Tinker Ready

1994: Women who say they are sick from breast implants, and the doctor who invented one of them

THE DOCTOR AND HIS IMPLANTS

by Tinker Ready               From the files of the N&O’s News Story Archive
March 31 1994

Can doctors with financial ties to medical products put a patient’s best interests ahead of their own? Or do potential payoffs cloud their medical judgment?

Page: A1           Section: NEWS         Edition: FINAL
Summary: A prominent Duke plastic surgeon invented a silicone prosthesis and
sold the idea to a manufacturer. He got a royalty every time he used
the implant to rebuild a patient’s breast. Now some women say the
leaking implants made them sick and debilitated.

Byline: TINKER READY
Source: STAFF WRITER

Text:

Duke plastic surgeon Nicholas Georgiade said he could do
something wonderful for Geneva Barker after she lost her breast to
cancer. He could remove her second breast, rebuild her entire bust
line and save her from another bout with the deadly disease.
What she didn’t realize was that he was doing something for
himself, too.
The two bags of silicone Georgiade put in Barker’s chest in
1977 bore his name. Every time he or another doctor used a
“Georgiade Surgitek” artificial breast, he earned royalties and
helped shore up his share of the lucrative implant market.
Barker, who lives in Greensboro, didn’t find out her doctor
had a financial interest in the devices until recently. By then,
Georgiade had operated on her seven times, removing and replacing
11 implants.

“I was a guinea pig,” she said. “They put these things in me
and I’ve suffered dearly.”

Now, Barker lives with constant pain and fatigue. Pale and
weak, she is usually confined to bed. During a January visit, she
shuffled across the room, climbed into a four poster bed and
sighed. She blames Georgiade and his silicone implants for her
condition.

“I’m so upset with FDA and the government and the doctor for
putting this monster in my body,” she said. “I thought everything
was great and the first thing I know it’s making me sick.”

Barker is one of at least 20,000 women involved in a massive
lawsuit against the nation’s implant manufacturers. The women say
the soft bags of gel turned into hard, painful balls. They say the
implants also leaked silicone into their blood, causing stinging
rashes, joint pain, constant fatigue, memory loss and brain damage.

A $4 billion settlement with several of those companies —
which would provide women with money to cover implant removals,
medical expenses and more — is pending. If approved, it would be
the largest single product liability agreement in U.S. history.
Georgiade, who declined to talk for this story, has retired
from Duke. His son, Gregory Georgiade, also a plastic surgeon, now
practices there, specializing in breast surgery. In some cases, he
has removed implants from his father’s former patients.
In a deposition taken in February as part of the lawsuit,
Nicholas Georgiade said Surgitek staff assured him they had tested
their silicone implants for safety. That satisfied him and still
does.

“I have great faith in American industry and I believed in
this company,” he said in the deposition taken in Washington.
Georgiade described his corporate financial tie to Surgitek as
“a small royalty of a few thousand dollars a year.” Court records
show that he earned about $90,000 over 17 years.

Although not a fortune, the money helped maintain an intimate
link between the doctor and the implant industry. He accepted the
implant maker’s safety guarantees with little question, according
to statements made during the deposition. Then, he went on to build
a career in reconstructive breast surgery. In turn, Surgitek used
his name and reputation to sell implants.

THE CORPORATE CONNECTION:

When questions about the safety of the implants arose,
Georgiade made only limited attempts to get answers. During the
December deposition, the doctor said every article he read linking
silicone gel in implants to human diseases was “hypothetical and
not based on fact.”
Still, the U.S. Food and Drug Administration had enough
questions about implant safety to virtually ban implants in 1992.
The agency ruled that manufacturers could not say how long the
devices would last and what happened to women if they broke or
leaked.

Now, one Georgiade critic says the Duke doctor’s implants
didn’t last long. The “teardrop” shape had a narrow end that
creased, folded and eventually leaked, said Pierre Blais, a former
medical device expert with the Canadian government who has examined
more that 50 pairs of Georgiade implants.

“They would fail with virtually no impact,” he said.

That would mean silicone, banned in its injectable form by the
FDA in 1965, leaked directly into his patients’ bodies.
Some of Georgiade’s patients now wonder whether his financial
ties to the company made him willing to continue using the Surgitek
implant, even though company records show he sent more than 200
damaged or defective implants back to the manufacturer.

They also wonder whether his corporate connection had anything
to do with his aggressive approach to breast reconstruction
surgery. The Duke doctor was a vocal advocate of a controversial
procedure for “high risk” women known as the subcutaneous
mastectomy in which a doctor replaces a woman’s cancer-free breasts
with implants to keep her from getting the disease.

“I don’t think Georgiade set out to put a bad product in
people’s bodies,” said Lynn Holtkamp, a Durham lawyer who
represents several of Georgiade’s patients, “The issue is — how do
you manage being an advocate for your patients and being an
advocate for your pocketbook?”

Officials at Duke University declined to comment for this
story, citing the pending breast implant litigation.

