Institute of Medicine Report on Breast Implants

Institute of Medicine. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. 1999.

The Institute of Medicine (IOM) of the National Academy of Sciences produced a report in 1999 concluding that though many local and sometimes serious complications occur with breast implants (such as pain, capsular contracture, and rupture), the existing evidence did not prove that breast implants cause disease. The report did not involve any new research; instead, it was a summary and review of the existing scientific literature on silicone breast implants. It reviewed only 17 studies concerning the health of women with implants. The report was never meant to be the “final word” on the topic, and since it was published in 1999 the research behind it is outdated.  However, it is still quoted so it is important to understand what the report did and did not include.

The report was also limited by the serious shortcomings of the research that had been conducted at the time the report was written. The flaws in the study designs are substantial, for example:

  • Studies with too few women. For example, the study by Dr. Sara Strom and her colleagues compared women with rheumatologic diseases with women without diseases, but only one woman with breast implants was in the study.
  • The women didn’t have implants long enough to develop a disease. For example, a study by Dr. Mark Schusterman and his colleagues did not include any women who had breast implants for more than 2 years. Most autoimmune diseases take much longer than 2 years to develop and be diagnosed.
  • Studies did not include a medical exam of the women with implants. Most of the studies relied on medical records, some of hospitalization records, and a few on self-reported illness.
  • Studies only evaluated a few diagnosed autoimmune diseases, not the kinds of autoimmune symptoms that are most widely reported by women with implants, such as pain, memory loss, and fatigue.

Most of the studies that were included in the IOM review were funded by implant manufacturers. In the years afterwards, there were several well-designed, long-term studies to show that women who have had implants for more than 7 years had an increase in cancer and suicide compared to other plastic surgery patients and an increase in fibromyalgia among women with leaking silicone implants. Recently, experts have also concluded that breast implants can cause a type of cancer of the immune system, which adds credibility to the reports of women who say that the autoimmune symptoms they developed after getting breast implants were cured after their implants were removed. To draw conclusions about the health risks of breast implants would require well-designed research on women with implants for at least 10 years.

Read the original report here.