Glamour: The shocking health claims against saline implants

[Guest guest]

http://www.BreastImplantAwareness.org/glamour-saline.html

BREAST IMPLANT HORROR

LEAKY, SCARRING, BLACK WITH MOLD

WHY WOMEN ARE TAKING THEM OUT

The shocking health claims against saline implants

By

Collier Cool

Glamour November 2000

[]

Could saline implants–hardening, leaking, deflating and turning black

with fungus–be making women desperately ill? Former implant recipient

Gordon thinks so, and a growing number of doctors agree.

Glamour investigates.

The squishy mound blackened with fungus in Gordon's fridge

isn't a lump of cheese gone bad. It's what the 33-year-old former

actress from Atlanta wore next to her heart, inside her bosom, for 11

years–a breast implant she claims made her so desperately ill, she

almost committed suicide.

In 1988, when Gordon was 21, she did what most of her friends had

done; she went to the doctor and got her bust enlarged from 34B to

34D. " I grew up in a beach town where if you didn't have big breasts,

you got them, " she explains. For the first seven years, she had no

complaints. But then she began to notice that her joints were

slightly

achy, she was more tired than normal, and her hair was thinning–

though

none of the symptoms was bad enough that she needed to see a doctor.

It wasn't until she began breastfeeding her newborn daughter in 1998

that her health really fell apart, she remembers: " We both got an

awful thrush infection that made my daughter's mouth and my nipples

bleed. After that, I was always exhausted, despite sleeping 15 hours

a

day. I had hot and cold chills up my spine, slurred speech and so

much

pain in my hands, I couldn't even open a jar of baby food. It was

like

having a horrendous case of the flu all the time, "

Over the next nine months, Gordon says, she saw several

doctors. " Each

time I'd outline my whole medical history, including my implant

surgery, " she recalls. " They'd ask if I had silicone gel, and when I

said, `No, saline,' they'd give me a big speech about how the body is

made of salt water, so it wouldn't matter if the implants had leaked

or ruptured. They all felt my implants couldn't be the problem–even

though by then, I had severe breast pain. "

In May of 1999, on the advice of a friend who knew someone whose

implant had ruptured in a car accident, she went to see Kolb,

M.D., a plastic surgeon in Atlanta. " I didn't even have to tell Dr.

Kolb my symptoms–she already knew what they were, " recalls Gordon. " I

started crying when she asked questions like, `Are you slurring your

words?' and `Do you feel like someone is scratching inside your

chest?' At last I'd found a doctor who didn't think I was crazy and

actually understood what I was going through. " Dr. Kolb, who has

saline implants herself, urged Gordon to have hers removed

immediately.

" When I opened her up, her breast tissue was very inflamed, and the

implants looked black, " recalls Dr. Kolb. " It was the third time I'd

seen black implants in the 100 saline [implant] removals I've done. I

believe the implants were darkened by a fungus, which then migrated

into 's bloodstream to cause the symptoms she was

experiencing. " Six weeks after Dr. Kolb removed Gordon's implants and

treated her with antibiotics and antifungal drugs, Gordon felt fine.

SAFETY DEBATE

Last year, more than 167,000 American women chose to have their cup

size upped with saline implants, paying an average of $3,000 per

pair.

Breast augmentation continues to be the second-most popular cosmetic

procedure (after liposuction) for women in this country, according to

The American Society of Plastic Surgeons (ASPS). So clearly the vast

majority of customers are happy with their implants. Indeed, a recent

University of Minnesota study of 450 women who had saline implants

put

in 10 or more years ago found that 93 percent of them

were " satisfied "

or " very satisfied " with their surgery results–and nearly 96 percent

said they'd do it all over again.

But new data just released by the very companies that manufacture

saline implants show that their products have a surprisingly high

rate

of failure. These findings may explain why 43,600 women had their

implants (both saline and silicone) removed in 1998, according to the

ASPS– a 41 percent rise over removal figures for 1992–and why among

those women, 17 percent of the augmentation patients and 26 percent

of

cancer victims who had chosen reconstruction opted not to get them

replaced.

To investigate the real price of bigger breasts, Glamour spoke to

experts on both sides of the saline implant safety debate, including

13 women with symptoms similar to Gordon's. Most of their

symptoms cleared up as soon as they had their implants taken out.

