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Audrey Ciancutti
“There
was no negative information given to me at the time to say that
they could affect my health in any way. It was the solution and
he told me quite frankly this will last you for the rest of your
life….You’ll never have to wear a bra again in your
life.”
For many years, Audrey Ciancutti has suffered from illnesses related
to her ruptured silicone breast implants. A native of Pittsburgh,
Pennsylvania, and mother of filmmaker Carol Ciancutti-Leyva, Audrey
is the inspiration of the documentary ABSOLUTELY SAFE. Today,
despite her illness, Audrey is an active and committed advocate
for breast implant safety.
Audrey’s relationship with silicone began
in 1974, when she was diagnosed with breast tumors and advised
by her doctors to have a double mastectomy and silicone-implant
reconstruction surgery. Within a year, Audrey’s implants
had ruptured and her doctors replaced her old implants with new
silicone implants which also eventually ruptured. In the years
since her multiple ruptures, Audrey’s health has steadily
declined. Unexplained rashes, severe joint pain, chronic fatigue,
crippling arthritis, and lupus—all of these mysterious,
debilitating conditions entered Audrey’s formerly healthy
life.
As Audrey learned more about silicone implants and
other women who had developed similar conditions after their ruptures,
Audrey concluded that her implants and the ruptured silicone migrating
throughout her body were making her sick.
Although Audrey’s last set of ruptured implants were removed
over twenty years ago, she continues to suffer from severe joint
pain and fatigue.
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Deneé
Dimiceli
“The feeling that I’m
expecting to get from that [breast implants] is just more confidence,
and to feel better in my clothes.”
“…I love Jessica
Simpson, I watch MTV, and I guess maybe because it started at
such an early age, those were the people I wanted to look like,
or be like…”
Deneé Dimiceli is a healthy, vibrant, and
happily married young woman who lives in Houston, Texas. Ever
since she was a teenager, however, Deneé felt incomplete
and yearned for larger breasts. Over the years, Deneé battled
her breast size insecurity with all sorts of products--padded
bras, water bras, air bras, tissue, and rubber falsies she called
“chickens.” In her twenties, Deneé began to
save money for breast implants calling it “her boob job
fund.” Finally, at the age of twenty-seven, Deneé
decided to have breast augmentation surgery.
The decision to have breast implants was not a
difficult one for Deneé, but it was difficult for her husband.
Deneé’s husband T.J. had concerns about her surgery
and did not want his wife to have breast augmentation, saying
“I think they’re just fine the way they are.”
Although her husband did not fully support her decision
and had questions about implant safety, Deneé did her own
research and concluded that the risks were worth the chance to
feel better about her body. With the help of Dr. Franklin Rose,
one of the most respected and experienced board-certified plastic
surgeons in Texas, Deneé’s dream came true—she
became a “a full C” with saline implants and now “feels
more like a woman.”
Today, nearly two years after her implants, Deneé
remains happy and healthy. Although Deneé did lose some
sensation in her nipples and her husband describes her breasts
as “not feeling natural”, she still believes that
implant surgery was the right decision for her.
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Wendi
Myers
“They feel alien to me. I don’t
want them in my body. I look at them as sacs of poison in my body.”
“I went to the original doctor
and he basically told me there’s nothing wrong with silicone
and it sounded like he had given this speech a million times before…he’s
telling me it’s all in my head, and there’s nothing
wrong with silicone.”
Wendi Myers had breast augmentation surgery with
silicone breast implants in the 1980s.
During the late 1990s, Wendi began complaining of
dizziness, fatigue, joint pain, hair loss, and nipple discharge.
Like many other women who believe that their implants have made
them sick, Wendi had been a healthy and energetic woman before
her mysterious illnesses emerged. Wendi believes that her health
problems all began when her implants ruptured in a car accident.
Although numerous doctors assured Wendi that her implants were
not ruptured and could not possibly be making her sick, Wendi
maintained that her implants were indeed ruptured and responsible
for her illness. Repeatedly, Wendi was told by doctors that her
illness “was in her head.”
