Oral Testimony of Dr. Diana Zuckerman
At the November 15, 2001 Hearing of the
Health Subcommittee of the
Committee on Energy and Commerce
U.S.
House of Representatives
I am Dr. Diana Zuckerman, President of the National Center for Policy Research for Women & Families. I am especially grateful to have the opportunity to testify today, because 11 years ago I was sitting where you are today, staffing the first Congressional hearing on breast implants. On that day, I listened to courageous women talk about their terrible experiences with breast implants, and wondered if their stories could possibly be true. At that point, almost one million women already had breast implants, but there was no research to tell us how often these implants caused health problems. There were just a few studies of rats and other animals -- none of humans.
Eleven years later there are studies of women, and it is now established that implants can cause serious complications, such as infections -- which can sometimes be fatal -- and the much more common problem of rupture and the need for additional surgery.
And, just a few months ago, two major new studies conducted by the National Cancer Institute (NCI) reported that women who have silicone or saline breast implants are at increased risk of some kinds of cancer, and increased risk of dying from brain cancer, lung cancer, and other respiratory diseases.
A third new study, conducted by the FDA, found that women with leaking silicone gel breast implants are more likely to have several painful and potentially fatal autoimmune diseases.
These studies are very important, because unlike previous studies, every woman in these studies had implants for at least 6 years. Studies that have not found a link between implants and disease usually include women who had implants for just a few months or years. The new NCI and FDA studies are not conclusive, but they raise frightening questions about the long-term risks.
The essential questions have not changed in the last 11 years:
1) do breast implants increase the likelihood of health problems and
2) do women with
implants die at a younger age than they otherwise would?
We especially need to know what the health risks are for women who have reconstruction with implants after mastectomies, and to provide informed consent to all patients before they have decided whether or not to undergo implant surgery. That’s why HR 1961, the Breast Implant Research and Information Act, is so important.
The number of American women and teenage girls getting implants for augmentation has more than doubled in the last 3 years. Meanwhile, the FDA has not bothered to evaluate the almost 200,000 adverse reactions that have been reported. And we are still listening to women with the courage to testify to Congress about their implant experiences, and many of you are probably still wondering: can this be true and how often does this happen?
It’s time to stop wondering. The studies that were conducted by the NCI were mandated by Congress. They would not have been conducted at all if it were not for Congressional pressure, but even so, they did not include a single mastectomy patient. It’s too late to fix those studies, but it is absolutely essential that we start a new study of mastectomy patients. We now know that this will not happen without a law that requires it. And, of course, all women deserve informed consent, which includes risk information from the new NCI and FDA studies showing a link with potentially fatal diseases. That is not happening, and it won’t happen unless Congress requires it.
I have two other suggestions. The NCI and FDA studies that have already been published should be continued. Almost all the women in those studies have had implants for at least 11 years by now, so we can learn more about the risks of cancer and other diseases -- and for a lot less money -- by continuing the studies that were already started.
And, 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. Since implants are used for many years, FDA approval should be based on long-term safety data.
In closing, I want to thank you for the privilege of testifying, and I especially want to thank Congressman Blunt and Congressman Green and their terrific staff for their leadership on this issue, and other members of the Committee, and their staff, who have listened to your constituents as they described their implant problems, and treated them with respect. Our nonprofit think tank thanks you on behalf of our organization and the thousands of consumers who have contacted us about health problems linked to implants and other medical devices.