Article received by Dr. Patrick O’Leary on March 19, 1993 with the FDA Talk Paper and two Dow Corning Studies.

ILLNESS LINKED TO IMPLANTS

Breast scar tissue source of reactions, study says

BY Charles Petyl

San Francisco Chronicle (March 15, 1993)

DAVIS—The immune system of more than a third of women with silicone implants appeared to be reacting against the scar tissue that formed in their breasts, researchers at the University of California, Davis, reported Sunday.

The finding, although preliminary, may help explain reports of high levels of “autoimmune” diseases, such as rheumatoid arthritis and a skin disease called scleroderma, linked to silicone filled breast implants.  The diseases led the Food and Drug Administration last spring to sharply limit use of the implants.

In recent months, many doctors have attacked the FDA, accusing it of overreacting to reports of adverse illnesses in some women after implant surgery.

But of 6 women with implants who visited the UC Davis allergy clinic, 16 women—or 35 percent—had high levels of antibodies to key proteins in collagen, a connective tissue common in scars that encapsulate implants after surgery.

Some levels were “unbelievably high” said Dr. M. Eric Gershwin, chief of the Division of Rheumatology, Allergy, and Clinical Immunology at the medical center and leader of the study.  Dr. Suzanne Teubor announced the results Sunday in Chicago a the annual meeting of the American Academy of Allergy and Immunology.

In an interview last week, before Sunday’s presentation of the data, Gershwin said more studies suggest that either silicone gel leaking from the implants or the tough silicone plastic bag of the implants in some women may react with immune system cells in the presence of the forming scar tissue.

Based on these and other findings, he said, there is no reason to believe that (rest of sentence did not scan)

Much more study is needed to be sure of the mechanism, he said.

The study compared the 46 women with implants with a similar number of healthy women matched for age and medical history but without implants.  The study found no increased antibody levels in the women without implants.  However, because the women with implants were referred to the clinic for a variety of allergy and immune system complaints, they do not represent a cross section of all women with implants.