| Ilena Rose 2006-10-20, 9:30 pm |
| Attention Health And Medical Editors:
http://www.newswire.ca/en/releases/...html?view=print
Statement of Dr. Diana Zuckerman, President, National Research Center
for for General Use
WASHINGTON, Oct. 20 /CNW/ -- 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."
The National Research Center for Women & Families is a nonprofit
research and education organization that focuses on health and safety
issues. Dr. Zuckerman is an epidemiologist and former Congressional
investigator, and can be reached at dz @ center4research.org.
www.BreastImplantInfo.org
CONTACT: Dr. Diana Zuckerman of The National Research Center for
Women &
Families, +1-202-223-4000, cell: +1-202-316-0230.
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