Breast Implants Found to Irritate Immune System

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Breast Implants Found to Irritate Immune System - The New York Times

http://query.nytimes.com/gst/fullpage.html?sec=health & res=9F0CE1D91E3EF933A15750C0A965958260

Breast Implants Found to Irritate

Immune System

By PHILIP J. HILTS,

Published: Saturday, March 20, 1993

In a turnabout, the Dow Corning Corporation reported today

that new studies on laboratory rats showed that

the silicone gel used in breast implants was NOT inert,

and in fact had been found to be a strong irritant of the immune system, at least in animals.

More than one million American women have received silicone-gel implants over the last 30 years. Dow Corning estimates three-quarters of them received its products. More than 3,500 women have sued the company, many claiming to have developed autoimmune disease.

The results echo findings Dow scientists made in 1974 but failed to report to the Food and Drug Administration until about 15 years later. Dow Corning abandoned its implant product last year as lawsuits mounted.

Today's announcement came on the heels of an ominous finding by researchers in California earlier this week: among 100 women with silicone implants, 35 were found to have antibodies against their own collagen, a protein that variously gives body tissues stiffness or elasticity. That meant that the women's immune systems were attacking their own bodies. Was Thought to Be Inert

Dr. Myron on, chief medical officer of Dow Corning, said in a telephone interview today that the finding was a surprise, because many in the company, as well as immune-system experts Dow Corning had consulted, had believed that silicone was essentially inert in the human body.

"The significance of this finding is that it raises a concern on the part of people like me that silicone might play some role in autoimmune disease," Dr. on said. "One expert told me he never thought that silicone would be shown to be an adjuvant," that is, a substance added to drugs to induce the immune system to produce antibodies.

The Dow Corning study replicated an earlier finding by Dr. Naim of Rochester General Hospital that silicone gel may arouse the immune system to attack the body's own proteins. In both studies, researchers took gel from a breast implant, pulverized it and injected it into rats. They then compared the effect of that to the effect of injected salt water, known to cause little reaction, and to Freund's adjuvant, a mixture of mineral oil and bacteria that causes a fierce reaction.

Dr. Naim found that silicone gel caused a reaction 100 times greater than salt water and as powerful as that produced by Freund's adjuvant. Human Effects Unknown

Because the gel was pulverized and the subjects were animals, it is not clear whether humans would react the same way.

At the request of the Food and Drug Administration, Dow Corning has set up a $10 million fund to investigate the health effects of silicone-gel implants even though it no longer makes them.

Today's finding is the first that such a reaction from silicone has been publicly reported by Dow. But Dr. on acknowledged that scientists at Dow saw something similar in research in 1974. The Dow researchers at the time did not report the immune system reaction, and failed to inform the drug agency of it until more than 15 years later. The information was disclosed in papers filed in lawsuits over the last few years.

Dr. on said he recognized that people might suspect that Dow Corning had hidden the earlier finding to avoid damaging sales. But he said he was not aware of any such motive.

The other finding, reported earlier this week, was by a group at the University of California at School of Medicine led by Dr. Suzanne Teuber and Dr. M. Gershwin.

Over the last year, the researchers have examined the blood of women with breast implants who came to the University Medical Center worried that their implants might cause damage to their bodies.

They found that 35 percent of the women had antibodies against collagen of the type found in their bodies, including that found in breast tissue. These women were compared with healthy women without implants who showed little or no reaction.

"In order to protect us, the immune system must be able to distinguish between our own bodies and invading organisms," Dr. Gershwin said. In lupus and rheumatoid arthritis, the immune system mistakes its own tissue for invading material and attacks it.

The California study suggests that many women with implants show just such a mistaken immune-system reaction against their own collagen.

Even so, the scientists said the results should not lead women to have their implants removed, because removal could entail more risk than keeping the implants.

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