Incidence of lymphomas in a nationwide prospective cohort study of breast-implanted women

BACKGROUND: The true incidence of Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL), a rare cancer associated with textured breast implants, remains uncertain due to limitations of implant exposure data and long-term follow-up. Concerns regarding other implant-associated malignancies are growing. This study aimed to determine the incidence of BIA-ALCL, non-BIA-ALCL lymphoma, and Breast Implant Associated-Squamous Cell Carcinoma (BIA-SCC). METHODS: 10,339 women with a first-time breast implantation during 1998-2011 were identified in the nationwide prospective Danish Registry for Plastic Surgery of the Breast (DPB). Linkage to national health registries provided outcome data. Incidence of non-BIA-ALCL was compared with the incidence in 1) 3486 women with breast reduction or mastopexia and 2) 153,728 age-matched women from the general population. Cumulative incidences were estimated using competing risk models. RESULTS: We followed 8516 women with cosmetic and 1823 with reconstructive implantation for a median of 17.3 and 17.4 years, respectively. Five BIA-ALCL cases were identified. The incidence rate of BIA-ALCL among women with textured cosmetic implants was 2.83 per 100,000 person-years (95% CI, 0.77-7.26), and for the reconstructive cohort, 3.44 per 100,000 person-years (95% CI, 0.09-19.16). No statistically significant differences were found across indications or implant texturing types, and almost all implant brands on the market were involved. The incidence of other lymphomas after cosmetic implantation resembled that of the control cohorts. No BIA-SCC cases were identified. CONCLUSIONS: This study provides a population-based estimate of BIA-ALCL incidence, more precise and higher than most previous studies. No textured implants are without risk.