Breast implant-related silicone granulomas: the literature and the litigation

Formation of a granuloma is a common tissue response to the presence of a variety of foreign materials. A silicone granuloma is, by definition, a type of tissue reaction elicited occasionally by silicone. Granulomas of this sort have not engendered a great deal of attention in the scientific literature since their first description in 1964, and they were considered by most surgeons through the 1980s to be an incidental finding of little or no consequence. Since it is tangible and readily visible to juries, the silicone granuloma became a frequent issue in breast implant litigation in the 1990s. Although most other complaints in this litigation have been subjective or causally unrelated to silicone, the presence of a granuloma has been used as a basis of local complication claims and, more creatively, as a mechanism for hypothetical systemic disease occurrence. This review examines the basic science and the clinical literature pertaining to breast implant-related silicone granulomas, viewing them in a context of current clinical thought and frequent issues of litigation. Clinically apparent silicone granulomas are a relatively rare complication of breast implant placement and surgical resection is indicated when they are symptomatic or of diagnostic concern. There is no evidence in the peer-reviewed scientific literature to support frequent plaintiff theories in litigation that silicone granulomas play some role in implant-related systemic disease. In fact, the very existence of such diseases, themselves, is equally unsubstantiated.