Implanting fear.

EARLY in 1991, a New York jury awarded a woman $4.45 million in damages for problems associated with polyurethane-coated breast implants. Later that same year, a jury in Alabama returned a verdict of $5.4 million in favor of an implant recipient. And in December 1991 a California court awarded an implant recipient $7.3 million in total damages.

While courts later reduced the New York and Alabama damage awards, the combination of these cases generated huge publicity. And, in January 1992, FDA Commissioner David Kessler urged manufacturers to cease producing silicone-gel-filled breast implants and urged doctors to stop using them for augmentation or other surgery. Defending his action in the face of an advisory-panel suggestion that implants should still be sold to women who chose to accept the possible risks, Dr. Kessler asserted that some rheumatologists had seen an increase in the incidence of auto-immune disease among implant users.

In February 1992, the FDA advisory panel recommended limited access for those who sought reconstruction and augmentation, and concluded that not enough scientific evidence linked implants to disease to warrant a complete ban. In fact, Britain's Department of Health refused to place such a ban on the use of these implants for this very reason: there was no scientific knowledge that warranted a moratorium. Nevertheless, the FDA under the direction of Dr. Kessler imposed an almost total ban on these implants in April of that year.

The effect of this moratorium was significant. Manufacturers felt pressure to settle lawsuits regarding their implants, and many of them abandoned the silicone market altogether. The FDA's announcement caused unwarranted fear among implant recipients and promoted the media's exaggeration of unproven risks. The ban limited a woman's ability to choose historically safe methods of medical and cosmetic intervention and it also caused significant increases in the prices of other medical devices composed of silicone including heart valves and catheters.

Was there any evidence at all that silicone breast implants were a threat to a woman's health? No. In fact, scientists cannot establish any causal link between silicone and the various diseases being suffered by implant recipients.

Silicon and silicone are all around us. We ingest silicon in our drinking water every day. Silicon compounds are used in deodorants, food fillers and preservatives, fruit juices and sauces, hamburgers and French fries. Silicone, which is a mix of silicon and oxygen, is as biologically inert as anything save saline or water. Silicones are used in cosmetics, hair products, shaving creams, toothpastes, oral medications, and colognes. There is simply no scientific data indicating that cancers, immunological reactions, or rheumatic conditions are caused by this chemical.

Most recently, several massive epidemiological studies have confirmed what had already been taken as scientific fact -- namely, that silicone implants do not increase the risk of the various diseases over which the implant manufacturers have been sued. Seventeen studies in total have shown no causal link between silicone and connective-disease disorders or numerous other "syndromes." The two largest and most recent studies are the Mayo Clinic Study performed by Dr. Sherine Gabriel, and the Nurses Health Study performed by Dr. Jorge Sanchez-Guerrero of the Harvard Medical School. Dr. Gabriel's study, published last year, was a population-based study of women in Olmsted County, Minnesota, who received breast implants between 1964 and 1991 -- a total of 749 women. The study found no association between breast implants and connective-tissue disease; only 5 implant recipients developed any tissue disease, as opposed to 10 non-recipients. Similarly, 25 women with implants developed arthritis, as opposed to 39 women who did not have the implants.

Dr. Sanchez-Guerrero's study, published on June 22 of this year, began in 1976. It included 876 women with silicone-gel breast implants. It also found no increased risk of connective-tissue diseases in women with implants. In fact, it found that women with the implants were 70 per cent less likely to contract connective-tissue disease.

Other studies of the relationship between silicone and disease have been run at the University of Michigan, Johns Hopkins, and the Universities of Texas, Maryland, Alabama, and Nevada; none have found any linkage between silicone and disease. Further, studies throughout the world, including Canada's University of Toronto, Australia's Royal North Shore Hospital, Italy's Molinette Hospital, Germany's Technische University, and Scotland's St. Johns Hospital (Edinburgh), have failed to find a correlation between implants and any of the diseases complained of by plaintiffs in breast-implant cases.

The FDA's actions with respect to breast implants have been indefensible, and are probably now irremediable. If the agency is to restore its own scientific credibility it must act in the future on scientific proof, not public fear generated by plaintiffs' lawyers.