Statement of Diana Zuckerman, Ph.D. 05-24-2001 Press Conference on The Breast Implant Research and Information Act

Statement of Diana Zuckerman, Ph.D., President

National Center for Policy Research for Women & Families

Regarding the Breast Implant Research and Information Act

At the U.S. Capitol May 24, 2001 Press Conference

Breast implants have been sold in this country for almost 40 years, but we still know very little about their long-term health risks. In fact, almost a million women had breast implants before the first epidemiological study was published about health risks. Before then, there were just a few studies of rats and dogs, which were studied for a few weeks or months.

This legislation is particularly timely because just this month, three major new studies reported that women who have breast implants are at significant risk for several debilitating and fatal diseases.

One study, conducted by researchers at the National Cancer Institute (NCI) reported that women with implants were more likely to die from brain tumors, lung cancer, other respiratory diseases, and suicide compared to other plastic surgery patients.

A second study, also by NCI, reported that women with breast implants were more likely to develop cancer compared to other women their age.

Both of these studies were of women who had either silicone or saline breast implants for at least 8 years. They were the first studies to evaluate the health of women who had implants for such a long period of time -- at least 8 years. Most previous studies included women who had implants for just an average of 8 years.

A third study, conducted by scientists at the Food and Drug Administration and several medical schools, found that women with leaking silicone gel breast implants are more likely to have several painful and potentially fatal autoimmune diseases or related illnesses, including fibromyalgia, pulmonary fibrosis, and other diseases.

At the same time that these studies were published in medical journals, the official statistics of the plastic surgery associations were also released -- announcing that almost 300,000 women got breast implants last year, most of them for augmentation of healthy breasts. The number of teenage girls getting implants has more than doubled in the last 3 years.

These 3 recently published studies remind us that we still know very little about the long-term dangers of breast implants -- because they have never been objectively studied until now. We already know that many women with implants suffer from complications that can be painful, debilitating, and expensive. We need much more information about the long term risk of systemic diseases. And yet, hundreds of thousands of women are deciding to get implants because they mistakenly believe that implants are proven safe for long-term use.

The two studies conducted by NCI were mandated by Congress is response to the controversy surrounding implants. They were designed to answer questions of great importance to the almost 2 million U.S. women who have breast implants: 1) do breast implants increase the risk of cancer and 2) do women with implants die at a younger age than other women?

These are still the essential questions that need to be answered, and that is the purpose of the very important legislation that is being introduced today. I am especially pleased that this legislation requires studies of women with implants after mastectomies. It will shock breast cancer patients across the country to learn that no breast cancer patients have ever been included in the studies that the federal government has conducted on the safety of breast implants.

Since 1992, the FDA has restricted the availability of silicone gel breast implants to women with mastectomies, breast deformities, and for the replacement of broken gel implants. However, the FDA recently increased the availability of silicone breast implants for augmentation patients. And meantime, a growing number of parents are signing consent forms so that their teenage daughters can get breast implants. These consent forms also sign away their rights to sue if they become ill.

We don’t know what will happen to those girls, or to the women who make the decision for themselves. It is time we answered that question with solid research and post-market surveillance.

It is now my great pleasure to introduce Congressman Roy Blunt, who is serving his third term for southwest Missouri. Congressman Blunt is the Chief Deputy to Majority Whip Tom DeLay.

Representative Blunt became interested in the risks of breast implants when he heard the story of one of his constituents, Kim Hoffman, who is here today. She and her husband told him about the serious medical problems that she had with breast implants. I think that this kind of interest and concern, translated into action, is constituent service and Congressional representation at its best.

We also have Congressman Gene Green with us this morning. He has been representing Texas in Washington since 1992. Congressman Green serves on the House Energy and Commerce Committee and has been a leader in promoting education, quality healthcare and job training issues.

Representative Green introduced an earlier version of this bill in 1998. His dedication and support of this issue has been invaluable and again, I believe that he has listened to his constituents and that his work on this issue represents constituent service and Congressional representation at its best.

Before I pass the podium to our legislators, I have just a few comments on our program this morning. Following Representatives Blunt and Green, we will hear from Mary McDonough and Cherien Dabis, two women who have first-hand experience with the complications associated with breast implants. They will share their stories, and will then take some questions.