TOXIC BREASTS 1/2 (implants)

[Guest guest]

Mother JonesJan/Feb 1992

TOXIC BREASTS

http://www.redflagsweekly.com/toxicbreasts.html

 

 

Over the course of ten years, one of the most popular breast implants - made

of the same industrial foam used in furniture upholstery - was ignored by

the FDA, barely tested by its manufacturer, and promoted by doctors who were

given shares of the profits. Thousands of women believed the implants were

safe. They were wrong.

 

By Nicholas Regush

 

When Sybil Niden Goldrich was diagnosed with breast cancer in 1983, she

blamed herself. Her body had failed her. It was embarrassing. No one but her

family had to know. " I was certain that everyone would think that my cancer

was due to an inability to handle stress, " says Goldrich, now fifty-two. She

resolved that she would wear falsies after her double mastectomy until she

could find the best plastic surgeon around to reconstruct her breasts. And

then she would go on with her life.

There seemed to be no reason not to have new breasts. Would any surgeon

amputate an arm or a leg and not offer a replacement? " This is why I thought

it would be easy to be reconstructed and complete my cancer process, "

Goldrich says. She discovered that at least twenty thousand women each year

were having their breasts reconstructed with silicone-gel implants following

cancer surgery, and another eighty thousand were electing to have implants

for cosmetic reasons. Goldrich interviewed three reputable plastic surgeons

before settling on Dr. Kurt Wagner; each assured her that the procedure

would be simple with very little risk involved. " My surgeon seemed

confident, so I too was confident, " she says.

 

But immediately after Wagner inserted the foam-covered implants in July

1983, Goldrich developed an infection. When her bandages were removed over

two months later, she had her first good look at herself in the bathroom

mirror. " My heart sank, " Goldrich says. " There were two baseball-shaped

protrusions from my chest wall and a small red scar clearly visible two

inches below them. Those were breasts? They were hard as rocks. Nothing like

the milky, flesh-toned breasts that I had expected. "

 

Desolate, she put on her shirt and curled up into a ball on her bed. " I

thought of myself as a two-time loser, " she says. " First cancer, and now

this. My body had obviously rejected the implant. " Two years later, after

five surgeries and countless days of pain and suffering, Goldrich had a

different idea of what had gone wrong. By then, news had trickled out about

the dangers of breast implants: they hardened, they ruptured, they blocked a

mammogram's ability to screen for cancer. Goldrich already had to live with

fears about a recurrence of her breast cancer, but now she has a new worry.

There is reason to believe that the leakage of silicone and a chemical from

the implants' foam could itself cause increased risks of inflammatory

diseases or cancer.

 

 

 

..

 

BEHIND THE STORY

 

 

When reporter Nicholas Regush first co-wrote a documentary for the

Canadian Broadcasting Corporation on breast implants in 1980, the main

controversy was whether the implants were hardening in women's bodies.

" There were a lot of people, even plastic surgeons, talking about the need

for a moratorium on implants, and the documentary basically highlighted

that, " Regush says. The film caused a bit of a stir, but nothing really came

of it. Even so, Regush kept his eye on the progress of implants off and on

over the course of the decade.

 

Then, in 1988, Dow Corning released a report saying that implants were

proving carcinogenic in rats. The day he read the report, Regush went to see

one of Montreal's most prominent plastic surgeons, who only wanted to talk

about the Même. " The doctor told me he wouldn't implant the Même in any

woman, because the company couldn't tell him what happened to the foam in

the body, " Regush says. " By the time I'd left the office, I heard enough to

make me concerned. "

 

Regush started digging and uncovered Canadian health - department memos

indicating a suppressed controversy over the Même. A few weeks later, he

came across a University of Florida study showing that the Même's foam

released a carcinogenic substance in laboratory tests. In January 1989,

Regush published an article in the Montreal Gazette, the first major story

to appear anywhere about the Même and its potential cancer risks. The paper

was flooded with calls from all over the world requesting copies of the

piece, and the debate on the safety of breast implants subsequently landed

on the floor of Canada's Parliament.

 

Regush has kept on the story ever since, systematically investigating

Surgitek, the Même's most recent manufacturer, as well as the FDA'S history

of inattention to implants. He's published about forty news stories on the

Même; his Mother Jones piece draws from those articles as well as from

original research that delves further into the reasons that an untested

medical device was implanted in 200,000 women. " The implant situation has

made me realize, more than anything I'd done, just how bad the treatment is

that women receive from medicine, science, and even doctors, " Regush says.

He also says that the story doesn't end here: " I'm still concerned about the

ongoing lack of proper guidelines and public discussion on what women should

be considering about implants. "

 

..

