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American Morning
Reintroduction of Silicone Breast Implants May Have Conditions
Aired October 16, 2003 - 09:34 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.
SOLEDAD O'BRIEN, CNN ANCHOR: Despite lingering questions about safety and durability, a panel advising the Food and Drug Administration is recommending that a ban on silicone gel breast implants be lifted with conditions. Dr. Sanjay Gupta is at the CNN Center with more for us this morning. Sanjay, good morning again.
DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: Good morning, Soledad. yes, eleven years ago when these silicone gel breast implants went off the market, very few thought that they would actually ever return, but that was the subject of two days of pretty emotional hearings over the last couple of days.
The FDA advisory committee hearing meeting, in hearing pleas from women on both sides of the aisle, women and men, I should say, about this particular issue. Final vote a close one, 9-6 in approval of actually not only letting these implants back on the market, but also letting a California-based company called Inamed to start marketing these again.
It does come with conditions, perhaps in a message to say that they're not taking this lightly. There are some conditions attached to this approval requiring annual checkups to check for possible ruptures after these implants go in. A patient registry to track long-term effects. This is important because they want to collect some longer-term data on these particular implants. Educational materials on the risks of the implants, as well. This is important because women need to be more educated, they say, about the possible harmful effects of these implants. And also biopsies required, a possible MRI when the implant is removed.
As I said, Soledad, lots of pleas on both sides. The FDA advisory committee people sort of summed up their proposal this way.
(BEGIN VIDEO CLIP)
DR. THOMAS WHALEN, ROBERT WOOD JOHNSON MEDICAL SCHOOL: It's a higher quality of data that we're hoping to be able to gather going forward to be able to finally demonstrate whether it's safe or not.
(END VIDEO CLIP)
GUPTA: But again there are several groups who are also opposed to this sort of thing. This is what one of those women had to say.
(BEGIN VIDEO CLIP)
DIANA ZUCKERMAN, CTR. FOR POLICY & RESEARCH FOR WOMEN & FAMILIES: Meantime, a million women could be getting breast implants, maybe more getting silicone gel breast implants, and they're going just to be part of a massive experiment.
(END VIDEO CLIP)
GUPTA: Taken off the market over ten years ago. Again, these implants, people were concerned, could they be causing autoimmune problems such as lupus? You may have heard of that. There was a study of this, several studies of this by the Institute of Medicine. That conclusion was no, there wasn't any definitive link there. But there is obviously local problems such as rupture which are being addressed in these hearings -- Soledad.
O'BRIEN: Sanjay, if the FDA indeed does accept this recommendation, how long before these implants are actually back on the market?
GUPTA: It would probably be a few months still, Soledad. This was an advisory committee hearing. Almost always the advisory committee, whatever they say, the FDA does accept that. That's been our experience in reporting on this for some time now.
But even after that it will probably be a few months before you not only see them on the market, but you'll probably start seeing the ads, as well. This is marketing as well of these devices so ads on television, magazines, things like that.
O'BRIEN: CNN's Sanjay Gupta for us at the CNN center this morning. Sanjay, thank you.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com
Conditions>
Aired October 16, 2003 - 09:34 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
SOLEDAD O'BRIEN, CNN ANCHOR: Despite lingering questions about safety and durability, a panel advising the Food and Drug Administration is recommending that a ban on silicone gel breast implants be lifted with conditions. Dr. Sanjay Gupta is at the CNN Center with more for us this morning. Sanjay, good morning again.
DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: Good morning, Soledad. yes, eleven years ago when these silicone gel breast implants went off the market, very few thought that they would actually ever return, but that was the subject of two days of pretty emotional hearings over the last couple of days.
The FDA advisory committee hearing meeting, in hearing pleas from women on both sides of the aisle, women and men, I should say, about this particular issue. Final vote a close one, 9-6 in approval of actually not only letting these implants back on the market, but also letting a California-based company called Inamed to start marketing these again.
It does come with conditions, perhaps in a message to say that they're not taking this lightly. There are some conditions attached to this approval requiring annual checkups to check for possible ruptures after these implants go in. A patient registry to track long-term effects. This is important because they want to collect some longer-term data on these particular implants. Educational materials on the risks of the implants, as well. This is important because women need to be more educated, they say, about the possible harmful effects of these implants. And also biopsies required, a possible MRI when the implant is removed.
As I said, Soledad, lots of pleas on both sides. The FDA advisory committee people sort of summed up their proposal this way.
(BEGIN VIDEO CLIP)
DR. THOMAS WHALEN, ROBERT WOOD JOHNSON MEDICAL SCHOOL: It's a higher quality of data that we're hoping to be able to gather going forward to be able to finally demonstrate whether it's safe or not.
(END VIDEO CLIP)
GUPTA: But again there are several groups who are also opposed to this sort of thing. This is what one of those women had to say.
(BEGIN VIDEO CLIP)
DIANA ZUCKERMAN, CTR. FOR POLICY & RESEARCH FOR WOMEN & FAMILIES: Meantime, a million women could be getting breast implants, maybe more getting silicone gel breast implants, and they're going just to be part of a massive experiment.
(END VIDEO CLIP)
GUPTA: Taken off the market over ten years ago. Again, these implants, people were concerned, could they be causing autoimmune problems such as lupus? You may have heard of that. There was a study of this, several studies of this by the Institute of Medicine. That conclusion was no, there wasn't any definitive link there. But there is obviously local problems such as rupture which are being addressed in these hearings -- Soledad.
O'BRIEN: Sanjay, if the FDA indeed does accept this recommendation, how long before these implants are actually back on the market?
GUPTA: It would probably be a few months still, Soledad. This was an advisory committee hearing. Almost always the advisory committee, whatever they say, the FDA does accept that. That's been our experience in reporting on this for some time now.
But even after that it will probably be a few months before you not only see them on the market, but you'll probably start seeing the ads, as well. This is marketing as well of these devices so ads on television, magazines, things like that.
O'BRIEN: CNN's Sanjay Gupta for us at the CNN center this morning. Sanjay, thank you.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com
Conditions>