In 2006, Wendi met plastic surgeon Dr. Edward Melmed,
the first doctor who acknowledged that breast implants can cause
illnesss. With the financial help of her mother and the surgical
skill of Dr. Melmed, Wendi had her implants removed in 2006. During
the surgery, Dr. Melmed discovered that both of Wendi’s
silicone implants were, in fact, severely ruptured.
Today, Wendi is a successful graphic designer and
advocate of implant education and safety. She hopes that sharing
her story with the public will help educate and inform other women
about breast implants.
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Dr.
Edward Melmed, MD
“They do not last. They rupture.
And the longer they’re in the body the more likely they
are to rupture. The statistics are kind of scary, because around
about 50 percent are ruptured by 10 years. And when it gets to
15 to 20 years you’re looking at almost 90 percent of implants
that are ruptured.”
“What is most worrisome is
that while most of the silicone is contained within the capsule,
some of it leaks out, we don’t know where it goes, we don’t
know what it does, we have no idea.”
Edward Melmed is a board certified plastic surgeon
. He has been doing plastic surgery for almost 40 years. Dr. Melmed
is certified by the American Board of Plastic Surgery. He is also
board certified in England, Scotland, and South Africa.
Dr. Melmed is unique among board-certified plastic
surgeons working in the United States. In addition to being one
of the few plastic surgeons to publicly question implant safety,
and criticize the long-term problems and complications, Dr. Melmed
is also one of the few plastic surgeons who removes implants without
replacing them. He has demonstrated that this can be done safely
and with excellent aesthetic results.
In the early years of the silicone debate, he, like
all other plastic surgeons, did not believe that problems existed.
After all, the manufacturers told plastic surgeons that implants
would last a lifetime. In 1992 he started seeing women with problems
almost all of whom had common symptoms—severe fatigue, short-term
memory loss, joint and muscle pains, hair loss, etc. Seeing and
treating women of all ages, and all walks of life who had these
symptoms in common convinced him that there was a problem.
In the film ABSOLUTELY SAFE, Dr. Melmed maintains
that implants have three major long-term problems—rupture,
encapsulation which is a natural reaction to all foreign material,
and in a certain percentage of women, symptoms from reaction to
silicone.
During the film, Dr. Melmed meets Wendi Myers, a
patient who suspects her silicone implants are ruptured and making
her sick. Wendi’s symptoms of fatigue, hair loss, and dizziness
are like those of other patients with silicone implants. Dr. Melmed
removes Wend’s implants with no replacement. In surgery,
Dr. Melmed finds that Wendi’s implants are severely ruptured.
Dr. Melmed believes that current implants have severe
flaws that worsen with time. With the reintroduction of silicone
gel, the manufacturers even agreed to recommend removal and exchange
every 10 years, and MRI examinations every 2-3 years. He is extremely
worried about the future of young women who have implants when
in their teens or early twenties.
In his spare time, Dr. Melmed volunteered his time
to head the Dallas County Gang Tattoo removal program. He is always
busy restoring antique cars (he tells people his occupation is
working in a body shop) or riding his motorcycles.
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Dr.
Franklin Rose, MD
“This is a safe bio-material
that reputable, ethical, board certified plastic surgeons are
placing in individuals who want a well performed operation. Every
scientific study that’s done by Mayo [Clinic], by Harvard,
by the plaintiff’s attorney’s own judge shows it’s
safe. It’s a safe implant.”
Dr. Franklin Rose is one of the most experienced
and respected board-certified plastic surgeons in the United States.
During his 18 year career in Houston, Texas, he has performed
over 4,000 breast augmentation surgeries.
Dr. Rose has a special interest in facial and hand procedures,
breast augmentation and reduction, and liposuction. In addition
to two research grants he received from the American Society for
Aesthetic Plastic Surgery, Dr. Rose is the recipient of several
distinguished awards from the Plastic Surgery Educational Foundation.
