Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: TUESDAY, July 18, 1995 TAG: 9507180027
SECTION: EXTRA PAGE: 4 EDITION: METRO
SOURCE: SUSAN SWARTZ THE N.Y. TIMES NEWS SERVICE
DATELINE: LENGTH: Medium
What was she supposed to do? She'd read of other women who had become seriously ill after their implants leaked or ruptured, their problems often starting between the third and seventh year.
Her breasts, the size C ones she'd received in 1988, had always been problem-free, but recently she'd noticed a burning sensation.
``I began to think I could have a time bomb inside me,'' she said.
To have the implants removed could cost $8,000 to $12,000, and it's something most health insurance doesn't pay for. And then what?
Now the woman, whom we'll call Franny, has new experimental breasts, with implants made from soybean oil. They contain a tiny microchip with a serial number that can be read by a scanner and connects her to an international data bank, identifying the implant, the manufacturer and her medical background. ``Maybe it's psychological, but these immediately felt healthier,'' Franny says.
She's had her new breasts for almost six months and has no complaints, save for a slight texture difference she thinks will improve with time. Otherwise she's delighted, relieved and, so far, a soybean believer.
Franny is part of a nationwide trial study on soybean implants being conducted on 50 women through five hospitals, including Stanford University Medical Center. The Stanford study is led by general surgeon Gail Lebovic and plastic surgeon Donald Laub.
How Franny and the others respond will determine when and if soybean oil becomes the revolutionary new, improved and clinically safe implant of the future.
For several years, doctors will regularly check Franny's blood, give her mammograms and document any changes in her body.
``You have to take responsibility for your own health, but there has been negligence in the industry,'' Franny says. ``The silicone implants weren't thoroughly studied to begin with. Yet we were told they were safe.
``When I tried to find out what my health status was, there was no place to turn. My plastic surgeon didn't know. I went to other doctors, and they didn't have a clue. No one wanted to be liable.''
She couldn't get an audience until she went to Stanford and found Lebovic.
``As a general surgeon interested in breast disease, it was important for me to know about these implants,'' Lebovic said. A primary worry was how both silicone and saline implants get in the way of mammograms and can mask breast lumps, preventing early cancer detection. X-rays can see through oil implants.
On the debate over silicone poisoning, Lebovic says that despite conflicting studies, she knows sick patients improve when silicone is removed.
``When we take away the silicone implant, the symptoms go away. The women all feel so much better. They can go back to work. You can't say this is psychological in all women.''
Some of her patients have the silicone replaced with saline. Some are in the soybean study. Some had their implants removed with no replacement.
Lebovic also knows that despite the controversy, women continue to want something to enlarge their breasts. ``The big thing is, they want to be informed about what they're getting,'' she says.
When Stanford was announced for the FDA-approved study, 20,000 women called in one week, she said. To qualify for the soy oil experiment, they had to have silicone implants that had ruptured or caused hard scar tissue. They also had to pay their own way - $10,000 for the surgery and hospitalization.
The implants, made by a Swiss-based company, are not entirely silicone-free. The soy oil is encased in a silicone envelope similar to what's used to coat pacemakers. The silicone is a different type than the troublesome silicone gel filling. Still, it's something researchers have to watch.
Lebovic sees the implant dilemma as a research opportunity instead of a product for doctors to be defensive about.
``I don't think there's a bad guy in this. Nobody's at fault. Everyone's at fault. We have to deal with what we have now. Look at this as a way for us to learn about the immune system, not just about silicone.''
(Susan Swartz is a columnist for the Press Democrat in Santa Rosa, Calif. Her column is distributed by The N.Y. Times News Service.)
by CNB