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American Morning
Silicone Implants Discouraged by Advisory Board Member
Aired November 07, 2003 - 09:43 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: Silicone breast implants might come back on the market, but are they any safer than before? The head of a government panel that just recommended ending the ban on the implants now wants the FDA to disregard that decision.
Medical correspondent Elizabeth Cohen joins us from the CNN Center with the details. Elizabeth, good morning. Very complicated story. What's going on here?
ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT: It is a complicated story, Soledad. And I'll start at the beginning.
Eleven years ago the FDA decided to take these till cone breast implants off the market. And then last month an FDA advisory committee said, You know what? We actually think they should be put back on the market. And the full FDA has yet to act on that recommendation.
Well now the chairman of that panel that said put them back on the market has now written a two-page letter to the commissioner of the FDA actually imploring him not to let these implants back on the market.
Let's read some of his arguments that he made to the FDA. Dr. Whalen said, "Long-term safety, the concern that prompted the removal from the market eleven years ago, was clearly not demonstrated. And to approve this device poses threats to women that are clearly unknown."
He then went on to say, "I need not point out to you in your position what the term 'FDA approved' represents to our citizenry. Once this horse is out of the barn, indeed for a second time, there will be no recourse."
So again, Dr. Thomas Whalen head of this FDA committee saying please don't let silicone breast implants back on the market. This follows two days of emotional testimony to this committee last month where women detailed short and long-term health problems that they say were because of their silicone breast implants -- Soledad.
O'BRIEN: But what we're seeing in that letter from Dr. Whalen, of course, does that indicate and underscore that he's completely at odds with the rest of the panel? And why, then, would the recommendation go forward in the first place if its chairman felt so strongly in the opposite direction?
COHEN: Well, the vote was 9-6. And Dr. Whalen didn't vote because the heads of the committees don't vote. They're more sort of there to facilitate the whole process. He didn't actually vote.
So the vote was 9-6, which is a pretty close vote. But that's why the recommendation was made. Nine of the people on the committee said they thought these ought to be back on the market.
And now the full FDA has to review it. Usually the full FDA, the agency, just kind of agrees with what the committee suggests. In this case, it's a little bit different. There's a very, very unusual letter and very strongly worded.
O'BRIEN: So, Elizabeth, obviously a lot still to be discussed and discovered. But what do they expect is going to happen now? A lot of people were thinking that these particular implants were basically marching toward approval.
COHEN: That's right. That is what many people thought because when I committee votes something, that's often the way that it goes. But now there's a real question mark as to whether or not these will be let back on the market.
Let's go through some of the arguments that people made at this hearing that happened last month. Women who had had these implants said that the implants caused ruptures, pain, scar tissue, neurological problems. There were also complaints that when the implants are in there it doesn't allow the mammogram to see the real breast tissue so you don't necessarily know if there's cancer.
So what the FDA committee did is they said, OK, let's approve these things, but let's have certain caveats. And these are the caveats. Annual checkups, if you get these implants. A patient registry so that those patients can be contacted later. Educational materials on the risks of the implants. And biopsies required if, indeed, something goes wrong.
Now some people, including Dr. Whalen, think that that's not nearly enough. They just think that these things should not be allowed on the market at all.
O'BRIEN: Elizabeth, interesting to see where this all goes. Thanks for that report this morning. Appreciate it.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com
Aired November 7, 2003 - 09:43 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
SOLEDAD O'BRIEN, CNN ANCHOR: Silicone breast implants might come back on the market, but are they any safer than before? The head of a government panel that just recommended ending the ban on the implants now wants the FDA to disregard that decision.
Medical correspondent Elizabeth Cohen joins us from the CNN Center with the details. Elizabeth, good morning. Very complicated story. What's going on here?
ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT: It is a complicated story, Soledad. And I'll start at the beginning.
Eleven years ago the FDA decided to take these till cone breast implants off the market. And then last month an FDA advisory committee said, You know what? We actually think they should be put back on the market. And the full FDA has yet to act on that recommendation.
Well now the chairman of that panel that said put them back on the market has now written a two-page letter to the commissioner of the FDA actually imploring him not to let these implants back on the market.
Let's read some of his arguments that he made to the FDA. Dr. Whalen said, "Long-term safety, the concern that prompted the removal from the market eleven years ago, was clearly not demonstrated. And to approve this device poses threats to women that are clearly unknown."
He then went on to say, "I need not point out to you in your position what the term 'FDA approved' represents to our citizenry. Once this horse is out of the barn, indeed for a second time, there will be no recourse."
So again, Dr. Thomas Whalen head of this FDA committee saying please don't let silicone breast implants back on the market. This follows two days of emotional testimony to this committee last month where women detailed short and long-term health problems that they say were because of their silicone breast implants -- Soledad.
O'BRIEN: But what we're seeing in that letter from Dr. Whalen, of course, does that indicate and underscore that he's completely at odds with the rest of the panel? And why, then, would the recommendation go forward in the first place if its chairman felt so strongly in the opposite direction?
COHEN: Well, the vote was 9-6. And Dr. Whalen didn't vote because the heads of the committees don't vote. They're more sort of there to facilitate the whole process. He didn't actually vote.
So the vote was 9-6, which is a pretty close vote. But that's why the recommendation was made. Nine of the people on the committee said they thought these ought to be back on the market.
And now the full FDA has to review it. Usually the full FDA, the agency, just kind of agrees with what the committee suggests. In this case, it's a little bit different. There's a very, very unusual letter and very strongly worded.
O'BRIEN: So, Elizabeth, obviously a lot still to be discussed and discovered. But what do they expect is going to happen now? A lot of people were thinking that these particular implants were basically marching toward approval.
COHEN: That's right. That is what many people thought because when I committee votes something, that's often the way that it goes. But now there's a real question mark as to whether or not these will be let back on the market.
Let's go through some of the arguments that people made at this hearing that happened last month. Women who had had these implants said that the implants caused ruptures, pain, scar tissue, neurological problems. There were also complaints that when the implants are in there it doesn't allow the mammogram to see the real breast tissue so you don't necessarily know if there's cancer.
So what the FDA committee did is they said, OK, let's approve these things, but let's have certain caveats. And these are the caveats. Annual checkups, if you get these implants. A patient registry so that those patients can be contacted later. Educational materials on the risks of the implants. And biopsies required if, indeed, something goes wrong.
Now some people, including Dr. Whalen, think that that's not nearly enough. They just think that these things should not be allowed on the market at all.
O'BRIEN: Elizabeth, interesting to see where this all goes. Thanks for that report this morning. Appreciate it.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com
