Absolutely Safe?

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http://www.empowher.com/news/herarticle/2009/06/16/are-breast-implants-absolutely-safeAre Breast Implants "Absolutely Safe?"

Written by Marcia G. Yerman on June 16, 2009 - 3:07pm

Her Writer

Marcia G. Yerman

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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. 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, lin 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, Swanson, and his wife

Colleen – who had implants – weigh in with 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. 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 Neveloff Dubler, LLB and

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