None

of these patients is suing her implant manufacturer (although some

other women are), but they shared their stories in hopes of alerting

others that when it comes to getting a " boob job, " the decision

should

not be taken lightly.

FAULTY DEVICES

Although saline implants have been on the market since the 1960s and

now generate roughly $800 million a year for manufacturers and

plastic

surgeons, the Food and Drug Administration (FDA) did not evaluate

them

for approval until this year. The initial lack of scrutiny was due to

the fact that the implants slipped into the marketplace before the

FDA

sanction was required for medical devices. However, prompted by

nearly

50,000 reports from women and doctors about adverse side

effects–including 118 deaths–allegedly related to implants since

1985,

the agency finally did order two major U.S. breast implant

manufacturers, McGhan Medical and Mentor Corp., to conduct ongoing

studies that would establish the safety of their products. Findings

from the first three years of the trials and some of the fourth-year

data were released at FDA hearings last March. The results surprised

many and caused some women's health advocates to caution strongly

saline implants.

The McGhan study of 1,169 women with its brand of implants found that

60 percent of those who had their breasts enlarged and 84 percent who

underwent reconstruction for medical reasons suffered at least one

complication within four years. The researchers uncovered a wide

array

of problems. More than one fourth of cosmetic patients ended up with

asymmetrical, wrinkled or scarred breasts, while 8 percent had

improperly positioned implants and 17 percent had either intense

nipple sensation or numbness. Sixteen percent suffered moderate to

very severe breast pain; 9 percent developed capsular contracture, an

often painful hardening of tissue around the implants that, in severe

cases, causes disfigurement; and another 9 percent had implants that

could be felt or seen through their skin.

Cancer survivors and other reconstruction patients fared far worse:

Almost three-quarters had scarring complications, folds, asymmetry or

implant positioning problems; 20 percent had visible or palpable

implants; and 15 percent were in moderate to very severe pain. In

addition, about one in 20 women in both groups had an implant that

leaked or deflated within three years. The studies conducted by the

Mentor Corp. showed similar results.

" This is shocking data, " charges Norman , M.D., former chair

of the FDA's medical devices committee from 1984 to 1988 and

currently

associate professor of medicine at s Hopkins School of Medicine

in

Baltimore. implored the agency to put a stop to saline

implants, testifying that they " have the potential to have the

highest

failure rate of any device ever approved by the FDA. " Despite his

pleas (there were 19 speakers, representing both individuals and

groups, who testified in support of saline implants; 18 testified

against them), they were approved in May. " It's a horrible

situation, "

he told Glamour. " These devices can deflate if they get a crack the

size of a pinhole. I have patients in my practice who have had as

many

as 14 implant operations. "

The FDA, however, stands by its decision to approve saline implants.

" The vast majority of complications don't affect health but rather

the

quality of the cosmetic results–such as a lack of symmetry, wrinkling

or capsular contracture, " contends al, M.D., director of

the

FDA's Center for Devices and Radiological Health. " As with many

cosmetic procedures, it's not unusual to have additional surgery. "

The

implant makers, for their part, maintain that such risks are a small

price to pay for the benefits of bigger breasts, all things

considered. " The FDA panel voted our product as a safe and effective

device that satisfies medical and psychological needs, " asserts Ilan

Reich, president of Inamed Corp., the parent company of McGhan. " All

of our studies show that implants make women feel better about

themselves and vastly improve the lives of cancer patients who have

had mastectomies. "

Yet Cherien Dabis, 24, believes that no amount of bust-boosting

confidence is worth the pain her implant caused her. In 1996, the

Silver Spring, land, publicist had her left breast, which failed

to develop due to a birth defect, reconstructed. First, her saline

implant shifted upward, making it noticeably higher than her other

breast. Soon after that, she developed chronic breast pain. By

January

of this year, her breast had become painfully hard, a fairly common

complication of saline implants, as shown by the manufacturers'

studies. All of this might have been bearable, but then in June, she

says, for no apparent reason her implant ruptured. " I stepped out of

the shower and noticed my left breast was gone, " she recalls. " It was

completely flat. I kept staring at myself in the mirror because I

couldn't believe this had really happened. "

