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Silicone Implant Studies

Some recent studies comparing the rates of immune-related diseases in women with implants versus those without implants have provided reassurance that women with implants are not at a greatly increased risk of these disorders.

The largest of these retrospective, or "look-back," studies is the Harvard Nurses' Health Study. The study used data from 87,501 nurses followed for other research purposes from 1976 through May 31, 1990, before there was widespread media coverage of the possible association between breast implants and connective tissue disease. None of the women had connective tissue disease at the start of the study.

In an article published in the June 22, 1995, New England Journal of Medicine, the researchers reported that 516 of the nurses had developed definite connective tissue diseases. Women with breast implants numbered 1,183. The types of implants included 876 silicone gel-filled, 170 saline-filled, 67 double lumen (silicone gel-filled implants with a saline-filled outer envelope), 14 polyurethane-coated, and 56 of unknown type. Only three of the 516 women with definite connective tissue diseases had implants (one silicone-gel filled, one saline, and one double lumen).

The authors reported they "did not find an association between silicone breast implants and connective tissue disease, defined according to a variety of standardized criteria, or signs and symptoms of these diseases."

Similarly, a 1994 study conducted at the Mayo Clinic found no increased risk of connective tissue diseases among implant recipients. The investigators based their conclusion on comparison of the medical histories of 749 women with breast implants in Olmsted County, Minn., with a similar group of women who did not have implants.

"Because of the limitations in the size and type of the studies, however, the true risk of these diseases is not known," says S. Lori Brown, Ph.D., a research scientist officer in the epidemiology branch of FDA's Center for Devices and Radiological Health. "Although the criteria others may be using to assess those studies show that some concerns are eliminated," Brown says, "unfortunately, they don't rule out a small, but significant, increased risk."

An immunology and epidemiology expert, Brown explains that an inherent problem in the studies is that some connective tissue diseases are extremely rare. "If you have a disease that has an incidence of 1 in 100,000 in the general population, for example, and you do a study of 750 women with implants, like the Mayo Clinic Study, then you wouldn't really expect to see even a single case of that disease," she says, "unless there's an exceedingly high--more than a hundredfold--increase in risk."

Small studies like these can rule out huge risks, but not smaller, yet significant risk increases that would only show up in studies that include several thousand women with implants, Brown says. Nor do the studies fully examine or answer whether the implants might in some women lead to symptoms not typical of classical disease manifestations.

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