For Dr. Rose, his stance in the breast implant debate
is clear—he believes that breast implants, both silicone
and saline, are safe products whose safety have been repeatedly
proven by studies conducted by respected organizations such as
the Mayo Clinic and Harvard University. Although, Dr. Rose is
aware that the silicone implant controversy continues, he remains
confident in their safety. Following the FDA guidelines, Dr. Rose
continues to augment women’s breasts with both silicone
and saline implants.
In the documentary ABSOLUTELY SAFE, Dr. Rose performs
saline implant surgery on his patient Deneé Dimiceli. Throughout
his conversations with filmmaker Carol Ciancutti-Leyva, Dr. Rose
remains committed and confident that implants are safe and effective.
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Dr.
Michael Harbut, MD, MPH, FCCP
“I think that the science on
the implants has been so discouraged from actually being undertaken
in a coherent and realistic fashion that we really don’t
know much about these devices at all.”
“The occupational medicine
literature is emphatic in its opinion that at no stage should
a worker be exposed to any liquid or solid containing any platinum
salt.”
Dr. Michael Harbut is one of the most preeminent
occupational and environmental health physicians working in his
field. Dr. Harbut was awarded the “Broad Street Pump Award”
from Physicians for Social Responsibility for his work to lower
the arsenic levels allowed in American drinking water. Internationally
renowned for his research regarding the link between toxic exposures
and disease, Dr. Harbut was awarded the Selikoff Lifetime Achievement
Award by the Asbestos Disease Awareness Organization in 2007.
As Co-Director at the National Center for Vermiculite and Asbestos-Related
Cancers at the Karmanos Cancer Institute, Dr. Harbut’s team
developed what is considered one of the most important blood tests
for cancer ever discovered. His team’s groundbreaking research
was published in the New England Journal of Medicine. Additionally,
Dr. Harbut has consulted for Public Citizen, testified before
the United States Senate regarding the diagnosis and treatment
of asbestosis, been invited to speak at the Whitehouse, and been
featured in author Andy Schneider’s book An Air That Kills.
Dr. Harbut has treated over 1,000 women with breast
implants and believes that platinum and other potentially toxic
heavy metals used in the making of silicone gel and silicone shells
in breast implants can cause or contribute to serious disease
and illness in breast implant patients.
In ABSOLUTELY SAFE, we meet Dr. Harbut and one of
his patients Dr. Joy Taylor. Dr. Taylor, once a healthy, vibrant,
successful, and active woman is now seriously ill with pleurisy
and respiratory disease. According to Dr. Harbut, Joy’s
illness is the result of “a clear sensitivity or allergic
reaction to silicone and/or components of silicone” in her
ruptured silicone implants.
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Dr.
Ernest Lykissa
“The IOM and the manufacturers
have never approached it by looking at implants that have been
taken out of women, after five years of implantation, and studied
those…that’s the difference between what I do and
what they do. I’m looking at failed devices.”
Dr. Ernest Lykissa is a forensic toxicologist with
over 25 years of experience. Dr. Lykissa’s commitment, dedication,
and passion for breast implant research is remarkable and has
sparked other scientists to enter the chemical debate about breast
implant safety. Many women with breast implants and their doctors
have turned to his lab ExperTox for chemical analysis of blood,
urine, and tissue samples.
For over a decade, Dr. Lykissa and his colleagues
have performed chemical studies on failed breast implants. According
to Dr. Lykissa’s studies, breast implants leak platinum
into the body and a toxic form of platinum (a charged, oxidized
form) may be the cause of the illnesses some women with breast
implants suffer.
Dr. Lykissa’s research is not without controversy,
as many other scientists have criticized the research methodology
and findings. While the IOM and the FDA have reviewed Dr. Lykissa’s
studies, the FDA
maintains that the platinum research is inconclusive because the
studies were flawed. For more information on Dr. Lykissa’s
platinum research visit the “Platinum
Salt Theory” section of this website.
