All but Forgotten - October 2001 - Nothing has changed!

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http://www.center4research.org/forgotten.html

Los Angeles Times

October 1, 2001

All but Forgotten

Once the center of a national debate, women who say

silicone breast implants made them sick now find

themselves ignored.

By TINKER READY, Special to The Times

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, "

http://www.siliconeholocaust.org/ 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

Zuckerman, the director of the National Center for

Policy Research for Women & Families, 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. "

Zuckerman and others have put their faith in several

government studies. One FDA study suggests that women

with broken implants with leaking silicone may be more

vulnerable to health problems, she said. And the first

of several NIH studies found that women with implants

are more likely than other plastic surgery patients to

take their own lives or die from brain tumors and lung

cancer.

Bondurant remains unconvinced by these new findings.

" If one or two studies came out to the contrary, it

would not be enough to upset the [iOM] conclusion, " he

said. " On the other hand, research is never complete.

There will always be an element of uncertainty. "

Sybil Niden Goldrich, one of the women depicted in the

1997 television movie " Two Voices, " helped push the

FDA to take action on implants. Now 62, she survived

breast cancer and a double mastectomy. But, Goldrich

said, she was in pain for years after Beverly Hills

doctors rebuilt her breasts several times with

silicone implants in the early 1980s. Today, her

implants are long gone and she considers herself

healthy. Her organization, the Command Trust Network,

is virtually inactive. She spends most of her time

working as the consumer representative to the Dow

Corning Settlement Fund, which is likely to begin

making payments next year. Still, Goldrich lives up to

the movie's German title, " Eine Frau Gibt Nicht Auf, "

or " a woman who doesn't give up. "

" There was an enormous number of people injured, " she

said. " No one wants to take responsibility for it, and

everyone wants to blame the victim. These women have

all of these symptoms, no place to turn and no money

to pay for it. "

It can be a terrifying and lonely experience to suffer

from an illness that has no apparent physiological

cause, said Lana Teirsky, an assistant professor of

psychology at Fairleigh Dickinson University in New

Jersey. Her research has focused on conditions such as

chronic fatigue syndrome and Gulf War syndrome. Women

with silicone breast implants have the added trauma of

being exposed to a chemical, being told it is making

them sick and then being told that it isn't, she said.

" They feel very invalidated, " she said. " They feel

that no one is listening to them. " So they get

depressed, only to be told that depression is causing

their physical problems, she said.

And doctors have little to offer them beyond

antidepressants, even though research has shown that

they can successfully treat many similar conditions

without identifying a cause, said Dr. Dush, a

psychologist at Central Michigan University. For

example, patients with chronic fatigue syndrome

improve when treated with a combination of

antidepressants, physical therapy and counseling. But

after reviewing the implant research, he found that no

one has explored the possibility of using a similar

approach for sick women with breast implants.

" When the [implant] research reached the conclusion of

no increased risk, it didn't go anywhere else, " he

said. The women " are just kind of left on their own. "

So they turn to each other, mostly through Internet

support groups, where they trade stories, find doctors

willing to remove implants and vent their anger.

Often, it is not enough. " Realistically, what these

groups do is provide information and shoulders to cry

on, and that's all they can do, " Zuckerman said.

Ashby won't choose silicone, but she is

choosing to replace the saline implants she had taken

out in 1994. Like many others, she finds comfort in

the studies that have found implants to be safe. " I

got caught up in all the media hype, " Ashby said. " I

read about all these women who were getting sick, and

I thought it was happening to me. "

Ashby, a Raleigh, N.C., mother of two, got implants

after two pregnancies left her with " small, saggy "

breasts. She says she soon began to feel aches and

pains and, at one point, was diagnosed with

fibromyalgia.

Although much of the focus has been on silicone

implants, many women insist that the silicone shell in

saline implants can cause problems. So Ashby had the

implants removed, and her health recovered. She now

believes that she overreacted to the implant scare and

that her symptoms were " all in my head. "

Thorpe also wanted her silicone implants

removed, but her insurance company refused to pay for

the surgery.

In 1992, she came to symbolize the emotional despair

of some women when she cut her implants out with a

razor blade. This dramatic act got the Farmington,

N.M., woman on TV talk shows but did little to improve

her health, said her daughter, Chrissy Thorpe.

Confined to her bed, Thorpe had a seizure and

choked to death on her own vomit in 1996. Even though

" silicone breast disease " is listed as a contributing

factor on 's death certificate, Chrissy

acknowledges that something besides implants may have

caused her mother's illness.

" It's hard to say, " said Chrissy, noting that her

mother was in perfect health before she got her

implants. " But it would be a pretty sick

coincidence. "

This article includes two corrections that were later

published regarding the article. The original article

incorrectly quoted 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.