Canadian FDA Declares Key Implant Ingredients Toxic and May Take Silicone Implants Off the Market

Health Canada may soon declare key silicone gel implant ingredients toxic and take silicone gel-filled implants off the market. Please read this article from The Ottawa Citizen:


Friday, May 16 , 2008

Silicone gel implants may lose approval
Key chemicals could be declared toxic
By Sarah Schmidt
The Ottawa Citizen

Wednesday, May 14, 2008

Health Canada may have to reverse its controversial 2006 decision to allow women to get silicone gel-filled breast implants if it proceeds with a plan to declare key chemicals found in them to be toxic, experts say.

Health Canada is expected to announce Friday its plans for synthetic chemicals found in silicone fluids as part of a risk assessment of 200 chemical substances, identified as top priorities for action because they are potentially harmful to human health or the environment.

It has already written to industry, explaining that "in the absence of additional relevant information," the government is "predisposed to conclude, based on a screening assessment, that this substance satisfies the definition of toxic (under the) Canadian Environmental Protection Act."

A toxic declaration about the Cyclohexasiloxane family, also known as D4, D5, D6, would start a process that could lead to a ban in certain products, as with bisphenol A in baby bottles.

"The different departments at Health Canada have been a bit of a dysfunctional family that don't listen to one another. If the environmental assessment decides this should be toxic, there should be a duty of the medical devices branches to study whether it should be taken off the market," said Dr. Kapil Khatter, scientific adviser for Environmental Defence.

Silicone implants were pulled from the market in 1992 amid concerns they were unsafe for women. Fourteen years later, Health Canada changed course and made them freely available to women with the caveat that "no medical device is 100 per cent safe."

Health Canada said it reviewed more than 65,000 pages of evidence submitted by manufacturers and more than 2,500 scientific articles in reaching its decision to grant licences to two companies to market silicone implants.

Until then, only breast implants filled with saline were licensed for sale in Canada.

The October 2006 decision came just months after Health Canada's scientific advisory committee said questions "had not been sufficiently addressed" about potential health risks if the gels leaked into women's bodies and about whether the implants increased the risk of auto-immune diseases in the long term.

In May 2007, as part of its chemicals management plan, Health Canada asked industry to prove D4, D5 and D6 were safe. The chemicals also were found in cosmetics and other personal care products.

Health Canada flagged D4 as a priority because the European Commission has listed it as a reproductive toxin. D5 and D6 were prioritized because of environmental concerns.

Dr. Kapil said he was hopeful a toxic designation would result in better departmental co-ordination at Health Canada.

"This will create that conversation," he said. "Through this program, there will be something overarching that will push the Health Canada departments that regulate cosmetics and medical devices to look at toxic substances in their area."

Health Canada also will announce Friday its decision about vinyl acetate, commonly used as a base in chewing gum.

© The Ottawa Citizen 2008

New York Times Features Absolutely Safe

Amaranth Productions is pleased to announce that
ABSOLUTELY SAFE is featured in this Thursday's edition of
The New York Times. In the article, "Do My Breast Implants Have
a Warranty", the hidden cost of breast implant failure is exposed.
Natasha Singer writes: "A new debate is emerging over whether breast implants constitute the kind of annuity medicine that will entail regular surgical tuneups, exposing patients to increased medical risk and out-of-pocket expenses. At a time when manufacturers have provided the F.D.A. with clinical studies that follow patients for just a few years, there is no established medical consensus on how long implants last, leaving doctors to rely on their anecdotal experiences when discussing durability with patients."

Filmmaker Carol Ciancutti-Leyva is Quoted:

"Your implants may last less than 10 years or more than 10 years, but when you start having problems with them, your health insurance is unlikely to cover the M.R.I. tests or the reoperations," said Carol Ciancutti-Leyva, the director of a 2007 documentary called "Absolutely Safe." "It can be a very expensive proposition, especially if you are young."

http://www.nytimes.com/2008/01/17/fashion/17SKIN.html

Dallas, Texas: Standing Room Only!

Over the past few months, Absolutely Safe has been on a screening tour around the country. Director Carol Ciancutti-Leyva was invited to the University of Buffalo, the University of Pittsburgh, the University of Connecticut, the University of Texas, Dallas, and Dallas Women in Film to speak about and screen Absolutely Safe.