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John
Byrne
Executive Editor, Business Week
“All you have to know is one
simple thing. The manufacturer never proved that the devices were
safe and effective, because they never did the due diligence,
the work that was necessary in clinical studies, and in scientific
discovery, to make that assumption, and to make that conclusion.
And that at the very base of this debate is what has to be done.”
John Byrne is one of the most respected and accomplished
business journalists working today. As Executive Editor of Business
Week magazine, former editor-in-chief of Fast Company
magazine, and veteran writer at Business Week for nearly
18 years, Mr. Byrne has written countless articles, cover stories,
and eight books on business, management, and leadership. His book
on General Electric CEO Jack Welsh, Jack: Straight from the
Gut, was an instant bestseller.
In his acclaimed book Informed Consent,
Mr. Byrne investigated the complex story of Dow Corning and the
silicone breast implant safety controversy. Framed by the stories
of Dow Corning executive whistle-blower John Swanson and his wife
Colleen Swanson, who fell quite ill from her Dow Corning made
silicone implants, Informed Consent tells the riveting
and disturbing tale of personal and corporate crisis. Through
the stories of the Swansons and extensive research on Dow Corning,
Mr. Byrne raised profound questions about government regulation,
corporate responsibility, and the very notion of what “informed
consent” means in an age of million dollar advertising campaigns
for billion dollar products like breast implants.
Despite the Dow safety cover-up, lawsuits, silicone
implant sale restrictions, and years of FDA hearings, breast implants
and the cosmetic surgery industry as a whole have boomed over
the last decade. As Mr. Byrne explains in the film ABSOLUTELY
SAFE, the conflict between government regulation and professional
ethics still taints the breast implant safety debate. In commenting
on the FDA advisory hearing to approve silicone breast implants
Mr. Byrne notes “the panel voted nine to six in favor
of silicone breast implants. Four of the nine “yes”
votes were by plastic surgeons who shouldn’t even have been
sitting on the panel because of their obvious self-interest.”
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Anne
Stansell
“The doctor says you have breast
cancer. You need a mastectomy, you need radiation, you need breast
implants. It’s like part of the whole treatment. In reality
I didn’t need the breast implants to get over the cancer.
But they make it seem like it was all part of the recovery. It
was a terrible thing.”
Breast cancer survivor Anne Stansell is one of the
most active and inspirational voices speaking out against breast
implants today. In addition to sharing her story and testifying
at numerous FDA hearings, Anne has also exhibited her powerful
and beautiful collection of photographs to FDA panels. Anne’s
photographs document the bodies of everyday women whose breast
implants failed, causing complications, sickness, and disfigurement.
After surviving breast cancer at the age of 39,
Anne’s doctors told her that along with her mastectomy and
radiation therapy, she needed silicone breast implants. Presented
as part of the standard treatment and not as a choice to consider,
Anne trusted her doctors whom she felt “had just saved her
life.” At this time, Anne did not know that breast cancer
patients with breast implants had not been fully studied.
Five years after getting her implants and recovering
from cancer, Anne became very ill. Her symptoms were unrelated
to past cancer and presented ailments she’d never experienced
before. Diagnosed with Grave’s Disease and Fibromyalgia,
Anne also suffered a torn retina from severely dry eyes.
After battling her insurance company to help with
the expense of implant removal, Anne had her implants removed
two years later. Upon ex-plantation, doctors discovered that half
of one of Anne’s implants was missing. During her FDA testimony,
Anne asked “where did the silicone go?” In the coming
years, Anne found silicone in her side, where it had eventually
migrated. Like many other women, Anne’s health improved
after her implants were removed from her body.
Today, Anne leads a support group in Albuquerque,
New Mexico, for breast cancer patients who have had similar experiences
with breast implants. Anne continues to speak out against breast
implant use in cancer patients and lobbies the FDA to require
more extensive research on breast implant safety for all populations.
Anne’s voice and creative eye are an inspiration to thousands
of women in the breast implant safety debate.
