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Improved Silicone Breast Implant Designed Not To Leak

Silicone-gel breast implants are so controversial, the Food and Drug Administration has banned them for general use. There are worries the silicone gel can cause health problems if the implants leak. But now, a clinical trial going on nationwide is testing a new kind of silicone gel implant, one that is designed not to leak.

In her matter-of-fact way, Gail Daggy faced breast cancer.

"All I ever wanted was just to stay myself as much as I could," said Daggy.

She thinks she’ll get that chance by participating in a clinical trial conducted at the Cleveland Clinic and approximately 30 other hospitals nationwide.

Surgeons are using a new type of silicone gel breast implant. It's designed to stay intact even if the implant is punctured or cut.

“Basically, the consistency of the implant is much thicker than the normal gel, which is the consistency of a jelly,” said Dr. Randall Yetman, a plastic surgeon at the Cleveland Clinic. “This is the consistency of a gummy bear."

Silicone implants, which some women say feel more natural than saline, have had a troubling past. Some women whose implants have leaked have complained about medical problems. And the FDA has pulled the implants off the market because investigators say there isn’t enough data on their safety.

A new generation of implants has been offered in Europe since the late 1990s. Surgeons in the United States started testing the implant two years ago for breast reconstruction. And the manufacturer plans to submit data for FDA approval by the end of the year.

Dr. Yetman has been part of this phase of the clinical trial since January. So far, he’s used these implants in nearly two dozen patients.

"Preliminary results are that they seem to behave very well,” said Yetman. “But I think all implants behave very well early on. It's how they live over an extended period of time that really shows the true value of implants."

Daggy knows there is a risk that comes with being part of a clinical trial. But she says she feels part of the future, and her participation will contribute to the comfort of women like her who are breast-cancer survivors.

If the FDA approves this new type of implant, a representative for the maker says it could be available in mid- to late 2005.

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