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Risk of connective tissue disease and related disorders among women with breast implants: a nation-wide retrospective cohort study in Sweden

BMJ 1998; 316 doi: https://doi.org/10.1136/bmj.316.7129.417 (Published 07 February 1998) Cite this as: BMJ 1998;316:417
  1. Olof Nyrén, associate professor (Olof.Nyren{at}mep.ki.se)a,
  2. Li Yin, statisticiana,
  3. Staffan Josefsson, programmera,
  4. Joseph K McLaughlin, senior scientistb,
  5. William J Blot, senior scientistb,
  6. Martin Engqvist, register coordinatorc,
  7. Lars Hakelius, professord,
  8. John D Boice Jr, senior scientistb,
  9. Hans-Olov Adami, adjunct professore
  1. a Department of Medical Epidemiology, Karolinska Institute, PO Box 281, S-171 77 Stockholm, Sweden
  2. b International Epidemiology Institute, Rockville, Maryland, USA
  3. c National Board of Health and Welfare, Stockholm, Sweden
  4. d Department of Plastic and Hand Surgery, University Hospital, Uppsala, Sweden
  5. e Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, USA
  1. Correspondence to: Dr Nyrén
  • Accepted 27 November 1997

Abstract

Objective: To examine the relation between connective tissue disease and related conditions and breast implants.

Design: Retrospective cohort study of all women in the Swedish national inpatient registry who underwent breast augmentation surgery with artificial implants during 1964-93, compared with women who underwent breast reduction surgery during the same period.

Setting: Sweden.

Subjects: 7442 women with implants for cosmetic reasons or for reconstruction after breast cancer surgery and 3353 women with breast reduction surgery.

Main outcome measures: Subsequent hospitalisation for definite connective tissue diseases (rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, and Sjögren's syndrome) or related disorders.

Results: 29 women with implants were hospitalised for definite connective tissue disease compared with 25.5 expected based on general population rates (standardised hospitalisation ratio 1.1 (95% confidence interval 0.8 to 1.6)). There were no diagnoses of systemic sclerosis, and no significant excess in risk for polymyalgia rheumatica, fibromyalgia, and several related disorders. Among women who underwent breast reduction surgery, 14 were hospitalised for definite connective tissue disease compared with 10.5 expected (standardised hospitalisation ratio 1.3 (0.7 to 2.2)). Compared with the breast reduction group, women with breast implants showed a slight reduction for all definite connective tissue disease (relative risk 0.8 (95% confidence interval 0.5 to 1.4)).

Conclusions: This large nationwide cohort study shows no evidence of association between breast implants and connective tissue disease.

Key messages

  • Anecdotal reports have suggested that silicone breast implants may cause immunological disorders

  • In a nationwide study of over 7000 Swedish women with breast implants and a control group of over 3000 women who had undergone breast reduction surgery, we found no excess risk for connective tissue disease

  • Of the women with implants, 29 were hospitalised for connective tissue disease compared with the 25.5 expected from national hospital discharge rates, while, of those who underwent breast reduction, 14 were hospitalised compared with the 10.5 expected

  • Direct comparison of the two groups of women showed that those with implants had a slightly lower risk of connective tissue disease

  • There is little likelihood of an association between breast implants and connective tissue disease

Footnotes

  • Accepted 27 November 1997
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