Silicone Breast Implants Could Make Comeback

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Silicone Breast Implants Could Make Comeback

FDA OKs trial of new version

By Robin

HealthScout Reporter

FRIDAY, April 20 (HealthScout) -- The U.S. Food and Drug Administration

may give silicone breast implants another chance.

The federal agency has approved a clinical trial for the first new kind

of silicone breast implant in more than 30 years. And researchers say

their study, which started this spring, could lead to the resurrection

of silicone breast implants in this country. The new implants have been

marketed in Europe since 1994.

What makes this new implant different from its troubled predecessors,

researchers say, is the gel inside. It's more cohesive, and that could

mean less leakage and migration into other parts of the body if the

implant's shell ruptures. Likening it to the consistency of a Gummi

Bear, the new implant's creator says the gel simply sticks to itself

better.

" It doesn't go anywhere, " explains Dr. B. Tebbetts, a Dallas-based

plastic surgeon. Even when the implant is cut in pieces like a pie, " it

just sits there. "

" We wanted to make a better implant for women that's more durable, that

will cause fewer complications, and will necessitate fewer

reoperations, " he explains.

But some wonder if this latest implant solves one problem and creates

another.

While a thicker gel may not leak or migrate, it might cause more breast

sagging down the road, says Dr. Norman , an associate professor

of medicine at s Hopkins School of Medicine.

" We've been down this route, " says, because one of the first

implants designed in the 1960s had a thicker gel inside. Years later,

the thicker, heavier gel yielded more to gravitational pull: " It looked

like a National Geographic breast. "

Tebbetts says sagging hasn't been a problem with the 100,000 women who

have received the new silicone implants in Europe. He did add that

sagging does happen normally with larger breasts as women age, but

saline implants are actually more of a problem when it comes to that.

Not that silicone implants haven't had their share of problems in the

past two decades.

Various health concerns with silicone implants first surfaced in the

1980s, and Dow Corning Co. was ultimately sued by tens of thousands of

women over rupture problems with the silicone implants the company made.

Since then, Dow offered a $3.2 billion settlement and filed for Chapter

11 bankruptcy.

On the governmental front, the FDA removed silicone implants from the

market in 1992 because of unanswered health concerns. It has only

allowed silicone implants in women who are undergoing reconstructive

surgery and are enrolled in clinical trials.

Since the FDA clamped down on silicone implants, several recent studies

-- including one from the National Cancer Institute and another from the

National Academy of Sciences Institute of Medicine -- have found no link

between silicone implants and breast cancer, immune disorders, migraines

or memory loss. The latter study did caution that painful scarring and

hardening of breast tissue was a common complication with silicone

implants.

That hasn't stopped women from getting saline breast implants. According

to the American Society of Plastic Surgeons, more than 200,000 women

underwent breast reconstruction or enlargement last year -- a 101

percent increase from 1997.

Although cautioned that any new implant needs at least 10 years

of follow-up study, he welcomes any new approach.

" At least the idea that people are looking forward, trying to develop a

better implant is long overdue, " says.

Tebbetts says McGhan Medical has marketed his implant abroad for more

than five years, with few complications and low rupture rates. McGhan is

funding the FDA study, and Tebbetts is a consultant to the medical

device manufacturer.

The U.S. study will look at 940 women at centers across the country.

Some will receive augmentation, while others get reconstructive surgery

and reoperations on existing implants, Tebbetts says. The women will be

evaluated over a 10-year period. But the FDA could give the company the

go-ahead to market the new implant in the United States after only three

or four years of positive data, he adds.

The new technology doesn't come cheap. While saline implants can cost

between $400 and $1,300, the new silicone implants sell for $2,000 a

pair.

" These implants are going to have to prove themselves over the years, "

Tebbetts notes. " But based on our experience in Europe, it's a damn good

implant. "

What To Do

If you're trying to decide whether to get breast implants, you need to

settle one thing first, Tebbetts says.

" If you're afraid of silicone, you shouldn't put any breast implant in

your body, " he says. " There's no current breast implant in existence

that doesn't haven't silicone. Saline implants have silicone shells. And

silicone is silicone. "

For a complete history of the controversy over silicone breast implants,

go to the FDA.

The National Center for Policy Research and Women and Families takes a

hard look at silicone breast implants.

For more on breast implants, read these HealthScout stories.

SOURCES: Interviews with Tebbetts, M.D., F.A.C.S., plastic surgeon,

Dallas; Norman , M.D., associate professor, medicine, s

Hopkins School of Medicine, Baltimore

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