Silicone Gel Implants May Lose Approval in Canada
Hi Everyone, This is such great news! I’m really hoping that the FDA will start to take notice and feel pressure from our neighbor to the North. It does not shock me that Canada is more advanced on the issue of implants and toxicity, as the government provides health coverage to all and the increased expense of taking care of women with problems can get costly. Here in the U.S. when a woman gets sick, the individual is the one that takes on the burden of meeting co-pays, deductibles, and paying for a percentage of the bill and the insurance company picks up the rest of the costs. I wonder if our government would think differently about approving breast implants, if they would be the ones responsible for the medical bills that might come as a result? ~Kacey
http://www.canada.com/ottawacitizen/news/story.html?id=e8e8a978-f360-47f2-98bf-35b8ff6a42f4
Silicone gel implants may lose approval
Key chemicals could be declared toxic
Sarah Schmidt
The Ottawa CitizenWednesday, 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.
Wow…I can’t wait to hear what the outcome of this is. If Canada does pull silicones off the market again, I wonder what the US will do? Doesn’t that kinda mean that the US HAS to take a look at them again? What if they do get pulled off the market again in the US, what is the FDA going to say to all of those girls who have been getting silicones (because they were FDA approved, so that makes them safe right?) for the last two years? “Oops?”
Comment by Krista — May 15, 2008 @ 8:08 pm
Silicone is in so many things it is frightening. One of the main reasons I believe that we may never get silicone breast implants off the market is because then it will mean that the FDA has to admit that silicone may be dangerous, period. Think of all the products they would have to pull (bottles, toys, cookware, etc.)! I think this is so big that it’s easier for the FDA to ignore or deny than admit their mistake and right a wrong.
Comment by Kacey — May 16, 2008 @ 2:32 pm
Did you know that the deodorants most people apply daily exposes you to more silicone than you could ever get from a gel implant?
Comment by JJ — May 23, 2008 @ 7:32 am
I have noticed that silicone in various forms exist in many products we use. I am worried about this since I have obvious sensitivities to the chemical that cause me many hardships. I try to avoid silicone products as much as possible, and have tried alternative deoderants periodically in the past. Althought I agree that silicone exists in many products, I would disagree that the exposure in these products comes as close to the degree of exposure you get when you implant silicone into your body. Skin contact is one thing (and I would agree should try to be avoided), but going under the skin and leaving the product there for years is something totally different.
Comment by Kacey — May 23, 2008 @ 11:45 am
JJ, I’m guessing you’re talking about intact implants. But implants can burst, and then silicone oozes into your body, which you can’t wash off. Also, a silicone breast left on a counter emits a greasy layer after just a few hours. Once in the body, how do you know what that greasy layer is doing inside you?
Comment by Gloria — May 23, 2008 @ 5:25 pm
JJ- If you look on the FDA website http://www.fda.gov/cdrh/breastimplants/handbook2004/localcomplications.html you will see right there on their site that when an implant ruptures, it is VERY difficult and in some cases impossible to get all of the lumps of silicone out of the body. The silicone in breast implants is a totally different consistency then what is in deodorant. In addition to that, with deodorant you only put it on the outside of your body, with implants, they are actually implanted in your body and stay there for many many years. Who really knows if you are exposed to more silicone in deodorants then an intact implant. What we REALLY need to think about is….what happens when the silicone implant ruptures or degrades with time? The implant manufacturers are making if seem like their new and improved silicone implants won’t rupture, but the truth is…we don’t know. Studies are currently being done, thousands of women are the lab rats, and we won’t know for many many years what the impact of these new and improved silicone implants have on the body. If implants were “perfectly safe?” then why is Canada taking them off the market again? Why the controversy? Why are women ill and explanting?
Comment by Krista — May 25, 2008 @ 8:54 am
WoW. While I am thrilled to see that the Canadian Government is taking seriously the many concerns regarding various synthetic chemicals … silicones included.
This statement, however, sounds like it comes straight from the doublespeak of George Orwell’s “Ministry of Truth” in 1984.
EXCERPT: “The government concludes these synthetic chemicals do not pose a risk to human health, but rather should be declared toxic to the environment.”
What ? ? ?
Dr. Zuckerman’s words are true and clear:
EXCERPT: “A more accurate assessment would have been to say that the health hazards are unknown for individual use of products with D4, because they have not been adequately studied. I would think that women of childbearing age would be especially concerned about having breast implants because of possible infertility problems that could
result from D4.”
I’m still astounded the Canadian Government can claim no possible risk to human life, when this science mentioned below is unfolding:
EXCERPT: “The government’s newly released risk assessment of D4, found in silicone breast implants, states the synthetic chemical impairs fertility. It also flags a finding of the Danish Environmental Protection Agency, identifying the liver as a “target organ for D4 exposures.”
Please help us keep the pressure on Health Canada … it’s time for
them … and the FDA … to stop caving into the demands of the
medical device makers. Full article here:
http://www.canada.com/topics/news/national/story.html?id=b0eeb176-6b3d-4a3e-bb18-29033eb044cc
Comment by Ilena Rose — May 25, 2008 @ 12:11 pm