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have estimated as many as 40,000 women) had breast injections in Las Vegas by 1976 when the practice became a felony under Nevada State law. Practitioners reportedly charged $800 to $2,000 for a series of injections in 1966 (Kopf, 1966; Kopf et al., 1976; Vinnik, 1991), and domestic reports continue from there and elsewhere (Leibman and Sybers, 1994; Morgenstern et al., 1985; Sánchez-Guerrero et al., 1995a,b).

Soft-tissue (excluding breast) augmentation by injection with medical-grade silicone was approved for experimental use in the United States under an FDA investigational new drug (IND) exemption to Dow Corning for use by six, and later seven, plastic surgeons and one dermatologist for about a decade, 1965-1975 (Ashley et al., 1967; Braley, 1971; Wustrack and Zarem, 1979). Although this material broke up into "innumerable droplets" on injection and tended to spread out from the injection site, results appeared promising at first (Ashley et al., 1965; Rees et al., 1970). After a few to as many as 28 years, however, problems began to appear (Rapaport et al., 1996). As with paraffin earlier, initial enthusiasm was tempered by the appearance of complications. The question of systemic effects is discussed in Chapter 8 of this report. Among the more clear-cut effects associated with silicone breast injection (as noted, not an FDA-approved use as part of the Dow Corning IND) have been pain, skin discoloration, edema, ulceration and necrosis, calcification, granulomas, migration of the fluid, infection, cysts, axillary adenopathy, disfigurement and loss of the breast, liver granulomas and dysfunction, acute pneumonitis or adult respiratory distress syndrome, pulmonary embolism, coma, and death (Baker, 1992; Boo-Chai, 1969; Brozena et al., 1988; Celli et al., 1978; Chastre et al., 1983a, 1987; Chen, 1995; Chen et al., 1993; Cruz et al., 1985; Edgerton and Wells, 1976; Ellenbogen and Rubin, 1975; Inoue et al., 1983; Ko et al., 1995; Koide and Katayama, 1979; Lai et al., 1994; McCurdy and Solomons, 1977; Parsons and Thering, 1977; Perry et al., 1985; Piechotta, 1979; Rodriguez et al., 1989; Solomons and Jones, 1975; Symmers, 1968; Truong et al., 1988; Vinnik, 1978; Winer et al., 1964). Some of these complications occurred instantly, such as acute pneumonitis with findings of substantial deposition of silicone in the lung, which was probably due to pulmonary embolism from inadvertent intravenous injection or other circulatory access of the silicone fluid (Solomons and Jones, 1975). More often, complications were noticed after a few years. Various reports cited a complication rate of 1% of patients per year (Kopf et al., 1976), a prevalence of 50% at five years after injection (Vinnik, 1976a,b), the onset of disturbing problems at two or three to five or six years (Ohtake et al., 1989; Wustrack and Zarem, 1979), or the average occurrence of problems at about nine years (Parsons and Thering, 1977). Presumably because medical-grade silicone is a "mild irritant" as opposed to adulterated silicone or other substances, which are irritating to a greater extent, compli-