PREVENTIVE MASTECTOMY

For 20 years, women from across the state came to Duke Medical
Center to consult with Georgiade. A confident man known for his
long hours, he helped pioneer breast reconstruction surgery. He was
considered the best in the state, perhaps one of the best in his
field.
Trained as a dentist, Georgiade enrolled in Duke Medical School
in the 1940s and made his career there, eventually becoming chief
of plastic surgery. He switched from a focus on head and neck
surgery to breast reconstruction in the 1960s. He built a
reputation and became president of the American Association of
Plastic Surgeons in 1977 and 1978.

During the deposition, Georgiade once said he saw breast
reconstruction as a challenge because of the scars left by radical
mastectomies, a common cancer surgery.

“No one really had an answer as to how to reconstruct the
patient’s deformed chest,” he said in the deposition. He wanted to
help these women, he said.

In addition to working with patients who had undergone
mastectomies, Georgiade was known at the time as one of the
strongest advocates for the preventive mastectomy.

Today, doctors rarely resort to the removal of healthy
breasts. They now know they cannot reliably predict who will get
breast cancer. But in the 1970s and ’80s, Georgiade and his
colleagues at Duke thought they could. In 1982, about 10 years
before Georgiade retired, he reported that Duke doctors had
performed the operation on 711 women.

IMMUNE SYSTEM GONE AWRY:

Geneva Barker lost her left breast to cancer at the age of 38.
Five years later, in 1977, she want to Georgiade for
reconstruction. At the time, she said, he suggested she have her
right breast removed because she would probably develop cancer
there.

Not all women get sick from the implants, but Barker says she
did. Her physical ailments started with what she described as
blinding headaches.

Every time an implant became hard or painful, Georgiade cut it
out and put in a new one, she said. The surgery made her feel
better for a while, she said, but she always grew ill again.

By the time she had the implants removed for good in 1991, a
rheumatologist had diagnosed her pains and fatigue as arthritis and
other painful joint conditions linked in some studies to silicone.
Bernard Patten — a neurologist at Baylor College of Medicine
in Houston who has treated hundreds of women with implants — told
her that her immune system had gone awry in response to the
silicone. Some doctors, including those on an American Medical
Association panel, argue that there is insufficient evidence to
link the implants to immune disorders.

Barker, however, has all the evidence she needs.

