Correspondence
More on Breast Implants and Connective-Tissue Diseases
N Engl J Med 1995; 332:1306-1308May 11, 1995
- Article
To the Editor:
Solomon et al. (Nov. 3 issue)1 report their experience as three rheumatologists “who have examined and evaluated a combined total of more than 3000 symptomatic women with silicone breast implants.” Their letter deserves further scrutiny. One wonders how three rheumatologists managed to see more than 3000 patients with what they characterize as “a new and unique rheumatic syndrome.” But then I recalled Dr. Solomon's lecture at North Shore University Hospital on April 21, 1994, in which he acknowledged that 80 percent of his patients had been referred by attorneys for evaluation.
Without impugning the authors' belief in this undocumented and unverifiable new “disease,” I certainly find it obvious that attorneys will not refer clients with breast implants to rheumatologists who fail to find such a disease. The validity of what has been called “human adjuvant disease” seems as uncertain as that of chronic fatigue syndrome and chemical hypersensitivity.
It is interesting that the $4.2 billion global settlement of the breast-implant class-action suit stipulates that every patient seeking compensation must be evaluated by a rheumatologist. The share for attorneys is estimated to be $1 billion.
The pity is that junk science and business considerations rule the day, so that both true science and patients suffer. But physicians must adhere to a high standard. And physicians who write letters or articles about breast implants and connective-tissue diseases should disclose the fact if their patients are primarily referred by product-liability attorneys, especially when the physicians claim to have found a new disease.
1 ReferencesJames N. Romanelli, M.D.
Plastic Surgery Center of Long Island, Huntington, NY 117431
Solomon G ,Espinoza L ,Silverman S . Breast implants and connective-tissue diseases. N Engl J Med 1994;331:1231-1231
Full Text | Web of Science | Medline
Author/Editor Response
The authors reply:
To the Editor: Dr. Romanelli raises several important points. We agree that any potential conflict of interest with regard to a publication or lecture should be fully disclosed, so that the reader or listener can decide whether the conflict affects the conclusions reached. It was for this reason that one of us, Dr. Solomon, disclosed that the majority of his patients with silicone breast implants had been referred by attorneys.
Each of us has seen patients who were referred by attorneys, as well as those who were self-referred or referred by other physicians. In view of the well-publicized global settlement of the breast-implant class-action suit, which requires an assessment by a physician, it is rare to encounter a patient with a breast implant whose case presents absolutely no legal issues. We do not believe that the source of the referral affects our findings on physical examination or the laboratory analysis of the serum specimens from a given patient.
The new disease that we think is present in many symptomatic patients with silicone breast implants was first described by the Japanese in the 1970s and early 1980s under the name “human adjuvant disease,”1 as we mentioned in our earlier letter. The findings by the Japanese investigators were confirmed by Europeans and Americans in the late 1980s, long before concern about litigation assumed a prominent role. Our main criticism of the study by Gabriel et al.2 is that it focused on classic connective-tissue diseases and failed to discuss atypical connective-tissue disease,3 despite the existence of a 20-year body of literature suggesting that the latter was the predominant clinical problem.
Hundreds of articles have been published in peer-reviewed journals about silicone metabolism within the body, immunologic responses to silicone, and clinical syndromes associated with silicone. Whereas Romanelli suggests that silicone-associated atypical connective-tissue disease is a fictitious entity created by the plaintiffs' attorneys, this disease is included as a nosologic entity in the 1993 edition of a standard rheumatology textbook,4,5 as well as in the current syllabus of the Medical Knowledge Self-Assessment Program of the American College of Physicians.6 On March 13 and 14, 1995, a conference on “Immunology of Silicones” was convened at the National Institutes of Health.
We believe that Romanelli is misguided in labeling clinical research related to silicone as “junk science.” We think that the available evidence strongly documents the potential adverse effects of silicone breast implants and supports the decision of the Food and Drug Administration to ban their use.
6 ReferencesGary Solomon, M.D.
Hospital for Joint Diseases Orthopaedic Institute, New York, NY 10003Stuart Silverman, M.D.
UCLA School of Medicine, Los Angeles, CA 90048Luis Espinoza, M.D.
Louisiana State University Medical Center, New Orleans, LA 701121
Kumagai Y ,Shiokawa Y ,Medsger TA Jr ,Rodnan GP . Clinical spectrum of connective tissue disease after cosmetic surgery: observations on eighteen patients and a review of the Japanese literature. Arthritis Rheum 1984;27:1-12
CrossRef | Web of Science | Medline2
Gabriel SE ,O'Fallon WM ,Kurland LT ,Beard CM ,Woods JE ,Melton LJ III . Risk of connective-tissue diseases and other disorders after breast implantation. N Engl J Med 1994;330:1697-1702
Full Text | Web of Science | Medline3
Solomon G . A clinical and laboratory profile of symptomatic women with silicone breast implants. Semin Arthritis Rheum 1994;24:Suppl 1:29-37
CrossRef | Web of Science | Medline4
Seibold JR. Scleroderma. In: Kelley WN, Harris ED Jr, Ruddy S, Sledge CB, eds. Textbook of rheumatology. 4th ed. Philadelphia: W.B. Saunders, 1993:1114.
5
Sergent JS, Fuchs H, Johnson JS. Silicone implants and rheumatic diseases. In: Kelley WN, Harris ED Jr, Ruddy S, Sledge CB, eds. Textbook of rheumatology. 4th ed. update 4. Philadelphia: W.B. Saunders, 1993.
6
Goldman L, ed. Medical knowledge self-assessment program 10. Rheumatology section. Philadelphia: American College of Physicians, 1995:412.
