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Link Between Implants, Immune Disease Is Seen

January 20, 1992|ROBERT STEINBROOK | TIMES MEDICAL WRITER

Dr. Steven R. Weiner was at UCLA in 1982 when he saw the first patient, the one who stood out "like a bright red light."

The 32-year-old woman had had silicone gel implants placed in her breasts in 1976. Now, she had a painful, swollen left elbow, and a large lymph node in her left armpit appeared to contain silicone. Her muscle and joint pains did not respond to anti-inflammation medications and steroid injections. The whole case could not be explained by any known rheumatic disease.

Finally, Weiner, a rheumatologist, and other UCLA physicians recommended that the woman's implants be removed. For the first time in years, her elbow returned to normal size and no longer hurt. Her other muscle and joint pains went away.

Over the last decade, Weiner, a UCLA associate clinical professor of medicine, has seen more than 500 patients with both silicone gel breast implants and possible rheumatic ailments.

In about 125 cases, Weiner concluded that the patient's problems "clearly were related" to their implants. These included about 50 "clean" cases with no other plausible explanation, he said. Of the women whose implants were removed, one-half to two-thirds have significantly improved, he said.

"I don't even think there is a shadow of a doubt that things are going on," Weiner said last week. These cases "stood out long before anybody was out there talking about the evils of implants" and "before anyone ever told me that a plastic surgeon would get mad at me if I suggested they did stand out."

On Jan. 6, the U. S. Food and Drug Administration called for a voluntary moratorium on the sale and use of silicone gel breast implants while it reviews safety data.

The FDA will decide this year whether the known problems and suspected hazards associated with the implants are severe enough to ban the devices or to restrict their use. The FDA could restrict use of silicone implants to women with severe breast deformities and woman who have had cancerous breasts removed.

Dr. David A. Kessler, FDA commissioner, said the growing number of autoimmune disorders, including various forms of arthritis, in patients with implants increased his concern about the safety of the devices. In an autoimmune disease, the body's immune system, which normally defends against infections, turns against the body, causing disease.

Manufacturers of implants and many plastic surgeons have challenged the reports of autoimmune diseases and vociferously championed the overall safety record of the implants, which were first used in humans in 1962.

Yet a review of scientific articles and interviews with researchers found considerable evidence to support a link between the implants and serious rheumatic ailments in a small percentage of implant patients.

Researchers, including Weiner, acknowledge that the implants' link to autoimmune diseases has not been established absolutely. This would require a large-scale comparison of women with implants to woman without implants. Implant manufacturers are beginning such a study with University of Michigan researchers. It will take several years to complete.

Little in medicine is known with absolute confidence. Medical ethicists note that the physician's obligation to patients, particularly when uncertainty exists, is embodied in the Latin maxim primum non nocere , or "first do no harm."

Interviews and the review of medical journal articles also made clear that silicone gel breast implants can have other adverse reactions and complications. There is no good data, however, on how often many of these problems occur.

* The implants can wear out and rupture, and must be removed and replaced. Dr. Donna de Camara, a plastic surgeon at the University of Illinois Medical School in Champaign, has studied 51 implants removed from 31 woman between 1987 and 1991. She found that 27 implants were ruptured and seven were leaking, according to her presentation at a meeting of plastic surgeons in 1991. Ruptures were more common the longer the implants had been in place.

When implants rupture, silicone gel can ooze into surrounding body tissues, causing inflammation, tenderness, swelling and lumps, according to a 1991 patient information booklet prepared by Dow Corning Wright of Arlington, Tenn., the largest manufacturer of the implants.

* A hard capsule of scar tissue can form around the implant, creating discomfort and pain. Such scar tissue normally forms around any foreign material placed in the body. When the capsule of scar tissue contracts around the implant--a frequent problem--repeat surgery may be required. The problem can recur.

* Even intact implants can ooze small amounts of silicone fluid into the body, although this problem is believed to be less common with newer implants. This is known as "gel bleed." Silicone can move into the scar tissue surrounding the implant, nearby breast tissue and muscle, or the lymph nodes in the armpit.

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