 

 

 

Breast implants, of course, are not the only form of plastic surgery

that has gained popularity in recent years. The numbers of face-lifts, tummy

tucks, liposuctions, nose jobs, and lip implants have all skyrocketed over

the last decade, as has the number of doctors who perform them. " Everywhere

you look, there are impossible and conflicting images of women, " says Robin

Lakoff, coauthor of Face Value: The Politics of Beauty. " Women are made to

believe that love and approval from men are dependent on the right image.

That desperation will continue until women become looked upon as full people

rather than just body parts. "

 

About 750,000 women a year elect to have cosmetic surgery, spurred on by

ubiquitous images of the body beautiful, by husbands or boyfriends, and by

doctors' newspaper ads that make nip-and-tuck look as easy as highlighting

one's hair. In Houston last March, plastic surgeon Dr. Franklin Rose took

out an ad in the Houston Chronicle, explaining that the " cultural influence

is such in this city that for a woman to feel attractive usually includes a

Mercedes, a gold Rolex, and three or four operations-nose, breasts,

liposuctions. It's just part of living in this city in a certain way, in a

certain socioeconomic strata. " The ad ends like this: " The Texas woman is a

combination of many things, not the least of which is a surgeon's scalpel. "

 

But breasts, more than thin thighs or a smooth brow, are most potent as

a symbol of women's sexual self-worth. So it's not surprising that over 2

million women have had breast implants, and 130,000 more seek them each

year. Breast augmentation is a $450-million-a-year business, as the American

Society of Plastic and Reconstructive Surgeons, Inc., a lobbying group of

4,500 doctors, is well aware. During a " practice enhancement " campaign in

the early eighties, the group issued a memo to the FDA, asserting, " There is

a substantial and enlarging body of medical information and opinion to the

effect that these deformities [small breasts] are really a disease " that,

left uncorrected, results in a " total lack of well-being. "

 

Among the most popular " cures " for this " disease " over the last decade

has been the Même implant, a silicone-gel sac with a unique polyurethane

foam cover that was supposed to prevent breast hardening. Since its

development in 1982, the Même has captured over a quarter of the current

implant market; over 200,000 women carry the Même in their bodies. But in

spite of the large numbers of women opting for the " improved " implant, the

foam used for its cover-originally manufactured for use in such things as

furniture upholstery, oil filters, and carburetors-went almost completely

unmonitored for eight years.

 

It wasn't until last April that the Food and Drug Administration

released a report showing that, in conditions similar to those in the body,

the foam can release the chemical 2,4-toluenediamine (TDA), which causes

liver cancer in rats and is a suspected human carcinogen. Days after the

announcement, the Même's manufacturer, Bristol-Myers Squibb, pulled the

implant from the market and, in September, the company closed down its

plastic-surgery unit that produced the Même.

 

Most of the Même's recipients thought that they were making a relatively

risk-free decision to augment their breasts. They were never warned of the

implants' potential dangers. There are now several dozen injury suits

against the three successive manufacturers of the Même. In one recent case,

a New York jury awarded a woman $4.45 million (the case is under appeal); in

another, a California woman settled out of court for $450,000. A

class-action suit against Bristol-Myers Squibb is being prepared in Canada.

 

Some lawyers are predicting that these suits, along with the several

hundred in process against the makers of other types of breast implants,

will eventually rival the multibillion-dollar litigation fight against A.H.

Robins, which manufactured the Dalkon Shield IUD. But as with the Robins

suit, financial reparations won't change this simple fact for many women:

They were told the Même implant was safe, that it wouldn't hurt them, by

manufacturers and doctors who should have known better-and the dangers were

then ignored by the government agencies that were supposed to protect them.

 

It is early morning in Ottawa. Pierre Blais, a private consultant on

medical products, is in the basement laboratory of his home. As the Canadian

government scientist who blew the whistle on the Même in January 1989, Blais

has been inundated with requests from former implant users and their doctors

and lawyers. Sets of damaged Même implants and other silicone-gel types

without the foam arrive by courier almost daily from different parts of the

United States and Canada, along with medical records and mammogram results.

The packages are beginning to pile up in the living room upstairs.

 

Among the eighty or so sets of damaged implants he's received so far,

Blais says that ones with broken covers are the most common. The gel

released from the silicone sacs has often seeped into armpits and lymph

nodes. In one typical case, an implant deflated, and leakage on both sides

began to erode the user's ribs. Some of the women who have contacted Blais

have also complained of symptoms ranging from sharp pain in their breasts

and pelvic regions to inflammation and severe fatigue. " I'm not only worried

about the potential of the implants to cause cancer, " says Blais, a small,

wiry fifty-one-year-old, " but also that their chemical constituents may

wreak havoc in the body over the long term. "

 

Right now, Blais is examining two Même implants. Only they don't look

much like implants. The two buckets on his desk that are holding the

products are filled with greenish gel. That is what is left of

fifty-two-year-old Janie Cruise's surgically implanted breasts. It took

almost seven hours on March 1, 1990, for doctors at the University of

California Medical Center in Los Angeles to make unexpectedly large

incisions under Cruise's breasts and then scrape out the seemingly endless

amounts of infected green ooze from her chest wall. The smell of the

infection was so bad that the chief surgeon became ill.

