My name is Kim Gandy. I am the President of the National Organization for Women. NOW is the oldest and largest feminist activist organization in the United States, advocating for women's equal rights, women's economic and social well-being, and women's health.

The National Organization for Women and myself represent only our own 501(c) 4 non-profit corporation and no other party. My appearance today is underwritten by our 500,000 members and contributing supporters across the country.

To be blunt, it is disappointing that we find ourselves here today. Just last year, the Food and Drug Administration (FDA) made it clear that there was insufficient long-term safety data on silicone breast implants. And here you are again, reviewing another petition for market approval — still without long-term safety data.

What sort of message is the FDA sending to the public and to industry petitioners when it backs down on its demands for patient safety?

Inamed's less than four years of data are not sufficient to demonstrate long-term safety. FDA reviewers agree that little can be learned about rupture and other aspects from studies of such short duration. And, indeed, from the companies' data that has been reviewed by the agency, there is substantial evidence that these products are not safe.

The agency reviewers' estimate that from 74 percent to 93 percent of the implants under study would rupture within ten years. Those projections, and the absence of sufficient clinical data, are solid reasons to recommend against allowing these risky devices to be marketed generally.

Aside from the prospect of frequent implant rupture, there is the equally serious problem of slow leakage. Silicone particles and chemicals from the implants can and do seep into the body. Inamed's own data submitted for the 2003 panel meeting reported significant problems with silent rupture, local complications, re-operations, and connective tissue disorder signs and symptoms. There are too few properly designed studies that have been conducted to determine exactly what effect silicone gel has on human physiology.

Especially troublesome is the lack of knowledge about the effect of chemical constituents of silicone gel in pregnant women, and on the developing fetus, as well lack of information about the transmission of potentially harmful chemicals to infants through breast milk — all of which are items we recommended last year for inclusion in guidance to the industry for further study. Such studies should also include following children born to women with implants to evaluate developmental or health problems resulting from exposure in utero or in breast milk.

Another area of great concern to us relates to the difficulties that implants pose for accurate mammogram readings: 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.

Our national commitment to reduce the incidence of breast cancer could be undermined by the industry's media campaign to sell more implants.

And the dramatically higher rate of implant rupture and complications experienced by post-mastectomy reconstruction patients seems a cruel consequence for women who have survived a life-threatening battle with breast cancer.

The number of U.S. women who receive breast implants is rapidly increasing each year. In 2004, a record 330,000 women received breast implants. Currently, several million women in the United States have some type of breast implant and, at the present accelerating pace, millions more will have them in the future. Many have been injured and become seriously ill while wearing breasts implants; more than 400,000 have successfully sued.

This panel has already heard, and will continue to hear, the heartbreaking stories of women who became seriously debilitated after receiving breast implants. Many of these women can no longer work or take care of their families due to grave health problems.

Stories like this from NOW members is what started our inquiry into this issue three years ago. I urge the panel members to consider how the availability of well-based, long-term clinical data and an effective regulatory process could have changed these women's lives.

These women are asking the FDA to take responsibility for regulating an industry that cannot or will not regulate itself.

It would poorly serve the FDA to renege on its requirement that the manufacturers supply evidence, to a reasonable standard, that their products are safe for long-term use. Revoking this requirement would send a message to the public that the FDA is either unconcerned with public health or is an ineffective agency for protecting us.

And in this specific instance, reneging on these reasonable requirements and approving silicone gel-filled breast implants could result in devastating health consequences for a hundreds of thousands of women. Such a public health catastrophe is preventable, and women are counting on you to prevent it.

Thank you.

Read more about NOW's work on breast implants.