authors conducted a retrospective cohort study in two large cancer centres in the Netherlands. Patients who had been treated for primary breast cancer between 1 January 2000 and 31 December 2015 were included. Data on treatment and oncologic outcomes were obtained from prospectively maintained institutional and nationwide registries. Patient files were reviewed manually to complement missing information. Missing data were accounted for by multiple imputations by chained equations (MICE). Reconstruction with a macro-textured SBI was analysed as a time-dependent variable. The main outcomes of interest were locoregional recurrence-free survival (LRRFS) and distant metastasis-free survival (DMFS). Hazard ratios (HRs) were estimated using multivariable Cox proportional hazard models., Results: Of the 4695 women who were eligible for inclusion, 2393 had undergone mastectomy. Of these women, 1187 (25%) had received breast reconstruction with a macro-textured SBI. The mean follow-up time was 11.5 (SD, 5.0) years. Compared with women who had undergone a simple mastectomy or autologous breast reconstruction, women with an implant-based reconstruction did not differ significantly in LRRFS or DMFS after accounting for various confounding factors [HR 1.27 (95% CI 0.93-1.72) and HR 0.94 (95% CI 0.74-1.20), respectively]. Sensitivity analysis in complete cases of patients and various subgroup analyses yielded similar results., Conclusion: Reassuringly, in this multi-centre cohort study no difference was found in long-term oncologic outcomes between women who had received breast reconstruction with a macro-textured SBI and women who had undergone a simple mastectomy or autologous breast reconstruction., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Implant-based breast reconstructions contribute considerably to the quality of life of breast cancer patients. A knowledge gap exists concerning the potential role of silicone breast implants in the development of so-called "breast implant illness" (BII) and autoimmune diseases in breast cancer survivors with implant-based reconstructions. BII is a constellation of non-specific symptoms reported by a small group of women with silicone breast implants., Methods: The Areola study is a multicenter retrospective cohort study with prospective follow-up aiming to assess the risk of BII and autoimmune diseases in female breast cancer survivors with and without silicone breast implants. In this report, we set out the rationale, study design, and methodology of this cohort study. The cohort consists of breast cancer survivors who received surgical treatment with implant-based reconstruction in six major hospitals across the Netherlands in the period between 2000 and 2015. As a comparison group, a frequency-matched sample of breast cancer survivors without breast implants will be selected. An additional group of women who received breast augmentation surgery in the same years will be selected to compare their characteristics and health outcomes with those of breast cancer patients with implants. All women who are still alive will be invited to complete a web-based questionnaire covering health-related topics. The entire cohort including deceased women will be linked to population-based databases of Statistics Netherlands. These include a registry of hospital diagnostic codes, a medicines prescription registry, and a cause-of-death registry, through which diagnoses of autoimmune diseases will be identified. Outcomes of interest are the prevalence and incidence of BII and autoimmune diseases. In addition, risk factors for the development of BII and autoimmune disorders will be assessed among women with implants., Discussion: The Areola study will contribute to the availability of reliable information on the risks of BII and autoimmune diseases in Dutch breast cancer survivors with silicone breast implants. This will inform breast cancer survivors and aid future breast cancer patients and their treating physicians to make informed decisions about reconstructive strategies after mastectomy., Registration: This study is registered at ClinicalTrials.gov on June 2, 2022 (NCT05400954)., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: In immediate implant-based breast reconstruction (IBBR), large variation is observed in current practices between a direct-to-implant and a two-stage approach (insertion of a breast implant after a tissue expander). This population-based study aimed to compare unplanned short- and long-term revision incidence between direct-to-implant and two-stage IBBR in The Netherlands., Methods: All patients who underwent immediate IBBR following a mastectomy between 2015 and 2019 were selected from the nationwide Dutch Breast Implant Registry. Short- and long-term unplanned revision incidences were studied per immediate IBBR, including revision indications and the total number of additional operations. Confounding by indication was limited using propensity score matching., Results: A total of 4512 breast implants (3948 women) were included, of which 2100 (47%) were for direct-to-implant IBBR and 2412 (53%) were for two-stage IBBR. Median (IQR) follow-up was 29 months (range, 16 to 45 months) and 33 months (range, 21 to 47 months), respectively. Short-term revision incidence was 4.0% and 11.7%, respectively (conditional OR, 0.31; 95% CI, 0.23 to 0.42%). Long-term revision incidence was 10.6% (95% CI, 9.2 to 12.1%) and 16.4% (95% CI, 14.8 to 17.9%), respectively. In the propensity score-matched cohort, similar results were found. In the direct-to-implant group, more breasts were reconstructed within the planned number of operations than in the two-stage group., Conclusions: Unplanned revision surgery occurred less often after direct-to-implant IBBR, and more breasts were reconstructed within the planned number of operations compared to two-stage IBBR. These results, based on real-world data, are important for improving patient counseling and shared decision-making., Clinical Question/level of Evidence: Risk, II., (Copyright © 2022 by the American Society of Plastic Surgeons.)