Hysteria is easier than science, and it pays better

August 07, 1996|By Joanne Jacobs

SAN JOSE, Calif. -- Sorry. Never mind.

After four years of hysteria about silicone breast implants, after thousands of terrified women had their implants removed, after millions in lawsuits and Dow Corning's bankruptcy, the scientific evidence is in.

A Food and Drug Administration review of 15 studies found that no study has indicated a significant increase in breast cancer or connective-tissue disease.

The ''time bomb in the breasts,'' as one magazine called it, turned out to be a dud. ''The cause and effect is simply not there,'' says FDA Commissioner David Kessler, who banned silicone breast implants for most uses in 1992. ''The scientific evidence is not there that supports the association between silicone and typical or atypical diseases.''

''Any link between breast implants and a variety of systemic diseases and symptoms is very small, if it exists at all,'' says Marcia Angell, executive editor of the New England Journal of Medicine and author of ''Science on Trial,'' a book on the breast-implant controversy.

Ms. Angell blames a variety of factors for the anti-implant hysteria: Many Americans do not trust science and do not understand it. Sick people want to know why they are sick. Lawyers can earn millions of dollars for persuading juries that a big corporation is to blame. Doctors who jump on the bandwagon can get rich too. The media get more viewers and readers with headlines about ''toxic breasts'' than from stories that try to explain epidemiology.

Finally, the belief that surgically enlarged breasts were poisoning women fit perfectly into feminist ideology. Patriarchy kills.

The first silicone gel implant was done in 1962. The woman, now 64, has the same implants today, writes Ms. Angell, and is quite happy with them. Since then, 1 million to 2 million American women have had implants: About 60 percent enlarge their breasts for cosmetic reasons, most of the rest are replacing breasts lost to cancer.

Implants always create scar tissue. In some cases, this contracts so severely that it causes pain or misshapen breasts. In as many as 5 percent of women, implants rupture. These problems were well known, but more than 90 percent of women said they were happy with their implants in a 1990 survey. Silicone gel was by far the most popular type of implant.

In the 1980s, the FDA asked manufacturers for safety data on implants. The agency had not looked at implants before because their use predated the FDA's regulatory power.

Immune response

Some people theorized that leaky silicone gel could cause an immune response leading to connective-tissue diseases such as rheumatoid arthritis, scleroderma and lupus. There was no evidence that the implants were dangerous after decades of use, but there also were no systemic studies proving their safety.

In 1991, a California jury awarded $7.3 million to a woman with mixed connective-tissue disease -- despite testimony by her doctor that she had showed symptoms two years before getting implants.

In 1992, Dr. Kessler announced a moratorium on silicone breast implants, saying there was insufficient evidence of their safety.

In the court of public opinion and in the law courts, silicone breast implants have been convicted. Juries are awarding multimillion-dollar awards to women who claim their illnesses were caused by their implants. A multibillion-dollar settlement collapsed; $4.25 billion was not enough money. Dow Corning, the largest maker of implants, filed for bankruptcy.

But in the lab, none of the charges against silicone implants have been proved.

''Since about 1 percent of American women have breast implants and about 1 percent have connective-tissue diseases, we could expect that by coincidence alone 10,000 would have both,'' Ms. Angell writes. But it takes large-scale studies to determine if women with implants are more likely to have these diseases.

A 1994 Mayo Clinic study found ''no association between breast implants and the connective-tissue diseases and other disorders that were studied.'' Harvard's Nurses' Health Study, released in 1995, looked for 41 types of disease among 88,000 nurses. It found ''no association between silicone breast implants and connective-tissue diseases, defined according to a variety of standardized criteria, or signs or symptoms of these diseases.'' Studies of cancer, rheumatoid arthritis, lupus and scleroderma found no link to breast implants.

The Women's Health Cohort Study of 400,000 female health professionals, released this year, found a slightly higher rate of connective-tissue disease reported by women with implants -- an extra one case for every 3,000 women. But women's reports of illness were not verified by medical diagnosis, and women were questioned at the peak of the anti-implant panic. The rise probably represents more fear rather than more sickness.

''The science is now here,'' says Elizabeth Connell, an Emory ob/gyn professor who chairs the FDA Breast Implant Advisory Panel that recommended the moratorium. It is time for the hysteria to stop, she says.

But nobody is listening to the science. Hysteria is easier, and it pays better.

K? Joanne Jacobs is a columnist for the San Jose Mercury News.

Pub Date: 8/07/96

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