Memphis Flyer story

[Guest guest]

Here's the article from the Memphis Flyer...Patty, if you want me to

mail you a paper, let me know...thanks, Colleen

An Imperfect Solution

Saline breast implants are touted as a safe alternative to silicone.

Bianca | 8/13/2004

In 1997, when Colleen McKenzie was 19, she had a breast augmentation

procedure performed by the Memphis Plastic Surgery Group. She was

told that her new saline-filled implants were perfectly safe.

Three years later, McKenzie began experiencing fainting spells,

extreme fatigue, muscle and body aches, and fever. Her vision blurred

and she had to start wearing glasses. She suffered from depression

and memory loss and had to take a leave of absence from her job as an

art director for Idex Creative Marketing. She went from doctor to

doctor for months, but none could give her an accurate diagnosis. A

rheumatologist told her that her illness was imaginary and suggested

she see a psychiatrist.

In 2001, McKenzie met Dr. Shanklin, a pathologist at the

University of Tennessee Health Science Center and a leader in

research linking saline implants to silicone poisoning. Saline

implants are filled with a saltwater solution, but the liquid is

encased in a silicone shell. Shanklin's studies indicate that the

silicone casing can cause the same kind of damage as a silicone-

filled implant. Shanklin diagnosed McKenzie with siliconosis, a

disease caused by too much silicone in the body. He said McKenzie's

symptoms were the same as those experienced by women with silicone

implants. Lawsuits from many of these women in the 1990s led the Food

and Drug Administration (FDA) to restrict the use of silicone

implants.

Shanklin says siliconosis can cause autoimmune diseases, cognitive

dysfunction, seizures, and lupus. Other physicians are not so

sure. Many plastic surgeons claim there's not enough research to

prove that silicone causes health problems. And many of those who do

acknowledge the possibility of silicone-related illnesses still tout

saline implants as a safe alternative.

I Must, I Must, I Must Increase My Bust

Women have long attempted to increase the size of their breasts with

implants of various kinds. In the 1800s, women injected paraffin

directly into breast tissue. And some had glass or ivory balls

implanted. During the 1940s, Japanese prostitutes began injecting

industrial-grade silicone into their breasts to please American

soldiers. Many of them died when the silicone migrated to other parts

of their bodies. When Las Vegas showgirls began using a similar

procedure in the 1950s, the Nevada state government banned the

procedure.

Recognizing the market for a safe breast enhancement procedure, two

plastic surgeons in Texas developed silicone implants in the 1960s.

In 1976, the FDA enacted the Medical Devices Amendment, which gives

it the authority to review and approve the safety and effectiveness

of medical devices. Since breast implants were already on the market,

they were " grandfathered " in and didn't have to meet the same

criteria.

In 1984, legal troubles began. A silicone implant recipient sued Dow-

Corning, an implant manufacturer, after she'd contracted systemic

autoimmune disease. The jury agreed that Stern's implants were

the cause of her illness, and she was awarded $211,000 in

compensatory damages and $1.5 million in punitive damages. The

evidence was sealed under court order.

By the early 1990s, implant manufacturers were being routinely sued,

and the FDA began requesting studies on the safety of silicone

implants. A class-action lawsuit eventually left Dow-Corning, once

the largest implant manufacturer, bankrupt. In early 1992, FDA

commissioner Kessler called for a voluntary moratorium on the

distribution and implantation of silicone gel implants and asked for

more studies on their safety.

In April 1992, new research was submitted to the FDA, and Kessler

lifted the moratorium, with the caveat that silicone implants should

only be made available to women who met certain criteria, such as

needing reconstructive surgery after a mastectomy. Women who

underwent such surgery had to take part in a lengthy study protocol.

Now women who want routine cosmetic augmentation have only one

choice -- saline implants, which are marketed as the safe alternative

to silicone.

The " Safe " Choice?

Shanklin got involved in studying silicone poisoning by accident. In

1986, a pathologist in Detroit was consulted in a lawsuit in which a

woman was claiming her implants had made her sick. When the doctor

learned that the surgeon being sued was a close friend, he asked

Shanklin to take his place.

" I went immediately to the library, because this was news to me, and

I was astonished to read papers from the 1960s and 1970s on the

issue, " says Shanklin. " One of the attorneys in the case asked me to

provide a list of all the things that could happen to this woman.

