Research Indicates Long-Term Risk to Women's Health from Silicone Breast Implants Not Fully Addressed in FDA Clinical Trials

Report: Conclusions from Symposium on the Safety and Effectiveness of Silicone Gel-Filled Breast Implants
(pdf format)

July 21, 2003

The National Organization for Women (NOW) was pleased to convene the recent symposium on the safety and effectiveness of silicone gel-filled breast implants. As an organization advocating on behalf of all women, we recognize that breast implants are an important public health issue, considering the escalating use of and demand for these devices and the long-standing and very public debate concerning their safety.

Speakers at the July 21 news conference at the National Press Club in Washington, D.C. included, from left: NOW President Kim Gandy; Dr. Paul Wooley of Wayne State University Medical School; plastic surgeon Dr. Edward Melmed. Photo by Lisa Bennett

It was our goal to highlight recent research on silicone gel-filled breast implants in order to encourage a continued dialogue between scientists, plastic surgeons, physicians and federal regulators about the safety and effectiveness of these medical devices. The complex conclusions of the Institute of Medicine (IOM) report released in 1999 were misinterpreted by the popular press. It was erroneously suggested that past research had definitively proven the safety of these devices. However, NOW and many scientists viewed the IOM conclusions as a demand for better and more extensive research. In view of the growing body of research in this field, it was our goal to provide an opportunity to review the status of clinical, toxicological, and immunological studies on silicone gel-filled breast implants.

Plastic surgeon Dr. Edward Melmed discussed the health risks of silicone-gel filled breast implants. Photo by Lisa Bennett

The relevance of this meeting was made more critical considering the fact that individuals engaged in research in this area meet resistance from scientific and medical journals in their effort to publish studies on silicone gel-filled breast implants. For many panel members, the symposium presented an opportunity to discuss the relevance of recent findings and make recommendations for future research.

The ongoing commitment of many scientists to study silicone gel-filled breast implants has included new research conducted at the National Institutes of Environmental Health Sciences at the National Institutes of Health and the Food and Drug Administration. These and other literature reports afford strong evidence of the need for a continued assessment of the growing body of information on the risks of these devices. We were privileged to have in attendance federal researchers from the Food and Drug Administration, the National Institutes of Health and the Armed Forces Institute of Pathology in addition to a number of prominent scientists from around the country.

This silicone gel-filled breast implant was removed from a patient after it ruptured. Silicone gel can be seen leaking from the right side. Photo by Lisa Bennett

An important part of NOW's mission is to ensure that women are provided with a thorough scientific basis for informed decisions about their health care, including the use of medical devices. New research in the area of silicone gel-filled breast implants has raised additional questions concerning the long-term safety of these devices and the need for frequent surgeries to correct complications. We, therefore, strongly encourage the Food and Drug Administration to consider both short- and long-term complications in a review of the clinical data on silicone gel-filled breast implants.

We would like to thank the panel members and presenters, as well as the many other individuals who helped to make this symposium possible.

Kim Gandy, President
National Organization for Women

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