Dabis had to have the implant removed. " What was left of it looked

really ugly, like a deflated balloon covered with dark purple,

mucuslike slime, " she says. " I decided not to have it replaced. "

REPEAT SURGERIES

One unsettling finding to emerge from the FDA hearings is how often

breast jobs have to be redone. The McGhan study showed that more than

one out of five women with cosmetically enhanced busts–and 39 percent

of cancer patients–need additional surgery within three years. The

top

reasons for such procedures include replacement of ruptured and

leaking implants and alleviation of hardened breasts caused by

capsular contracture and other factors. And new implants don't always

solve the problem. After a second surgery, nearly half of cancer

patients (whose remaining breast tissue and immune systems may be

more

fragile due to surgery, radiation and chemotherapy) develop severe

capsular contracture, and 26 percent require a third set within two

years.

Kim Green, a 36-year-old homemaker with two children in West

Hartford,

Connecticut, got breast cancer in 1998, when she was seven months

pregnant, and had her breasts rebuilt after a double mastectomy. So

far, she has endured 11 operations, at a cost of more than $70,000

(all of it covered by insurance). And with only one implant right

now,

she faces still more surgery this coming January for the second. Each

time implants have been removed, she says, " it's like having a

mastectomy all over again, with total anesthesia and drains in my

chest. It's been devastating–I spent a whole year having surgery

almost every month. When I was diagnosed with breast cancer–which

killed my mother when she was 35–I just wanted to live. I never

dreamed reconstruction could be this bad. It's worse than

chemotherapy. " Yet she's determined to keep trying. Getting her

" breasts " back is somehow a symbol that she's gotten past her

disease.

" I want to look as normal as possible, " she confesses.

Despite stories like this and the complication rates shown in the

latest studies, FDA officials feel it's ultimately up to consumers to

decide what risks they will take. Thanks to the hearings, both

implant

companies now have new package inserts that detail the study

findings,

which are also posted on the FDA Web site at www.fda.gov. " Patients

can [now] look at the brochures to find out about the experiences of

women who have these implants, " says the FDA's Dr. al. " The whole

purpose of the FDA approval process was to gather information so

patients know exactly what to expect. "

THE EXCRUCIATING PAIN

When Gordon's black implant was sent for testing to Dr.

Pierre

Blais, Ph.D., a former senior scientific adviser at Canada's version

of the FDA, Health Canada's Health Protection Branch, the results

were

unnerving. " The implant was full of dead fungus–aspergillis [sic]

niger, aspergillis [sic] fumigatis and a subtype of the albicans

family–which could make the recipient very ill, " explains Blais, who

has analyzed more than 7,000 breast implants. But he also found

something far worse–dead, antibiotic-resistant bacteria: " Enough to

fill a teaspoon. "

The bacteria and fungi were dead because the implant had been dunked

in formaldehyde upon removal from Gordon's chest, as is customary–so

clearly this wasn't mold that had grown afterward. " We've seen

hundreds of cases like this, " maintains Blais. " But Ms. Gordon's

implant ranks number four among the most contaminated implants we've

ever tested. "

In Blais' analysis, small amounts of the bugs had leaked into

Gordon's

body as her implant aged, making her feel sick. When the

organism-filled sac was removed, antibiotics and antifungal drugs

were

able to wipe out the remaining germs in her body and restore her

health. " Had the implant stayed in longer, she might have been

chronically ill; had it ruptured, her body could have been flooded

with bacteria and fungus that drugs would have been unable to fight.

She was really lucky to walk away from this, " notes Blais solemnly.

" If I were her, I would not buy a lottery ticket for a long time. "

Mounting evidence suggests that in a small percentage of women, like

Gordon, implants become tainted with bacteria or fungus,

which

sometimes causes the sacs to discolor and, over time, the wearers

develop autoimmune-like illnesses. Although the FDA maintains that

implants do not cause these illnesses, the agency is planning to

review additional reports from the manufacturers' ongoing studies

(which will continue for about six more years). Mentor Corp.'s

studies

so far have already shown that 2 percent of augmentation patients and

9 percent of reconstruction subjects developed unspecified infections

within three years. Six women in each of the manufacturers' studies

were also deemed, using very strict criteria, to have autoimmune

problems.

