Press Information Details for Cosmetic Plastic Surgery in the UK and USA

Deanna Long live with her saline breast implants for more than 10 years despite her disappointment with how heavy they felt and the visible ripples they formed in her skin. She coped by wearing very supportive sports bras. But two weeks ago Ms. Long 41, had her implants replaced and this time got the silicone kind.

Silicone breast implants are banned for general cosmetic use in the United States, but Ms. Long got them anyway after Dr. James Wells, her surgeon in Long Beach, Calf., enrolled her in a government-sanctioned study that includes women who have had trouble with saline or older silicone implants.

As the Food and Drug Administration takes up a controversial and highly publicized recommendation by one of its expert committees to lift the 13-year ban on silicone breast implants, it might seem that the implants have been impossible to obtain. But thousands of American women manage to get them every year through open studies like the one Ms. Long joined, called an adjunct study, or through more restricted clinical trials.

Along with women who travel to Europe or South America or who simply cross the border into Mexico for breast enlargement, these women have easily and legally evaded the ban. And this gray market is likely to continue even if in the coming months the F.D.A. makes silicone implants available, because a next-generation implant sought by some patients will still be restricted here.

"There's just a very big demand for the newer gels, because the word is out among patients," said Dr. Mark Jewell, a plastic surgeon in Eugene, Ore., the president-elect of the American Society of Aesthetic Plastic Surgery.

Kim Gandy, the president of the National Organization for Women, who helped coordinate opponents of silicone implants testifying at the agency hearings last week, said she suspects women enter the adjunct studies and clinical trials on bad advice from their doctors. "Their doctors have told them that the restrictions are a big joke, and this is the only way they can get around these silly regulations," Ms Gandy said. "But the restrictions are there for a reason." That reason, she said, is the evidence that silicone implants can rupture and make women sick.

In recommending that a brand of silicone implants made by the Mentor Corporation become available the advisory committee accepted arguments that silicone leakage done not pose a risk of connective-tissue and autoimmune diseases. But rupture is still a concern. The committee advised requiring that Mentor, based in Santa Barbara, Calif., continue studying the risk of rupture.

Mentor implants contain a patented silicone substance known as Memory Gel, dating back to the late 1980's. It is part of what many surgeons describe as a third generation of implants, which have a jellylike consistency. The silicone is not runny like that used in the 70's and 80's, which had the density of motor oil. Fourth-generation implants, more viscous still, have the consistency of gummy candy. They have been in use outside of this country since 1995.

Dr. Jewell conducts clinical trials of the newer implants for Mentor and the Inamed Corporation, an other implant maker in Santa Barbara. When word of his trials go out, Dr. Jewell said, women from as far away as Florida and Hawaii asked to join. But because participants need to be examined regularly for 10 years, he includes only women who live close by his office.

Clinical trials are typically limited to about 1,000 patients, divided among 10 to 30 surgeons. These women pay for their own surgery. Dr. Jewell charges $5,700.

Roughly half the participants in clinical trials are women having their breasts enlarged for the first time, usually in their early 30's, said Dan Cohen, a vice president of Inamed. About a quarter are women having older implants replaced, and the rest are cancer patients wanting breast reconstruction.

In the adjunct studies, on the other hand, the numbers are not limited. The majority are thought to be breast cancer patients who want reconstruction, but the program is also open to women whose breasts are unevenly sized, to those whose breasts sag so much they are candidates for implants and a breast lift, and to those, like Ms. Long, who want to replace old implants. More than 160,000 women have taken part in the adjunct studies since 1992.

The gummy-candy-like implants, approved only outside this country, are molded into the teardrop shape of a woman's breast and come in many variations in width and height.

"We have about 130 different implants to choose between," said Dr. Per Heden, a plastic surgeon in Stockholm, who estimates he has implanted more than 5,000 of them in the last 10 years, dozens in
American patients. "That means we can customize the fit to the patient's particular glandular tissue, to her thoracic shape and to her desire."

In Europe, where women choose silicone over saline implants 90 to 95 percent of the time, the firmer implants are used in 7 out of 10 breast augmentations, Mr. Cohen said.

Dr. Heden said they last twice as long as older implants, which must often be replaced in 8 to 10 years. Not all surgeons are so keen on them however. Prof. Laurence Kirwan, who practices in New York and in London, said he finds the softer gels are more natural, and he prefers their round shape. "I don't shop in the teardrop aisle," he said.

Many women say any type of silicone feels more natural than saline. But the saline kind are adjustable in size. And at about $300 each, saline implants are cheaper than silicone, at $800 to $1,000.

Even if the F.D.A. soon allows Mentor's silicone implant, some women may choose to wait. Inamed has applied for permission to market its fourth-generation implant, and the agency could act on that request early next year, Mr. Cohen said. Mentor has plans to file a similar application this year, said Josh Levine, the company's president.

Inamed has developed a fifth-generation device, also teardrop-shape but slightly softer than the fourth-generation implant.

And a new material used in making artificial heart valves, part silicone and part urethane is being made into an implant. Dr. Jewell, who plans to describe this material to a meeting of plastic surgeons next week, called it the most lifelike yet.