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Colleen
and John Swanson
“Profit. Money. These are
profitable devices. People make money on them. They want them
out there. There’s a market for them.” –John
Swanson
“I said, ‘If I have
to take these out myself with a razor blade, they’re coming
out.’ I said, ‘We can do this secretly. We can go
someplace where nobody knows us. Dow Corning will never have to
know.’” –Colleen Swanson
Colleen Swanson and John Swanson have been in the
epicenter of the breast implant safety debate in more ways than
one. As a long-time employee at Dow Corning Corporation, formerly
one of the largest manufacturers of silicone breast implants,
John Swanson helped lead the company’s ethics policy, and
at times, was involved in the company’s private and public
defense of silicone implants. In the midst of the heated public
controversy regarding breast implant safety, John’s wife,
Colleen Swanson, privately believed that she, like thousands of
other women believed, was sick from her silicone implants manufactured
by Dow Corning.
In ABSOLUTELY SAFE, John and Colleen share their
story of personal and corporate crisis. Assured by experts at
her husband’s company that breast implants were safe, Colleen
Swanson had breast implants put in her chest in 1974. Immediately,
Colleen began to suffer from unexplained health problems. After
nearly seventeen years of suffering from mysterious symptoms associated
with lupus and scleroderma, Colleen Swanson made a radical decision
regarding her implants—she wanted them out of her body forever.
As she explains in the film, expressing her belief that her implants
caused her illness risked her marriage and John’s career.
John was a company man in the company community of Dow Corning.
Colleen was adamant, however, and had her implants ex-planted.
Upon removal, Colleen’s doctor discovered two severely ruptured
implants; her rheumatologist connected all of her symptoms to
the silicone gel implant ruptures.
Faced with a “huge corporate sense of denial”
and a beloved wife who was severely ill and convinced that her
implants were the cause, John Swanson ultimately stopped towing
the company line and took his wife’s side on the issue.
In 1991, after 26 years at Dow Corning and believing that the
company’s popular product—silicone breast implants---were
safe, John Swanson recused himself from participating in the company’s
decision to continue to sell silicone breast implants.
The Swanson’s story is thoroughly told in
the acclaimed book Informed Consent by Business Week
Executive Editor John Byrne. In addition to offering the corporate
context of the breast implant controversy, the story of Colleen
and John Swanson provides a revealing window into the toll that
the safety debate takes individuals, both men and women. Ultimately,
Colleen and John’s story stands as a metaphor of everyday
people---including thousands of women like Colleen and their families—who
are caught in the dangerous, confusing traffic jam of corporate
greed, health, and personal courage.
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Dr.
Joy Taylor
“I was a practicing physician
until two years ago. And I had to finally go on disability because
I was just not able to function any longer on the job. I’m
here because I have become very ill from my silicone implants.
I had them in when I was 30 trying to save a bad marriage, and
it didn’t work anyway.”
Dr. Joy Taylor has spent the last decade suffering
from illnesses that she and her doctors believe are caused by
her ruptured silicone breast implants. Once a healthy, vibrant,
active, and successful professional, Dr. Taylor is often too sick
to get out of bed.
Ten years ago, Dr. Taylor developed severe respiratory
problems and was diagnosed with pleurisy. During a CAT scan, doctors
discovered that her breast implants were ruptured. Two years later,
Dr. Taylor’s health continued to decline and she was forced
to leave her profession because she could no longer function on
the job.
Dr. Taylor’s doctor, Dr. Michael Harbut, describes
Joy’s story as one of the best examples of how implants
can make women sick. As a “bright, energetic” woman
who was “engaged in life, engaged in her profession,”
Dr. Taylor had “a deeply vested interest in being able to
be active and healthy.” According to Dr. Harbut, Dr. Taylor’s
health crisis is caused by a “hypersensitivity or allergic
reaction to silicone and/or components of the silicone in Joy’s
breast implants.”
Today, Dr. Taylor continues to suffer from health
problems. Although she had her ruptured implants removed, both
migrated silicone and platinum remain in her body.
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