Statement on Silicone Breast Implants
American College of Rheumatology
October 22, 1995
The American College of Rheumatology recognizes that many women who have received silicone breast implants have musculoskeletal complaints that are also very common in the general population. Many rheumatologists have examined women with implants who have scleroderma, lupus, fibromyalgia, or other well-defined disorders. The problem has been to determine whether any cause and effect relationship exists between silicone implants and the musculoskeletal symptoms. Previous data were solely based on anecdotal evidence. In 1994, the American College of Rheumatology stated the importance and great need for scientific analysis of this question.
Two large studies now have been completed. The first was conducted on all women in a single county in Minnesota who received implants between 1964 and 1991. At a mean follow-up of 7.8 years, there was no association between breast implants and connective tissue or rheumatic disease. (NEJM 330:1697-702, 1994). The second study was a follow-up of the Nurses Health Study. Among this very large cohort, after 14 years of follow-up, no evidence existed for an association between silicone breast implants and connective tissue diseases. (NEJM 332:1666-70, 1995).
The American College of Rheumatology believes that these studies provide compelling evidence that silicone implants expose patients to no demonstrable additional risk for connective tissue or rheumatic disease. Anecdotal evidence should no longer be used to support this relationship in the courts or by the FDA. Clinicians, scientists, academicians, and editors who have been harassed by plaintiffs' attorneys for their involvement in scientific research efforts related to silicone implants deserve the continued support of their institutions and professional societies.
In future cases involving rheumatic diseases possibly associated with an environmental agent, we call upon the FDA and other regulatory agencies to allow professional societies, such as the American College of Rheumatology, to foster appropriate and scientifically developed epidemiological studies. Anecdotal reports, while of importance to call attention to a potential problem, should not be utilized to formulate decisions and regulations.
The American College of Rheumatology is the professional organization of rheumatologists. It includes practicing physicians, research scientists, and health professionals who are dedicated to healing, preventing disability, and eventually curing the more than 100 types of arthritis and related disabling and sometimes fatal disorders of the joints, muscles, and bones.
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