No Major Hazard Found for Breast Implants

By William J. Cromie

Gazette Staff

Breast implants do not put women at major risk for crippling or lethal diseases, according to the largest comparison to date of women who did and did not get the grafts.

Medical School researchers found that the likelihood of implantees getting connective-tissue diseases was much smaller than claimed in various legal battles. These diseases, which effect tendons, cartilage, and blood vessels, include rheumatoid arthritis, lupus, scleroderma, polymyositis, and several rare maladies of the skin, organs, and joints.

"This study of 395,543 women provides assurance for women and their physicians that breast implants do not cause a large hazard for connective-tissue diseases," says Charles Hennekens, John Snow Professor of Medicine at Brigham and Women's Hospital. "However, they also raise the possibility of a small increased risk for these diseases, and that risk remains virtually constant regardless of age and how long a woman has the implant."

"Our study is compatible with reports from two other large studies that put to rest claims that the breast implants raise the risk of connective-tissue diseases by 50 to 500 percent," agreed Julie Buring, associate professor of ambulatory care and prevention. "The 24 percent increase we found compares with a risk of 2,000 percent for smoking and lung cancer and 100 percent for smoking and heart disease."

One of the other studies Buring referred to, the Nurses' Health Study, was done by other Harvard researchers who reached the same conclusion last year.

Small Risk Remains

Hennekens and Buring analyzed information from questionnaires completed by nurses and other female health professionals, 10,830 of whom received breast implants.

The research was partly supported by Dow Corning, the major manufacturer of breast implants who is being sued successfully by women who claim medical damages from the grafts.

"We, not Dow, initiated the research," Hennekens points out. "The National Institutes of Health provided $17 million for a study we designed to evaluate the risks and benefits of aspirin and vitamin E in the prevention of heart disease and cancer. Dow provided an additional $1.3 million to process and analyze information about implants included on the questionnaires."

From 1962 to 1992, an estimated 1 million to 2 million women in the U.S. and Canada received breast implants. In 1992, accusations about connective-tissue disease from some of these women prompted the U.S. Food and Drug Administration (FDA) to ban the devices, except for use in research studies.

"The FDA mandated that research be done to determine how much risk is involved," Hennekens said. "That's why we initiated our study."

Connective-tissue diseases arise from problems with the immune system wherein the body rejects its own tissues and organs. In rheumatoid arthritis, for example, the body attacks its own joints. The Harvard study found that women with breast implants are 24 percent more likely than non-implantees to get rheumatoid arthritis and several other so-called autoimmune diseases. The latter include Sjogren's syndrome, in which the eyes, mouth, and vagina become excessively dry; polymyositis, or dermatomyositis, a rare but sometimes fatal condition marred by muscle weakness and inflamed skin; and scleroderma, which affects skin, arteries, kidneys, lungs, heart, joints, and other organs.

No significant increase in risk was found for systemic lupus erythematosus, a potentially lethal illness that damages joints, kidneys, and nervous and other body systems.

Those affected by autoimmune illnesses are born with a genetic disposition for them, which may be triggered by a virus or other unknown causes.

"Women predisposed to such diseases can get them whether they have implants or not," Buring points out. "It's possible that implants trigger the predisposition but our research does not resolve that issue."

"A little less than 1.4 out of every 1,000 women per year without breast implants get connective-tissue diseases, a little more than 1.4 out of 1,000 with implants get the same diseases," Hennekens explains. "It's premature to call the difference a hazard, but neither should it be swept under the rug."

"We can assure women who decide to get implants that the risk is small, but we cannot say yet whether there is no risk at all," Buring adds.

In fact, this small risk may not be real. It might come from various biases that occur when people report on their own health.

"Further research is needed before firm conclusions can be drawn," Hennekens admits. "We continue to follow the health of the dedicated women who participate in the study, and to validate answers on questionnaires by comparing them with medical records. This comparison should eliminate possible bias due to overreporting of connective-tissue diseases. We will look at other medical conditions thought to be associated with breast implants."