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Subj: More information from Dr. Zuckerman: Date: 11/13/2002 8:25:28 PM Eastern Standard Time From: devans@... Please Post Thank you...love....Lea ----- Original Message ----- Sent: Wednesday, November 13, 2002 6:20 PM Prepared Witness TestimonyThe House Committee on Energy and CommerceW.J. "" Tauzin, Chairman

HelpHow do I find...?Contact UsAbout The CommitteeSearchMenuHomeActionScheduleMembersNewsSubcommitteesIssuesLettersLegislationPublications Raising Health Awareness Through Examining Benign Brain Tumor Cancer, Alpha One and Breast Implant Issues.Subcommittee on HealthNovember 15, 20012:00 PM2123 Rayburn House Office Building Witness Panel Dr. Zuckerman Executive DirectorNational Center for Policy Research for Women and Families1444 I Street, N.W., Suite 900Washington, DC, 20005 My name is Dr. Zuckerman and I am president of the National Center for Policy Research for Women & Families. Our organization is a nonprofit think tank dedicated to improving the lives of women and families by explaining and disseminating medical and scientific research information<I style="mso-bidi-font-style: normal">. I am honored to be on this panel with Congressman Roy Blunt and these courageous women, to talk about the need for H.R. 1961, a bill that will help to ensure and protect women’s health and well-being. The Breast Implant Research and Information Act calls for more research on breast implants. I am here to tell you why this bill is so essential. 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, but no published studies of human beings. In 1990, as a scientist working on what is now the House Reform and Oversight Committee, I started an investigation of the FDA’s regulation of breast implants. We found that the FDA had ignored the concerns of its own scientists by allowing the sale of breast implants without requiring that the manufacturers prove that implants were safe. As a result of our hearing, the FDA finally required the manufacturers to submit studies of silicone gel implants. Unfortunately, those studies were so badly designed that they could not prove whether or not implants were safe. In response to pressure on both sides, the FDA did something they almost never do – they refused to approve implants but allowed them to stay on the market as a “public health need.†I think the last two months have shown us what a true public health need is – and breast augmentation does not qualify. But, at the time, Congress went along with the FDA decision, but required the NIH to conduct long-term research. There were no studies of women with implants in 1990, but quite a few epidemiological studies have been conducted since then. I have read all of them. Despite what you may have heard in the media, the research and the report by the Institute of Medicine does not conclude that implants are safe -- to the contrary, they show many serious problems related to implants. In fact, just a few months ago, 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 cancer, 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 are 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. In contrast, the studies showing no increase in disease for women with implants included many women who had implants for short periods of time – even as short as one month. Obviously, cancer and autoimmune diseases do not develop that quickly. A third study, conducted by scientists at the FDA, found that women with leaking silicone gel breast implants are more likely to have several painful and potentially fatal autoimmune diseases. Implants were found to be increasingly likely to break as they got older, and most implants were broken by the time they were 10-15 years old. This study may provide an important clue: it is possible that illnesses reported by women with implants are a result of leaking implants – which would explain why most women do not have systemic health problems until after they have had implants for several years. At the same time that these new studies were released, the plastic surgery organizations announced that almost 300,000 American women got breast implants last year, most of them for augmentation. Although they don’t boast about it, their statistics also show that the number of teenage girls getting implants has more than doubled in the last 3 years. These three new studies remind us that, although relatively few women become ill after having implants for a year or two, we need to be concerned about the long-term dangers. And women who are considering implants deserve to be accurately informed about the risks -- what is known, and what is not known. 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. They were designed to answer two essential questions: 1) do breast implants increase health risks and 2) do women with implants die at a younger age than other women?These are still the essential questions and that is the purpose of H.R. 1961. I am especially pleased that this legislation requires studies of women with implants after mastectomies. It is unfortunately true that not one single breast cancer patient was included in the studies that the federal government has conducted thus far. I want you to know that Congress requested that mastectomy patients be included in those studies, but the head of NIH at the time, Dr. Bernadine Healy, refused. It’s too late to fix those studies, but it is absolutely essential that studies of reconstruction patients be conducted as soon as possible. At this point, most of what we know is based on the manufacturers’ own studies, which show that one in four reconstruction patients need to have at least one additional surgery within the first three years after getting saline implants, and that other complication rates are also extremely high. We need to know what happens after three years, and we need to tell breast cancer patients about these complications so that they can make an informed decision about what would be best for them. In addition to new studies, it would be very cost-effective for the NIH to continue to study the breast augmentation patients in the NCI and FDA studies that I described a few minutes ago. At the time the NCI studied the women’s medical records, they had implants for at least 8 years. They have now had implants for at least 11 years, so it is important to study what has happened – whether the cancer rates, autoimmune diseases, and death rates of women with implants have increased or decreased in the last three years. Although I am especially concerned about the lack of information about the long-term safety of reconstruction, I m also concerned about the thousands of teenage girls that are getting breast implants every year. We don’t know what will happen to those girls, but unfortunately neither they nor their parents realize how little is known about long-term risks. It is time we answered that question. And H.R. 1961 would help ensure that patients -- and teenage patients’ parents -- know what the risks are well before they decide whether or not to get implants. In conclusion, I want to thank the Committee for holding this hearing, and especially thank Congressman Blunt and Congressman Gene Green for their essential work on this legislation. And, I thank the Committee members who have supported this legislation and shown respect and support for their constituents who have courageously shared their experiences with implants. We need your continued help. If Congress doesn’t require that these important studies be conducted by NIH, it is unlikely that they ever will be. And so, we’re counting on this Committee to make sure that NIH moves forward as quickly as possible. I hope the Committee will also undertake a careful review of the role of the FDA regarding the lack of long-term safety data on breast implants. Breast implants have been sold for almost 40 years, and yet the FDA has never required long-term safety data. They have not required that patients be informed of the risks of implants. Meanwhile, more than 127,000 adverse reactions have been reported regarding silicone gel implants and more than 65,000 for saline-filled implants – and yet the FDA has not even bothered to examine them. As this Committee considers legislation to reform the FDA in the coming year, I urge you to include a provision requiring long-term safety data for implanted medical devices that are already on the market. This is not like a new medical product: women who have had implants for many years are available to be studied, and the FDA should be mandated to do so. I would be glad to answer any questions, and I invite staff to go to our website, www.center4policy.org, to read some of the medical and lay articles that we have written on the topic, and to link to FDA’s consumer materials about breast implants. 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