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

Arch Intern Med. 2001;161:973-979.

Objective  To examine the occurrence of connective tissue diseases (CTDs) as well as ill-defined and other rheumatic conditions among Danish women with cosmetic silicone breast implants.

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.

From the Institute of Cancer Epidemiology, Danish Cancer Society, Copenhagen, Denmark (Drs Kjøller, Friis, Olsen, Mellemkær, and Winther); the International Epidemiology Institute, Rockville, Md (Drs McLaughlin, Lipworth, Blot, and Fryzek); and Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville, Tenn (Drs McLaughlin, Lipworth, Blot, and Fryzek).

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