LEAKY, SCARRING, BLACK WITH MOLD
WHY WOMEN ARE TAKING THEM OUT
The shocking health claims against saline implants
Lisa Collier Cool
implants–hardening, leaking, deflating and turning black with fungus–be
making women desperately ill? Former implant recipient Kathryn Gordon
thinks so, and a growing number of doctors agree.
The squishy mound blackened with fungus in Kathryn 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
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
Susan 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 Kathryn’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.
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 Kathryn 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.
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 Anderson, M.D., former chair of the
FDA’s medical devices committee from 1984 to 1988 and currently associate
professor of medicine at Johns Hopkins School of Medicine in Baltimore.
Anderson 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 David Feigal, 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
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, Maryland, 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
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."
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. Feigal. "The whole purpose of the FDA approval
process was to gather information so patients know exactly what to expect."
THE EXCRUCIATING PAIN
When Kathryn 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
Mounting evidence suggests that in a small percentage of women, like Kathryn
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
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
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 James 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
Frank Vasey, M.D., chief of rheumatology at the University of South
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
Diana 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 Kathryn
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.
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
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.
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.