Time Not on Their Side, Say Women With Implants : Health: Angry and scared, they say they cannot afford to wait until late 1994 for the results of government studies.
Accumulating evidence that silicone implants may cause serious health problems in women--and, perhaps, even in some of their children--has triggered a new wave of fear and is leading more women to file suit or have their implants removed, say experts close to the controversy.
Local attorneys say about 2,000 California women have sued implant manufacturers, a substantial proportion of the 6,000 suits filed nationwide. The number of women who are having their implants removed--in so-called “explant” procedures--is estimated in the thousands, but some local doctors and several consumer groups say that number is also steadily rising.
Many women say they feel they cannot wait for government-ordered safety studies to be completed before they act.
“I don’t want to see 30 years go by before someone says, ‘Yes, there is a problem,’ ” says Lois, a Los Angeles woman who asked not to be further identified because of a pending lawsuit. She has joint pain she says was caused by the implants and recently had them removed.
“Women believe now that something is really wrong with implants. And they’re getting scared,” agrees Beverly Hills attorney Jeffrey Steinberger, who is representing about 1,000 women.
The Food and Drug Administration banned silicone implants on April 16, 1992, pending completion of safety studies, which is not expected until late 1994. The studies will try to resolve the most pressing question of whether silicone implants cause serious autoimmune disorders, including arthritis, lupus and scleroderma, a connective-tissue disease that causes the skin to harden.
But several trends threaten to eclipse whatever conclusion the FDA reaches. In the past two months:
* Mentor Corp., a silicone implant manufacturer in Santa Barbara, agreed to a $24-million settlement on litigation and to stop selling the implants within 18 months of the settlement closing. Mentor is the last manufacturer to pull out of the market.
* A Texas jury awarded $25 million in damages to a Houston woman who maintained that she developed autoimmune disease from ruptured silicone implants. Negotiations on a “global settlement” that could affect thousands of women are under way between attorneys for consumers and manufacturers.
* Two studies have found a strong association between silicone implants and autoimmune disease. And some preliminary evidence indicates that women with implants might pass toxic substances from the implants to their children while pregnant or during breast-feeding.
Still, there remains widespread disagreement on the bottom line: Are silicone implants dangerous?
“I think that the new studies are pretty convincing,” says El Requa, a Las Vegas woman who has organized the advocacy group Women Informed Now. “At the same time, I think there are many doctors who still have their heads in the sand. I think they are going to look pretty foolish in a year.”
But the American Society of Plastic and Reconstructive Surgeons continues to discourage women from having their implants removed, says spokeswoman Laura Koblis.
“So far, there has not been anything definitive linking silicone implants to serious health risks,” she says. “We are still waiting for definitive studies.”
Dr. Neal Handel of The Breast Center in Van Nuys says he honors requests to have the implants removed no matter what the reason. But he adds:
“People are in a hurry for answers. But these things take time. There are good studies underway now. And when the data is in, we’ll be able to say if there is a connection between silicone implants and autoimmune disease.”
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Silicone-gel breast implants became available more than 30 years ago. It was not until 1976, however, that the FDA was granted the authority to regulate medical devices. Because implants were already being sold, the product was “grandfathered” onto a list of acceptable devices without testing.
But last year, the FDA yielded to thousands of complaints and issued the product ban. Currently, women can get silicone implants only if they agree to be part of the authorized safety studies. Saline-filled implants are still available, but the FDA in January ordered manufacturers to prove the safety of those devices if they are to remain on the market.
About 1 million U.S. women have silicone implants, 80% for breast enlargement and 20% for reconstruction following a mastectomy. The implants are known to have side effects, such as capsular contracture (a hardening of the tissue surrounding the implant) and possible rupture. But the question everyone wants an answer to is whether silicone is toxic or harmless in the body.
In March, the largest implant manufacturer, Dow Corning Corp., reported on studies showing that silicone can irritate the immune system in rats.
Also in March, UC Davis researchers reported that in a study of 100 women with silicone implants, 35 had antibodies against their own collagen--a sign of autoimmune dysfunction in which the body attacks its own tissue.
