By: Noel Cohen and Leslie Nicholson
Leader's Product Liability Law and Strategy
June 1992
CONTRARY TO the fears of many silicone-gel breast implant recipients that the devices may cause breast cancer, two recent studies indicate that breast cancer is no more common among women who have had implants than among the general female population. Although breast implant suits largely focus on adverse immunological responses, "fear of future cancer" claims do exist, and use of these studies at trial might help neutralize them.
"The first human epidemiological studies showing the relationship of cancer to silicone are emerging, and the defense will use them," says plaintiffs' attorney Kenneth B. Moll of McDowell, Moll, Fitzgibbons and Drew in Chicago. "But are they convincing? I don't think so," he added. Critics such as Mr. Moll contend that because the latency period for developing cancer from exposure to toxins can be as much 30 years, these studies have not followed their subjects for enough time.
The first study, led by Dr. Dennis Deapen, a University of Southern California assistant professor of preventive medicine, looked at women who received implants for cosmetic reasons between 1959 and 1981. The researchers found no increased risk of breast cancer among women with implants (including those with polyurethane coatings) nor any evidence that implants hindered or delayed detection of the cases of breast cancer that did occur. The study, published in the April issue of Plastic and Reconstructive Surgery, was partially funded by several implant makers.
Canadian Study
A more recent study by Canadian researchers at the University of Calgary Medical School, sponsored by the Alberta Cancer Board in Edmonton, which looked at nearly 12,000 women who had gotten implants from 1973 through 1986 for purely cosmetic reasons, supports the proposition that breast implants do not constitute a risk factor for breast cancer. The researchers postulated that breast cancer among these recipients may be low because these woman constitute a low-risk group to begin with (i.e, the majority of women seeking implants hope to enlarge small breasts, and smaller-breasted women are generally at a lower risk of getting breast cancer than those with larger breasts).
The study appears in the June 18 issue of the New England Journal of Medicine, Vol. 326, No. 25. It is accompanied by an editorial and a separate report challenging the Food and Drug Administration's decision to severely limit the availability of silicone implants, and another report by FDA Commissioner David Kessler defending the agency's action.
Mr. Moll said it could take some time before plaintiffs have data to refute the findings of the aforementioned studies. "They may have knocked out one claim for the time being [fear of cancer], but the big one still is the immunological response," he said . And even if defendants introduce the studies at trial, "We could attack their validity or try to have the testimony disallowed as prejudicial," Mr. Moll noted.