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Are Breast Implants “Absolutely Safe?”

 
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In 2007, the dollars spent on breast augmentation surgery in the United States was $1.5 billion. By 2012, the numbers are projected to top 2 billion per year. Statistics from The American Society of Plastic Surgeons show that breast augmentation headed the list of surgical procedures in 2008. For those women who have had mastectomies, implants will be presented as a standard part of the recovery process.

Carol Ciancutti-Leyva, director of the documentary “Absolutely Safe,” is the daughter of a cancer survivor. Her mother’s journey, from a double mastectomy to silicone implants in the early 70s – which resulted in chronic illness, formed the impetus for the film.

The documentary came out in 2007, after a ten-year struggle for funding. It is currently being booked for screenings on college campuses and is being used in classrooms devoted to women’s studies, bioethics, and public policy.

Currently, Ciancutti-Leyva is working to create strategic partnerships to mobilize an “Informed Consent” campaign about the use of breast implant devices. Her model for legislation is a New York State Law (State of New York - Article 24-E, Section 2499w New York State law) that required the state’s Department of Health to publish a booklet that must be received by every woman considering a hysterectomy. It succinctly outlines risks, complications, alternative treatments, and recuperation expectations. Presently, the FDA has a guide on breast implants, but it is not legally mandated that prospective patients receive it. The "FDA Breast Implant Consumer Handbook" was published in 2004. Ciancutti-Leyva told me that the information reads as “a cautionary tale.”

I spoke with Judy Norsigian, Executive Director of Our Bodies Ourselves by telephone, “We see this film as one of the best tools for understanding both the known and unknown consequences of implants for a woman’s health,” she said. The film is an eye opener. In her January 17, 2008 article, “Do My Breast Implants Have a Warranty?” New York Times writer Natasha Singer referenced “Absolutely Safe” as an “anti-implant documentary.” In response to that description, Ciancutti-Leyva said, “Everybody brings their own stuff to the table. I was trying to create a dialogue.”

The two main stories profile a woman and her doctor on the breast augmentation path, contrasted with a woman seeking to have her implants “explanted” by the doctor who supports her decision.

We meet Wendi Myers, a single mother at the time she got silicone implants in the 1990s. Trying to make ends meet by working at an “upscale gentleman’s club” in Houston, her motivation for the procedure was to succeed in her job. In a sardonic definition of the Texas mindset, she explains that in her state the philosophy for everything is “the bigger the better.” Myers, who believed that her implants ruptured in a car accident, started to draw a connection between her symptoms of dizziness, hair loss, and “green and black discharge from her nipples” to the occurrence of the accident. In response to her physical ailments she was told by her original doctor, “It’s all in your head.” It wasn’t until 2006, when Myers met Dr. Edward Melmed, that she found an advocate for her concerns.

Melmed, a plastic surgeon with nearly forty years of practice under his belt, is board certified in the United States, England, Scotland, and South Africa. One of the leading medical voices questioning implant safety, he is on screen with a series of pithy remarks. Early on he offers, “There’s so much smoke, there has to be some fire.” Melmed is not opposed to breast implants, but makes clear, “I don’t believe the implants we’ve got do the trick.” He adds pointedly, “If this was a surgery that was done to men, do you think they would tolerate procedures like this?”

Deneé Dimiceli and her physician, Franklin Rose, are the flip side of the coin. At age twenty-seven, after years of coping with body image insecurity, Dimicelli had breast augmentation surgery. Despite the objections of her husband who says on camera, “It doesn’t make a lot of sense,” she is thrilled that her saline implants (encased by a silicone lining) bring her to a full size C cup. Rose, a board certified plastic surgeon with a national reputation and eighteen-year career in Houston, is adamant about the safety of both silicone and saline implants. He looks to the studies put forth by the Mayo Clinic and Harvard University as his guidelines. When he is introduced to viewers during a pre-op scrub, he mentions that he has performed over 4,000 breast augmentations. He points out that there is “a huge demand for this operation.” While examining Dimiceli he notes, “We are about to take a patient who has very pretty breasts, and make them even prettier.

The remaining voices weigh in like a Greek chorus, commenting on their particular issues and experiences. Audrey Ciancutti and Anne Stansell advocate for breast cancer survivors. Stanselli has repeatedly testified at FDA hearings, to question why implants are represented as part of the mastectomy process.

Dow Corning’s quintessential company man, John Swanson, and his wife Colleen – who had implants – weigh in with John Byrne (Executive Editor of BusinessWeek), who related their story in his book Informed Consent. A classic whistleblower’s tale, Swanson was forced to choose between his corporate affiliation and his relationship to his wife – who believed her lupus and scoloderma symptoms were related to her implants. (Her fears were confirmed when the implants were removed and discovered to be ruptured.) Swanson characterizes the corporate denial as being induced by the profit factor. Byrne posits that the manufacturer never proved the implants were safe, because they didn’t do the due diligence or adequate research in clinical studies to make a conclusion.

