NOW President Testifies Before FDA on Danger of Silicone Breast Implants

Statement of NOW President Kim Gandy

April 11, 2005

Will the Food and Drug Administration (FDA) approve the general use of a product -- silicone gel-filled breast implants -- that has not been proven safe for long-term use? The FDA must not allow women to fall victim to the greed of two companies, Inamed Corp. and Mentor Corp., that want to bring these implants back to the open market without protecting women's health. It is incumbent upon the FDA to side with women, and not big business. It's time for the FDA to put science ahead of politics.

FDA regulators now estimate that up to 93 percent of silicone implants rupture within 10 years. What happens when these implants rupture and silicone enters a woman's body? The data provided by Inamed and Mentor continues to be unimpressive - despite years of clinical trials, silicone implant manufacturers simply have not provided regulators with the necessary data.

According to a five-year evaluation of seven mammography centers, breast implants obscure and greatly reduce the accuracy of mammogram readings - 55 percent of breast cancers went undetected in women with breast implants, which is 67 percent greater than in women without implants.

Yet another concern that has not been fully evaluated is the hazard to children born to women with silicone breast implants, particularly breastfeeding infants. Women of childbearing age must know all the facts before they become pregnant, so they can make informed choices about getting or keeping breast implants.

The women who will share their stories with the FDA panel today are true survivors - they became seriously ill and debilitated after receiving breast implants, and their presence before the panel demonstrates the seriousness of this issue. Other women who could not be in Maryland today because of the degree of their illness have sent their testimony along to be read to the panel. Many of these women can no longer work or take care of their families due to grave health problems. These women are asking the FDA to take responsibility for regulating an industry that cannot or will not regulate itself. They, and we, are asking the FDA to protect the health and lives of women who could one day be standing in their place.

NOW proudly stands with these women. We strongly urge the FDA not to approve silicone gel breast implants - a product that is fraught with dangerous consequences for millions of women.

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