Myrl Jeffcoat myrlj@jps.net

DR. MELMED: Good morning. I'm Edward Melmed. I have no conflict of interest. I am a plastic surgeon who has done breast implants since the day they were introduced. I did my first year of residency in 1963, when Cronin first introduced silicone implants. So I have seen the evolution through the Cronin implant; the Jenny (phonetic) inflatable, which was a balloon through to the silicone pads; the Dacron patches; Meme implants, et cetera.

I wrote extensively about this in the Plastic and Reconstructive Journal in the '90s. But from 1992, I had a complete change-around. I started seeing the devastation and complications from breast implants. And since 1992, I have explanted over 800 women with breast implants. I wrote about this in Plastic and Reconstructive Surgery in 1998.

My statistics that I wrote in 1998 showed a rupture rate at 10 years of approximately 50 percent, a rupture rate at 15 years of 70 percent, and a rupture rate at 20 years of 94 percent. My current figures show no deviation from this. It's a time-dose-related phenomenon. Research that shows two, three, or four years' duration, my statistics show the same. It shows a four percent rupture rate.

The problems become manifest the longer the implants are in. The implants will rupture and just disintegrate. And sometimes no wall of the implant can be found.

I have brought some short clips that I'd like to just show in the background of what implants really look like when you get into the 10-15-year rate of removal. The silicone will simply well out with no visible evidence of any wall.

Now, if we take the statistics that are currently available, approximately 330,000 women received breast implants in -- at least 2004. If we extrapolate that figure -- sorry. Let me backtrack and say that if we accept that no medical device is safe -- and I think we must say that -- then just assuming there's one percent failure rate, at 10 years, you're going to have 33,000 women with problems, which if it becomes 3 percent is 100,000 women.

Now, no batch can be identified of what implants disintegrate. So we're left with this uncertainty of the future of these women. So a girl of 16 who you are going to allow this device in is very different from the 70-year-old who has a hip prosthesis that might fail, a woman who is going to be left with an inevitability of having four or five operations in their lifetime.

Lastly, how do you recall implants? If I buy a new Ford and it has a brake problem, the National Highway Traffic Safety will report it if there was more than one percent failure rate. Here we've got 17 percent failure rate. How do we recall them?

Thank you very much.