Dr. Ernest Lykissa, toxicologist, refers to the implants as “failed devices.” Dr. Michael Harbut, who has treated over 1,000 women with implants and is prominent in the fields of occupational and environmental health, maintains that the platinum and other toxic heavy metals employed in the manufacturing of the silicone gel and silicone shells of breast implants can cause and contribute to serious diseases in the recipients. He has petitioned the FDA, which is self-described on its website as “Protecting and Promoting Your Health,” with the results of his research.

When Dr. Melmed and Dr. Rose represent their specific philosophies, their personalities and demeanor emerge and impact the message. Melmed is matter-of-fact in his delivery, with a touch of ironic wit. He rattles off the three main problems with implants. “They rupture and silicone leaks out. (We don’t know where it goes. We don’t know what it does. We have no idea.) They all get encapsulated. Do they make women ill?” After removing Myers implants, we see that they have ruptured. As he struggles to excise what can best be described as goo, he observes that the implants don’t resemble their original state and offers, “And I’m not sure you want to put this into your 16 year old daughter for graduation…at least I don’t recommend it.”

Dr. Rose, in response to Ciancutti-Leyva, is firm in his opinion that implants are made from “safe bio-material.” He rhetorically asks her, “How many studies do you want to do?” He suggests a reason for the lack of resolution around implant safety. “It keeps coming up because you’ve got all these ultra-liberal feminine groups that keep on beating a drum…and they’re well organized.” In exasperation he tells the filmmaker, “Honey, look. I don’t know how many more times we can keep rehashing the same old thing. I mean they’re safe.”

When women with either silicone or saline implants have mammograms, there is a 30% chance that detection of tumors will be missed. In order to ensure that implants are intact and have not ruptured, women need to have MRIs every two years. If they decide to have them explanted, the cost of the operation for those who had augmentation will not be covered by insurance. (Myers had to borrow $10,000 from her retired parents to fund her procedure.) In considering some of these pragmatic concerns, Ciancutti-Leyva suggests, “I don’t think women are getting all the information.” Norrigan concurs, citing that there have not been sufficient longitudinal studies. It doesn’t help the case for implants to read a list of those “declining to be interviewed” – the Mayo Clinic Study, Allergan Corporation, and Dow Corning Corporation among them – at the close of the film.

Without question, future conversations about breast implants
will have to do more than just scrutinize the medical uncertainties. The need for informed consent was addressed as far back as 2000, in an editorial appearing in the Fall issue of The Journal of the American Medical Women’s Association. Written by Nancy Neveloff Dubler, LLB and Anna Schissel, JD, it was entitled “Women, Breasts, and the Failure of Informed Consent.” The authors examined whether “informed consent for breast augmentation is too fragile a reed to withstand the storm of commerce.” Norrigan sees part of the push for “informed consent” starting with outreach to legislators and policy makers.

A potent brew, comprised of cultural demands in tandem with big advertising dollars spent to promote the desirability of a specific body image, helps to fuel the demand for breast augmentation. In the area of breast reconstruction, options other than implants are not always promoted. In the December 22, 2008 article, “The Choices on Breast Reconstruction Are Not Always Clear,” Natasha Singer delves into why. The two primary reasons are inadequate training for cutting-edge procedures, and profit margin factors for the surgeon.

For any operation, information to reach an educated decision is mandatory. A survey by the American Society of Plastic Surgeons showed that almost 40% of women believed that they should have been more knowledgeable and better advocates for themselves around the choice to receive breast implants.

Clearly, there is something wrong with the picture.

Additional Resources:

“Absolutely Safe” DVD: Alive Mind Media

Breast Implant Information.org: Project of the National Research Center for Women and Families provides the ”most recent research and analysis”

Breast Cancer Action: Articles on Breast Implants

New Attitude: Breast Prosthesis alternatives to Implants

Add a Comment17 Comments

Please see the information at www.thenakedtruthaboutbreastimplants.com including the foreword by Dr. Douglas Shanklin, a prominent silicone researcher, about the problems with breast implants. We actually do know where the silicone goes (animal studies) and much more about how to help women regain their health. If surgeons do not remove the entire capsule (and few know how to do this in every case), treat with antifungals around the time of surgery, address the immune, endocrine, and neurological issues, treat the ADH deficiency that can cause intraoperative bleeding, and treat the chemical, silicone, and biotoxicity (from mold) issues with detoxification, recover is very slow or nonexistant. See the peer reviewed article partially paid for by the FDA on the FDA website that shows that women with ruptured silicone implants are likely to have fibromyalgia (and make sure you go to doctors who understand why this is and how to treat it).

