Despite Ban, a Gray Market in Silicone Implants Thrives

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http://www.nytimes.com/2005/04/21/fashion/thursdaystyles/21implant.html

Despite Ban, a Gray Market in Silicone Implants

Thrives

By MARY DUENWALD

Published: April 21, 2005

EANNA LONG lived 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. Wells, her surgeon in Long

Beach, Calif., 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 for 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 does 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 this country since 1995.

DR. JEWELL conducts clinical trials of the newer

implants for Mentor and the Inamed Corporation,

another implant maker in Santa Barbara. When word of

his trials got 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 20 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. Dr.

ce Kirwan, who practices in New York and in

London, said he finds the softer gels 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.