86.2 (1988)

137.6 (1988)

Mayes et al.i (2003)

United States 1989-1991

242 [213-274]

398 (95% CI 353-430).

increased on an average of 3.6% per year over the whole period. The prevalence of morphea was 220/100,000 population.

Risk Factors for SSc

As for SLE a family history of SSc increases the risk of SSc. An estimated prevalence of approx. 1% of SSc in relatives was calculated in a recent study of Englert et al. (1999) based on 715 sclerosis patients and 371 controls. Possible risk factors for SSc were for a long time only in the focus of a few selected scientists. Everything changed when silicon implants were suspected as possible risk factors in a few case series. Miyoshi et al. (1964) were the first to report the development of connective tissue diseases (CTD) in cosmetic surgery patients who had received injections of foreign substances. Van Numen et al. (1982) reported three different cases of CTD in women with silicone breast implants (SLE, MCTD, and rheumatoid arthritis (RA) with Sjogren's syndrome). In 1984, Kumagai et al. summarized the Japanese experience, reporting 24 cases of defined CTD in breast augmentation patients who had received injections of either paraffin or silicone. They suspected that a possible excess of scleroderma was primarily in patients injected with paraffin. Subsequently, case reports have included RA (Van Numen et al. 1982; Hammer and Krippner 1991), SLE (Van Numen et al. 1982; Guillaume et al. 1984), SSc (Spiera 1988; Gutierrez and Espinoza 1990; Marik et al. 1990), Sjogren's Syndrome (Van Numen et al. 1982; Haga et al. 1992), dermatomyositis/polymyositis (Haga et al. 1992) and MCTD (Van Numen et al. 1982). These cases from many different countries demonstrated world-wide concern and several epidemio-logical studies were initiated. Some studies focused on scleroderma alone (Weisman et al. 1988; Burns 1994; Englert and Brooks 1994; Hochberg et al. 1996), others on CTD, comprising a variety of diagnoses (Schusterman et al. 1993; Gabriel et al. 1994; Giltay et al. 1994; Goldman et al. 1995; Perkins et al. 1995; Sánchez-Guerrero et al. 1995b; Park et al. 1997; Edworthy et al. 1998; Nyrén et al. 1998). The relative risks in Tables 8-11 are for CTD if not indicated otherwise. Results for the different specified CTD (mostly SSc) are given in the text as far as available.

The first report, whose results could be compared with other studies came from Spiera (1988) of New York City, who reported that five of his 113 new female SSc patients had breast implants as had one of his 286 RA patients, and none of his patients with SLE or polymyositis. The next comparative report of SSc and breast implants from Wigley et al. (1992) stated that 1% of female SSc patients in Baltimore and Pittsburgh had breast implants and that 50% of them had received their implant only after the disease had begun or had been diagnosed. The pre-diagnosis implant prevalence was not different from the prevalence estimated for U.S. adult females. The cohort study

Table 8. Different Cross-Sectional Studies about Breast Implants (BI) as a Risk Factor for CTDs



Average follow-up time in years

No. of CTDs in women with BI/No BI

Relative Risk of developing a CTD (95% CI)

Goldman et al.



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