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American Morning

Silicone Implants

Aired October 16, 2003 - 07:45   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 gel breast implants could soon be back on the U.S. market. A panel of government advisors is recommending that the FDA lift an 11-year-old ban with several conditions.
Dr. Sanjay Gupta joins us from the CNN Center with details on this.

Hi, Sanjay. Good morning.

DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: Good morning, Soledad.

Yes, 11 years ago when these implants went off the market, very few thought that they would ever return, but they are one step closer to that. As of yesterday, an FDA advisory committee, a relatively close vote, 9-6 in favor of actually letting a corporation, known as Inamed, start to release these devices and market these devices once again.

This is an FDA advisory committee hearing. It still has to go to the FDA. But that is the plan as of now.

Inamed, incidentally, is a California-based company, presenting a lot of its findings over the past couple of days.

Now, this loss of restriction actually comes with some conditions. Take a look at some of them. They're recommending annual checkups to check for possible ruptures. So, the women are going to have that recommendation made to them at the time of the implant. There's also going to be a patient registry to track long-term effects, an important thing to gather long-term data. Educational materials are going to be a mandate. Women need to read these educational materials at the time of the implant. And also, interestingly, biopsies are going to be required in cases of suspected rupture.

There was a lot of talking back and forth on this particular issue. There are folks that came out for this. There were people who came out against it. Let's hear a little bit from some of the folks from the FDA committee as they outlined their goals.

(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: And there's also -- there's opposing groups as well that came out. They were heard as well over the last couple of days.

(BEGIN VIDEO CLIP)

DIANA ZUCKERMAN, CTR. FOR POLICY AND RESEARCH FOR WOMEN AND FAMILIES: And meantime, a million women could be getting breast implants, maybe more, getting silicone gel breast implants. And they're going to just be part of a massive experiment.

(END VIDEO CLIP)

GUPTA: Many people remember the Institute of Medicine actually studied whether or not these breast implants actually led to these autoimmune disorders such as lupus. That was never conclusively proven, although there were a lot of problems with these in dealing with local rupture and things like that -- Soledad.

O'BRIEN: Sanjay, a couple of questions for you. First, during this hearing, were the makers of the implant able to show that in some way their product had improved, that it was safer today than it was 11 years ago? Or was it just the sense that there was no medical connection; therefore, why not move forward?

GUPTA: Quite simply there were a couple of things. They showed some data that showed that their rupture rate was no different than the saline implant rupture rate. That's the existing implant out there today. But the point of contention was that their data was based on 2-year data. And opposing groups came out and said, listen, most of the ruptures occur about five to seven years, so the 2-year data is really meaningless.

Nevertheless, they're still going to go forward with this recommendation to the FDA to go ahead and approve it, while still gathering the data over the next 10 years.

O'BRIEN: Sanjay, a quick question for you. The recommendation, how much weight will this finally have, do you think?

GUPTA: We've studied a lot of these sorts of cases. This is one of the more controversial ones, but nevertheless, the FDA probably, almost always in fact, takes the recommendations of the advisory committee. That process will take place over the next couple months. But I wouldn't be surprised early next year if we see these things back on the market.

O'BRIEN: All right, Sanjay, thanks.

GUPTA: All right, see 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 16, 2003 - 07:45   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 gel breast implants could soon be back on the U.S. market. A panel of government advisors is recommending that the FDA lift an 11-year-old ban with several conditions.
Dr. Sanjay Gupta joins us from the CNN Center with details on this.

Hi, Sanjay. Good morning.

DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: Good morning, Soledad.

Yes, 11 years ago when these implants went off the market, very few thought that they would ever return, but they are one step closer to that. As of yesterday, an FDA advisory committee, a relatively close vote, 9-6 in favor of actually letting a corporation, known as Inamed, start to release these devices and market these devices once again.

This is an FDA advisory committee hearing. It still has to go to the FDA. But that is the plan as of now.

Inamed, incidentally, is a California-based company, presenting a lot of its findings over the past couple of days.

Now, this loss of restriction actually comes with some conditions. Take a look at some of them. They're recommending annual checkups to check for possible ruptures. So, the women are going to have that recommendation made to them at the time of the implant. There's also going to be a patient registry to track long-term effects, an important thing to gather long-term data. Educational materials are going to be a mandate. Women need to read these educational materials at the time of the implant. And also, interestingly, biopsies are going to be required in cases of suspected rupture.

There was a lot of talking back and forth on this particular issue. There are folks that came out for this. There were people who came out against it. Let's hear a little bit from some of the folks from the FDA committee as they outlined their goals.

(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: And there's also -- there's opposing groups as well that came out. They were heard as well over the last couple of days.

(BEGIN VIDEO CLIP)

DIANA ZUCKERMAN, CTR. FOR POLICY AND RESEARCH FOR WOMEN AND FAMILIES: And meantime, a million women could be getting breast implants, maybe more, getting silicone gel breast implants. And they're going to just be part of a massive experiment.

(END VIDEO CLIP)

GUPTA: Many people remember the Institute of Medicine actually studied whether or not these breast implants actually led to these autoimmune disorders such as lupus. That was never conclusively proven, although there were a lot of problems with these in dealing with local rupture and things like that -- Soledad.

O'BRIEN: Sanjay, a couple of questions for you. First, during this hearing, were the makers of the implant able to show that in some way their product had improved, that it was safer today than it was 11 years ago? Or was it just the sense that there was no medical connection; therefore, why not move forward?

GUPTA: Quite simply there were a couple of things. They showed some data that showed that their rupture rate was no different than the saline implant rupture rate. That's the existing implant out there today. But the point of contention was that their data was based on 2-year data. And opposing groups came out and said, listen, most of the ruptures occur about five to seven years, so the 2-year data is really meaningless.

Nevertheless, they're still going to go forward with this recommendation to the FDA to go ahead and approve it, while still gathering the data over the next 10 years.

O'BRIEN: Sanjay, a quick question for you. The recommendation, how much weight will this finally have, do you think?

GUPTA: We've studied a lot of these sorts of cases. This is one of the more controversial ones, but nevertheless, the FDA probably, almost always in fact, takes the recommendations of the advisory committee. That process will take place over the next couple months. But I wouldn't be surprised early next year if we see these things back on the market.

O'BRIEN: All right, Sanjay, thanks.

GUPTA: All right, see 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.