The most definitive study yet of the health effects of silicone breast implants has failed to find any association between the implants and connective tissue diseases.
The new study is so compelling and its results so consistent with previous studies that some leading rheumatologists contend that the issue of whether implants cause these diseases can now be considered closed. They maintain that it is time for the Food and Drug Administration to lift the voluntary moratorium on sales of the implants it requested in 1992.
But some doctors contend that the new study, like those that preceded it, is flawed. They say silicone breast implants are causing a new and ill-defined disease that has not been detected in studies.
The latest study, by epidemiologists and rheumatologists at Harvard Medical School, Brigham and Women’s Hospital, and the Harvard School of Public Health, all in Boston, is being published Thursday in The New England Journal of Medicine. The study was financed by the National Institutes of Health.
The researchers studied 87,501 nurses, 1,183 of whom had implants. They analyzed data from June 1976 through May 1990, before an avalanche of lawsuits over purported links between silicone breast implants and connective tissue diseases.
The investigators found that women with implants were, if anything, slightly less likely to develop connective tissue diseases like rheumatoid arthritis, or even to complain of signs and symptoms of disease that resembled those of connective tissue diseases.
While thousands of women are suffering from fatigue and aches and pains, and believe that implants are responsible, proof from medical studies has so far been lacking.
Several previous studies had failed to find links between implants and specific diseases, like scleroderma and rheumatoid arthritis. Another study, by researchers at the Mayo Clinic failed to find evidence that women with implants developed any specific connective tissue disease.
Researchers said they did the study in response to growing public alarm over a possible link between implants and connective tissue diseases. In 1992, when the FDA requested the voluntary moratorium on the sale of silicone breast implants, it said the data available were not sufficient to show that they were safe.
At that time, some women with implants had developed connective tissue diseases, like rheumatoid arthritis, lupus and scleroderma, but there was no proof the implants caused the diseases.
Although the FDA was careful to say there was no scientific evidence linking implants and connective tissue diseases, the moratorium fueled the litigation. In the past few years, tens of thousands of women have come forward with illnesses that they believe were caused by implants.
Since then, implant manufacturers have entered into a $4 billion settlement of a class-action suit brought on behalf of women with implants. More than 400,000 women have registered for the class.
So many women have claimed injuries that they can expect a small fraction of what had been promised, raising questions about the future of the settlement.