The study “affirms that silicone should not be considered an inert substance,” says Dr. M. Eric Gershwin, co-author of the UC Davis study. “I think it is reasonable at this point that people ask not whether silicone implants cause disease but how often they cause disease, and whether there are special markers to predict which patients might get sick.”
The new evidence has fueled scores of lawsuits.
“With every report of a major medical study, we see additional claims,” says Joseph Dunn, a Costa Mesa attorney who has been assigned as plaintiff liaison for the cases filed in California courts.
“Instead of asking us where to find doctors, women are calling and asking us where to find lawyers,” says Sybil Goldrich of the Beverly Hills advocacy group Command Trust Network. “Because women are having difficulty getting enough money to handle their medical problems, they see no other way of getting it without suing.”
Among these women, the anger is palpable. Joan, a 59-year-old Las Vegas woman, had her implants removed after years of pain and having one of the implants rupture. She says she has been left disfigured, without enough money to pay for reconstructive surgery. She is also suing.
“I asked the doctor if the implants were safe, because I wouldn’t have anything done if it was dangerous,” says Joan, who received her implants for augmentation 17 years ago. “He said it was safe. He said my own tissue would form a sac around the implant, and if it did leak it would stay within this surrounding tissue.”
Within a few years, Joan began having chest and stomach pain.
“I kept having all these symptoms, and I would ask doctors, ‘Could it be these implants?’ They would always say no, there is no research (to prove that).”
A year ago, one implant ruptured and was removed. Five weeks later, Joan was back in an operating room for removal of the remaining implant which, she says, had caused her breast to become “rock hard.”
“I’m terribly angry,” she says, beginning to cry. “I’m not only angry for me, I’m angry for everybody who has had silicone implants. And I’m fighting those manufacturers.”
Dow Corning has offered $1,200 to women wishing to have the implants removed. But implant removal costs usually range from $3,500 upward and many women have trouble getting their health insurers to cover the cost, says Alice Wolfson, a San Francisco attorney who specializes in insurance bad-faith issues.
Women who have had implants for breast reconstruction are more likely to receive coverage than those who had augmentation, she says. And virtually all the women must prove that having the implants removed is “medically necessary” before insurers will pay.
For example, because the link between implants and autoimmune disease has not been proven, insurers sometimes deny autoimmune disease is a valid reason for removal.
“The term ‘medical necessity’ is a complete loophole out for insurers,” Wolfson says.
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Other women, while not experiencing problems with the implants, are still suing manufacturers. Under the state’s statute of limitations law, women must file suit within one year of recognizing there is a problem.
Requa’s organization encourages women who have not had problems to discuss their legal rights with a lawyer.
“Women should at least file a claim for future medical problems,” she says. “Some people may not react (physically) right away. Some may be lucky and never react. At least talk to an attorney and find out how to protect your right to sue later.”
Another factor muddying the picture is whether children can become ill from silicone that is transmitted prenatally or through breast milk. One New York doctor says he has examined about a dozen children with gastrointestinal complaints that appeared related to immune disorders. But he and other researchers, including Gershwin, say there is not enough information yet to determine if there is a link in children.
The FDA also is monitoring reports of autoimmune cases in children. And attorneys representing women are reporting a growing number of suits filed on behalf of children.
“We just want to know: Does it or doesn’t it harm children?” says Jama Russano of Children Afflicted by Toxic Substances, a Hauppauge, N.Y., advocacy group. “Why are these kids sick? The answer keeps coming back that it’s OK to breast-feed with silicone implants, but there really is no research to say it’s OK.”
A sense of betrayal is growing among consumers, says Russano, who believes her two children have the same autoimmune disease she has from silicone transmitted prenatally or through breast-feeding. A few weeks ago, she notes, the FDA announced that penile implants made of silicone may be causing health problems in men.
“I think people are under the impression that this is about women with implants and their kids,” she says. “But this is about not getting the right information from manufacturers. It’s everyone’s responsibility that we demand safe products so that this doesn’t happen again.”
