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Title of Journal: Arch Intern Med

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Connective Tissue Disease and Other Rheumatic Conditions Following Cosmetic Breast Implantation in Denmark

Authors: Kim Kjøller, Søren Friis, Lene Mellemkjær, Joseph K. McLaughlin, Jeanette F. Winther, Loren Lipworth, William J. Blot, Jon Fryzek, Jørgen H. Olsen,

Publish Date: 2001/04/09
Volume: 161, Issue:7, Pages: 973-979
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Patients and Methods  A total of 2761 women with breast implants and 8807 control subjects were identified from plastic surgery private clinics and from public hospital plastic surgery departments. Women operated on at plastic surgery private clinics were identified through the files of each clinic, while women operated on at public hospitals were identified using the nationwide Danish National Registry of Patients. The control group consisted of women who underwent cosmetic surgery other than breast implantation or who only had a consultation. All women were followed up from January 1, 1977, through December 31, 1996, through the Danish National Registry of Patients for the occurrence of CTD as well as ill-defined and other rheumatic conditions. For the study period January 1, 1977, through December 31, 1994, the Danish National Registry of Patients contains information on hospitalization only, whereas data on outpatient visits are included from 1995 on, thus improving the sensitivity of the data. The implant and control groups were compared with the Danish population rates for CTD and ill-defined and other rheumatic conditions, and a direct comparison between the implant and control groups was also performed.Results  When compared with rates from the general population, no excess of definite CTD was observed in the implant cohorts. For ill-defined and other rheumatic conditions, statistically significant excesses of unspecified rheumatism were observed in both the implant and control cohorts when compared with national rates. A direct comparison between the implant and control cohorts found no material differences between the groups.Conclusions  The findings of this study support previous investigations and independent review panel conclusions that an association between silicone breast implants and definite CTDs is unlikely. The observation of an excess of unspecified rheumatism among women with implants and among control women suggests that women undergoing cosmetic plastic surgery have hospitalization rates for this condition in excess of those from the general population.SILICONE BREAST implants were introduced in the early 1960s, following decades of breast augmentation using paraffin and silicone oil injections, autologous tissue, and polyvinyl sponge implants.1 The use of these techniques was greatly limited by adverse outcomes and numerous local complications.1 Compared with these methods, silicone implants had the advantage of significantly better outcomes, although the risk of local complications, such as capsular contraction, was not eliminated.2,3It was not until the 1970s that the adverse systemic effects of silicone breast implants were considered. The placement of silicone implants adjacent to the breast tissue raised concern about the carcinogenic potential of breast implants. However, subsequent epidemiological studies have not identified an association between silicone breast implants and breast cancer or cancer at other sites.4-8In the early 1980s case reports emerged suggesting an association between silicone breast implants and various connective tissue diseases (CTDs), in particular systemic sclerosis.9-21 Only limited analytic epidemiological data addressing this hypothesis were available22 then. As a consequence, in 1992, the Food and Drug Administration banned the use of silicone breast implants in the United States other than for reconstructive purposes or as part of prospective safety studies.22 Since then, many epidemiological studies addressing the potential association between silicone breast implants and CTD have been published.22-40 All22-33,35-40 but one34 have failed to demonstrate an increased risk of systemic sclerosis or any other CTDs. The one study34 that found a small, but significant, excess of CTD was based on self-reporting of diseases, the subsequent validation of reported CTDs found evidence for overreporting, as only 22.7% of the self-reported cases could be confirmed.41 Three independent scientific review bodies have recently evaluated the available data on silicone breast implants42-45; all concluded that an association between silicone breast implants and CTDs has not been demonstrated and is unlikely to exist.



citation_title=Breast implants, cancer, and systemic sclerosis [letter].; citation_author=McLaughlin JK; citation_author=Olsen JH; citation_author=Friis S; citation_author=Mellemkjær L; citation_author=Fraumeni Jr JF; J Natl Cancer Inst.; citation_year=1995; citation_volume=87; citation_pages=1415-1416;

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