British Journal of Rheumatology 1994,33^01-604 EDITORIALS SILICONE BREAST IMPLANTS AND RHEUMATIC DISEASE SIUCONE breast implants became available for use in infer causality, we require knowledge of either the inci- the United States in 1962 , and it is estimated that dence of these rheumatic symptoms and connective tis- approximately 1% of adult women aged 18 and above sue diseases in cohorts of women who have and have in the United States have undergone augmentation not undergone augmentation mammoplasty with sili- mammoplasty, most with implantation of silicone gel- cone gel-filled prostheses, or the frequency of the sur- filled prostheses [2, 3]. The vast majority of these pro- gical procedure in groups of women with and without cedures were performed for cosmetic augmentation, rheumatic symptoms and connective tissue diseases. while only about 20% were performed for breast Thus, what is required are data from either cohort or reconstruction after mastectomy. Because of concerns case-control epidemiologic studies. Preliminary data regarding both short- and long-term safety, including a from two studies were presented at the 1993 annual possible increased risk for the development of 'arthri- meeting of the ACR [14, 15] and will be briefly Downloaded from http://rheumatology.oxfordjournals.org by on July 13, 2010 tis-like and other auto-immune diseases', silicone gel- reviewed. filled prostheses are no longer available for routine use Gabriel and colleagues presented data from a retro- in either the United States  or Canada ; they spective cohort study which utilized the Rochester Epi- remain available, however, in the United Kingdom and demiology Project database and identified all women almost all other countries within the European Com- who had undergone augmentation mammoplasty with munity (Ludgate, personal communication). silicone gel-filled breast implants between January Reports of connective tissue disease occurring in 1964 and December 1991 and were residents of patients who had undergone augmentation mammo- Olmsted County, Minnesota . A total of 824 plasty with injections of silicone, paraffin and other women, aged 15 to 79 years, received silicone gel-filled materials began with that of Miyoshi et al. in 1964 who prostheses during this interval; over 80% of procedures described the syndrome of human adjuvant disease . were for cosmetic breast augmentation. The medical The vast majority of cases with disease following injec- records of each exposed women and two age-matched tions of these materials have been reported in the control women were reviewed for the occurrence of Japanese literature . A task force of the American any connective tissue disease; all diagnoses were vali- Society of Plastic and Reconstructive Surgery con- dated with ACR classification criteria. Over an average cluded recently that this diagnostic category was follow up of 8 years in both groups, there were two imprecise and should not be used in future clinical cases of definite connective tissue disease among the reports . exposed women (RA and SjOgren's syndrome, 1 each) The first report of patients developing well-defined and five among the controls (all RA); no cases of connective tissue disease after augmentation mammo- systemic sclerosis were observed. The relative risk for plasty with silicone gel-filled implants was by Van development of connective tissue disease among the Nunen and colleagues in 1982 . Recently, Sanchez- exposed women was 0.83 (95% CI: 0.14,3.8) which was Guerrero and colleagues reviewed the English lan- not statistically significantly different from unity. guage literature from 1964 through June 1993 and iden- Hochberg and colleagues presented preliminary tified reports of 293 patients with rheumatic symptoms results from a multi-centre case-control study of the following augmentation mammoplasty with silicone association of augmentation mammoplasty with gel-filled breast implants ; these cases are summar- systemic sclerosis . The study includes 840 women ized in Table I. The vast majority of these cases, includ- with systemic sclerosis and up to three age-, race- and ing those reported by Bridges and colleagues , had sex-matched controls identified through the process of rheumatic symptoms including arthralgias/itis, myal- random digit dialing. Data on history of augmentation gias and fatigue, and did not fulfill diagnostic or classifi- mammoplasty, including the type of prosthesis, occur- cation criteria for any recognized connective tissue disease. Of those 72 patients who did fulfill such cri- TABLEI Diagnoses in 293 patients with rheumatic symptoms following teria, the majority had a diagnosis of systemic sclerosis augmentation mammoplasty with silicone gel-filled breast or a scleroderma-spectrum disorder such as mixed con- implants* nective tissue disease ; included herein are cases reported by Speira et al. [12, 13]. Definite connective tissue disease 57 (Systemic sclerosis, 38) The above data are derived either from single case Possible connective tissue disease 15 reports or case series, and do not provide an adequate Connective tissue disease-like 56 basis to infer a causal association between the silicone Human adjuvant disease 1 Rheumatic symptoms 164 gel-filled implants and the development of rheumatic symptoms and connective tissue diseases. In order to •Modified from reference . 