ArticleJournal of the National Cancer Institute2026
Risk of autoimmune and rheumatic diseases in breast cancer patients with silicone breast implants.
Article in Journal of the National Cancer Institute, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05400954 (Association of Silicone Breast Implant Reconstruction and -Enlargement With Overall Wellbeing, Lymphoma and Auto-immune Disease - Breast Implant Illness), which is not on this map. Not yet cited in PubMed.
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Association of Silicone Breast Implant Reconstruction and -Enlargement With Overall Wellbeing, Lymphoma and Auto-immune Disease - Breast Implant Illness
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Abstract
backgroundOver the past decade, various large observational studies have suggested an association between silicone breast implants and autoimmune and rheumatic diseases, rekindling long-standing breast implant safety concerns among breast cancer survivors with breast reconstructions and newly diagnosed breast cancer patients.
methodsWe investigated the association between silicone breast implants and autoimmune and rheumatic diseases in a large multicenter cohort of women treated for breast cancer, part of whom received silicone breast implants for reconstructive purposes. Clinical data and events of interest were identified through linkages with prospectively maintained nationwide and institutional registries. Hazard ratios (HRs) for autoimmune and rheumatic diseases were calculated using Cox proportional hazards regression models adjusted for potential confounders.
resultsOf 12 262 women in the cohort, 3082 (25%) had received silicone breast implant-based breast reconstructions. Median follow-up time was 12.0 years (IQR = 7.0 years). The event rate of autoimmune and rheumatic disease diagnoses was 62.5 per 10 000 person-years. Compared with women without silicone breast implant exposure, women with an implant-based breast reconstruction did not have an increased risk of autoimmune and rheumatic diseases (multivariably adjusted HR = 1.06, 95% CI = 0.89 to 1.27). In addition, no statistically significant association was found between silicone breast implant exposure and inflammatory arthritis, systemic rheumatic disease, inflammatory dermatosis, inflammatory bowel disease, or any specific condition. Sensitivity analyses in which silicone breast implant exposure was analyzed as a time-dependent variable confirmed the results of the main analysis.
conclusionThe findings of this study indicate that silicone breast implant exposure is not associated with an increased risk of autoimmune and rheumatic diseases in women with breast cancer and challenge the results of earlier studies in women with cosmetic implants. REGISTRATION: This study is registered at ClinicalTrials.gov on June 2, 2022 (NCT05400954).
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