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Daily Dose: Silicone May Soon be Coming to Doctors' Offices
Aired October 16, 2003 - 11:31 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
DARYN KAGAN, CNN ANCHOR: They were taken off the market in the U.S. 11 years ago because of health concerns. Now, silicone gel breast implants may soon be available again. Our medical correspondent Elizabeth Cohen has been tracking this. She is here with our "Daily Dose." Good morning to you.
ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT: It probably seems amazing to many people, because 11 years ago all you heard was...
KAGAN: How bad they were.
COHEN: Right. Exactly. So I'm going to explain what happened.
The food and drug administration had two days of hearings about silicone breast implants and whether or not they should be allowed back on the market. On the one side, were some women who said they had caused great harm. But on the other side were scientists who said that studies showed that actually these silicone breast implants did not cause problems.
Let's take a look at what the FDA advisory committee actually recommended. They said that they should be let back on the market, but with several caveats. Such as, women should have annual checkups to make sure they hadn't ruptured. And also there should be a patient registry of who gets them, so that long-term effects could be tracked.
Also, educational material on the risks should be given out to the women. And biopsies should be required when an implant is removed, and possibly even an MRI to see if indeed there are any problems.
Now, again, this is a recommendation by a committee within the FDA. It will go to the FDA, which has a couple of months to act. And then the company that makes these says that immediately they'll be able to put them on the market.
The person who's the head of this panel says that he thinks that it will be safe if women choose -- or he said that he thinks it will be -- that women, if they choose to get these, they'll continue to study them to see if they're safe.
(BEGIN VIDEO CLIP)
DR. THOMAS WHALEN ACTING PANEL CHAIRMAN: It's a higher quality data that we're hoping to be able to gather going forward, to be able to finally demonstrate whether it's safe or not. DIANA ZUCKERMAN, SILICONE IMPLANT OPPONENT: In the meantime, a million women could be getting silicone gel breast implants, and they're going just be part of a massive experiment.
(END VIDEO CLIP)
COHEN: Neither side managed to convince each other. So this debate about whether they're safe or not is sure to continue.
KAGAN: It does, but what about the debate about which is better, silicone or saline? Clearly there's some people who really want silicone. Why do they think they're better?
COHEN: Right. Both are available, and many people will tell you that the saline is safer. The reason why women want silicone is, well, they want them for cosmetic reasons. They want them for breasts that look and feel natural. And many people will tell you, many customers will tell you that the silicone simply looks and feels better. And that's why they want them. They say the saline just doesn't do the trick.
KAGAN: And then in listening to what you had to say, if this all kind of goes like appears, a few months down the line some people would get them?
COHEN: Possibly. Possibly as soon as a few months.
KAGAN: All right, Elizabeth Cohen, thank you for that.
COHEN: Thanks.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com
Offices>
Aired October 16, 2003 - 11:31 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
DARYN KAGAN, CNN ANCHOR: They were taken off the market in the U.S. 11 years ago because of health concerns. Now, silicone gel breast implants may soon be available again. Our medical correspondent Elizabeth Cohen has been tracking this. She is here with our "Daily Dose." Good morning to you.
ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT: It probably seems amazing to many people, because 11 years ago all you heard was...
KAGAN: How bad they were.
COHEN: Right. Exactly. So I'm going to explain what happened.
The food and drug administration had two days of hearings about silicone breast implants and whether or not they should be allowed back on the market. On the one side, were some women who said they had caused great harm. But on the other side were scientists who said that studies showed that actually these silicone breast implants did not cause problems.
Let's take a look at what the FDA advisory committee actually recommended. They said that they should be let back on the market, but with several caveats. Such as, women should have annual checkups to make sure they hadn't ruptured. And also there should be a patient registry of who gets them, so that long-term effects could be tracked.
Also, educational material on the risks should be given out to the women. And biopsies should be required when an implant is removed, and possibly even an MRI to see if indeed there are any problems.
Now, again, this is a recommendation by a committee within the FDA. It will go to the FDA, which has a couple of months to act. And then the company that makes these says that immediately they'll be able to put them on the market.
The person who's the head of this panel says that he thinks that it will be safe if women choose -- or he said that he thinks it will be -- that women, if they choose to get these, they'll continue to study them to see if they're safe.
(BEGIN VIDEO CLIP)
DR. THOMAS WHALEN ACTING PANEL CHAIRMAN: It's a higher quality data that we're hoping to be able to gather going forward, to be able to finally demonstrate whether it's safe or not. DIANA ZUCKERMAN, SILICONE IMPLANT OPPONENT: In the meantime, a million women could be getting silicone gel breast implants, and they're going just be part of a massive experiment.
(END VIDEO CLIP)
COHEN: Neither side managed to convince each other. So this debate about whether they're safe or not is sure to continue.
KAGAN: It does, but what about the debate about which is better, silicone or saline? Clearly there's some people who really want silicone. Why do they think they're better?
COHEN: Right. Both are available, and many people will tell you that the saline is safer. The reason why women want silicone is, well, they want them for cosmetic reasons. They want them for breasts that look and feel natural. And many people will tell you, many customers will tell you that the silicone simply looks and feels better. And that's why they want them. They say the saline just doesn't do the trick.
KAGAN: And then in listening to what you had to say, if this all kind of goes like appears, a few months down the line some people would get them?
COHEN: Possibly. Possibly as soon as a few months.
KAGAN: All right, Elizabeth Cohen, thank you for that.
COHEN: Thanks.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com
Offices>