When I said she could die, attorneys woke up all over the room. "

The case was eventually settled out of court, but Shanklin continued

his research. He teamed up with fellow UT pathologist Dr.

Smalley, and the two wrote a number of research papers on the effects

of silicone on the human body. Their studies focused not only on

breast implants but the effects of silicone in other medical devices

as well. From February 1996 to June 2002, they ran an implant follow-

up clinic at UT to study poisoning from implants and to give affected

women a place to get help.

According to their findings, siliconosis is a real disorder that

generally shows up several years after implantation. Most of the

research provided to the FDA by the implant manufacturers was

conducted on subjects who had had implants for a year or less,

according to Shanklin.

" In long-term patients, we saw everything from rashes to

forgetfulness, " says Shanklin. " Some developed a broadly based food

intolerance, and one woman I saw had broken out into wandering

vasculitis, where various vessels swell up and the tissue around them

breaks and leaves scars, " says Shanklin. " I've had several implant

patients die of lupus in their 50s. "

According to the National Center for Policy Research for Women and

Families (CPR), manufacturers' studies do not take into account that

the types of diseases associated with silicone poisoning, such as

autoimmune and connective-tissue diseases, take years to develop. But

these manufacturer-approved studies are commonly accepted by many

plastic surgeons, including Dr. Wallace, a plastic surgeon

with UT Medical Group, Inc.

" If I went home tonight and my wife said, 'I'd like some breast

implants,' I'd say okay with no hesitation, " says Wallace.

Wallace has performed hundreds of saline breast implant

augmentations, and he says none of his patients have complained of

symptoms of siliconosis. He says he has " explanted " a couple of

siliconosis patients who got implants from other surgeons.

" There may be a small subset of people who really do have a reaction

[to silicone]. It's not our position to judge or try to browbeat

these people, telling them they're fine and they should get back to

work, " says Wallace. " But the medical science commissioned by the

courts came away with the conclusion that silicone does not make you

sick. "

(a Germantown nurse who requested that her name be

changed to protect her identity) had saline implants put in nine

years ago and she agrees. She says she hasn't experienced any signs

of silicone poisoning, nor has she experienced the more common risks,

such as deflation or capsular contracture.

" I've heard claims made by women about silicone poisoning, but I

don't believe there's actually a link between silicone and diseases, "

says , who went from a B-cup to a C-cup. " It's used in all kinds

of medical devices, like tubes for kids' ears and artificial joints.

Historically, it's been found to be a very inert and safe material. "

However, Shanklin and Smalley's studies found that adverse reactions

also occurred in some patients who had been implanted with these

other medical devices. In one of their studies, which was published

in the Journal of Nutritional and Environmental Medicine, 22 men and

21 women who had been injected or implanted with non-mammary silicone-

containing devices were tested to determine the silicone's effect.

Their findings indicated that implantation of any silicone-containing

device has the same immunogenic consequences as those shown in women

with siliconosis. The study also showed that how long the devices had

been implanted was a more important risk factor than the amount of

silicone implanted.

Not all women who receive saline implants are at risk. Between 1985

and 1996, there were 23,454 adverse reaction reports filed with the

FDA for saline implants, versus 103,343 for silicone gel implants.

There's been little research to determine why some women are more

susceptible than others. Shanklin believes some women are simply more

genetically prone to adverse reactions to silicone.

McKenzie, who participates in a nationwide Internet support group,

isn't so sure. " The women in my group have had several conversations

trying to find that common link, " says McKenzie. " What is it about us

that would cause us to get sick? We can't find the answer. "

Finding that answer would mean more FDA-sanctioned manufacturer

research on women who have had implants for an extended period of

time. Many who believe that saline implants can cause siliconosis are

convinced that such studies will never happen, since proof that

saline implants can cause diseases could damage a multimillion-dollar

industry. Meanwhile, women like McKenzie try rigorous detoxification

programs and work to get health-care coverage from skeptical medical

insurance companies.

The Road to Recovery

Now 25, McKenzie is feeling much better, but she says she's still got

some healing ahead. She had her implants removed a year ago. On good

days, she's fine as long she's home and in bed fairly early. At

night, she still experiences intense pain, especially in her hands

and wrists. On bad days, she wakes up, takes her medicine, and goes

back to bed.

