NATIONAL SCIENCE PANEL FINDS NO EVIDENCE LINKING SILICONE BREAST IMPLANTS TO SYSTEMIC DISEASE

December 1, 1998

An independent National Science Panel appointed by Federal District Judge Sam C. Pointer, Coordinating Judge for the Federal Breast Implant Multi-District Litigation, has completed its report, finding no evidence linking silicone breast implants to systemic disease.

The panel of four scientific experts in the fields of immunology, epidemiology, toxicology and rheumatology was appointed in August 1996 and instructed to review and critique the scientific literature pertaining to the possibility of a causal association between silicone breast implants and connective tissue diseases, related signs and symptoms and immune system dysfunction.

The major findings and conclusions from each of the experts are summarized as follows:

Toxicology: The preponderance of data from these studies indicate that silicone implants do not alter incidence or severity of autoimmune disease. There is no evidence that silicone breast implants precipitate novel immune responses or induce systemic inflammation.

Immunology: There are no consistent data to suggest systemic inflammation or systemic induction of anti-silicone or autoreactive responses in women with silicone breast implants. The main conclusion that can be drawn from existing studies is that women with silicone breast implants do not display a silicone-induced systemic abnormality in the types or functions of cells of the immune system.

Epidemiology: No association was evident between breast implants and any of the individual connective tissue diseases, all definite connective diseases combined, or the other autoimmune/rheumatic conditions. There was no association between silicone gel-filled implants and any of the definite connective tissue diseases or the other autoimmune/rheumatic conditions.

Rheumatology: Many of the rheumatologic complaints reported are common in the general population and as presenting complaints in physicians offices. No distinctive features relating to silicone breast implants could be identified.

ASPRS President Paul Schnur, MD, says, "We are delighted that the findings fully support the plastic surgery-sponsored research. As plastic surgeons our goal has always been to foster scientific investigation of all issues that have been raised about breast implants in order to ensure the safety and well-being of our patients. This scientific panel's findings will better enable women to make informed decisions about their own bodies and is of great importance to the more than 1 million women in the United States who have breast implants."

Panel members are Betty A. Diamond, MD, Professor, Department of Microbiology and Immunology, Albert Einstein College of Medicine, Bronx, New York; Barbara S. Hulka, MS, MD, MPH, Kenan Professor, Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Nancy I. Kerkvliet, MS, PhD, Professor of Toxicology and Extension Toxicology Specialist, Department of Environmental and Molecular Toxicology, Oregon State University, Corvallis, Oregon; and Peter Tugwell, MBBS, MD, MSC, FRCP, Professor and Chairman, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.

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