Risk of autoimmune and rheumatic diseases in breast cancer patients with silicone breast implants

Jonathan Spoor; Marc A M Mureau; Daphne de Jong; Renaud L M Tissier; Marijn Vis; Hinne Rakhorst; Juliëtte Hommes; Mintsje de Boer; Hester S A Oldenburg; Esther M Heuts; Yvonne L J Vissers; Anneriet E Dassen; Daniel J Evers; Linetta B Koppert; Laura H Zaal; Rene R W J van der Hulst; Marie-Jeanne T F D Vrancken Peeters; Eveline M A Bleiker; Flora E van Leeuwen

doi:10.1093/jnci/djag115

Risk of autoimmune and rheumatic diseases in breast cancer patients with silicone breast implants

Jonathan Spoor
, Marc A M Mureau
, Daphne de Jong
, Renaud L M Tissier
, Marijn Vis
, Hinne Rakhorst
, Juliëtte Hommes
, Mintsje de Boer
, Hester S A Oldenburg
, Esther M Heuts
, Yvonne L J Vissers
, Anneriet E Dassen
, Daniel J Evers
, Linetta B Koppert
, Laura H Zaal
, Rene R W J van der Hulst
, Marie-Jeanne T F D Vrancken Peeters
, Eveline M A Bleiker
, Flora E van Leeuwen

The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Department of Plastic and Reconstructive Surgery
Maastricht University
Department of Surgery
Department of Maxillofacial Surgery and Plastic Surgery

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

BACKGROUND: Over the past decade, various large observational studies have suggested an association between silicone breast implants (SBIs) and autoimmune and rheumatic diseases (ARDs), rekindling long-standing breast implant-safety concerns among breast cancer survivors with breast reconstructions and newly diagnosed breast cancer patients.

METHODS: We investigated the association between SBIs and ARDs in a large multicenter cohort of women treated for breast cancer, part of whom received SBIs for reconstructive purposes. Clinical data and events of interest were identified through linkages with prospectively maintained nationwide- and institutional registries. Hazard Ratios (HRs) for ARDs were calculated using Cox proportional hazards regression models adjusted for potential confounders.

RESULTS: Of 12,262 women in the cohort, 3,082 (25%) had received SBI-based breast reconstructions. Median follow-up time was 12.0 (IQR, 7.0) years. The event rate of ARD-diagnoses was 62.5 per 10,000 person-years. Compared with women without SBI-exposure, women with an implant-based breast reconstruction did not have an increased risk of ARDs (multivariably adjusted HR, 1.06, 95% CI [0.89 to 1.27]). In addition, no statistically significant association was found between SBI-exposure and inflammatory arthritis, systematic rheumatic disease, inflammatory dermatosis, inflammatory bowel disease or any specific condition. Sensitivity analyses in which SBI-exposure was analyzed as a time-dependent variable confirmed the results of the main analysis.

CONCLUSION: The findings of this study indicate that SBI-exposure is not associated with an increased risk of ARDs 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 2nd 2022 (NCT05400954).

Original language	English
Article number	djag115
Journal	Journal of the National Cancer Institute
DOIs	https://doi.org/10.1093/jnci/djag115
Publication status	E-pub ahead of print - 19 Apr 2026

Bibliographical note

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This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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https://academic.oup.com/jnci/advance-article/doi/10.1093/jnci/djag115/8658319

Cite this

Spoor, J., Mureau, M. A. M., de Jong, D., Tissier, R. L. M., Vis, M., Rakhorst, H., Hommes, J., de Boer, M., Oldenburg, H. S. A., Heuts, E. M., Vissers, Y. L. J., Dassen, A. E., Evers, D. J., Koppert, L. B., Zaal, L. H., van der Hulst, R. R. W. J., Vrancken Peeters, M.-J. T. F. D., Bleiker, E. M. A., & van Leeuwen, F. E. (2026). Risk of autoimmune and rheumatic diseases in breast cancer patients with silicone breast implants. Journal of the National Cancer Institute, Article djag115. Advance online publication. https://doi.org/10.1093/jnci/djag115