“I used to be a tall, attractive woman,” she said. A wedding
portrait on her wall confirms her recollection.
Now, at 60, her face looks pale and puffy. She tires so easily,
she said, that she must lie down after emptying the dishwasher. The
pain has eased since she began seeing Patten late last year, she
said, but he ordered her to stay in bed.
Except for a small, misshapen bulge of tissue on her right
side, she has no breasts — just two horizontal scars across her
chest.
Like all of the patients interviewed for this story, Barker
said Georgiade never mentioned his link to the implant
manufacturer. By the time he began operating on Barker, however, he
had been receiving royalties for several years.
Georgiade signed his first licensing agreement with Surgitek in
1974, allowing the company to make and sell a “thin-walled” breast
implant called the “Georgiade Prosthesis.” Georgiade also agreed to
promote the use of the implant in discussions with surgeons. In
exchange, twice a year he received a royalty check for 5 percent,
then 4 percent, of the implant sales.
After signing the agreement, he returned it to the company with
a letter asking officials to rush implants to him for an upcoming
plastic surgeons meeting.
“I would like to have these samples available for the meeting
at the time I present my paper on Augmentation Mammoplasties, as I
will refer to the Surgitek product at that time,” he wrote. He also
referred to the implant in some of the articles on breast implant
techniques he wrote for academic journals.
In 1988, after Bristol Meyers-Squibb Co. bought Surgitek,
Georgiade signed a new licensing agreement. This one included a
clause exempting him from any product liability suits brought
against the company.
Two years ago, Georgiade’s royalty checks stopped coming.
Unable to produce safety studies belatedly required by the FDA,
Surgitek shut down its breast implant business.
Other plastic surgeons are split on whether Georgiade should
have informed his patients about his financial interest in the
implants.
###
REMOVING HEALTHY BREASTS:
Verne C. Lanier, a Durham plastic surgeon, doesn’t think
Georgiade was obligated to disclose his corporate connection to his
implant patients.
The doctor would compare his implant to others, “but he never
called me and said ‘you should use my implant,'” said Lanier, who
trained under Georgiade in the early 1970s. “His pitch was more for
his textbooks than his implants.”
Some of those textbooks outlined his technique for the
subcutaneous mastectomy for a non-cancerous breast. In that
procedure, the doctor would retain the outer skin and nipple but
remove most of the breast tissue and replace it with the implant.
At that time, Georgiade’s team performed three to five of the
operations a week, Lanier recalled.
The procedure fell out of vogue in the late 1970s, mostly
because of implant complications. Lanier said women experienced
scarring that made their breast look “look more like a grapefruit.”
Some had “very attractive breasts prior to surgery,” he said. “Now
the breasts were deformed and painful.”
Today, few doctors would trade a cancer-free breast for an
implant.
“I personally do not do the operation,” Lanier said. “If you
took a poll and called 100 surgeons, you would find that the
majority share my feelings.”
One reason doctors shy away from the operation is that they no
longer think they can predict who will get cancer by examining
benign cysts in breast tissue. Researchers are working toward
identifying a breast cancer gene, but most doctors have dismissed
the theory that common forms of a condition known as fibrocystic
disease vastly increase a women’s chance of developing breast
cancer.
Some women are clearly at higher risk — such as those with a
close relative who had breast cancer. Even then, only 20 percent to
30 percent of all breast cancer cases occur in high risk women.
In addition, doctors now can detect cancer earlier with
improved mammography and can sometimes remove just the tumor, not
the entire breast.
Still, as recently as 1988, Margaret Anne Bowen said Georgiade
told her that she should have a double mastectomy even though her
breast lumps were benign. Her fibrocystic disease — along with a
family history of breast cancer — placed her at extreme risk, she
said he told her.
The Roanoke, Va., woman remembers telling Georgiade she was
nervous about the implants because of her numerous allergies. She
said he assured her they were safe.
“Georgiade was supposed to be the best on the East Coast,”
Bowen said. “Why would I question him when he said no one was
allergic to them?”
She reluctantly agreed to allow the surgeon to remove the
tissue from her breasts and replace them with two “Surgitek 450CC
Teardrop” implants. Ten months later, she said, she developed
severe arthritis. Today, Bowen blames the implants for her chronic
pain, fatigue and memory losses.
At 61, she walks with a cane and has no balance and a poor
memory. She has had numerous strokes, and Patten, the Texas
specialist, recently told her the silicone has caused brain and
nervous system damage.
“I wasn’t sick,” Bowen said. “That’s the kicker. I could have
fought breast cancer easier than this.”
Cases like Bowen’s were common at Duke when Georgiade practiced
there, said Janet Ward Black, a Greensboro lawyer who is handling
the breast implant lawsuits for about 300 women.
“It seems to me that there were a large number of women who had
mastectomies at Duke who did not have cancer but had a family
history of cancer or had fibrocystic disease,” Black said.
###
HOW MANY GOT IMPLANTS:
Nationally, it is estimated that about one million women
received implants — 80 percent for cosmetic reasons, 20 percent
for cancer-related reconstruction.
That breakdown looks different in North Carolina, according to
a data base compiled on 515 women by the Carolina Implant
Information Network, a patients’ support group. About a third had
cancer, another third underwent cosmetic surgery and a third had
subcutaneous mastectomies for fibrocystic disease, according to the
group’s spokesman, Denise Tomczak. Women who underwent cosmetic
surgery may be under-represented in that group, she said, because
they are often unwilling to come forward.
The subcutaneous mastectomy still has defenders, among them
John Woods, Georgiade’s counterpart at the Mayo Clinic in
Rochester, Minn.
Woods, who recently retired, said he and other doctors at the
Mayo clinic performed the procedure on 1,750 women. Only seven have
developed breast cancer.
“We continue to do them,” he said. “We think it is a worthwhile
procedure.”
However, the clinic is careful about choosing patients and
never does the procedure on women who have only fibrocystic
disease, he said.
In addition, he thinks Georgiade should have told his patients
that he received royalties for the implants.
Those royalties might have been higher, but Georgiade’s implant
was never a huge seller, said Blais, the former Canadian device
inspector. The feature that made the implant unique — its teardrop
shape — also made it more likely to break, he said. It was “out of
fashion” by the early 1980s, he said.
Leaks in the Georgiade teardrop implant often began when the
narrow end folded over inside a woman’s chest, Blais said.
“The tear is always at the same place,” he said. “It would cut
right there at about four years. Pretty much after six, they were
perforated and leaking like a sieve, and by 10 years, they were all
busted.”
In fact, some didn’t even make it from the factory to
Georgiade’s office intact. Some of the more than 200 implants he
sent back to Surgitek arrived at his office with tears and creases,
while others had ruptured during or after implantation.
But the FDA couldn’t have known that, because silicone implants
were virtually unregulated for nearly 30 years. Congress ordered
the agency to begin reviewing the safety of medical devices in
1976, but the FDA exempted the implants because they had been on
the market for more than 10 years.
It wasn’t until 1992 — after hundreds of complaints, studies,
hearings and thousands of lawsuits filed nationwide — that the FDA
determined that it could not guarantee the safety of the implants.
Two years ago, Commissioner David Kessler ordered that they only be
made available to women enrolled in tightly controlled studies.
“We know more about the life span of automobile tires than we
know about the life span of these implants,” Kessler said at the
time.
Nicholas Georgiade has retired from Duke, but, at 75, he still
works with residents at the Veterans Affairs hospital in Durham. He
also runs a part-time practice in Western North Carolina, where he
sees some of his former Duke implant patients, he said during the
deposition.
He still has a hand in the implant business as well. Last
summer, Georgiade obtained a patent on the use of a substance
called hyaluronic acid as a filler for breast implants. Already
used in eye surgery, the substance is derived from rooster combs.
He is now working with the manufacturer to find an interested
implant maker.

Copyright The News & Observer Publishing Co. All Rights Reserved 1997
From the files of The News & Observer

You can find this and other News & Observer stories by Tinker Ready in The N&O archives

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