All But Forgotten

Tinker Ready, Special to The Los Angelos Times: October 1, 2001

In the made-for-TV movie about two women who took on Dow Corning Corp. and other medical device makers over the safety of silicone breast implants, the women emerge as winners. In real life, P.J. Brent’s story did not have such a happy ending.

Like the movie heroines, the Atlanta mother of six believed she had been poisoned by leaking implants. But by March 2000, when she testified before the Food and Drug Administration, public and scientific opinion had shifted. Many scientists and doctors now consider the breast implant scare to be nothing more than a case of junk science meeting legal excess. Brent told the panel that silicone ruined her health and harmed two of her children whom she breast-fed. But a Pennsylvania pediatrician contradicted her, telling the FDA that there is no scientific evidence linking Brent’s implants to her children’s severe leg numbness, rashes and difficulty swallowing.

Brent’s story ended a few months after the FDA hearing. One summer morning, she drove to the top of a five-story parking garage at a shopping mall in suburban Atlanta, climbed over the railing and leaped to her death.

“She said she was going grocery shopping, and 30 minutes later she was dead,” her husband, Ed Brent, said.

For years, women like Brent who blame breast implants for chronic illnesses had lawyers, activists, journalists and a small but determined group of doctors and scientists to back them up. Plagued by fatigue, constant pain and memory loss, the women were the subject of talk shows, scientific papers and scores of published articles. They filed lawsuits by the thousands and began winning cases with multimillion-dollar damage awards. In one 1992 case, a Texas woman was awarded a whopping $25 million.

Then, in the mid-1990s, their cases began to unravel. New research failed to find a connection between their symptoms and their implants. Even as breast implant manufacturers agreed to a record-breaking class-action settlement, prestigious medical journals were publishing studies concluding that women with implants were no more likely to be sick than the rest of us.

Today, 10 years after the FDA removed silicone implants from the market, doctors, implant makers and regulators cite these studies as irrefutable evidence that silicone implants are safe. Indeed, breast implant procedures–now using saline implants that have a silicone coating–are more popular than ever in this country. About 267,000 U.S. women had implant surgery last year, more than twice the number that did so in 1996, according to the American Society of Plastic Surgeons. And a new type of firmer silicone gel implant, already available in Europe, is being tested as part of the manufacturer’s plan to introduce it in the United States. Meanwhile, some women have sought out underground clinics and house parties where they can get illegal silicone injections to smooth facial wrinkles or fill out their breasts and lips.

For many women, however, the years since the implant controversy dropped from the front pages of newspapers have been especially hard. They feel doubly victimized by the flip-flop in public, legal and scientific opinion on this issue. Despite evidence to the contrary, many of these women still insist their implants triggered chronic, debilitating illnesses. They suffer health problems ranging from joint pain to lupus to multiple sclerosis but now find themselves cast not as victims, but as frauds. Many feel a sense of betrayal from doctors who no longer take their complaints seriously, from lawyers who once courted them and now refuse to take their phone calls, and from the media, which once played up the dangers of silicone implants and now largely ignore their stories.

“It is depressing to continue to be sick, know why you are sick and have people tell you that implants are perfectly safe and it’s all in your head,” said Margaret Melvin, an Orlando, Fla., woman who hosts a Web site discussion, called “Silicone Holocaust,” on implant safety. “Depression is one of the biggest things we battle.”

P.J. Brent’s suicide was not the first among women who believe they are ill from implants, Melvin noted. Women with silicone breast implants are four times more likely to commit suicide than other plastic surgery patients, according to a study by the National Cancer Institute.

At the time of her death, Brent seemed depressed by her own fatigue and her struggle to get confirmation for the link between her implants and her children’s health problems, her husband said. “That’s the only explanation I can give you as to why she took her life,” Ed Brent said.

