Testimony of Diana Zuckerman, PhD at the FDA on Silicone Gel Breast Implants

Diana Zuckerman, PhD, National Research Center for Women and Families,  April 2005

I’m Diana Zuckerman. I am President of the National Research Center for Women and Families, and I’m very pleased to be here. I have no conflicts. I’m a psychologist and epidemiologist and president of a nonprofit center that scrutinizes research to see what the implications are for health and safety.

We’ve heard that implants are the most studied medical product in the United States, but in 1991 there were about a million women with breast implants. The number of empirical published studies at that time was zero.

And at that time when they submitted their PMA, Inamed had only studied 39 breast cancer patients. Thirty-nine. And in their augmentation sample they had lost 65 percent of their augmentation patients at three to six months, according to the FDA summary.

Now, it brings us to 2003. Things have changed a little. We’re looking at the two to three year data that was available in 2003. It showed very high complication rates, including a lot of reoperations. It showed an increase in auto-immune symptoms, just about all of them that were measured. And it also showed no improvement and some worsening in most self-esteem and self-concept measures.

Now we know that most of the people talking have said this product has improved the quality of their life. But as has been pointed out by Panel members, the data just don’t support it. There is some improvement on body image, but not on quality of life, not on all of these other measures that have been touted as the main advantage of implants.

It’s very worrisome that all the patients in these studies are white, just about all of them. And, yes, I understand that most people getting breast implants for augmentation are white, but that is certainly not true of reconstruction patients. There are many, many thousands of reconstruction patients in this country that are women of color, and yet just a handful — I thought it was six African-American women, and five Asian American women, but according to the data shown this morning, it’s actually even lower. And I don’t understand how it could possibly be acceptable to approve a product with no data.

The reason why it’s important to have racial diversity in these samples is because there are racial differences in scarring and in auto-immune disease. African-American women are more likely, more susceptible to auto-immune disease. So we’d want to know are they more at risk, and we can’t conclude that because not only weren’t they analyzed separately, there weren’t even enough women to analyze separately.

That brings us to 2005. I thought that we’d have additional year of data. I was very interested to see what would the new data show and how would it be different. So I thought there’d be more data on complications compared to last time, but no, there aren’t. And I thought that there’d be another year of data on auto-immune, and no, there aren’t. And I thought there’d be another year of data on self-esteem and quality of life, and no, there aren’t. There is rupture data, and that’s great. But it was really for the three-year MRI data. It’s called four-year data, but since MRIs were done in the third year, it doesn’t take us very far.

When Inamed compared ruptured and intact implants, they did not evaluate connective tissue disease symptoms for most women with ruptures. I say that based on the FDA’s scientific analysis in your package.

They did find a significant increase in muscle pain. They didn’t find too many increases, but they had a very, very small sample to work with, partly because it just wasn’t measured.

The Adjunct Study has, according to Inamed, included 25,000 paients, but they didn’t follow-up on them. This is very upsetting because this was such a great opportunity to provide really good data and longer term data. And let me say that the young woman who testified about her problems not being reported, whether she was in the Adjunct Study or the Core Study, her problems should have been reported. And it says something about the commitment of the sponsor that they seem to think as long as it was the Adjunct Study, it doesn’t matter. I think it does matter. They should be taking care of patients in their studies, and they should be reporting them regardless of which — I don’t know which study she was in, but whichever one it is, she should have been reported.

And also remember that Inamed started their studies in 1990. Had they followed those women, we’d have at least a dozen years of safety data, the data we want. But they didn’t do that.

The literature review that FDA did talked about the Danish registry, but the mean number of years of women, and that was less than four years –not long enough.

It talked about the Danish rupture study. Forty percent of the implants were tested with a faulty MRI, so that study was not helpful.

And basically the data that many of you talked about showing up to ten years of rupture is faulty data. And I hope that Dr. Blumenstein will say something more about that later.

The FDA study did have a 21 percent extracapsular leakage for implants that were seven years old or more, and they also found an increase in fibromyalgia, which has not really been discussed at this meeting.

Thank you.