 

While Cruise's case may be extreme, Blais says that her history is all

too typical. Cruise, then forty-four, was living in Southern California when

she decided to get implants. Her seven-year marriage had just fallen apart,

and she was facing re-entry into the singles scene. Encouraged by a close

friend - " Janie, you'll look flawless! " - Cruise handed over a few thousand

dollars for what seemed like a miracle cure for her sagging self-confidence.

" My girlfriend planted the seed and it started growing, " Cruise says. " I

especially wanted to look nice in a bathing suit. "

 

Cruise's plastic surgeon, Dr. Howard Sterling of Fullerton, California,

assured her that the Même, a new implant, would keep her breasts soft and

give her a " happy surgery. " The doctor was known to brag that his own wife

was a pleased Même user.

 

Within a couple of days after her surgery on November 22, 1983, Cruise

felt severe pain in her left breast, but Sterling shrugged it off. " He said

his wife had similar pain, and he called us both big babies, " Cruise

recalls. " So I never bothered going back to him. "

 

The following year, Cruise quit her job as a regional sales manager for

a piano distributorship and moved from California to Florida, hoping to

start a new life. The breast pain journeyed with her. Then came the severe

headaches, fatigue, muscle and joint pain, numbness in her right hand,

bronchitis, and gastrointestinal ailments; often, when she would wake up in

the morning, her chest felt like someone was sleeping on it. All of these

symptoms and more, she says, " sort of evolved over a period of a year and a

half. "

 

She visited one medical specialist after another - about two dozen all

told. She took medication for her pain, enrolled in pain clinics, tried

biofeedback, and talked with a psychologist. Nothing helped. " There was not

one single suspicion voiced that my symptoms might be linked to the

implants, " she says. Cruise began blaming her medical problems on the damp

Florida weather. Now she is waiting for Blais's evaluation of the evidence:

Did her implants break because of design, or because of the use of

substandard raw materials?

 

Blais believes that most, if not all, of these products will fail in

time. He says women who assumed that their doctors could be counted on to

give them safe and effective breast implants misplaced their trust. " Plastic

surgeons have been putting in a lot of junk that has been very poorly

manufactured, " he says. " It's never been made to last, and that means a lot

of women are going to have broken implants and leaking gel and other

chemicals and debris moving through their bodies. I'm very fearful that the

health problems we are seeing today with all the implants are merely a hint

of the disaster to come. "

 

Dr. Howard Sterling doesn't much remember Janie Cruise, one of his

earliest Même recipients. Didn't she once send him porno-type pinups? No,

wait. That was someone else. Oh, so Cruise had some problems. A lot of pain?

Really? " Well, she never reported any of them to me, " he says, ending that

topic of discussion.

 

But Sterling, who intermittently clears his throat and speaks very

quickly into the phone, does want to talk about the Même. In fact, he boasts

that he is " probably one of the plastic surgeons who has implanted the most

Mêmes in the whole damn U.S. of A. " - roughly 670 sets of the implants.

Though he's never formally studied his Même patients, Sterling volunteers

that most of them, including his wife, two daughters, and " girls " in his

office, have had " beautiful experiences. " His complication rate runs about

15 to 20 percent, but he says that's mostly because some of the implants

harden.

 

Sterling did have some fleeting concerns about the Même in 1983, the

same year that Cruise had her surgery. Some of his patients were developing

blood blisters between the implant's foam layer and the inner silicone-gel

bag. The accumulation of blood made the implants heavier. " When I took the

Mêmes out, I could see that parts had a shiny surface, indicating that there

was little or no adhesion there to the foam, " he explains.

 

Why did he continue implanting the Même? " Because it didn't make breasts

harden to the same extent as other implants did, and it was the best thing

available at the time, " he replies. And by 1984, his cases of blood blisters

had dropped dramatically, perhaps partly because Sterling had stopped giving

his patients an anti-inflammatory drug for infection control that was linked

to blood-clot formation.

 

Sterling also believed that the Même had a long history of safety

because it was similar to the Natural-Y, a foam-covered implant developed

for mastectomy patients. One of that implant's developers in the late

sixties was Sterling's mentor, Dr. Franklin Ashley, who headed the

plastic-surgery department at the University of California at Los Angeles.

