Connective Tissue Disease and Other Rheumatic Cond

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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Abstract

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 illdefined 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 illdefined and other rheumatic conditions and a direct comparison between the implant and control groups was also performedResults  When compared with rates from the general population no excess of definite CTD was observed in the implant cohorts For illdefined 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 groupsConclusions  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 populationSILICONE BREAST implants were introduced in the early 1960s following decades of breast augmentation using paraffin and silicone oil injections autologous tissue and polyvinyl sponge implants1 The use of these techniques was greatly limited by adverse outcomes and numerous local complications1 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 eliminated23It 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 sites48In the early 1980s case reports emerged suggesting an association between silicone breast implants and various connective tissue diseases CTDs in particular systemic sclerosis921 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 studies22 Since then many epidemiological studies addressing the potential association between silicone breast implants and CTD have been published2240 All22333540 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 selfreporting of diseases the subsequent validation of reported CTDs found evidence for overreporting as only 227 of the selfreported cases could be confirmed41 Three independent scientific review bodies have recently evaluated the available data on silicone breast implants4245 all concluded that an association between silicone breast implants and CTDs has not been demonstrated and is unlikely to exist

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