Here is an update from Carol Ciancutti-Leyva, Author of the documentary “Absolutely Safe.” This was published in Alive Mind Woman on September 18, 2008.

In 1995, I went to Washington, DC to film a rally on the Washington mall. Women and their families and friends from all over the country had convened to protest the lack of safety information the government was requiring manufacturers of breast implants to provide. I walked around in the crowd and interviewed woman after woman who told me the same basic story about their failed implants. Maybe slightly different symptoms, some had implants ruptured, some had great pain but virtually all of them believed they were sick from their implants and all believed the device had failed them. This crowd was asking the government to force breast implant manufacturers do to more and better research. This is the first step I took in making my film, ABSOLUTELY SAFE.

Fast forward 13 years and what has changed. Not much EXCEPT both saline and silicone implants were approved by the FDA based on two to three years of safety data. The FDA approval was given despite the fact that long term safety is an important concern for women getting implants. Breast augmentation is more popular than ever. According to the American Society of Plastic Surgeons breast augmentation was the #1 most performed surgical procedure in the US in 2007. They also state that “despite domestic concerns like inflation and the home lending crisis, average American continue to spend money on plastic surgery.” ASPS state there was a 7% increase in procedures from 2006 to 2007.

For breast cancer patients who are recommended to have mastectomies, the recommended reconstruction of the breast is with silicone implants. Also, now women with the breast cancer gene are recommended to have radical mastectomies and have silicone implants put in.

I started my film, ABSOLUTELY SAFE, many years ago to give voice to the women who believed their health had been harmed by breast implants. My Mother was (and is) one of them. The question remains has the public or the medical community truly heard these voices? Have other women contemplating this surgery heard these voices? Are women getting Informed Consent? Do they still want implants even if they understand the possible health risks and the unknowns of breast implants safety? I don’t have the definitive answers and I have never set out to prove implants harmful. I set out to give a certain group of women a voice.

Informed consent is defined as:

A medical doctrine based on the notion that every patient has a right to decide what’s going to be done to his or her body. It requires doctors to inform patients of all the risks and benefits connected with an operation or procedure. Patient must not only be informed of such risks, they must also fully understand them.”

So, do women get informed consent? Do they understand the risks of implants? After a screening of my film last year at Boston College, a young man raised his hand to make a comment. A young woman who appears in the film got saline implants and lost sensation in her nipples. This a possible risks of implants that was clearly on her surgical permission form she signed. Now did she read it, did she understand it, did she want the implants despite this possibility?

This particular young man was completely baffled why a woman would get implants if loss of nipple sensation was a possible risk. I do think though if a young man was going to have a penile implant and he was told that he may possibly lose sensation, I can say with fair certainty that he would say “No thank you! How I feel is important than anyone’s perception of how I look.” Do women feel the same way?