Controversy That Won't Go Away :...


Back in 1981, Patricia Fodor was a newlywed with "a cute little figure" and the belief that silicone-gel breast implants would enhance it. It was "a self-esteem issue," she said. Because she worked in a doctor's office, Fodor even got a discount on the procedure.

Now Fodor, 33, fights debilitating pain that she links with those implants. She fears the "explantation," as the implant removal is called, will leave her deformed. But not necessarily cured.

At times, she blames herself for having been so vain all those years ago. The price of feeling good about herself has been higher than she could have imagined.

"Now we make the joke that maybe I just should have bought a Rolex," she said.

It has been 18 months since the Food and Drug Administration severely limited the sale of silicone gel implants. The stories about the alleged link between implants and such immune-system diseases as rheumatoid arthritis are no longer headline news.

But for thousands of women, including Fodor, that doesn't mean the silicone-gel controversy is settled.

More than 1 million women have had the implants since 1965, 80% for breast enlargement. In the wake of the FDA's decision to restrict implant use, thousands have acted, and thousands more are struggling to decide what to do:

* Nationwide, 13,500 lawsuits have been filed, including 300 in Orange County and 1,000 in Los Angeles County.

* More than 25,000 women have had implants removed.

* Support groups that believe implants are dangerous are flooded with requests for information. One group, Laguna Hills-based Breast Implant Information Foundation, draws about 300 people to its monthly meetings, said founder Marie Walsh.

Meanwhile, many physicians continue to reassure nervous implant recipients, arguing that the stories of implant danger are the product of media-driven hysteria, not science.

And, in the midst of this, there is an emerging backlash. A number of women who have lost breasts to cancer believe silicone implants should be available to anyone. And they fear that litigation may drive implants off the market altogether.


The implant controversy reached its height in January, 1992. After an eruption of news stories about women who blamed silicone-gel implants for immune-system illnesses, the FDA ordered a moratorium on the use of implants.

Then, in April of 1992, the FDA announced it would only allow silicone implants to be used in controlled clinical studies. Currently, only Mentor Corp. has such a study for women who want implants for reconstruction, said FDA spokeswoman Susan Cruzan. At this point, women who want to enlarge their breasts can only get implants filled with saline.

Studies on such possible effects as immune-related disorders and cancer are underway. If the studies establish that implants are safe, manufacturers will be able to reapply for FDA approval to market them. But until then, the sale of implants will continue to be restricted.

As of early summer, implant manufacturers had made federally mandated reports to the FDA of 32,822 "adverse events," including illnesses and deaths, associated with silicone-gel implants. Another 5,855 incidents involved saline implants.

Each month, another 20 lawsuits are filed in Orange County, adding to the thousands of cases already filed by women against implant manufacturers in federal and state courts, said Joseph Dunn, a Costa Mesa attorney who is acting as plaintiff's liaison counsel for the state.

In September, Dow Corning Corp., which was the leading silicone-implant manufacturer, proposed paying $4.75 billion to compensate women who claim their health was harmed by implants. Another manufacturer, Mentor Corp., last month reached a court-approved settlement of between $24 and $26 million for the claims brought against it.

Despite the limitations the FDA has put on implants, the administration advises consumers "there is no conclusive evidence that women with breast implants have an increased risk of developing autoimmune-like disorders."

It advises that if women are not having problems, there is no need to have the implants removed.

Dr. Brian Kent, a plastic and reconstructive surgeon in Orange, said he believes the fears over breast implants were exaggerated at first, and now have dissipated.

"I don't see the same level of anxiety as when this first hit the public," he said. "Since it's not in the media much lately, it's died down."


Not all women are reassured, however.

"Even though it's not on the front pages, our phones are ringing all the time," said Sibyl Niden Goldrich, co-founder of the Command Trust Network, a Beverly Hills-based clearinghouse for breast-implant information.

Citing her conversations with some of the 25,000 women who have contacted the network, Goldrich said women are bombarded with conflicting emotions as they confront what to do about their implants. Many first have to deal with the "discounting" they get from doctors, she said.

"Thousands of women come forward to report these problems, and they're told it's just media hysteria," she said. "They want us to go away, to be quiet little girls."

On the contrary, said Dr. John West, surgical director at the Breast Care Center in Orange. He said he and other doctors try to give their patients balanced information about implants to counter what he believes are one-sided, sensational stories in the media.

West said he tells woman that if they are not having medical problems with their implants, they should simply continue to do breast self-examinations, have regular mammograms and not worry.

"I think most of them are reassured," he said. "The majority of patients seem to be doing fine."

