Statement of Dr. Diana Zuckerman on Health Canada's Approval of Silicone Breast Implants for General Use

http://www.drugnewswire.com/7711/

Statement of Dr. Diana Zuckerman, President, National Research Center
for Women & Families on Health Canada's Approval of Silicone Breast
Implants for General Use

October 25, 2006 - 2:53 PM



WASHINGTON, Oct. 20 /PRNewswire/ -- After more than a dozen years of
limiting access to silicone gel breast implants, Health Canada today
announced that it was granting licenses to two companies, Mentor and
Inamed, to sell these products for breast augmentation or
reconstruction. The following is the statement of Dr. Diana Zuckerman
of the National Research Center for Women & Families:


"This shocking and unfortunate decision will jeopardize women's health
for many years to come. In addition to the impact on individual women,
this ill- advised decision will create a financial strain on the
Canadian health care system. A Canadian study by Aleina Tweed and her
colleagues in British Columbia indicated that augmentation patients
are hospitalized more often and for longer periods of time than other
Canadian women of the same age. Will Health Canada pay for regular
MRIs to determine if women's silicone gel breast implants are leaking?
Will Health Canada pay for immediate removal of breast implants for
women whose implants are leaking silicone into their bodies? If they
don't, they are turning their backs on women whose health could be
irreparably harmed by today's decision. If they do, it will cost
Health Canada many millions of dollars that could otherwise be spent
to fight deadly diseases.


"Last week, very serious new allegations were made by a chemist who
worked at one of the companies, Mentor Corporation. Health Canada
appears to be indifferent to these and other allegations by Mentor
scientists who have come forward to explain how the company provided
inaccurate safety information about their breast implants. Although
Dr. Sharma stated during today's press conference that Health Canada
was aware of the allegations, it seems that she was referring to
allegations made last year, not the ones made last week."


Dr. Sharma stated during the press conference that Health Canada "can
and will revoke the licenses if the required conditions are not met"
or if other information comes to light about safety concerns. Dr.
Zuckerman has contacted Health Canada to urge them to immediately look
into the allegations questioning the integrity of Mentor's safety
data. Meanwhile, the FDA is being urged by several organizations and
individuals to investigate these allegations before making a decision
in the U.S.


The licenses are contingent on five conditions, most of which require
additional research. Since the companies have not conducted
well-designed long-term studies in the more than 40 years that breast
implants have been on the market, Zuckerman believes that "it is naive
of Health Canada to think that this research will be appropriately
conducted and completed after granting a green light to the
companies."


"It is especially shocking that Health Canada is granting licenses
prior to meeting the conditions of approval regarding the use of focus
groups to test labels that ensure informed consent for patients.
Moreover, they do not even require a registry, as was recommended by
their advisory committee. We would consider a registry a minimum
safeguard."

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www.BreastImplantInfo.org
Dr. Zuckerman's site

www.BreastImplantAwareness.org

http://www.humanticsfoundation.com/2...adianStudy.htm