Rheumatic Disease Among 1167 Women Reporting Local Implant and Systemic Problems After Breast Implant Surgery

Abstract

Concerns about the safety of silicone breast implants have grown since 1988, when the Food and Drug Administration (FDA) designated silicone gel-filled breast implants as devices posing a risk to public safety. Potential risks include the development of connective tissue diseaselike syndromes and rheumatic disease, as suggested by numerous case reports. This study describes the frequencies of physician diagnoses and symptoms of the rheumatic diseases, systemic sclerosis (scleroderma), systemic lupus erythematosus, and rheumatoid arthritis, in 1167 women who have had breast implant surgery and who have reported local implant or systemic problems to the FDA. The investigators used a telephone survey of 820 respondents who were from all of the contiguous United States except Vermont. Among the 820 women, 232 (28%) reported a diagnosis of one of these three diseases after breast implant surgery. Many more met epidemiologic criteria for scleroderma, systemic lupus erythematosus, and rheumatoid arthritis after breast implant surgery. Statistically significant associations (p < 0.05) were breast implant type with scleroderma, breast implant manufacturer with systemic lupus erythematosus, geographic area with rheumatoid arthritis, and breast implant leakage or rupture and reason for implant surgery with each of the three rheumatic diseases. Analysis using a subgroup of women who had implant surgery at least 10 years before the interview and reported a physician diagnosis of or met epidemiologic criteria for at least one of the diseases revealed a higher percentage for scleroderma in the first year after implant surgery and for systemic lupus erythematosus in years 8 through 10. These findings warrant further study.