The available epidemiologic evidence does not support a carcinogenic effect of silicone breast implants on breast or other cancers. Data on cancer risk other than breast cancer are limited and few studies have assessed cancer risk beyond 10-15 years after breast implantation. We extended follow-up of our earlier cohort study of Danish women with cosmetic breast implants by 7 years, yielding 30 years of follow-up for women with longest implant duration. The study population consisted of women who underwent cosmetic breast implant surgery at private clinics of plastic surgery (n 5 1,653) or public hospitals (n 5 1,110), and a control group of women who attended private clinics for other plastic surgery (n 5 1,736), between 1973-95. Cancer incidence through 2002 was ascertained using the Danish Cancer Registry. Risk evaluation was based on computation of standardized incidence ratios (SIR) and Cox proportional hazards models, adjusting for age, calendar period and reproductive history. We observed 163 cancers among women with breast implants compared to 136.7 expected based on general population rates (SIR 5 1.2; 95% confidence interval [CI] 5 1.0-1.4), during a mean follow-up period of 14.4 years (range 5 0-30 years). Women with breast implants experienced a reduced risk of breast cancer (SIR 5 0.7; 95% CI 5 0.5-1.0), and an increased risk of non-melanoma skin cancer (SIR 5 2.1; 95% CI 5 1.5-2.7). Stratification by age at implantation, calendar year at implantation and time since implantation showed no clear trends, however, the statistical precision was limited in these analyses. When excluding non-melanoma skin cancer, the SIR for cancer overall was 1.0 (95% CI 5 0.8-1.2). With respect to other site-specific cancers, no significantly increased or decreased SIR were observed. Similar results were found when directly comparing women who had implants at private clinics with women who attended private clinics for other plastic surgery, with rate ratios for cancer overall, breast cancer and non-melanoma skin cancer of 1.1 (95% CI 5 0.8-1.6), 0.7 (95% CI 5 0.4-1.3) and 1.5 (95% CI 5 0.8-2.7), respectively. In conclusion, our study lends further support to the accumulating evidence that silicone breast implants are not carcinogenic. Reasons for the consistently reported deficit of breast cancer among women with breast implants remain unclear, whereas increased exposure to sunlight may explain the excess occurrence of non-melanoma skin cancer. We found no indication of delayed diagnosis of breast cancer due to the presence of breast implants. ' 2005 Wiley-Liss, Inc.Key words: breast implants; cancer incidence; risk; epidemiology; cohort studyThe carcinogenic potential of silicone has been questioned since the 1950s when silicone and other foreign materials were found to induce sarcomas in rodents.1,2 Such foreign body carcinogenesis, however, occurs in rodents with exposure to a wide array of substances, and there is no convincing evidence that a similar risk exists in humans.3,4 Silicone has also been reported to induc...