Most women need several years to recover from siliconosis, and since

many doctors don't believe the disease exists, many victims turn to

alternative medicine.

" I've only encountered two doctors who have believed me, " says

McKenzie. " My rheumatologist told me I didn't have to be sick if I

didn't want to. He suggested intensive psychotherapy. Why would I

want to be sick and bedridden by age 23? "

McKenzie gets emotional support as well as nutritional and

detoxification tips from Saline Support, a nationwide Internet group

for women who believe they have contracted siliconosis through saline

implants. The 433-member support group began in July 2000 when Patty

Fausett, a siliconosis victim from , Nevada, noticed a lack

of support for women who'd contracted the disease from saline

implants. She decided to start a group devoted to women with saline

implants.

" My goal was to really help us get better, because what I saw in the

other group was a lot of older women with horrible medical problems

that didn't seem to improve over time, " says Fausett. " The ones who

were showing improvement were doing it through alternative medicine --

detoxification, healthy eating, and organic foods -- rather than

going to doctors, who'll just give out prescription drugs to further

poison our bodies. "

The women in Saline Support use the group to share detox methods that

have worked and to share stories about their issues with doctors and

family members.

" Our group is a safe haven for women to come to, where they can feel

that they will not be rejected, " says Fausett. " So many doctors have

said this is all in their heads. Women can come here when they have

emotional problems from the frustration of dealing with doctors who

don't understand. We're like women on a stormy sea trying to keep our

heads above water, and there's no one there to help us. "

Fausett says she thinks the problem will only get worse as more and

more women opt for saline implants. According to CPR statistics, the

number of women who underwent augmentations doubled between 1997 and

2002. In 2002, approximately 236,888 women had cosmetic breast

implants.

" I don't know if they'll ever really find the answers until some

government agency steps in and realizes that women are getting sick, "

says Fausett. " We need to stop and find out what's going on and how

we should fix the problem. "

The Next Big Thing

" A number of years ago, " says Shanklin, " I had some patients that had

gotten implants as high school graduation presents, and that's

apparently become a sub-industry. You don't get a limousine ride or a

convertible anymore. You get breasts. When they're 35, they're going

to be sick as shit. I've seen it happen again and again. "

According to the American Society of Plastic Surgeons, 3,841 girls 18

or younger received breast implants last year. With the recent

popularity of plastic-surgery makeover shows, such as The Swan and

Extreme Makeover, breast implants and other forms of cosmetic surgery

seem more appealing to young girls.

" It's a tragedy that so many young women are running to plastic

surgeons to fix their bodies instead of learning how to accept

themselves as they are, " says Fausett. " I would just plead with them

not to get implants as a way to cure their self-esteem problems. "

Fausett worries that some teens who may be susceptible to silicone

poisoning will begin to see health problems before they reach 25. And

since there's no real cure, she says they're likely to be stuck with

some complications for the rest of their lives. Although Fausett's

almost back to normal after five years of recovery, she's still

dealing with an autoimmune thyroid disease.

But implant science is marching on, and there may soon be an

alternative to silicone and saline implants. Several biotechnology

companies are working on a tissue-engineering technique that would

inject cells from another part of the body into the breast area,

creating larger breasts. The technique would initially be marketed to

women who have had lumpectomies or mastectomies, but the method could

eventually be used for cosmetic breast enhancement as well. The

future of the technique depends on FDA approval.

For now, victims of siliconosis continue to publicize their plight. A

few weeks ago, a film crew from MTV's I Want a Famous Face was in

Memphis filming McKenzie for a segment of the show. Each show

counters a positive plastic surgery experience with a negative one.

One episode this fall will feature McKenzie in the negative story

slot.

The issue is slowly gaining more attention, and McKenzie is planning

on putting together a calendar of explanted women who've contracted

siliconosis through saline implants. She says she'll probably use

some of the women in her support group as models. Each month will

feature a different woman's pictures and story. Some of the women

have lost husbands and homes. Others spent months unable to care for

their own children.

" This is a lose-lose situation, " says Shanklin. " They lose their

health, and if the situation is severe enough, they lose their

augmented breasts. Sometimes they lose their husbands and their jobs.

They lose their self-esteem, and it's all downhill. All they've got

left is a chest so full of scars it looks like a railroad switching

yard. "