All of the screenings have sparked interesting discussions and questions, illustrating that most people do not know that breast implants are a controversial product that carry health risks--risks that even the FDA and implant manufacturers acknowledge.

In Dallas, two characters from Absolutely Safe participated in panel discussions at the Dallas Women in Film screening and the University of Texas, Dallas screening—Wendi Myers and Dr. Edward Melmed. Wendi explained her experiences and health problems with implants and her decision to have an “explant.” Her doctor, Dr. Melmed, explained his experiences with implant complications and why he no longer puts implants into women’s bodies. Dr. Melmed now only takes implants out of women’s bodies.

At the University of Texas, Dallas, there was standing room only in the theater. Students, both young men and women, filled the space and peppered the panelists with one question after another. Professor Erin Smith, Associate Director of the Gender Studies Program summarized the event:

“Our screening and panel discussion of ABSOLUTELY SAFE was the best attended gender-related programming we’ve had in the history of the University of Texas at Dallas. Our students loved this program. ABSOLUTELY SAFE explained the science behind the controversy over the safety of breast implants, but put a human face on all those statistics and research. The white-coated doctors and scientists in the film made their points, but students also went along on the journeys of two women—one getting breast implants and one getting her ruptured implants removed. This film engaged our students, who had over an hour of questions and comments after the screening. They left the program (in their own words) “enlightened,” “angry,” “disgusted,” “appalled,” and--above all—wanting to talk some more about women’s health, ideals of beauty, and the health risks of implants. And they did—to their roommates, their girlfriends, their mothers, and their friends, among others. This is just an amazing, powerful film for engaging students with issues of gender, power, and health policy. “

--Erin Smith
Associate Director, Gender Studies Program, University of Texas, Dallas

Elective Mastectomy: The New York Times Glosses Over Implant Risk

Recently, the New York Times did a feature article about young, healthy women who have a genetic risk of breast cancer and choose to have radical mastectomy as preventative medicine. It was a disturbing article for many reasons. However, what was most disturbing to us is that the article did not even mention the risks that come with reconstructive surgery and breast implants—both the known and unknown risks. The article also did not emphasize the point that the vast majority of breast cancer patients do not have the BRCA gene and that many women with the BRCA gene are cancer free.

Here is a link to the article “Cancer Free at 33, But Weighing a Mastectomy”
http://www.nytimes.com/2007/09/16/health/16gene.html

Carol Ciancutti-Leyva, director of Absolutely Safe wrote a terrific letter to the Editor of the New York Times. Here is the letter:


To the Editor:

Re: Cancer Free, but Weighing a Mastectomy (front page, September 16th)

I am a documentary filmmaker based in New York City. For several years, I have worked on a film about the controversy over the safety of breast implants. I was inspired to make this film after my mother had many complications from silicone breast implants. Her doctors advised her to have both breasts removed due to the frequent recurrence of breast tumors. She was told this would help prevent her chances of developing breast cancer. Within a year, one implant had ruptured. She had the implant replaced and soon after she experienced another rupture. Years of sickness followed her ruptured implants.

The article, Cancer Free, but Weighing a Mastectomy, neglected to discuss or even mention any of the possible complications associated with breast implants. Even though the FDA approved silicone implants in November 2006, the FDA acknowledges that breast implants (silicone and saline) carry known and unknown risks (www.fda.gov/cdrh/breastimplants). Both the FDA and implant manufactures agree that breast implants do not last a lifetime and will likely require removal or additional surgeries.

For the mastectomy patients discussed in the article, the notion of “risk” is the most alarming. Getting rid of one’s breasts and reconstructing new breasts with implants does not necessarily get rid of risk. These healthy women should know that they may be trading one set of potential risks—genetic--for another. In their latest advertising campaign for the “Natrelle” collection of breast implants, implant manufacturer Allergan, Inc. states that “the health consequences of ruptured silicone gel-filled breast implants have not been established.”

As women analyze their DNA and agonize over mastectomy to avoid a potential risk of cancer, they also need to read the fine print about saline and silicone breast implants. Like the BRCA gene, breast implants carry serious, potential risk. A “previvor” may outwit her family history, but unfortunately, she may not have the same luck with her implants.

Sincerely,

Carol Ciancutti-Leyva