The other was Harold Markham, who became president of Natural-Y Surgical

Specialties, Inc., and eventually masterminded the development of the Même.

Schooled in advertising and marketing, Markham was previously a

medical-device salesman and consultant.

 

Ashley's published claims of good test results initially generated only

sporadic clinical interest in the Natural-Y. Some doctors reported

difficulties in removing the Natural-Y cleanly when hardening or infection

developed. They said that the foam got entangled with breast tissue. In

spite of that, by the late seventies, the implant had gained the faithful

support of a small group of plastic surgeons, and Natural-Y, Inc., began

work on a lighter, more-streamlined foam-covered implant, primarily for

cosmetic purposes-the Même. " Because the Même was supposedly an improved

design, we [plastic surgeons] assumed it was probably safe, " Sterling says.

" The company said it was. All we really knew is what the company told us. "

 

The company couldn't have provided Sterling with much in the way of

clinical trial data on the Même. For example, it had sponsored a small,

uncontrolled study, which followed only eighty-one Même recipients over

eighteen months. Dr. Steven Herman, the New York City plastic surgeon who

published the study in 1984, claimed excellent results for the implant.

However, there was something Herman didn't mention: according to a detailed

1986 deposition, which includes a description of cutting checks, Markham

claims that Herman undertook the study in exchange for a royalty on Même

sales. (Herman continues to deny receiving any compensation from the

company.)

 

Early animal studies on the Même, which the company cited to plastic

surgeons as further proof of the implant's safety, were of the shortcut

variety, according to Pierre Blais. As senior scientific advisor to Canada's

Health Protection Branch, an agency similar to the FDA, Blais reviewed

numerous types of implants, and a colleague had brought the Même to his

attention. " Their approach [to testing] was rudimentary, " he says. " Sorely

lacking was toxicological testing for the presence of chemical by-products

of the foam in the body over the short and long term. Concerns had been

raised by biomaterials scientists since the early sixties about the

potential of some polyurethane foams to release toxic substances, if not

carcinogens. But this issue was apparently not a priority for the company. "

 

Blais would later learn that, until June 1988, the Même's manufacturer

had incomplete knowledge about the foam's chemical structure and the way the

foam was produced. Instead of scientific study, the company relied heavily

on promotional literature to sell the Même, including numerous testimonials

from plastic surgeons about the " excellent results " they were getting with

the implant. The anecdotes were packaged in the form of information

bulletins by Markham's daughter, Jacqueline, who had a master's degree in

fine arts. In a September 1986 bulletin, she stated emphatically that " there

is absolutely no theoretical or factual basis for concerns about cancer with

our foam. "

 

From 1987 until the implant was pulled from the market in April 1991,

the right to manufacture the Même was sold twice: once to Cooper Surgical,

part of the Cooper Companies, Inc., of New York, which primarily

manufactures optical products, and then to Surgitek, a division of

Bristol-Myers Squibb. In its grab for the implant market, Surgitek trumpeted

the success of an Atlanta plastic surgeon, Dr. T. Roderick Hester, whose

enthusiasm for the Même was such that he had implanted it in about twelve

hundred women, almost doubling Sterling's mark. Like Sterling, Hester did

not run a controlled study on his patients. But he did publish some data in

Perspectives in Plastic Surgery in 1988, claiming that the Même was

performing very well indeed; he was later forced to admit that his research

was not carried out in a particularly rigorous manner. Meanwhile, he was

paid a thousand dollars a crack on at least four occasions to speak at

conferences on behalf of the Même; once, Surgitek paid his travel expenses

to California so he could " explain clinical stuff " to company employees.

" It's standard practice among surgeons to receive a small honorarium in

exchange for their time, " Hester says.

 

The FDA has long been empowered to require more rigorous studies on

breast implants. The agency could easily have directed manufacturers to

conduct detailed studies on every aspect of the Même, especially its foam

cover. But again and again, over two decades, FDA officials bowed to the

interests of plastic surgeons and manufacturers and turned their backs on

the women who used breast implants.

 

In 1976, Congress passed amendments to the Federal Food, Drug, and

Cosmetic Act, enabling the FDA to regulate the use of medical devices,

including breast implants. But it wasn't until 1982 that the agency showed

signs of making a move. With an eye on the lobbying by plastic surgeons, who

were represented on its medical-device advisory panel, the FDA declined to

take strong regulatory action. Instead, it only proposed that implants be

placed in a category indicating that there was insufficient evidence to

provide reasonable assurance of their safety and efficacy. It took another

six years, during which time approximately half a million women received

implants, for the FDA to notify manufacturers that they would be required to

submit safety and efficacy data on their products for review. And it wasn't

until last April-another thirty months and approximately 330,000 implants

after the notice-that the ruling was finalized.