Fwd: breast implants on C-Span!

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Note: forwarded message attached.

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I participated in a press conference on breast implants today at the National Press club. Much to my amazement, it was live on C-Span! I would have let you all know if I had known. Check www.cspan.org for later listings. It will apparently be on C-Span 2 around 3:48 am EST. Not exactly prime time, but perhaps if they receive requests, they will show it again.

Here's the description. I was shocked that I was actually mentioned first!

Breast Implant Regulation News Conference Zuckerman from National Research Center for Women and Families, Kim Gandy from the National Organization for Women, Dr. Sidney Wolfe from the Public Citizen, and others hold a news conference on breast plant regulation.8/9/2005: WASHINGTON, DC: 1 hr.

Kim Gandy's speech is on the NOW website. My presentation was on research. Here it is:

Statement of Zuckerman, Ph.D.

National Research Center for Women & Families

I'm Dr. Zuckerman. I am President of the National Research Center for Women and Families. I'm an epidemiologist and I’m going to talk about why we’re concerned about the research.

I’ve heard some plastic surgeons say that breast implants are the most studied medical product in the U.S. That would be sad if it were true.

Let’s start with one undeniable fact: silicone breast implants have been sold for 40 years, but the companies only provided 2 or 3 years of data to the FDA.

If these implants are so safe, why don’t the companies prove it by studying women who have had them for a long time? Let’s see if we can figure out the answer to that key question.

I was a Congressional investigator in 1990, when I initiated a hearing on the FDA regulation of breast implants. At that time, there were almost one million women with breast implants. The number of published clinical trials or epidemiological studies at that time was zero.

So, in 1991, the FDA finally required implant companies to submit safety data. The data were so pathetic that the FDA rejected their applications. And how did the companies respond? Did they try to improve their studies? No, they stopped the studies and lost track of all the women in them.

Meanwhile, there were reports in the medical literature about women with breast implants who were sick, and reports from doctors that some women had silicone leaking out of their nipples. Dow Corning – the maker of silicone –started spending millions of dollars on research that they then used to defend themselves in a class action lawsuit.

In 1999, the Institute of Medicine did a review of all the research on breast implants.

This is probably the most misunderstood IOM report in history.

It’s a long report, but most of the studies were of animals or cells. There were not many studies of women, and almost all of them were funded by Dow Corning. The studies funded by Dow Corning had 3 major flaws:

they studied small numbers of women

the women had breast implants for too short a period of time. One study had women with implants for 2 years or less.

And, they didn’t conduct medical exams on the women

So, it’s not surprising that the results showed no clear evidence that breast implants cause disease.

After the IOM report came out, scientists at the NIH, National Cancer Institute, and FDA did their own studies. Their studies were better than the Dow-funded studies. The government scientists evaluated women who had breast implants for at least 6 years. They found statistically significant health problems among those women. For example, women with breast implants were twice as likely to die of brain cancer and three times as likely to die of lung cancer, compared to other plastic surgery patients. Other government studies found silicone in women’s lymph nodes.

But a funny thing happened to those NCI and FDA studies when the implant makers presented their data to the FDA a few months ago. Those government studies disappeared. It’s as if they don’t exist. Only studies paid for by Dow Corning – of which there are now dozens – were reported in the literature review. And, it might not surprise you that those studies all concluded that breast implants are safe.

FDA required Mentor and Inamed to study local complications, and they were surprisingly high. They didn’t expect an increase in disease symptoms in just two years. But there were. Women who had breast implants for two years had more symptoms of autoimmune diseases than they had BEFORE getting breast implants. Those symptoms included joint pain, fatigue, and memory loss.

A main concern was whether the implants break. Most didn’t. But these women only had their implants for 2 or 3 years, so they weren’t expected to break. That’s why we need long-term data.

The worst part is that there is no meaningful data on breast cancer patients. Neither company cared enough to study their long-term safety. Most breast cancer patients live a long time, and they deserve to know how implants affect their health. But, the companies didn’t study that, so we don’t know.

In summary, 2 million women now have breast implants. The companies could have provided really good data on the long-term health of a few thousand of these women, but they didn’t. And, we have reasons to be concerned about the integrity of the data that the companies have collected. Pearson, Executive Director of the National Women's Health Network, will talk more about that.