Objective: Although clinical reports have raised concern that breast implan
ts may either increase the risk of breast cancer or delay its diagnosis, ep
idemiologic studies have generally shown implant recipients to be at a redu
ced risk of subsequent breast cancer. A large retrospective cohort study wa
s undertaken to clarify effects of cosmetic breast implantation.
Methods: Medical records of 13,488 women receiving cosmetic implants at 18
plastic surgery practices and a group of 3936 patients who received other t
ypes of plastic surgery at the same practices were reviewed and information
abstracted. Questionnaires were sent to all subjects located as alive, wit
h 71% being completed. Attempts were made to obtain medical verification fo
r all reported cancers and to obtain death certificates for deceased subjec
ts.
Results: A total of 136 breast cancers were observed among the breast impla
nt patients. External analyses, using general population rates from the Sur
veillance, Epidemiology and End Results (SEER) program, resulted in 152.2 c
ases expected and a standardized incidence ratio (SIR) of 0.9 (95% CI 0.8-1
.1). A comparable SIR was found for the other plastic surgery patients (SIR
= 1.0, 95% CI 0.7-1.2). Internal analyses, directly comparing the implant
patients with the other plastic surgery patients, showed a RR of 0.8 (95% C
I 0.6-1.1). In neither the external nor internal analyses was there any sys
tematic variation in risk by age or calendar year of initial implant. Risk
also did not vary by years of follow-up or by type of implant. Risk was not
affected by exclusion of patients who received their implants following su
rgery for benign breast disease. Although breast tumors tended to be detect
ed at a somewhat later stage among the breast implant than the comparison p
atients, the difference was not statistically significant, nor was there an
y significant difference in breast cancer mortality between the two groups.
Conclusions: Breast implants do not appear to alter the risk of subsequent
breast cancer.