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Silicone Implants

A successful silicone (urethral) implantation was reported in 1950 (De Nicola, 1950); subsequently silicone use for shunts and joints was proposed (Marzoni et al., 1959), and many such shunts, joints, and other devices were developed and used in medical practice. These clinical experiences, animal experiments, and early work on tissue reaction to silicone (Child et al., 1951; Kern et al., 1949; Rees and Ashley, 1966; Rowe et al., 1948; see also Chapter 4) provided a context and encouragement for the consideration of this technology in cosmetic breast surgery. The disappointing results with other technologies for breast augmentation or reconstruction provided an opportunity and an unmet need. The response to this need was the introduction of the silicone breast implant in 1962 and its continued development through the 1990s, as described in Chapter 3. The specific experimental basis for the clinical introduction of this device was the work reported by Cronin and Gerow (1963) on implantation of silicone shells (four to six per animal) filled with either dextran or electrolyte solution in each of 12 dogs for periods of a few days to 18 months without signs of toxicity or other complications.

Silicone Implants and Patient Satisfaction—Its Importance and Effect on Demand

Although the silicone implant was considered an improvement, it was not problem-free. Some implant complications such as small areas of epidermolysis or necrosis and small, isolated seromas are minor, although they might require medical attention; other complications, infections, implant ruptures, and severe fibrous capsule contractures are of greater import. Complications are less frequent in augmentation than in reconstruction, but as noted in Chapter 5, they still occur with considerable frequency. The more serious risks of reconstruction with implants, especially immediate reconstruction (Spear and Majidian, 1998), must be balanced against the psychological benefits (Stevens et al., 1984; Wellisch et al., 1985). Implants for augmentation are placed in healthy women who would otherwise not be operated on and incur such risks. Placement of a breast implant for either augmentation or reconstruction does not treat the physical component of human disease or disordered physiology. It is, in this sense, elective and therefore warranted only if it is relatively safe and provides patient satisfaction.

Satisfaction has an effect on the demand for interventions to manage or relieve complications and thus on the implications of complications for the safety of silicone breast implants. The high overall level of satisfaction of women in medical reports, if accurate and lasting, implies a low level