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FDA Study Raises New Concerns Over Silicon Breast Implants

Aired May 18, 2000 - 1:39 p.m. ET

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

LOU WATERS, CNN ANCHOR: A new study conducted by the Food and Drug Administration of silicon breast implants could raise health concerns for an estimated one million women. For the first time, MRI technology was used to examine the implants. It revealed previously undetected ruptures in two-thirds of the subjects.

CNN medical correspondent Eileen O'Connor joins us now from Washington with more about all of this -- Eileen.

EILEEN O'CONNOR, CNN MEDICAL CORRESPONDENT: Well, Lou, the study was done by the FDA and, as you said, it used this magnetic resonance imaging, which is a new technology, to look at breast implants, and determined leakage in 344 women who had had no systems of illness or problems.

Silicon breast implants were found to leak in nearly two-thirds of the women in the study. Sixty-seven percent had at least one rupture; 21 percent, the gel leaked beyond the breast capsule. It was always found that the newer the implants, the more likely they were to rupture. Two-thirds of the implants that were over 26 years old ruptured, but a much higher 79 percent of those between only 11 and 15 years old rupture.

Now, this may be because older implants were made with a thinker gel. That was made thinner later to make the implants more natural looking, but it leaks more easily. Because leaking silicon can cause health problems, in some cases it travels to the lungs and actually caused a couple of deaths, it lead in part to their removal from the market in general.

And this is cause for concern for women's health advocates, this new report. Because about one million still have silicon implants, and silicon implants are still being used by women for -- after they have had cancer surgery for reconstruction of their breasts.

Now this new study, though, has prompted two women's groups at least to call for a complete moratorium on the use of silicon implants -- Lou.

WATERS: So Eileen, so what are women with silicon breast implants now expected to do? or what should they do?

O'CONNOR: Well, the FDA has issued no advisory to women, but if they are concerned they should go and consult their doctor, as always, and perhaps they might want to consider having this MRI done to see if there is any kind of leakage.

Now, silicon has not caused health problems in every woman in which a silicon implant ruptured. So it is not cause for panic. But if they are concerned, as always, they should go and consult their doctor.

WATERS: Is that MRI an expensive proposition?

O'CONNOR: It is, and it would be -- and you would have to consult your doctor. If he feels it is necessary, then it is covered usually by insurance. But it is a more expensive test -- Lou.

WATERS: All right, Eileen O'Connor in Washington.

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