NCPA - National Center for Policy Analysis


June 6, 2005

As the Food and Drug Administration considers whether or not to allow breast implants back on the market, it is imperative that they base their decision on sound science rather than on loud rhetoric, says Peter Pitts, a senior fellow at the Pacific Research Institute and a former Associate Commissioner at the Food and Drug Administration (FDA).

Researchers at the Institute of Medicine (IOM) found no evidence of harm from using silicone breast implants. Recent epidemiological studies, as well as voluminous data on the chemicals used in implants, led the IOM to several key conclusions:

  • There is no evidence to suggest silicone in implants is toxic to humans; when individual studies have pointed to possible toxic, immunological or neurological effects, more extensive analyses failed to uncover associations with specific diseases or conditions.
  • There is no established link between implants and a unique disease syndrome; syndromes of the type ascribed to implants generally involve nonspecific symptoms common in the general population.
  • There is no evidence conclusively linking silicone to harmful effects on the immune system; early studies addressing the immunology of silicone were limited and had substantial technical problems -- follow-up analyses have failed to uncover associations with specific immunological diseases or other conditions.
  • There is no evidence that mothers with implants pass silicone on to infants when breast-feeding; much higher levels of silicon -- the element on which the silicone family of organic compounds is based -- have been found in cows? milk and commercially available infant formula than in the milk of nursing mothers with implants.

Pitts says the IOM?s well-documented, thoughtful exploration of safety of these silicone breast implants has laid down the scientific marker that patients, doctors and the regulatory community must now consider in any future actions.

Source: Peter J. Pitts, "When Science Rules," Pacific Research Institute, May 26, 2005.

For Institute of Medicine study:


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