Silicone breast implants and long-term health effects: When are data adequate?

The epidemiological literature examining the possible association between silicone breast implants and breast cancer or rheumatological conditions or diseases is far greater today than it was when, in early 1992, FDA determined that the data were not adequate for the assessment of their safety. A literature data base exists for assessing the magnitude of risk for certain diseases that might be associated with silicone breast implantation and for narrowing the uncertainty in those estimates. The studies reported in this series make a major contribution to that database. As for future research needs, some general observations can be made. First, it is likely that completed, ongoing and planned studies will prove more than adequate in accurately delineating any cancer risks that might be associated with breast implantation. Second, the risks of developing scleroderma will also be reasonably well established. Further study may be desirable for other specific connective tissue diseases and for connective tissue disease considered as a whole.