Good Morning America

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GRRRRRRR!!!!!!!

They're Back

Researchers Testing New Silicone Implants

Dec. 4 — Silicone breast implants, banned from use since 1992, are now back in clinical trials with improvements that researchers say will keep them from leaking, and help put them back on the market.

Until a decade ago, a generation of women used silicone breast implants — bags of liquid silicone — for breast augmentation and reconstruction. But then came a series of lawsuits filed by women claiming that their breast implants were leaking and causing serious health problems. Breast implant manufacturer Dow Corning paid a $4 billion settlement, and the Food and Drug Administration pulled the implants off the market, amid questions about how long they lasted, and the possible link to disease among women who had them. Now, silicone implants could be coming back. Researchers say the consistency of the new Contour Profile Gel Implant, manufactured by Mentor Corp. of Santa Barbara, Calif., is less liquid, more similar to Jell-O, and unlikely to leak into the body. There are other advantages, too, according to Dr. , a plastic surgeon at the University of Texas-Southwestern who is medical director of the ongoing trials. "There seems to be a better soft-tissue response to the implant, and what that means is the implant may actually impart a better shape to the breast than the existing implants," said. "There's also some other benefits such as less wrinkling with the implant, or visibility of the implant." Since silicone was yanked off the market, many American women have turned to saline breast implants, which were approved by the FDA in 2000. A record 220,000 American women had implants last year, twice the number of those who had them a decade ago. Several Years Of Testing

Since they are still being tested, it will be at least three to six years before the new silicone implants could hit the market. Since the Dow-Corning settlement, new research has shown that the implants are safe, ABCNEWS' Medical Correspondent Dr. Snyderman said. "Hundreds of medical studies then and since then have been done, not finding any link between silicone implants and cancer, MS, lupus, or other diseases," Snyderman said. "They've been published in journals, but never really picked up by the mainstream media." Still, for now, silicone implants remain banned. One of the women participating in the trials is 26-year-old Aimee DeHart of , Texas, who spent many hours researching different options before choosing the new silicone implants. "I wanted to be fuller, I wanted to look more feminine," she said. After enrolling in the preliminary trial that was under way with , she jumped from a 34B to a D. "I seem to be more confident," DeHart said. "I was confident before, but I seem to be more confident now [with] how I look in my clothes. Most American women will have to wait if they are interested in getting the implants. The implant is currently not approved for use in the United States unless you are a participant in one of those trials. Over the last five years, the new silicone implants have become the most popular type in Europe and Brazil. One U.S. trial is over, and another is set to start in 2003. The data will be presented to the FDA within the next two to five years. "So that would mean possibly in the next three to six years these implants would be available for clinical use," said. Those who want to get them sooner will have to rely on the saline implants. "Saline is the only safe way to do it now," Snyderman said. "You can't get the silicone, period, unless you're in one of these trials. Or go out of the country, and some women do."