How could the implants become contaminated? When breast implants are

shipped to a surgeon, they arrive deflated; in the office, the doctor

fills them with saline solution through a valve. If the conditions

aren't completely sterile–if, for example, the solution is exposed to

air–germs could be introduced. Also, some doctors have been known to

add ingredients like antibiotics and disinfectants in the hope of

preventing infections. These additives degrade in the implant's

solution after years inside the body. In fact, in Gordon's implant,

Blais did find degraded Keflin, an antibiotic, which contributed to

the black color. Worse, instead of protecting her it encouraged the

growth of bacteria that were resistant to the drug, hence more

dangerous.

Some experts believe that microbes can pass through the implant's

envelope and through imperfect valves. According to this theory, bugs

could enter the sacs from the body, and/or germs growing inside could

wind up on the device's outer surface, infect the surrounding tissue

and travel into the bloodstream. The idea is controversial, however.

" Cases of contamination have been cited in the past, but with today's

sterile techniques, bacteria or fungus should not enter the implant

during filling or afterward, " contends Diane Hart, program manager of

patient services at Mentor, the company that made Gordon's implant.

Meanwhile, Blais, who has authored 250 scientific papers on the

safety

of implantable medical devices, believes women are still in danger.

He

has seen hundreds of black, brown and green implants–both saline and

silicone-gel implants, which were banned for cosmetic use in 1992 but

allowed for reconstruction patients–removed from women who had all

types of health problems, including autoimmune symptoms. These colors

correlate to certain types of microbes present in the implant, he

explains. " One of the most common contaminants in black implants is

aspergillus niger, a black variety of fungus, while two other forms,

aspergillus fumigatis and Bouffardi's black, cause dark brown

discoloration. " In the case of blue or green implants, the culprit is

usually algae.

V. Leroy Young, M.D., professor of plastic surgery at Washington

University in St. Louis, is another scientist who has shown that

disease-causing microbes including E. coli, staph bacteria and

aspergillus can grow in saline implants. Further, a handful of

studies

have shown a connection between symptoms associated with autoimmune

disease and germ-ridden implants of both the saline and silicone

variety.

In one of these studies, Marek .K. Dobke, M.D., head of the division

of plastic surgery at the University of California, San Diego School

of Medicine, cultured both kinds of implants, removed from more than

300 hundred women complaining of muscle or joint pain, chronic

fatigue, skin rashes, low grade fever, dry eyes and mouth, hair loss,

and confusion or impaired memory. He found bacteria (most commonly

staph) or fungi in approximately 70 percent of cases–three times the

rate of occurrence of bugs in implants removed from healthy women who

were having an " explant " for cosmetic reasons (such as trading up a

cup size). He also found high rates of microbe contamination in women

with capsular contracture and breast pain–a connection that many

agree

with, including Dr. Young, who fingers bacteria as the culprit. " This

strong correlation between microbes–mostly bacteria–and symptoms, "

maintains Dr. Dobke, " may be the key to the health troubles so many

women with implants have. "

Still, many experts discount such findings. Dr. Young, despite his

own

microbe studies, contends that the real discoloring culprits in most

cases are the substances often added to the saline fill, such as

Betadine, an antiseptic, which is brown. He's also suspect of

research

finding live germs in contaminated implants. " If the device has been

sitting around in someone's closet, you may find fungus, but that

doesn't mean it was there when the implant was removed, " he

contends.

Others believe that implant patients' autoimmune complaints are

coincidental. " Women are genuinely suffering [from autoimmune

problems], " explains L. Baker Jr., M.D., clinical professor of

plastic surgery at the University of South Florida in Tampa, " but

women who have implants have the same rate of these diseases as those

who don't. " Dr. Baker also points out that people who have other

kinds

of implantable devices in their bodies aren't complaining of an

autoimmune epidemic. But this is another point of debate. Small

studies by Dr. Dobke and others have shown a link between painful

symptoms in men and contaminated penile implants. Blais adds that

because implants are soft and fluid-filled, they may provide a more

conducive environment for germs to grow than, say, a hard chin

implant

or knee replacement. However, he admits, a dearth of research on

other

types of devices leaves many questions unanswered. " With many medical

implantable devices, " he notes, " the patients are elderly, so

autoimmune problems that take time to develop may not show up before

a

patient dies or may never be linked to the implant. "

A PERSONAL DECISION

Not all scientists who believe that implants trigger autoimmune

disorders finger microbes as the culprits. Many, despite substantial

scientific evidence showing otherwise, steadfastly claim that

silicone

is to blame. " Many women don't realize that saline implants are

surrounded by a silicone shell, just like the one that surrounds

silicone-gel implants, " points out Vasey, M.D., chief of

rheumatology at the University of South Florida.

