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FDA Reconsiders Silicone Implants
Aired October 14, 2003 - 13:35 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.
KYRA PHILLIPS, CNN ANCHOR: The FDA took them off the market a decade ago after some women complained that silicone gel breast implants made them sick. Now the FDA is reviewing that decision and women are getting the chance to voice their concerns. Our Christy Feig joins me with the story. Christy, what do you know?
CHRISTY FEIG, CNN CORRESPONDENT: Well, Kyra, you're exactly rate. It is indeed a contentious day at a meeting Gaithersburg, Maryland right outside Washington D.C. At issue here is whether or not silicone-filled breast plants are indeed safe enough to be sold on the U.S. market.
Now you may remember back in 1992, when the FDA pulled these off the market because they had fears they could rupture in a woman's body and spread silicone throughout the tissues in their body possibly calling disease. Now a company called Inamed Corporation, they're out of California has a product they believe is safe.
So the FDA has created an advisory committee. They will hear testimony over the next two days and make the recommendation whether they feel these products are safe enough to sell. Already today they have heard hours of emotionally charged stories.
(BEGIN VIDEO CLIP)
UNIDENTIFIED FEMALE: The MRI showed that the shell looked like spaghetti in my chest. And the only thing holding the silicone in place was scar tissue. And I couldn't go in the sun anymore because my chest just burned and I would get these big splotches on my chest. And I decided to have it taken out, the implants taken out.
UNIDENTIFIED FEMALE: The implants we're trying to get approved today are the new ones, the new style, the improved ones. Not the ones of yesteryear.
(END VIDEO CLIP)
FEIG: Now last year in the U.S. more than 200,000 woman chose to have breast implants. Those who wanted them for reconstruction after breast cancer could opt to have the silicone breast through clinical trials. But those who wanted them because they wanted larger breasts had to opt for the only thing on the market, saline breast implants.
Women familiar with both say there is no competition here. The silicone gel filled implants are much more realistic. They look better, they feel better. So now this FDA advisory committee meeting still has a day and a half of hearings to go. They will go to 10:00 tonight.
After that, they will make their recommendation. Take a vote and tell the FDA whether or not they think, based on this testimony, they think it is safe enough to be sold in this market again in the U.S. The FDA is not bound by the vote but a lot of times follow the decision -- Kyra.
PHILLIPS: Christy, what about the women getting sick? What are their options? What about the one that had them taken out? Do they still feel sick? Better? In the clear?
FEIG: There is conflicting studies on this. And there was some more evidence presented just this morning, women who had problems just after having the breast implants put in were more likely to have long- term problems. Those women who got theirs removed as soon as they started feeling problems less likely and more likely to recover. Those who waited a long time and had scar tissue build around the implants where the silicone gel had gotten mixed in and it was hard to get out, some seemed to be having long-term problems.
So it depends how much seeped into the tissue, how long it took to get them out. A lot of conflicting evidence on that and a lot of it is anecdotal.
PHILLIPS: Christy, 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
Aired October 14, 2003 - 13:35 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
KYRA PHILLIPS, CNN ANCHOR: The FDA took them off the market a decade ago after some women complained that silicone gel breast implants made them sick. Now the FDA is reviewing that decision and women are getting the chance to voice their concerns. Our Christy Feig joins me with the story. Christy, what do you know?
CHRISTY FEIG, CNN CORRESPONDENT: Well, Kyra, you're exactly rate. It is indeed a contentious day at a meeting Gaithersburg, Maryland right outside Washington D.C. At issue here is whether or not silicone-filled breast plants are indeed safe enough to be sold on the U.S. market.
Now you may remember back in 1992, when the FDA pulled these off the market because they had fears they could rupture in a woman's body and spread silicone throughout the tissues in their body possibly calling disease. Now a company called Inamed Corporation, they're out of California has a product they believe is safe.
So the FDA has created an advisory committee. They will hear testimony over the next two days and make the recommendation whether they feel these products are safe enough to sell. Already today they have heard hours of emotionally charged stories.
(BEGIN VIDEO CLIP)
UNIDENTIFIED FEMALE: The MRI showed that the shell looked like spaghetti in my chest. And the only thing holding the silicone in place was scar tissue. And I couldn't go in the sun anymore because my chest just burned and I would get these big splotches on my chest. And I decided to have it taken out, the implants taken out.
UNIDENTIFIED FEMALE: The implants we're trying to get approved today are the new ones, the new style, the improved ones. Not the ones of yesteryear.
(END VIDEO CLIP)
FEIG: Now last year in the U.S. more than 200,000 woman chose to have breast implants. Those who wanted them for reconstruction after breast cancer could opt to have the silicone breast through clinical trials. But those who wanted them because they wanted larger breasts had to opt for the only thing on the market, saline breast implants.
Women familiar with both say there is no competition here. The silicone gel filled implants are much more realistic. They look better, they feel better. So now this FDA advisory committee meeting still has a day and a half of hearings to go. They will go to 10:00 tonight.
After that, they will make their recommendation. Take a vote and tell the FDA whether or not they think, based on this testimony, they think it is safe enough to be sold in this market again in the U.S. The FDA is not bound by the vote but a lot of times follow the decision -- Kyra.
PHILLIPS: Christy, what about the women getting sick? What are their options? What about the one that had them taken out? Do they still feel sick? Better? In the clear?
FEIG: There is conflicting studies on this. And there was some more evidence presented just this morning, women who had problems just after having the breast implants put in were more likely to have long- term problems. Those women who got theirs removed as soon as they started feeling problems less likely and more likely to recover. Those who waited a long time and had scar tissue build around the implants where the silicone gel had gotten mixed in and it was hard to get out, some seemed to be having long-term problems.
So it depends how much seeped into the tissue, how long it took to get them out. A lot of conflicting evidence on that and a lot of it is anecdotal.
PHILLIPS: Christy, 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
