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| |  Silicone Breast Implants Not a Significant Risk Factor; Danish Scientists WASHINGTON -- July 21, 1997 -- A new long-term study of more than 2,500 Danish women with breast implants published in the July issue of the Annals of Plastic Surgery adds to the growing body of epidemiological evidence that implants are not a cause of connective-tissue disease in women. Equally as important, the study indicates that breast surgery of any kind may contribute to an increase in symptoms that some doctors allied with the plaintiffs' bar claim are unique to women with breast implants. This study indicated that they are not unique to implanted women. "This study should be reassuring to women with silicone breast implants who have been needlessly alarmed by the controversy surrounding this issue," said Garrey Carruthers, Chairman of The Advancement of Sound Science Coalition (TASSC). The study, which was conducted by the Danish Cancer Society, included four separate groups of women -- 1,135 who received breast implants for cosmetic purposes, 1,435 who received implants for breast reconstruction -- and two non-implanted control groups totaling 11,023 women who had either breast reduction or breast cancer surgery. The study found no statistically "significant excess of definite connective-tissue disease" in any of the four groups, either for any of five individual connective-tissue disease such as rheumatoid arthritis, scleroderma or lupus, nor for all the five diseases combined. Seventy percent (7 out of 10) of the implanted women and 64 percent (16 out of 25) of the non-implanted women with connective tissue disease had been diagnosed with rheumatoid arthritis, the most common connective tissue disease affecting women. Because the study only included women who received implants between 1977 and 1992, before the controversy over breast implants reached epidemic proportions, and also because diagnoses were obtained through the national Dutch Central Hospital Discharge register, the study authors conclude that the "possibility of reporting bias due to the publicity surround(ing) breast implants ... is unlikely in our register-based study in Denmark." The results of this study are consistent with more than a dozen epidemiological studies on breast implants that have been conducted in recent years by such prestigious institutions as Harvard Medical School, the Mayo Clinic, the University of Michigan and numerous others. The study did find, however, a statistically significant excess in all four groups of "Muscular rheumatism, fibrositis, and myalgia," which the study referred to as "ill-defined rheumatic conditions." These are the types of vague complaints that have been suggested as constituting a new or atypical disease unique to breast implants. However, the authors of the Danish study conclude that "a likely explanation of this finding would be that the excess of muscular symptoms is related to breast surgery per se, rather than to any systematic effect of silicone breast implants." A recent study published in the Journal of American Medical Association (JAMA) found that women who receive breast implants for cosmetic purposes had higher rates of certain lifestyle risk factors -- such as smoking, drinking and number of sexual partners -- that could contribute to an increased risk of disease in those women. "This study adds breast surgery itself to this list of confounding factors that must be controlled for in evaluating the risk -- if any -- of breast implants," said Carruthers.
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