Abstract: Research conducted on laboratory rats to determine the relationship between silicone gel and immune-related disorders did elicit an antibody response when the gel was mixed with an antibody adjuvant. The nature of the study does not provide conclusive results about the relationship.

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 Full Text COPYRIGHT U.S. Department of Health and Human

Services 1993

 Two recent studies of laboratory rats may help provide a scientific rationale for the possible link between silicone gel-filled breast implants and autoimmune-like disorders. On the basis of these studies, FDA is requiring breast implant manufacturers to update information about the possible connection between the implants and immune-related disorders in the informed consent documents for women receiving these breast implants under clinical studies.

 The animal studies do not, however, establish the connection with certainty, particularly since they were designed to intentionally stimulate an antibody response by mixing a known antigen with the silicone. More research, some now under way, is needed to determine the relevance of the studies to women with the implants.

 In the two studies--one conducted in New York state by John Naim, Ph.D., and his colleagues and the other by Dow Corning Corporation, a supplier of silicone gel for implants--silicone gel was blended with liquid silicone and a known antigen (bovine albumin) and injected into the rats. Under these test conditions, the antigen alone would not have been expected to produce an immune response. In the presence of silicone gel or another antibody adjuvant (a substance that stimulates antibody production), however, it produced a strong antibody response. Naim's study appeared in the March 22 issue of Immunological Investigations. 

FDA continues to advise women with silicone gel-filled implants to be alert to symptoms of autoimmune disorders and consult a doctor if the symptoms do not subside. They include: 

* pain and swelling of joints 

* tightness, redness or swelling of the skin 

* swollen glands or lymph nodes 

* unusual and unexplained fatigue 

* swelling of the hands and feet 

* unusual hair loss. 

Many women--with or without implants--may experience such symptoms from time to time. But people with immune-related disorders, which are relatively rare, generally experience a combination of these and other symptoms that don't go away.