The Institute of Medicine of the National Academy of Sciences produced a report in 1999 on the safety of silicone breast implants. The report did not involve any new research; instead, it was a summary and review of the existing scientific literature on silicone breast implants.
The study concluded that there were many local and sometimes serious complications with breast implants, such as pain, capsular contracture, and implant rupture. They reviewed 17 studies of the health of women with implants and concluded that the weight of existing evidence did not prove that breast implants cause diseases.
The Institute of Medicine report is based on the research published prior to 1999, and therefore becomes outdated as new research is conducted. It was never meant to be the “final word” on the topic. The report was also limited by the serious shortcomings of the research that had been conducted at the time the report was written. Unfortunately, press accounts tended to simplify the reports findings making it seem that the report was concluding that implants were safe.
The shortcomings of the 17 epidemiological studies that the report summarized include:
- Studies that have too few women with implants to study rare diseases. For example, the study by Dr. Sara Strom and her colleagues compared women with rheumatological diseases with women without diseases, and only one woman with implants was in the study.
- The women in the studies 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 just 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. The most objective, reliable measure would be by a physician who was unaware of whether the woman had implants or not.
- Studies only evaluated a few, classically diagnosed autoimmune diseases, not the kinds of symptoms that are most widely reported by women with implants, such as pain, memory loss, and fatigue.
The IOM study was a review of existing literature, much of which was funded by implant manufacturers. Since then, there have been several well-designed, long-term studies of women who have had implants for more than 7 years, and those have found an increase in cancer and suicide among implant patients compared to other plastic surgery patients, and an increase in fibromyalgia among women with leaking silicone implants. Research is needed on women with implants for at least 10 years to get more information about health risks.
For an online copy of the report itself, click here.