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					British Journal of Rheumatology 1994,33^01-604


SIUCONE breast implants became available for use in                   infer causality, we require knowledge of either the inci-
the United States in 1962 [1], 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

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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 [4] or Canada [5]; 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 [14]. 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 [6].                 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 [7]. 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 [8].                                                          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 [9]. 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 [10]; these cases are summar-              systemic sclerosis [15]. 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 [11], 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 [10]; 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 [10].

0263-7103/94/070601 + 04 $08.00/0                                                            11994 British Society for Rheumatology
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-

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possible that only women with complications of these               moplasty connective tissue disease. Arthritis Rheum
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
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   1992326:1713-5.                                                 (suppl):S66.

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