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Marcia G. Yerman

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Are Breast Implants "Absolutely Safe?"

Posted: 06/19/09 06:12 PM ET

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?"

Denee 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 speak 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."

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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"

New Attitude:
Breast Prosthesis alternatives to implants


This article originally appeared at Empowher


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