EXCELLENT NEWS: Silicone gel implants may lose approval in Canada!
Ilena Rose
First good news I've heard in the breast implant world for years!
www.BreastImplantAwareness.org/
http://breastimplantawareness.blogspot.com
Wednesday » May 14 » 2008
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 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.