Health and Consumer Groups To Call On U.S. FDA To Slow Breast Implant Approval Process

July 16, 2003

FDA Not Considering Enough Data, Say Scientists and Clinicians

The National Organization for Women (NOW) will be joined by Public Citizen, other advocacy groups and scientists and clinicians to present a consensus document summarizing the latest research on silicone breast implants at 10:00 a.m. Monday, July 21st at the National Press Club. Based on the conclusions of this document, the organizations are calling on the U.S. FDA to delay reviewing applications for approval of the silicone gel-filled devices. According to the American Society of Plastic and Reconstructive Surgeons, more than 300,000 women received implants of all types last year - more women than ever before.

FDA is considering roughly two years worth of data, yet, as the summary document illustrates, research shows that problems with the implants do not begin for, on average, seven to ten years. In early May the National Organization for Women convened a panel of scientists and clinicians to review the latest data on the safety and efficacy of these breast implants, including representatives of the National Institutes of Health, the Food and Drug Administration (FDA) and the Armed Forces Institute of Pathology. The summary document is drawn from this meeting.

What: Release of Summary of Latest Science on Breast Implants

When: 10:00 a.m. Monday, July 21

Where: The National Press Club
The First Amendment Room
529 14th Street, N.W.

Who: Kim Gandy, President, National Organization for Women
- Dr. Paul Wooley, Professor of Orthopaedic Surgery, Immunology and Microbiology and Biomedical Engineering, Wayne State University Medical School
- Dr. Edward Melmed, Plastic Surgeon
- Sidney Wolfe, M.D., Director, Public Citizen Health Research Group
- Dr. Diana Zuckerman, Ph.D., Director, Center for Policy Research for Women and Families
- Cynthia Pearson, National Women's Health Network

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