All of the implant companies, except Dow Corning, agreed to a class-action settlement in 1994 that was supposed to deliver some relief and vindication to these women. Instead, it has only added to their disappointment. On paper, at least, it appeared that thousands of women would be eligible for payments of up to $1.4 million. But legal sources say few women received more than $50,000. A small group of financially strapped implant suppliers paid out as little as $700. (All of the women agreed not to disclose settlement amounts.)

And tens of thousands of women who had Dow Corning implants have received no money at all. That company, which made the silicone gel used in the implants, set up a separate $3.2-billion settlement plan in 1998 and declared bankruptcy soon after. So the settlement has been tied up in bankruptcy court since then. Women like Melvin, who opted out of the class-action settlements to pursue their cases in court individually, have not fared much better. In many cases, lawyers now refuse to take their cases because they say the odds of winning are too low.

Still, the debate over the science of implant safety quietly persists. Some consumer activists and scientists who launched this debate years ago contend that much remains unknown about the health risks of silicone implants. They contend there are flaws in the research that concluded implants pose no safety risk, saying those studies did not include enough women or follow them long enough to detect diseases that can take 10 years or more to develop. They say that a series of pending studies by the National Institutes of Health of 13,000 women will provide more definitive answers by following more women for a longer time period. They also cite a recent, separate FDA study that, for the first time, looked at women with ruptured, leaking implants. The researchers found women with silicone that had leaked from their implants and beyond the chest area were much more likely to develop chronic diseases, including fibromyalgia, than women with intact implants.

But such information doesn’t help women like Margaret Melvin cope with the everyday realities of life. Melvin had her leaking silicone implants surgically removed in 1992. But two years ago, BlueCross/BlueShield of Florida rejected Melvin’s application for an individual insurance policy, citing the company’s policy to not sell individual policies to women who had experienced a ruptured silicone implant.

“This is because there is still a potential for further health problems after removal,” a company representative wrote in a September 1999 letter to Melvin.

Melvin says she contacted 20 lawyers but none would pick up her case after her first lawyer insisted she settle. How could her silicone-related health problems be considered real enough to justify an insurer’s decision to deny coverage yet insufficiently valid to make a case in court, she wonders. “How,” she asks, “can they have it both ways?”

The tide began to turn in the implant debate in 1996 when a federal judge overseeing a class-action suit against implant makers convened a scientific panel to examine a pile of conflicting research. At about the same time, Congress also stepped in to help sort out the science. Stuart Bondurant, the dean emeritus of the University of North Carolina medical school, headed the congressional panel, which was based at the prestigious Institute of Medicine. By then, more than 1.5 million U.S. women had silicone implants and roughly 1,200 scientific papers had been written on the issue. Bondurant’s group issued its report in 1999, concluding that the evidence linking silicone implants to serious illness is “insufficient or flawed.” The court-ordered study came to a similar conclusion.

“There are many, many women with terrible diseases who have breast implants,” Bondurant said in a recent interview. “And those women are convinced that the implants have caused their disease, but the scientific evidence does not support that. They are still sick, but the position the committee takes is that it is not the implants causing these diseases.”

The Institute of Medicine report was not intended to be the last word, but many doctors, judges and journalists have interpreted it that way, said Diana Zuckerman, the director of the National Center for Health Research, a Washington, D.C.-based think-tank. As a result, the two reports had “an enormous chilling effect” on both the legal case against implants and the potential for further research, she said.

“It’s a travesty,” said Zuckerman, an epidemiologist and former Capitol Hill aide who organized the first congressional hearing on implant safety. “The women are desperately trying to get someone to help them. They are told it is in their head, and they are treated as if they are just out to get money.”

 

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This article includes two corrections that were later published regarding the article. The original article incorrectly quoted Diana Zuckerman regarding silicone in the bloodstream, rather than silicone leaking out of the implant. And, the original article referred to an FDA study finding an increased risk of lupus and fibromyalgia, which should have stated fibromyalgia and other diseases.