Safety of Silicone Breast Implants (1999) / Chapter Skim
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8 Epidemiological Studies of Connective Tissue or Rheumatic Diseases and Breast Implants
8 Epidemiological Studies of Connective Tissue or Rheumatic Diseases and Breast Implants
Pages 215-232
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From page 215... ...
Taken together, they do not support an association between connective tissue disease, combined or individually, or stated another way, an elevated relative risk for these diseases, in women with silicone breast implants.Although there are some informative abstracts and letter reports (e.g., Dugowson et al., 1992; Lacey, 1998; McLaughlin et al., 1994, 1995a; Wolfe, 1995a) , with a few exceptions the committee limited its review of the epidemiology of connective tissue disease to full reports in the peer-reviewed, scientific literature, and focused on connective tissue diseases, combined and individual (primarily SSc, SLE, RA, DIP, and SS)
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From page 216... ...
The principal results of these studies, that is, the risk of CTD associated with silicone breast implants, are summarized in Table 8-1. CROSS-SECTIONAL STUDY Goldman et al.
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From page 217... ...
though six women who had implants after the diagnosis of RA or other CTD were included (Goldman et al., 1995~. Rheumatoid arthritis and connective tissue disease overall were statistically significantly less frequently diagnosed in patients with silicone breast implants than in those without implants.
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From page 218... ...
In this way, 287 cases and 252 controls were identified. Three cases and three controls had silicone gel breast implants before diagnosis or prior to the selected date for controls.
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From page 219... ...
and 167 with undifferentiated connective tissue disease, first in an abstract and subsequently in a full report. (The abstract is cited because it contains information on the distribution of breast implants and an odds ratio not found in the full report.)
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From page 220... ...
There were 749 women with implants and 1,498 controls; 5 of the 749 women with breast implants and 10 of the 1,498 controls had a connective tissue disease. The adjusted relative risk was 1.10 (95% CI, 0.37-3.23)
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From page 221... ...
(1995) carried out a study using the Nurses' Health Study Cohort to investigate the association between connective tissue disease and breast implants.
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From page 222... ...
Furthermore, information on other than defined connective tissue disease was collected and analyzed. These considerable strengths make this an important study that finds no relationship between connective tissue disease or rheumatic conditions and breast implants.
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From page 223... ...
Expected numbers of each connective tissue disease were calculated by multiplying the number of person-years of follow-up in the groups by the sex-specific national hospital discharge rates for each five-year age group and the calendar period of observation. For connective tissue diseases combined, the observed-expected ratio for cosmetic breast implant patients was 1.1 (95% CI, 0.2-3.4)
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From page 224... ...
Women who had silicone gel breast implants for augmentation between 1982 and 1991 were compared with a control group of outpatients in a plastic surgery department. A second group, cancer patients reconstructed with silicone gel implants during the same decade, was matched with a control group of breast cancer patients without implants.
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From page 225... ...
Excluding this report, a very substantial body of evidence, consisting of a number of independent investigations and other analyses, does not provide evidence for an association of silicone gel- or saline-filled breast implants with defined connective tissue disease. Although others (e.g., Hulka, 1998)
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From page 226... ...
As discussed earlier, 156 women with defined connective tissue disease were also reported. One woman with silicone breast implants was found in each group (specifically one woman with SSc and one with unexplained polyarthritis)
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From page 227... ...
Five reports (Edworthy et al., 1998; Friis et al., 1997a; Hennekens et al., 1996; Nyren et al., 1998a; and Sanchez-Guerrero et al., 1995) discussed earlier did not study undifferentiated connective tissue disease and breast implants specifically, but did evaluate a range of conditions besides defined CTD, including early, mixed, atypical, and ill-defined connective tissue diseases; fibromyalgia; and constellations of up to 41 signs and symptoms that occur in defined and undifferentiated CTD and in rheumatic-like conditions.
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From page 228... ...
If such a condition could be defined and this definition applied to a reproducible set of signs, symptoms, and clinical laboratory criteria, then epidemiological studies to explore this condition in relation to silicone breast implants could be carried out. A definite diagnosis of this disease was proposed by the reference group of physicians to require the presence of a silicone gel filled breast implant and the presence of local disease, that is, any of the following: capsular contracture, rupture, more than six weeks of chest wall pain, more than six weeks of breast pain, axillary adenopathy, entrapment neuropathy, immune skin rash or immune granulomas in the implant capsule.
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From page 229... ...
Others have recently stressed the prevalence of this constellation of signs and symptoms, the reliance of research on self-report data, and the uncertain boundaries of the multiple associated diagnoses (Lloyd, 1998~. Many of these criteria have also been reviewed in existing studies of women with breast implants.
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From page 230... ...
(1994~; swollen axillary glands were more common in the patients than in controls. The cohort studies reviewed here did not find sicca complex, rash, myalgia, skin tightening, or thickening significantly more frequently in women with breast implants compared to controls.
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From page 231... ...
CONCLUSIONS The committee finds no convincing evidence for atypical connective tissue or rheumatic disease or a novel constellation of signs and symptoms in women with silicone breast implants. Case reports, of which there
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From page 232... ...
The controlled epidemiological studies cited provide stronger, contrary evidence. In view of the paucity, weakness, and conflicting nature of the evidence, the committee concludes that there is no rigorous, convincing scientific support for atypical connective tissue or any new disease in women that is associated with silicone breast implants.
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