National Cancer Institute Breast Implant Study: Fact Sheet National Cancer Institute Breast Implant Study - National Cancer Institute

National Cancer Institute Breast Implant Study: Fact Sheet

In 1992, researchers at the National Cancer Institute (NCI) initiated a study on the long-term health effects associated with silicone breast implants. It is estimated that between 1.5 million and 2 million women in this country have had breast implants since they first appeared on the market in 1962.

One of the longest and largest studies to date on the health effects of implants, the NCI report involves 13,500 women with an average follow-up time of 13 years. Most previous investigations have looked at the health effects over a shorter time period, typically less than 10 years, and have been too small to evaluate uncommon diseases.

In addition, earlier reports did not include detailed information about types of implants or risk factors affecting health, such as medical history, screening practices, and lifestyle behaviors all of which are included in the current study.

Another unique feature of the NCI study is that the investigators compared the health risks of the implant patients to both the general population and other plastic surgery patients. Prior reports have used only the general population as a comparison group.

The purpose of the NCI study is to evaluate the effect of implants on the risk of:

Developing breast cancer;
Developing cancers other than breast;
Dying from all causes of mortality; and
Developing connective tissue disorders.
The results will be published in various scientific journals. As the publications appear in the literature, the findings will be summarized at the end of this fact sheet.

Background

Breast implants were first marketed in the early 1960s, before the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act required that medical devices be shown to be safe and effective. Silicone was initially assumed by manufacturers to be biologically inactive and, therefore, to have no harmful effects. However, cases of connective tissue disorders and cancers were reported in several short-term studies.

Because there were few reports on the long-term safety of implants, in 1992, the Food and Drug Administration (FDA) restricted the use of silicone gel breast implants to controlled clinical trials of women seeking breast reconstruction. That year, Congress also directed the National Institutes of Health to undertake a large follow-up study to assess the long-term health effects of exposure to silicone breast implants.

Types of Implants...


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National Cancer Institute Breast Implant Study - National Cancer Institute