BCAM's Statement to Health Canada on Silicone Breast Implants
Breast Cancer Action Montreal (BCAM) is a non-profit organization
dedicated to raising awareness about the issues surrounding breast
cancer. Our organization has a corporate donations policy that refuses
donations from entities that might present a conflict of interest. We
have no conflicts of interest regarding these public hearings.
BCAM is very concerned about both the lack of long-term safety data and
the high rate of local complications. Silicone breast implants have been
on the market since the 1960s despite the absence of credible long-term
safety data. We would hope that scientists and regulatory bodies have
learned something from the scandal surrounding hormone replacement
therapy. We need to make sure this kind of error is not repeated with
breast implants. Since reasonable and safe alternatives exist, there is
no need to approve these devices until rigorous safety standards have
been met. This is not an unreasonable request. The heart valve
manufacturer, CarboMedics, was asked to provide 14 years of follow-up
data before receiving approval from the FDA, and CarboMedics complied.
Why should silicone breast implants for women meet different safety
standards? Women are counting on Health Canada to protect them. The
establishment of a national breast implant registry to monitor implant
procedures would further scientific research by tracking long-term data.
We continue to be concerned about implants that interfere with
mammography reading (even when special procedures are used) as well as
about higher risks of complications and repeat surgeries for women
subject to breast-conserving surgery with implants for early breast
cancer, rather than mastectomy with reconstruction. We are also very
concerned about the conflict of interest that characterizes research
that supports implant safety. We would point out that independently
funded studies tend to focus on women who have had implants for longer
periods of time, and often show increased risks that are not apparent in
industry-funded studies.
On the basis of these facts, Breast Cancer Action Montreal recommends
that silicone breast implants not be approved at this time.
September 27, 2005