PURPOSE: There has been limited investigation of cancer risk other than bre
ast cancer among patients with breast implants, despite some clinical and l
aboratory evidence suggesting links with certain cancer sites, including he
matopoietic and connective tissue malignancies.
METHODS: A retrospective cohort study of 13,488 patients who received cosme
tic breast implants at 18 plastic surgery practices in six geographic areas
was conducted to assess long-term health effects. After an average of 12 y
ears of follow-up, questionnaires were administered to subjects located and
alive (78% of eligible population). Attempts were made to obtain death cer
tificates for deceased subjects and medical verification for all reported c
ancers. Expected numbers of cancers were derived using general population c
ancer incidence rates and an internal comparison series of 3936 patients wh
o received other types of plastic surgery at the same practices as the impl
ant patients.
RESULTS: A total of 359 malignancies was observed versus 295.95 expected ba
sed on general population rates, resulting in a standardized incidence rati
o (SIR) of 1.21 [95% confidence interval (CI) 1.1-1.4]. Individual malignan
cies for which incidence was significantly elevated inducted cancers of the
stomach (SIR = 2.65), cervix (SIR = 3.18), vulva (SIR = 2.51), brain (SIR
= 2.16), and leukemia (SIR = 2.19). No excess risks were observed for other
hematopoietic malignancies, including multiple myeloma. The internal analy
ses, however, based on cancer rates derived among the comparison patients,
showed no increased cancer risk among the implant patients [relative risk (
RR) = 1.00, 95% CI 0.8-1.2], as well as no statistically significant elevat
ions for most individual sites. Cervical cancer continued to be elevated (R
R = 1.78), although to a lesser extent than in the external analyses, while
the risk for respiratory cancers was higher (RR = 2.40). Non-significant e
levations in risk persisted in this analysis for liver cancer (RR = 2.65),
brain cancer (RR = 2.83), and leukemia (RR = 1.83). Many of the cancers sho
wing excesses were defined on the basis of death certificates, requiring ca
ution in interpretation. The histologies of the leukemias were quite varied
, which makes a biologic relationship appear unlikely. However, respiratory
cancers showed some evidence of increasing risk with follow-up time and bo
th respiratory and brain cancers were elevated in the mortality analyses.
CONCLUSIONS: Although excesses of cervical and vulvar cancer among implant
patients might he attributable to lifestyle factors, reasons for excesses o
f respiratory and brain cancers were less apparent. Ann Epidemiol 2001;11:2
48-256. (C) 2001 Elsevier Science Inc. All rights reserved.