A more tangible area of concern, acknowledged by almost everyone in

the medical community: Implants may make it harder to detect breast

cancer. One reason is that cancer cells can be confused with

calcifications around the implant on a mammogram. Also, the sizeable

sacs may obscure lumps one would normally notice in a self-

exam. " This

is very scary, " charges Zuckerman, Ph.D., president of the

National Center for Policy Research for Women and Families in

Washington, D.C., " because cancer may be missed or diagnosis delayed

until the disease reaches a later stage, when it's less curable. "

Women need to push their doctors to be up-front about the risks,

cautions Zuckerman, because some may downplay any bad news that could

deflate their profits. And the FDA approval should not put you at

ease, she warns: " To call saline implants safe on the basis of three-

or four-year studies paid for by implant manufacturers leaves women

dangerously in the dark. " That's why if you're considering surgery,

it's crucial to check the FDA Web site (www.fda.gov) to learn about

possible side effects and discuss them in depth with your surgeon.

" Getting implants is a lifelong decision, because even if you later

have them removed, your breasts will never look as good as they did

before the operation, " she stresses.

Ultimately, says Dr. Kolb, the Atlanta plastic surgeon who removed

Gordon's implants, it's up to women to make up their own

minds–a conclusion shared by most medical professionals. Despite

falling ill herself with unshakable fatigue, dizziness, muscle aches,

numbness in her arms, dry eyes and memory problems after getting

silicon[sic]-gel implants, Dr. Kolb continues to augment other

women's

breasts, with saline, and now is delighted with the salt-water pair

she wears herself. " How can I be totally against something I have in

my own body? I agree there's vast room for improvement, but as long

as

women are fully informed of the risks. Why can't they decide for

themselves, as I did? "

ADDITIONAL REPORTING BY DINA ROTH

Saline Sound Off!

Here, two experts duke it out over saline implant safety.

THE PROS

LORI SALTZ, M.D., is a plastic surgeon in La Jolla, California, who

has had silicone implants for 24 years and believes silicone and

saline implants are safe.

ON THE DANGERS OF INFECTION / DEFLATION: While there is a risk of

infection in any elective surgery, I only fill implants with sterile

saline through a closed system–from the IV bag through a sterile tube

into the implant. If an implant deflates, your body will absorb the

solution, which is the same as what's in an IV bag at the hospital.

ON THE CONNECTION BETWEEN IMPLANTS AND AUTOIMMUNE DISORDERS: There's

no proof to justify pinning the autoimmune complaints on implants. A

million other things could be causing these symptoms. I haven't seen

any of these problems in my practice.

BOTTOM LINE: I'm not saying everyone with breast implants is going to

be happy. I see some women whose scar capsule around their implants

contracts and hardens when we put them in. But it should be a woman's

choice, not the government's decision.

THE CONS

ILENA ROSENTHAL is director of the Humantics Foundation for Women,

Breast Implant: Recovery and Discovery in San Diego.

ON THE DANGERS OF INFECTION DEFLATION: The labels on 1-liter bottles

of saline IV solution recommend storage at 77 degrees and include a

discard date of about 18 months. With implants, the saline is stored

in your body at 98.6 degrees for years, which, I believe, makes it a

very good medium for fungi and other microbes to grow. I've run

across

a lot of women who have saline implants and symptoms of subclinical

infections.

ON THE CONNECTION BETWEEN IMPLANTS AND AUTOIMMUNE DISORDERS: I think

the saline implant's silicone shell could cause systematic (sic)

[read: " systemic " ] reactions in some cases. Women with saline

implants

complain about the same autoimmune problems that those with

silicone-gel sacs did.

BOTTOM LINE: I've seen thousands of women who got implants suffering

healthwise. I just want anyone thinking about enhancing her breasts

to

realize that the risks are very real and serious, and that the

complication rate is extraordinarily high.

EILENE ZIMMERMAN