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American Morning
Paging Dr. Gupta: Return of Silicone Implants
Aired October 02, 2003 - 08:44 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.
HEIDI COLLINS, CNN ANCHOR: More than a decade after they were taken off the market, it looks as if the government regulators are ready to reverse the ban on silicone gel implants for breast enlargements.
Dr. Sanjay Gupta joins us from the CNN Center now with more on this. Good morning, Sanjay.
DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: Good morning, Heidi.
Later on this month, the FDA advisory committee is going to decide about this issue. It's been a decade-long issue. Many people know about silicone breast implants.
At issue now is a California based company called Inamed (ph). The question is whether or not they will start marketing silicone implants again.
Let's take a quick look at the history of silicone implants. Most people are surprised when, they learned, in fact, that it was 1962, when the first woman recipient, over 40 years ago, of a silicone gel implant. 1977, just 15 years later, the first trial win for a woman. So already lawsuits back as far as 1977. '92 is when the FDA declared a moratorium. That took effect in April of '92, where the FDA restricted the availability of silicone implants. They've still been available in certain situations, such as women in clinical trials and women who have had reconstructive-type operations.
Now, the question for a long time has been, you know, why are these bad? And there has been some studies, some reports, in fact, that perhaps these silicone implants actually migrate away from breast. In fact, there have been case reports where the silicone, after the silicone implant, the actual silicone itself was found in the liver, the spleen, in various organs throughout the body. There was also a concern that perhaps it caused immune problems, as well.
Now, the IOM, the Institute of Medicine, for their part, did a study and tried to figured out exactly what kind of symptoms these silicone gel implants cause. What they came up with, is they can rupture, they can cause pain. The capsule around the implant can actually contract, and that can be very painful and cause disfigurement, and it can also develop serious infections.
That's sort of where we are. There are people out there on both sides of this issue, a very controversial issue. Some of this is going to be decided later on this month -- Heidi. COLLINS: Well, that's exactly what I was going to ask -- exactly who is it then that would be opposed to this reintroduction?
GUPTA: Well, I'll tell you, first of all, there are a lot of women out there who feel that they have been harmed by these silicone gel implants in the past. They have released statements, in particularly a statement from the National Organization for Women. This is what they had to say: "Long-term safety has not been adequately addressed in past research. There is no reason to lift restrictions on their sale until we are sure they are safe and effective."
They're basically saying, listen, not enough studies have been done to show that it's time for these silicone gel implants to make a comeback. Obviously, a lot of women out there, this was a big issue. You may remember the covers of magazines, women actually significantly harmed, they say, by these particular silicone gel implants. That's going to be very interesting to see what happens.
There are scientists who say, we've heard all that, we've heard the anecdotal data, but there is no scientific evidence to suggest these silicone gel implants cause those sorts of problems. So this is one we're going to keep on top of, Heidi, because it's going to be interesting to see how this plays out. They are going to have a lot of hearings, in fact two-day hearings on this particular issue, which is a long time for the FDA advisory committee -- Heidi.
COLLINS: All right, very good, we'll be watching that. Dr. Sanjay Gupta, thanks so much this morning.
GUPTA: All right, 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
Aired October 2, 2003 - 08:44 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
HEIDI COLLINS, CNN ANCHOR: More than a decade after they were taken off the market, it looks as if the government regulators are ready to reverse the ban on silicone gel implants for breast enlargements.
Dr. Sanjay Gupta joins us from the CNN Center now with more on this. Good morning, Sanjay.
DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: Good morning, Heidi.
Later on this month, the FDA advisory committee is going to decide about this issue. It's been a decade-long issue. Many people know about silicone breast implants.
At issue now is a California based company called Inamed (ph). The question is whether or not they will start marketing silicone implants again.
Let's take a quick look at the history of silicone implants. Most people are surprised when, they learned, in fact, that it was 1962, when the first woman recipient, over 40 years ago, of a silicone gel implant. 1977, just 15 years later, the first trial win for a woman. So already lawsuits back as far as 1977. '92 is when the FDA declared a moratorium. That took effect in April of '92, where the FDA restricted the availability of silicone implants. They've still been available in certain situations, such as women in clinical trials and women who have had reconstructive-type operations.
Now, the question for a long time has been, you know, why are these bad? And there has been some studies, some reports, in fact, that perhaps these silicone implants actually migrate away from breast. In fact, there have been case reports where the silicone, after the silicone implant, the actual silicone itself was found in the liver, the spleen, in various organs throughout the body. There was also a concern that perhaps it caused immune problems, as well.
Now, the IOM, the Institute of Medicine, for their part, did a study and tried to figured out exactly what kind of symptoms these silicone gel implants cause. What they came up with, is they can rupture, they can cause pain. The capsule around the implant can actually contract, and that can be very painful and cause disfigurement, and it can also develop serious infections.
That's sort of where we are. There are people out there on both sides of this issue, a very controversial issue. Some of this is going to be decided later on this month -- Heidi. COLLINS: Well, that's exactly what I was going to ask -- exactly who is it then that would be opposed to this reintroduction?
GUPTA: Well, I'll tell you, first of all, there are a lot of women out there who feel that they have been harmed by these silicone gel implants in the past. They have released statements, in particularly a statement from the National Organization for Women. This is what they had to say: "Long-term safety has not been adequately addressed in past research. There is no reason to lift restrictions on their sale until we are sure they are safe and effective."
They're basically saying, listen, not enough studies have been done to show that it's time for these silicone gel implants to make a comeback. Obviously, a lot of women out there, this was a big issue. You may remember the covers of magazines, women actually significantly harmed, they say, by these particular silicone gel implants. That's going to be very interesting to see what happens.
There are scientists who say, we've heard all that, we've heard the anecdotal data, but there is no scientific evidence to suggest these silicone gel implants cause those sorts of problems. So this is one we're going to keep on top of, Heidi, because it's going to be interesting to see how this plays out. They are going to have a lot of hearings, in fact two-day hearings on this particular issue, which is a long time for the FDA advisory committee -- Heidi.
COLLINS: All right, very good, we'll be watching that. Dr. Sanjay Gupta, thanks so much this morning.
GUPTA: All right, 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
