Breast implants and breast cancer--reanalysis of a linkage study

N Engl J Med. 1995 Jun 8;332(23):1535-9. doi: 10.1056/NEJM199506083322302.


Background: In 1992, Berkel and colleagues reported in the Journal the results of their study of the potential association of breast augmentation and breast cancer. The study reported that women who had breast augmentation had a significantly lower subsequent risk of breast cancer (P < 0.01) than the general population, with a standardized incidence ratio of 0.48 overall. Assuming a 10-year induction period (that is, assuming that cancers found within 10 years of the augmentation might have been the result of a process begun before surgery and therefore should not be considered), the reported standardized incidence ratio was 0.16. Problems were later identified involving some of the study methods. This paper reports a second analysis of these data.

Methods: We used a data set from Alberta Health Care to identify eligible women with bilateral breast augmentation. Using a combination of deterministic and probabilistic methods, we linked this data set to the Alberta Cancer Registry to identify subsequent breast cancers that developed during the study period. Multiple estimates of standardized incidence ratios were calculated on the basis of differing study-eligibility dates, induction periods, and types of breast-cancer (invasive only or invasive plus in situ).

Results: The reanalysis found substantial differences in the numbers of person-years at risk, resulting in higher standardized incidence ratios than in the original analysis. The final ratios for all breast cancers, with October 1, 1973, used as the starting date of the study, were 0.76 (95 percent confidence interval, 0.55 to 1.02), 0.85 (95 percent confidence interval, 0.58 to 1.19), and 0.68 (95 percent confidence interval, 0.32 to 1.25) for induction periods of 0, 5, and 10 years, respectively. None of these standardized incidence ratios were significantly different from 1.

Conclusions: On the basis of this reanalysis, the incidence of breast cancer among the women who had breast augmentation could not be said to be either significantly higher or lower than that among the general population over the period during which this cohort was followed.

MeSH terms

  • Adult
  • Alberta / epidemiology
  • Breast Implants / adverse effects
  • Breast Implants / statistics & numerical data*
  • Breast Neoplasms / epidemiology*
  • Breast Neoplasms / etiology
  • Confidence Intervals
  • Data Collection / statistics & numerical data*
  • Databases, Factual / statistics & numerical data
  • Female
  • Humans
  • Incidence
  • Male
  • Mammaplasty
  • Middle Aged
  • Probability
  • Registries / statistics & numerical data
  • Risk