0263-7103/94/070601 + 04 $08.00/0 11994 British Society for Rheumatology 601 602 BRITISH JOURNAL OF RHEUMATOLOGY VOL. 33 NO. 7 rence of complications and need for explantation, were 5. Independent Advisory Committee on Silicone-gel- obtained through interview. Augmentation mammo- filled Breast Implants. Summary of the report on sili- plasty was reported by three (1.0%) of 290 cases resid- cone-gel-filled breast implants. Can MedAssocJ 1992; ing in either Maryland, Virginia, District of Columbia 147:1141-6. or California and five (1.3%) of 384 controls; the 6. Miyoshi K, Miyaoka T, Kobayashi Y et al. Hyper- adjusted odds ratio for the association of augmentation gammaglobulinemia by prolonged adjuvantirity in man: disorders developed after augmentation mam- mammoplasty with systemic sclerosis was 0.86 (95% maplasty. Ijishimpo 1964;2122.-9-14. CL 0.20,3.63). 7. Kumagai Y, Shiokawa Y, Medsger TA, Rodnan GP. Thus, neither these nor previous studies [16-18] Clinical spectrum of connective tissue disease after demonstrate a statistical association between augmen- cosmetic surgery: observations on eighteen patients tation mammoplasty with silicone gel-filled prostheses and a review of the Japanese literature. Arthritis and the development of connective tissue diseases, Rheum 1981^7:1-12. particularly systemic sclerosis. All studies, however, 8. Brody GS, Conway DO, Deapen DM et al. Consensus lack adequate statistical power to definitively exclude a statement on the relationship of breast implants to small excess risk, and may not have adequate follow-up connective tissue disorders. Plast Reconstr Surg 1992; to account for a long latency period between implan- 90:1102-5. tation and development of disease. In addition, it is 9. van Nunen SA, Gatenby PA, Basten A. Post-mam- Downloaded from http://rheumatology.oxfordjournals.org by on July 13, 2010 possible that only women with complications of these moplasty connective tissue disease. Arthritis Rheum 1982^5^94-7. implants, including rupture with migration of silicone 10. Sanchez-Guerrero J, Schur PH, Sergent JS, Liang MH. to regional lymph nodes, may be at increase risk of Silicone breast implants and rheumatic disease: clini- development of rheumatic symptoms and connective cal, immunologic, and epidemiologic studies. Arthritis tissue diseases; these and similar studies would be Rheum 199437:158-68. unable to demonstrate such an association because of 11. Bridges AJ, Conley C, Wang G, Burns DE, Vasey FB. small sample size and low exposure frequency. A clinical and immunologic evaluation of women with Furthermore, it remains possible that women with sili- silicone breast implants and symptoms of rheumatic cone gel-filled breast implants are at increased risk of disease. Ann Intern Med 1993;ll&929-36. developing an atypical rheumatic disease which would 12. Speira H. Scleroderma after silicone augmentation not be recognized in studies wherein case status is mammoplasty. JAMA 1988;26(h236-8. based on medical record review. Thus, the issue of 13. Speira H, Kerr LD. Scleroderma following silicone causation remains unresolved and, in addition, there implantation: a cumulative experience of 12 cases. J Rheumatol 1993,20358-60. are no uniform guidelines for the management of 14. Gabriel SE, Melton LJ, Woods JE, O'Fallon WM, patients with rheumatic symptoms and/or connective Kurland LT. Silicone-containing breast implants and tissue diseases with silicone gel-filled breast implants. connective tissue diseases: a population-based retro- MARC C. HOCHBERG spective cohort study (abstract). Arthritis Rheum Division of Rheumatology and Clinical Immunology, 199336(suppl):S70. Department of Medicine, and Department of Epidemi- 15. Hochberg MC, White B, Steen V, Medsger TA, Weis- ology and Preventive Medicine, University of Maryland man M, Wigley FM. The association of augmentation School of Medicine, Baltimore, MD 21201, USA mammoplasty with systemic sclerosis: preliminary results from a case-control study (abstract). Arthritis REFERENCES Rheum 199336(suppl):S71. 1. Cook RR, Harrison MC, LeVier RR. The breast 16. Weisman MH, Vecchione TR, Albert D, Moore LT, implant controversy. Arthritis Rheum 199437:153-7. Mueller MR. Connective tissue disease following 2. 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