Audrey Ciancutti

Deneé Dimiceli

Wendi Myers

Dr. Edward Melmed, MD

Dr. Franklin Rose, MD

Dr. Michael Harbut, MD, MPH, FCCP

Dr. Ernest Lykissa

John Byrne

Anne Stansell



Colleen and John Swanson

Dr. Joy Taylor

 

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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