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title = "Risk of autoimmune and rheumatic diseases in breast cancer patients with silicone breast implants",

abstract = "BACKGROUND: Over the past decade, various large observational studies have suggested an association between silicone breast implants (SBIs) and autoimmune and rheumatic diseases (ARDs), rekindling long-standing breast implant-safety concerns among breast cancer survivors with breast reconstructions and newly diagnosed breast cancer patients.METHODS: We investigated the association between SBIs and ARDs in a large multicenter cohort of women treated for breast cancer, part of whom received SBIs for reconstructive purposes. Clinical data and events of interest were identified through linkages with prospectively maintained nationwide- and institutional registries. Hazard Ratios (HRs) for ARDs were calculated using Cox proportional hazards regression models adjusted for potential confounders.RESULTS: Of 12,262 women in the cohort, 3,082 (25\%) had received SBI-based breast reconstructions. Median follow-up time was 12.0 (IQR, 7.0) years. The event rate of ARD-diagnoses was 62.5 per 10,000 person-years. Compared with women without SBI-exposure, women with an implant-based breast reconstruction did not have an increased risk of ARDs (multivariably adjusted HR, 1.06, 95\% CI [0.89 to 1.27]). In addition, no statistically significant association was found between SBI-exposure and inflammatory arthritis, systematic rheumatic disease, inflammatory dermatosis, inflammatory bowel disease or any specific condition. Sensitivity analyses in which SBI-exposure was analyzed as a time-dependent variable confirmed the results of the main analysis.CONCLUSION: The findings of this study indicate that SBI-exposure is not associated with an increased risk of ARDs 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 2nd 2022 (NCT05400954).",

author = "Jonathan Spoor and Mureau, \{Marc A M\} and \{de Jong\}, Daphne and Tissier, \{Renaud L M\} and Marijn Vis and Hinne Rakhorst and Juli{\"e}tte Hommes and \{de Boer\}, Mintsje and Oldenburg, \{Hester S A\} and Heuts, \{Esther M\} and Vissers, \{Yvonne L J\} and Dassen, \{Anneriet E\} and Evers, \{Daniel J\} and Koppert, \{Linetta B\} and Zaal, \{Laura H\} and \{van der Hulst\}, \{Rene R W J\} and \{Vrancken Peeters\}, \{Marie-Jeanne T F D\} and Bleiker, \{Eveline M A\} and \{van Leeuwen\}, \{Flora E\}",

note = "{\textcopyright} The Author(s) (2026). Published by Oxford University Press.",

year = "2026",

month = apr,

day = "19",

doi = "10.1093/jnci/djag115",

language = "English",

journal = "Journal of the National Cancer Institute",

issn = "0027-8874",

publisher = "Oxford University Press",

}

Spoor, J, Mureau, MAM, de Jong, D, Tissier, RLM, Vis, M, Rakhorst, H, Hommes, J, de Boer, M, Oldenburg, HSA, Heuts, EM, Vissers, YLJ, Dassen, AE, Evers, DJ, Koppert, LB, Zaal, LH, van der Hulst, RRWJ, Vrancken Peeters, M-JTFD, Bleiker, EMA & van Leeuwen, FE 2026, 'Risk of autoimmune and rheumatic diseases in breast cancer patients with silicone breast implants', Journal of the National Cancer Institute. https://doi.org/10.1093/jnci/djag115

TY - JOUR

T1 - Risk of autoimmune and rheumatic diseases in breast cancer patients with silicone breast implants

