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Breast implants and connective tissue disease


Bandolier 74 featured a formal risk assessment of silicone breast implants, but bemoaned the fact that the review did not state that it was systematic. Then, just like the proverbial buses, along comes a superb meta-analysis investigating the risk of connective tissue disorders in women with breast implants [1].


Searching four electronic databases augmented publications identified by previous meta-analyses. Cohort, case-control and cross sectional studies were sought. Disease variables were presence or absence of individual connective tissue disease, of all connective tissue diseases combined, or of other autoimmune or connective tissue diseases. Presence or absence of any breast implant or implants described as silicone gel filled implants was noted.


There were nine cohort studies with 14,500 women with implants and 103,000 women without implants, nine case control studies with over 3000 women with disease and over 11,000 women without disease, and two cross sectional studies, one of which was very large with nearly 400,000 women. This large study used self-reported disease status, rather than a review of medical records to confirm disease, and was subject to other methodological problems.

There was little or no evidence of any association between breast implants and connective tissue disease. In the cohort studies, for instance, five studies had the outcomes of definite or any connective tissue disease. In women with breast implants, 53 of 13520 women (0.39%, 95% confidence interval 0.29%-0.50%) had this outcome, while 575 of 102,917 (0.56%, 95% confidence interval 0.51%-0.60%) of women without implants had the outcome (Figure).

Figure: Connective tissue disease in women with and without breast implants

There were several ways of looking at the results, including whether the relative risks were adjusted or not, and whether the very large cross sectional study was included or not. The most conservative way of looking at the results, using adjusted relative risks (Table) showed no increased risk for all breast implants or for those with silicone gel fill.

Table: Adjusted relative risks for connective tissue diseases in women with any breast implant and for those definitely identified as silicone gel filled implants

  All breast implants Silicone breast implants
Disease Number of studies Relative risk (95% CI) Number of studies Relative risk (95% CI)
All connective tissue diseases 13 0.80 (0.62 to 1.04) 6 0.82 (0.46 to 1.46)
Rheumatoid arthritis 7 1.04 (0.72 to 1.51) 3 0.98 (0.40 to 2.37)
Systemic lupus erythematosus 4 0.65 (0.35 to 1.23) 1 0.94 (0.17 to 5.23)
Scleroderma or systemic sclerosis 4 1.01 (0.59 to 1.73) 3 0.85 (0.32 to 2.25)
Sjögren's syndrome 3 1.42 (0.65 to 3.11) 1 0.99 (0.17 to 5.94)
Other autoimmune or rheumatic conditions 6 0.96 (0.74 to 1.25) 2 0.61 (0.41 to 0.91)
Adjusted relative risks. Significant increase in connective tissue disease in women with breast implants would be shown by a lower limit of the confidence interval greater than 1.


This study is interesting in that it formed part of a report from a science panel appointed by a US judge to examine the scientific evidence for a case involving harm caused by breast implants. It is difficult, on this evidence, to implicate breast implants, silicone filled or not, in development of connective tissue disorders in women.


  1. EC Janowsky, LL Kupper, BS Hulka. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. New England Journal of Medicine 2000 342: 781-790.
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