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Safety of Silicone Breast Implants (1999)
Institute of Medicine (IOM)

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efforts with so-called open-pore polymer sponge implants such as Ivalon or Etheron led to hard, unnatural-looking breasts and other complications (Broadbent and Woolf, 1967). Thousands of women had these implants, which made up about a third of implantations in the 1960s according to one large international survey (De Cholnoky, 1970).

Injections

During the decades after the Second World War an array of liquid substances were injected, often illegally by unlicensed practitioners, to augment the breast (and other sites; see e.g., Christ and Askew, 1982). These are cited in reports from Japan, the Far East, and domestic plastic surgeons. They include paraffin; other poorly defined, more radiolucent hydrocarbons called "Organogen" and "Bioplaxm" (Yamazaki et al., 1977) and some forms of petroleum jelly such as Vaseline (Ohtake et al., 1989). Adulterated silicone oil (e.g., the "Sakurai'' formula) was also commonly used. It was believed to have been adulterated with 1% ricinoleic acid (Pearl et al., 1978); 1% animal and vegetable fatty acids (Kagan, 1963); or 1% mineral and vegetable (perhaps castor) oil (Chaplin, 1969), 1% olive oil (Tinkler et al., 1993), or to contain croton oil, peanut oil, concentrated vitamin D, snake venom, talc and paraffins (Kopf, 1966; Rapaport et al., 1996). Use of a variety of unknown oils has been reported, some with silicone of mostly unknown origins (Ortiz-Monasterio et al., 1972), as well as beeswax, shellac, glaziers' putty, epoxy resin (Symmers, 1968), and industrial silicone fluids. Medical-grade silicone fluid, including Dow Corning 200, 350, and MDX 44011 (Ashley et al., 1967); silicone (Elicon-Kogen Kogyo Co. Ltd.) gel (Boo-Chai, 1969); and silicone Silastic S-5392 RTV (room temperature vulcanized) fluid with a stannous octoate catalyst to form a silicone rubber within the breast tissue were also used for breast augmentation and other plastic surgical purposes with positive early reports (Ashley et al., 1967; Conway and Goulian, 1963; Freeman et al., 1966; Harris, 1965). Substantial amounts of these substances were injected on occasion, as much as 2 liters for breast augmentation and body contouring in a single patient (Kagan, 1963) or half a liter of fluid and catalyst per breast (Conway and Goulian, 1963).

Results with other than medical-grade silicone were poor, and included loss of both breasts and death (see references below). Dow Corning Medical Grade 360 fluid, which according to Vinnik (1991) was used extensively in Las Vegas, also resulted in complications, but the silicone mentioned in many reports was undoubtedly adulterated in the misguided hope that an adulterant would inhibit fluid migration and give better results. Sakurai personally reported 72,648 cases injected, including the breast among other sites (Kagan, 1963). At least 12,000 women (some

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