AU - Spoor, Jonathan

AU - Mureau, Marc A M

AU - de Jong, Daphne

AU - Tissier, Renaud L M

AU - Vis, Marijn

AU - Rakhorst, Hinne

AU - Hommes, Juliëtte

AU - de Boer, Mintsje

AU - Oldenburg, Hester S A

AU - Heuts, Esther M

AU - Vissers, Yvonne L J

AU - Dassen, Anneriet E

AU - Evers, Daniel J

AU - Koppert, Linetta B

AU - Zaal, Laura H

AU - van der Hulst, Rene R W J

AU - Vrancken Peeters, Marie-Jeanne T F D

AU - Bleiker, Eveline M A

AU - van Leeuwen, Flora E

PY - 2026/4/19

Y1 - 2026/4/19

N2 - BACKGROUND: Over the past decade, various large observational studies have suggested an association between silicone breast implants (SBIs) and autoimmune and rheumatic diseases (ARDs), rekindling long-standing breast implant-safety concerns among breast cancer survivors with breast reconstructions and newly diagnosed breast cancer patients.METHODS: We investigated the association between SBIs and ARDs in a large multicenter cohort of women treated for breast cancer, part of whom received SBIs for reconstructive purposes. Clinical data and events of interest were identified through linkages with prospectively maintained nationwide- and institutional registries. Hazard Ratios (HRs) for ARDs were calculated using Cox proportional hazards regression models adjusted for potential confounders.RESULTS: Of 12,262 women in the cohort, 3,082 (25%) had received SBI-based breast reconstructions. Median follow-up time was 12.0 (IQR, 7.0) years. The event rate of ARD-diagnoses was 62.5 per 10,000 person-years. Compared with women without SBI-exposure, women with an implant-based breast reconstruction did not have an increased risk of ARDs (multivariably adjusted HR, 1.06, 95% CI [0.89 to 1.27]). In addition, no statistically significant association was found between SBI-exposure and inflammatory arthritis, systematic rheumatic disease, inflammatory dermatosis, inflammatory bowel disease or any specific condition. Sensitivity analyses in which SBI-exposure was analyzed as a time-dependent variable confirmed the results of the main analysis.CONCLUSION: The findings of this study indicate that SBI-exposure is not associated with an increased risk of ARDs 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 2nd 2022 (NCT05400954).

AB - BACKGROUND: Over the past decade, various large observational studies have suggested an association between silicone breast implants (SBIs) and autoimmune and rheumatic diseases (ARDs), rekindling long-standing breast implant-safety concerns among breast cancer survivors with breast reconstructions and newly diagnosed breast cancer patients.METHODS: We investigated the association between SBIs and ARDs in a large multicenter cohort of women treated for breast cancer, part of whom received SBIs for reconstructive purposes. Clinical data and events of interest were identified through linkages with prospectively maintained nationwide- and institutional registries. Hazard Ratios (HRs) for ARDs were calculated using Cox proportional hazards regression models adjusted for potential confounders.RESULTS: Of 12,262 women in the cohort, 3,082 (25%) had received SBI-based breast reconstructions. Median follow-up time was 12.0 (IQR, 7.0) years. The event rate of ARD-diagnoses was 62.5 per 10,000 person-years. Compared with women without SBI-exposure, women with an implant-based breast reconstruction did not have an increased risk of ARDs (multivariably adjusted HR, 1.06, 95% CI [0.89 to 1.27]). In addition, no statistically significant association was found between SBI-exposure and inflammatory arthritis, systematic rheumatic disease, inflammatory dermatosis, inflammatory bowel disease or any specific condition. Sensitivity analyses in which SBI-exposure was analyzed as a time-dependent variable confirmed the results of the main analysis.CONCLUSION: The findings of this study indicate that SBI-exposure is not associated with an increased risk of ARDs 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 2nd 2022 (NCT05400954).

U2 - 10.1093/jnci/djag115

DO - 10.1093/jnci/djag115

M3 - Article

C2 - 42001600

SN - 0027-8874

JO - Journal of the National Cancer Institute

JF - Journal of the National Cancer Institute

M1 - djag115

ER -

Risk of autoimmune and rheumatic diseases in breast cancer patients with silicone breast implants

Abstract

Bibliographical note

UN SDGs

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