Editorials

Silicone breast implants and connective tissue diseases

In 1992 the United States Food and Drug Administration, after hearings before two independent advisory committees, placed a moratorium on the use of implants other than in research because of inadequate data on their safety.² This year certain manufacturers of breast implants and their suppliers set aside funds of $4.225bn to deal with potential legal suits; and, in a unique move, women were given until 17 June this year to decide whether to join a class action suit that guaranteed a settlement of $200 000 to $ 2 million, to not litigate, or to litigate separately.

Whether silicone implants are associated with connective tissue diseases, therefore, is an important public health issue which is now embroiled in regulatory and legal controversy.³ Among the first cases reported, scleroderma was seemingly disproportionately common - intriguing, given that, of all connective tissue diseases, scleroderma and scleroderma-like disorders have been most convincingly linked to environmental causes (for example, exposure to silica, polyvinyl chloride, toxic oil, and tryptophan). But, as attention on women with silicone breast implants increased, other connective tissue diseases were also reported, including systemic lupus erythematosus, inflammatory myopathies, Sjogren's syndrome, rheumatoid arthritis, and an ill defined syndrome inappropriately termed "human adjuvant disease,"⁴ characterised by malaise, low grade fever, aches, and pains. While the number of anecdotal cases increased, studies that included a control group failed to detect any association.*RF 5-9* Although no single study could definitely rule out such an association, if one existed then it could be only very small. As scientific inquiries continue, the legal debate has shifted from whether silicone breast implants cause connective tissue diseases to whether implants cause a unique rheumatic disease that cannot be defined by existing criteria.⁹

The question of risks to health, particularly the potential risk of connective tissue disease, is difficult to study. No precise data exist on how many women have received silicone breast implants; no systematic follow up data have been collected. Virtually nothing is known about how many women have had repeat implant procedures or how many with silicone breast implants have died. Even the best epidemiological studies are limited by having a relatively small sample size or by potential ascertainment bias, reporting bias, or information bias (which results from systematic differences in the way data on exposure or outcome are obtained). This is shown by two controlled studies, which found that self reported diagnoses of connective tissue disease and symptoms were more common among women with breast implants but that medical evaluation failed to confirm the diagnosis of connective tissue disease or any difference in objective findings between women with and without breast implants.^6,10

What should doctors advise women who have silicone breast implants? If they are well and have not had local problems such as hardening or rupture of the implant we recommend that they do nothing. They should be reassured by the epidemiological studies, all of which show no association.*RF 5-9* Patients with connective tissue diseases or rheumatic complaints and silicone breast implants need to be treated on a case by case basis.

Whether removing the silicone breast implants alters the course of a connective tissue disease is unknown. Among 12 reported cases, some improvement was described in seven.¹ Four of nine patients with scleroderma had cutaneous improvement (one of them also had visceral improvement). In two cases of systemic lupus erythematosus both clinical and serological manifestations improved. In one case of "human adjuvant disease" some improvement was noted. No firm conclusion can be drawn from the reports.

Whether silicone breast implants are associated with connective tissue diseases remains controversial. Despite the increased number of cases reported in the literature no association has been convincingly established.

J Sanchez-Guerrero, M H Liang 

1. Sanchez-Guerrero J, Schur PH, Sergent JS, Liang MH. Silicone breast implants and rheumatic disease. Clinical, immunological, and epidemiological studies. Arthritis Rheum 1994;37:158-68. [Medline]
2. Kessler DA. The basis of the FDA's decision on breast implants. N Engl J Med 1992;326:1713-5. [Medline]
3. Angell M. Do breast implants cause systemic disease? Science in the courtroom. N Engl J Med 1994;330:1748-9. [Free Full Text]
4. Brody GS, Conway DO, Deapen DM, Fisher JC, Hochberg MC, LeRoy EC, et al. Consensus statement on the relationship of breast implants to connective tissue disorders. Plast Reconstr Surg 1992;90:1102-5. [Medline]
5. Gabriel SE, O'Fallon WM, Kurland LT, Beard CM, Woods JE, Melton LJ III. Risk of connective tissue disease and other disorders after breast implantation. N Engl J Med 1994;330:1697-702. [Abstract/Free Full Text]
6. Giltay EJ, Bernelot Moens HJ, Riley A, Tan RG. Silicone breast prostheses and rheumatic symptoms: a retrospective follow up study. Ann Rheum Dis 1994;53:194-6. [Abstract/Free Full Text]
7. Wigley FM, Miller R, Hochberg MC, Steen V. Augmentation mammoplasty in patients with systemic sclerosis: data from the Baltimore Scleroderma Research Center and Pittsburgh scleroderma data bank [abstract]. Arthritis Rheum 1992;35(suppl 9):S46.
8. Dugowson CE, Daling J, Koepsell TD, Voigt L, Nelson JL. Silicone breast implants and the risk for rheumatoid arthritis [abstract]. Arthritis Rheum 1992;35(suppl 9):S66.
9. Goldman JA, Lamm SH, Cooper W, Cooper L. Breast implants are not associated with an excess of connective tissue disease [abstract]. Arthritis Rheum 1992;35(suppl 9):S65.
10. Bridges AJ, Conley C, Wang G, Burns DE, Vasey FB. A clinical and immunological evaluation of women with silicone breast implants and symptoms of rheumatic disease. Ann Intern Med 1993;118:929-36. [Abstract/Free Full Text]