Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women

Objective. To assess whether breast implant rupture or extracapsular silico ne are associated with selected symptoms of self-reported physician-diagnos ed connective tissue disease (CTD). Methods. Women with silicone gel breast implants responded to a questionnai re that included questions on health status, satisfaction with implants, sy mptoms of CTD, and physician-diagnosed disease. These women then had magnet ic resonance imaging (MRI) of their breasts to determine the status of the implants with respect to rupture and extracapsular silicone. Results. Women with breast implant rupture diagnosed by MRI were no more li kely to report a diagnosis of selected CTD than those with intact implants or those with implants of indeterminate status. Women with extracapsular si licone (silicone gel outside of the fibrous scar that forms around breast i mplants) were more likely to report having fibromyalgia (FM, p = 0.004) or other CTD, which included dermatomyositis, polymyositis, Hashimoto's thyroi ditis, mixed CTD, pulmonary fibrosis, eosinophilic fasciitis, and polymyalg ia (p = 0.008) than other women in the study. The association with FM remai ned statistically significant when adjusted for multiple comparisons (7 dia gnoses) and implant age, implant location, or implant manufacturer (p < 0.0 5 in all cases), but became of border line statistical significance when ad justed for multiple comparisons and self-perceived health status (p = 0.094 ) or self-perceived rupture status (p = 0.051), The association with other CTD remained statistically significant when adjusted Tor multiple compariso ns and implant location or implant manufacturer, but became borderline or i nsignificant when adjusted for multiple comparisons and for implant age (p = 0.051), self-perceived health status (p = 0.434), or self-perceived ruptu re status (p = 0.145). Logistic regression was used to compute odds ratios of self-reported diagnoses comparing women with and without extracapsular s ilicone. The odds ratios were 2.8 (95% CI 1.2 to 6.3) for FM, and 2.6 (95% CI 0.8 to 8.5) for other CTD after adjustment far implant age, implant loca tion, implant manufacturer, implant type, self-perceived health, self-perce ived rupture status, and site of surgery practice. Conclusion. These data suggest an association between extracapsular silicon e. from ruptured silicone breast implants and FM. If this association persi sts in other studies, women with silicone gel breast implants should be inf ormed of the potential risk of developing fibromyalgia if their breast impl ants rupture and the silicone gel escapes the fibrous scar capsule.