Connective Tissue Disorder

Silicone Breast Implants and Connective Tissue Disorders Connective tissue disorders (CTDs) are described as a group of generalized disorders affecting the connective tissues (i.e., fat, bone, and mucous). It has been theorized that silicone breast implants may increase the risk of developing a CTD. As the following clinical studies indicate, actual statistical information has provided no significant evidence that silicone breast implants greatly increase the risk of developing CTDs.

A 1993 University of Texas, Houston study published in the Annals of Plastic Surgery investigated 603 women undergoing reconstructive breast surgery between 1986 and 1992. In this study 250 women had breast reconstruction with silicone gel-filled breast implants and 353 women had breast reconstruction utilizing their own tissue. Results of this preliminary report found that "the incidence of autoimmune diseases in mastectomy patients receiving silicone gel implants is not different than in patients who had reconstruction with autogenous [patient's own] tissue."

A 1994 Mayo Clinic study published in the New England Journal of Medicine compared 749 women who had breast implant surgery between 1964 and 1991, with 1,498 women who did not have breast implant surgery. Study results showed "no association between breast implants and the connective tissue diseases and other disorders that were studied."

A 1995 Harvard/Brigham's Hospital study published in the New England Journal of Medicine analyzed 14 years of follow-up data from the Nurses Health Study Cohort. This resulted in the review of over 87,000 women, with and without breast implants. Results found no "association between silicone breast implants and connective tissue diseases."

A 1994 Scottish study published in Plastic and Reconstructive Surgery compared 317 women with silicone-filled breast implants over a 10 period with women who did not have breast implants. The average follow-up time was 68 months. This study concluded, "no differences were found in the symptoms or physical signs of connective tissue diseases between the study patients and their controls. This study has failed to find any case for a link between silicone gel-filled breast implants and connective tissue diseases."

A 1996 Canadian study published in The Journal of Rheumatology was a retrospective study in Alberta that recruited 1,576 women including 1,112 who had received silicone breast implants between 1978 to 1986. Postsurgical diagnoses of the principal targeted conditions of rheumatoid arthritis, systemic lupus erythematosus, scleroderma and Sjögren's syndrome did not indicate an increased incidence of typical or atypical CTD. "The results of this study do not support the hypothesis that silicone gel-filled implants induce or promote CTD."

A 2000 brochure published by the Institute of Medicine, Information for Women About the Safety of Silicone Breast Implants states "there is no evidence that silicone breast implants contribute to an increase in autoimmune (connective tissue) diseases. A review of 17 separate studies of the occurrence of connective tissue disease in the population was remarkable for the consistent finding of no elevated risk or no indication of an association of implants with disease. Evidence suggests that such diseases are no more common in women with breast implants than in women without them."

A published statement prepared by the American College of Rheumatology (ACR) - a task force of plastic surgeons, rheumatologist specialists, and the American Medical Association - advises that while a theoretical risk for CTDs might exist, especially for a patient with a CTD, there is "no reason to discourage women from considering breast [implant surgery] on the basis of acquiring or exacerbating a connective tissue disorder."