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elucidate the possible role of subclinical infection. Research to validate (or not) the work of certain other investigators was suggested.

The IOM committee found the IRG and NSP reports useful documents and is in general agreement with their findings. The NSP's thorough compilation and detailed descriptions and analyses of the epidemiological and immunological studies, and the insights from the careful meta-analyses, are particularly useful. The conclusions of each chapter of the NSP report were well supported by data and analysis and were conservatively stated. Although the report was focused, this was by design, and it had the advantage, as noted earlier, of allowing an in-depth approach.

The IOM committee agrees with the NSP's general conclusions regarding the formation of silica from silicone in the tissue of women with implants, although a discussion of the availability and biological significance, or lack thereof, of amorphous silica from implant silicone elastomer shells would have been interesting. Also, the panel cites a "fairly high estimate" of the frequency of U.S. women with breast implants (1%) and uses this value in calculating population attributable fractions. The IOM committee's estimate is approximately 1.5% of U.S. women with silicone breast implants of all kinds (1.5 million to 1.8 million U.S. women in 1997), so the source of the NSP's estimate would be of interest. The effect of this difference on the numbers of cases of connective tissue disease theoretically attributable to implants would not be significant, however. The committee's recommendations for research differed from those of the IRG. This difference may reflect the committee's and the IRG's responses to the situation and needs in their respective countries.



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