Some women are having health problems, but are afraid to make the link to implants, Goldrich said. Others are filled with rage at the doctors and government agencies who assured them the implants were safe. Others fear that even if they're fine now, they might be sick in the future. Many worry that silicone was passed on to children they nursed. Not a few are afraid they will lose the men they love if they take out their implants.

Guilt, like Fodor felt, is common, she said. And misplaced.

"I do hear women say, 'It was my fault; it was my vanity,' " she said. "But it's not valid. The blame can't go to the woman. She was denied access to information. The ones who denied her that have to take the full and total rap for it."

If women do have implants removed, they don't immediately feel relieved, Goldrich said. Instead, they mourn the loss of their breasts.

"I felt I was having a mastectomy all over again," said Goldrich, who finally had her implants removed after constant problems following her 1983 breast cancer surgery. "You develop a sense of ownership about the product--your shape, your balance, how you feel."


For Catherine, a 64-year-old Orange County woman who asked that her real name not be used, the only thing worse than the illness she believes was caused by leaking implants is life without implants.

Catherine got her implants in 1987, when she was 58.

"I was one of those women who didn't get everything some women have," she said. "I have poor hair, fine, thin hair. I can't do much about my hair, but for my bust, I thought this would be great. I was so thrilled."

Catherine immersed herself in the world of ballroom dancing. She had gowns made to show off her new figure. She made new friends and "everyone commented on how good I looked," she said.

Then she began to have sharp, radiating pains, breast soreness and discharge from the nipple. Her doctor determined the implants were leaking and she had them removed.

Catherine said that it was "devastating" to lose the breasts that had made her feel so special.

"When that image is destroyed, it leaves a big emptiness," she said. "And naturally, when things go wrong, you feel you shouldn't have done it. But when you've been a shrinking violet all your life, not as attractive, sometimes you grasp at a straw. You'll do anything."

Now Catherine wears heavily padded bras. Because of the implant removal and other unrelated surgery, she has discontinued much of her dancing. She wants back the life she thinks her implants gave her.

"If there is the slightest, remotest chance I could get implants that would not leak and not react, I would do so in a second," she said.


While women like Fodor and Catherine are living with the anxieties implants have brought into their lives, there is another group of fearful women: They worry that all implants will become unavailable in the wake of the controversy about them.

Most of the women who are speaking out in favor of implants are those who have lost their breasts to cancer. They believe implants are necessary to restore their bodies and their self-image.

Carole Shaw said that if she hadn't had reconstructive surgery with implants, her mastectomy and its scar would have been a symbol of "dying, not living."

Shaw, 50, said she weighed the risks presented by silicone implants, signed the lengthy consent form and went ahead. She also had a cosmetic implant in her other breast at the same time. She calls it "a present to myself" for surviving cancer.

"I'm afraid, because of what I've read, that they may take these implants (off the market)," said Shaw, who lives in Cypress. "If I have a problem and my implant can't be replaced, I think, psychologically, it will leave me in a very poor state."

"Just because it's a breast, they think it's something I want for beauty," she said. "But it's part of my body and I want everything to be there."


Sandy Finestone, who had a bilateral mastectomy and has had implants for 10 years, helped found the Irvine-based Women's Implant Information Network because she said women weren't getting balanced and unbiased information about implants. The organization's goal is to "make silicone gel breast implants a woman's choice between a patient and her doctor."

"Since I have implants, I'd be stupid not to be concerned," she said. "But I'm not going to do anything foolish until I know."

But Finestone thinks there might never be answers. Because of litigation over implants, she fears companies will simply stop making them and discontinue funding further research into whether they are safe.

"We need to know if there is a problem," she said. "I'm willing to accept bad news. But I don't like no news."

Information and Support

"A Matter of Choice," a symposium on the silicone-gel implant controversy, will he held Saturday at St. Joseph Hospital in Orange. The program will feature physicians, a representative of the FDA and the president of an implant manufacturing company, Mentor Corp. It is sponsored by the American Cancer Society, St. Joseph Hospital and the Orange County Breast Cancer Coalition. For more information, contact the American Cancer Society at (714) 751-0441.


There are also several breast-implant information and support groups in Southern California, including:

Breast Implant Information Foundation: Meets monthly and has a newsletter and information packet. For more information, call (714) 448-9928.

Command Trust Network: For information packet, send $2 to cover postage and printing, and a self-addressed stamped envelope to the network, 256 S. Linden Drive, Beverly Hills, 90212.

Women's Implant Information Network: Meets monthly and has a newsletter. For information, call Sandy Finestone at (714) 251-1542.

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