Background: Claims have been made that breast augmentation induces a previously unrecognized disease ("silicone-osis").
Aims: To confirm the existence of "silicone-osis", qualify and quantify its characteristics.
Methods: In this population-based retrospective cohort study, the health status of 458 female Sydney residents who had augmentation mammoplasty for cosmetic reasons ("augmentation mammoplasty-exposed" or "exposed" cohort) between 1979 and 1983 was compared with the health status of 687 female Sydney residents who had non-silicone-associated plastic surgery ("augmentation mammoplasty-nonexposed" or "non-exposed" cohort). Both groups were matched for age (+/- 5 years), year of plastic surgery (+/- 2 years), plastic surgeon, anaesthetist and mode of anaesthesia. Outcome measures comprised dummy symptoms to assess reporting bias, as well as symptoms and symptom clusters from a comprehensive 78-symptom list.
Results: Dummy variables were not over-reported by the exposed cohort. The following individual symptoms developed more commonly in the exposed cohort after index plastic surgery: "memory loss/confusion", "altered bowel habit", "chest pain made worse by deep breathing", "shortness of breath after walking up 10 steps", "breast pain", "sweating mainly at night" and "tunnel vision". Of eight identified symptom clusters, three were rejected as biologically unimportant: "joint swelling of the bunion joint", "haemorrhoids" and "breast lumps" (the latter two occurring more commonly in the non-exposed cohort). In contrast, five symptom clusters were thought to have potential biological importance and occurred more commonly in the exposed cohort. The symptom "night sweats" was common to all five clusters, and comprised the sole symptom in one instance. The other four multisymptom clusters were also characterized by "low energy" (lethargy) and "pins and needles", whereas "breast pain", "impaired memory", "muscle pain" and "reflux", occurred in three of the four clusters.
Conclusion: Cluster analysis suggested the existence of a multisystem disorder occurring more commonly in the exposed cohort and characterized by night sweats, lethargy, breast pain, impaired mentation, reflux, paraesthesiae, hand muscle weakness and myalgia. The argument against this being a new disease entity --"silicone-osis"-- however, was its presence, albeit at lower frequency, in the silicone-unexposed cohort. Thus this study did not confirm the existence of a new disease entity "silicone-osis" uniquely and causally associated with silicone exposure. The possible interpretations of these findings are discussed.