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AMERICAN MORNING

Silicone Implants

Aired October 14, 2003 - 07:52   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 have been banned by the U.S. government for more than a decade, but this morning regulators will open a two-day meeting to hear arguments from a company that wants the ban reversed.
Dr. Sanjay Gupta joins us from the CNN Center with details this morning.

Hey -- Sanjay. Good morning.

SANJAY GUPTA, CNN MEDICAL ANALYST: Good morning, Soledad.

This is pretty interesting stuff here. The FDA Advisory Committee is going to have 14 hours of meetings over the next couple of days. It promises to be pretty dramatic, including testimonials from women who have been adversely affected by silicone implants in the past, as well as testimonials from companies who stand to make millions with new data, supposedly, about these silicone implants as well.

At issue, specifically, is the company called Inamed. That's a California-based company that wants to present some of this data and possibly get the approval from the FDA to go ahead and release the implants, as well as market them over the next period of months and years.

Now, let's take a look at the history of these silicone gel implants, and most people have sort of followed the story along over the past several years. Most people don't know that it was actually over 40 years ago that the first woman actually ever received silicone gel implants. Fifteen years later, you had the first trial win for a woman with a ruptured implant.

In January of '92 -- that's when a lot of action started happening around these implants, that's when an FDA moratorium was placed in April of '92 -- the availability of these implants was restricted, except for two populations of people: women who were having reconstructive surgery after cancer surgery, as well as women who were parts of clinical trials.

Interesting, Soledad, the numbers have increased actually by sevenfold in terms of breast augmentation surgery -- most of those obviously being saline implants. About 220,000 women a year or so are getting these implants.

Now, one of the concerns obviously has been the health concerns. And let me tell you quickly the concern about the silicone actually traveling away after a rupture of the implants -- traveling away from the breast to areas such as the spleen, the uterus and the liver.

The Institute of Medicine did a pretty rigorous study on this and did not find that the breast implants, the silicone implants were actually linked to any autoimmune problems, but did say there are some local concerns about these silicone implants. The greatest concerns being rupture, pain, what is known as capsular contracture -- that's where the capsule around the implant actually contracts, that can be quite painful -- disfigurement and severe infection.

So, after a decade of limited availability, there is going to be some interesting testimonials and some interesting debate over the next couple of days. This is the Advisory Committee hearing, but it may be a couple of months or even longer before we get a final word from the FDA -- Soledad.

O'BRIEN: Sanjay, a quick question for you. In light of the Institute of Medicine's study, what's the expectation about this hearing and how all of this will go? Or do you think it's just really truly too early to say?

GUPTA: It's really interesting. If you look at some of the data, you know, out there, the data about these silicone implants that will be presented today, they're really not that much different than the existing saline implant data. They say the rupture rates are about the same. What other folks will come back and say is the data that's available is too short-term. It's only based on a couple of years of data versus 7 to 10 years of data.

There is a quote actually from one of the organizations, 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."

The concern being that maybe the data just isn't there yet. This is going to be very interesting. We'll follow it along and keep you posted.

O'BRIEN: Dr. Sanjay Gupta, as always, Sanjay, thanks. Appreciate it.

GUPTA: Thank you.

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