June 13, 2013 - 5:14am
EmpowHER Guest
Anonymous

Anytime you are altering your body there can be risks involved. A good plastic surgeon should explain the pros and cons of any procedure with you before you undergo the knife. You should also be given all possible options. Orange County breast augmentation surgeon Dr. Michael Jazayeri is just one of many doctors who makes sure that all of his female patients understand their options and any risks associated with their surgeries. As with any serious decision in life the most important thing to remember is if the risks outweigh the benefits and which mean more to you.

February 15, 2010 - 2:12pm
EmpowHER Guest
Anonymous

"Even if the stories of these women are 1 in 100 or even 1 in 500 cases"

Well, it's been exhaustively demonstrated that this is not the case in studies including many hundreds of thousands of women. This has been confirmed around the world. There is not and never has been any connection to systemic disease demonstrated in the literature.

July 12, 2009 - 7:24am
EmpowHER Guest
Anonymous

Even if the stories of these women are 1 in 100 or even 1 in 500 cases, I agree with the last poster that we shouldn't play Russian roulette with our bodies. Even if breast implants are "relatively safe," why take the chance on a medical procedure that is absolutely unnecessary? As a 121 lb 22 year old with a C cup, even I feel the pressures of our media to alter my body, and this is completely uncalled for. Nowadays, plastic surgery advertisements have made their way to my local newspapers and radio--and I live in rural Ohio.
In truth, women are never going to be satisfied with their bodies as long as they keep feeding us the lie that we shouldn't be.
---shala

July 12, 2009 - 7:19am
EmpowHER Guest
Anonymous

Take it from someone who has been through 16 years of severe illness. I was implanted in 1984 at 24 years of age to fit with what society pounded into me about appearance. In 10 years both implants ruptured and oozed continuously from my breasts. There is not enough time nor do I have the strength at 49 years of age ( how sad is that) to list my health issues. If this is "absolutely safe" well there is no exuse for those who will not listen to those who were not told thr truth when we were told 25 years ago it would take a crushed chest to rupture the implants and after 10 years and no crushed chest, having a surgery that removed not only the pathetic devices called safe but also what little breast I had as well as the entire skeletal muscle in the area soaked in silicone and after 16 years of following Dow Corning deadlines (as they still make millions with scrubbing bubbles and spray and wash) the lying cowards have yet to pay a medical bill. As for absolutely safe, I will NEVER play russian roulette with my health again and I would not trust any of them. I have nothing to gain but protecting someone from the hell I have gone through they have Everything to gain financially. You decide. I would not purchase their products either.

June 19, 2009 - 7:54pm
EmpowHER Guest
Anonymous

I have seen this film and it is powerful! To say that these implants are "absolutley safe" or even to say that they are "safe" is a farce! Women are suffering - all for the sake of so-called beauty, without considering the "absolute risks" with this procedure. There are so many alternatives rather than mutilating bodies. The FDA should take an OBJECTIVE look without the influence of the companies and doctors making huge profits from implants.

June 18, 2009 - 1:58pm
EmpowHER Guest
Anonymous

When are breasts like cigarettes?

Big Tobacco said for years there was no "proof" that cigarette smoking caused cancer. They influenced scientists and legislation. Now, we all know the truth.

I know that I was sick and old before my time. I had an explantation and 6 months later I felt great. Today I am well.

Eventually, there will be enough women harmed by this mutilation that the truth will override Big Pharma's influence just as it did with Big Tobacco.

Sharon Wilson
in Texas

June 18, 2009 - 10:55am
EmpowHER Guest
Anonymous (reply to Anonymous)

has anybody here had hairloss with breast implants
I have mine taken out in 2004, because I had a mysterious eye infection....when took them out, it went away. Now I have hairloss. I'm almost bald.

Please help
Lisa L

October 3, 2010 - 4:55pm
EmpowHER Guest
Anonymous

Please don't confuse your political agenda with science. Breast implants are the most studied of any device used in medicine. There is no "medical-industrial" conspiracy hiding information from consumers, and the suggestion of it is pure paranoia. At the end of the day, there are hundreds of independent studies which have examined this issue, many of which are ongoing longitudinal populations. There continues to be consistant findings in these women of no immunologic, rheumatologic, and cancer related phenomena.

While you may object to the fact that many women choose breast augmentation for aesthetic appeal, it is 100% wrong to suggest that there is evidence that either saline or silicone implants cause any known illness.

June 18, 2009 - 7:28am
(reply to Anonymous)

You can fool some of the women, some of the time...

July 5, 2009 - 7:10pm
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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.

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