By Gabriel S.E., et al.
New England Journal of Medicine1994;330:1697-702

Background: We conducted a population-based, retrospective study to examine the risk of a variety of connective-tissue diseases and other disorders after breast implantation.

Methods: All women in Olmsted County, Minnesota, who received a breast implant between January 1, 1964, and December 31, 1991 (the case subjects), were studied. For each case subject, two women of the same age (within three years) from the same population who had not received a breast implant and who underwent a medical evaluation within two years of the date of the implantation in the case subject were selected as control subjects. Each woman's inpatient and outpatient medical record was reviewed for the occurrence of various connective-tissue diseases, certain other disorders thought to have an autoimmune pathogenesis (e.g., Hashimoto's thyroiditis), and cancer other than breast cancer, as well as related symptoms and abnormal results of laboratory tests. The case subjects were categorized according to whether they received implants for cosmetic reasons, for reconstruction after mastectomy for breast cancer, or for reconstruction after subcutaneous mastectomy for cancer prophylaxis. Additional control subjects (women treated for breast cancer who did not have breast reconstruction) were studied for comparison with the case subjects.

Results: A total of 749 women who had received a breast implant were followed for a mean of 7.8 years, and 1,498 community controls were followed for a mean of 8.3 years. In 5 case subjects, as compared with 10 subjects in the control group, one of the specified connective-tissue diseases was diagnosed (relative risk, 1.06; 95 percent confidence interval, 0.34 to 2.97). Twenty-five case subjects had signs or symptoms of arthritis, as compared with 39 control subjects (relative risk, 1.35; 95 percent confidence interval, 0.81 to 2.23). Among the various signs or symptoms examined, only morning stiffness was significantly increased among the women who had received a breast implant (relative risk, 1.81; 95 percent confidence interval, 1.11 to 2.95).

Conclusions: We found no association between breast implants and the connective-tissue diseases and other disorders that were studied.