Reported Complications of Silicone Gel Breast Implants: An Epidemiologic Review

15 April 1996 | Volume 124 Issue 8 | Pages 744-756

Purpose: To review the range of local and systemic complications attributed to silicone breast implants and to evaluate the epidemiologic literature on these complications.

Data Sources: Epidemiologic studies of the potential risks of silicone breast implants identified by MEDLINE search and literature review.

Study Selection: Epidemiologic studies with cohort, case–control, and cross-sectional designs. When epidemiologic studies were unavailable (as for estimates of local complications), case series were reviewed.

Data Extraction: Epidemiologic studies evaluated for methodologic quality, including such characteristics as study design, sample size and selection, determination of silicone exposure and outcome variables, and duration of follow-up.

Data Synthesis: The epidemiologic literature on the potential complications of silicone breast implants has concentrated primarily on connective tissue disorders and cancer. Estimates of the true incidence of local complications, such as rupture, capsular contracture, and breast pain, are unavailable. Studies of scleroderma and other defined connective tissue diseases suggest that implant recipients have no substantially increased risk for these disorders; however, the epidemiologic literature is insufficient to rule out an association between breast implants and connective tissue disease-like syndromes. Overall, the rate of breast cancer does not seem to be increased in women with silicone breast implants. However, the risk to women as they reach the postmenopausal years is not yet known.

Conclusions: Information is insufficient to adequately advise women who currently have or are seeking to obtain breast implants about the overall risk of these devices. No epidemiologic study has indicated that the rate of well-defined connective tissue disease or breast cancer has greatly increased in women with silicone breast implants, but no studies have ruled out a moderately increased risk for these diseases. No studies have adequately addressed the crucial issue of local complications such as rupture and capsular contracture, although evidence increasingly points to a higher risk for rupture as implants age.

Author and Article Information

From the U.S. Food and Drug Administration, Rockville, Maryland.
Acknowledgments: The authors thank Ruth B. Merkatz, PhD, RN, Louise A. Brinton, PhD, Sahar M. Dawisha, MD, Larry Kessler, ScD, and D. Bruce Burlington, MD, for their review of and comments on the manuscript.
Requests for Reprints: Barbara G. Silverman, MD, MPH, Center for Devices and Radiological Health, HFZ-541, U.S. Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850.
Current Author Addresses: Drs. Silverman, Brown, Bright, and Kaczmarek: U.S. Food and Drug Administration, Center for Devices and Radiological Health, HFZ-541, U.S. Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850.