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AMERICAN MORNING

FDA Considering Lifting Ban on Silicon Breast Implants

Aired July 21, 2003 - 07:37   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

SOLEDAD O'BRIEN, CNN ANCHOR: The FDA is considering lifting a ban on silicon breast implants. The gel filled implants have been off the market since the mid-1990s because of safety concerns. Implant manufacturers say the new and improved devices are safe and they're asking the government to lift all restrictions.
But later today, the National Organization for Women and other groups will make a public appeal for the FDA to go slow with the approval process.

Joining us from Washington, D.C. this morning is NOW President Kim Gandy. And also this morning Paul Wooley. He is a professor at Wayne State University.

Good morning to both of you.

And I thank you for joining us.

Professor Wooley...

KIM GANDY, PRESIDENT, NATIONAL ORGANIZATION FOR WOMEN: Good morning, Soledad.

PAUL WOOLEY, WAYNE STATE UNIVERSITY: Good morning.

O'BRIEN: Let's begin with you, Professor Wooley.

Ten years ago, as we mentioned, about, silicon breast implants were banned because researchers said they wanted to do a little more research into them. In the 10 years or so that have followed, what's the research show?

WOOLEY: Well, the National Organization for Women convened a meeting of 12 scientists and really we have three concerns. First is the actual failure of the device. It seems to rupture on a fairly regular basis, somewhere between 10 and 17 percent after about five years. The second is the tissue reaction, what's called capsular contraction when the implants actually harden in contact with silicon. And third, and possibly most important are the long-term or latent effects, what can happen after silicon exposure at a good time down the line. And the FDA is only really calling for about two years of data. And...

O'BRIEN: Two years of data -- forgive me for interrupting you, sir. But two years of data now. But didn't the National Academy of Sciences' Institute of Medicine actually do a very large study which found essentially that women with breast implants are no more likely than women in the rest of the population to have any kind of cancer or neurological problems or any kind of immunological disease, you know, if they had breast implants?

WOOLEY: Well, there are three factors in there. There's no evidence that I'm aware of of cancer. But certainly in terms of connective tissue disease, there is a small but significant increase in relative risk associated with breast implants. And that's in the largest study that was done in Boston.

O'BRIEN: Ms. Gandy, why is the National Association -- Organization -- forgive me -- National Organization for Women joining this debate?

GANDY: We believe that women have a right to know about what goes into their bodies and that the FDA has an obligation to make sure that everything that goes into our bodies, from breast implants to pacemakers, is safe for us. And silicon gel implants were taken off the market in 1992 because there were a lot of indications that they were not safe.

Since then there has been additional research. These 12 researchers, clinicians, scientists, all came to the conclusion that there are still serious problems with silicon gel filled implants. We had...

O'BRIEN: Serious problems or serious questions, because it sounds to me like there are scores of studies -- and if you go through the research -- scores of studies that will say that there is no proven link between neurological disease and sips.

GANDY: Well, I think it depends on whether you're a scientist or a lay person. The scientists looked at this and said gee, this raises a lot of questions. We need to do some more research. As a woman, I looked at it and said, gee, this raises a lot of questions, I think I don't want one of these things in my body and I think that most women don't know about these questions. Most women don't know that 25 percent of women who get implants have to have surgery within five years to have them removed because of problems. Twenty-five percent. That's a huge number within five years.

O'BRIEN: You have said that you want the FDA to go slow.

GANDY: Yes.

O'BRIEN: Describe for me specifically what that would mean.

GANDY: It means longer-term studies. What the scientists said is that for the women who do have serious longer-term health consequences, these don't begin to appear until, on average, seven or perhaps even 10 years after implantation, after the gel has had a chance to leak into the body. The gel chemical properties changes over time. We think that a longer-term study than the two years that the FDA is considering needs to be provided to the FDA by the manufacturer.

After two years, you're not going to see many problems... O'BRIEN: Now, that two...

GANDY: ... because the devices don't have problems after only two years.

O'BRIEN: That two year date is the amount of time before the companies can start filing for an approval application, right, once they...

GANDY: What the -- that's what the companies have offered the FDA and what the FDA has said that they're going to consider, they're going to consider only two years of data. And we asked someone else at the FDA but why isn't the FDA looking at its own studies? Why isn't the FDA looking at the follow-up that was done in previous silicon gel implant patients. And the response was, well, there's the pre-market application side of the FDA and then there's the rest, there's the post-approval side, and essentially they don't talk to each other.

Well, we want them to talk to each other.

O'BRIEN: Professor Wooley, we're almost out of time, but I want to give you the final word this morning. Manufacturers will say, you know, we make breast implants, silicon breast implants now that will not leak. If they are ruptured, they will not leach into the body.

Does that solve the problem here?

WOOLEY: No, not really, because you have to remember even a saline implant contains silicon. The actual bag that contains the saline or gel is still silicon. And silicon does have an immunological effect on the body. Everyone agrees with that.

What the argument is at the academic level is whether this immune response contributes to disease pathology.

O'BRIEN: Professor Paul Wooley and Ms. Kim Gandy, thanks for joining us.

I appreciate your time.

GANDY: Thank you.

WOOLEY: Thank you.

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