Breast Cancer Action Montreal (BCAM) ... Reasonable and safe alternatives exist

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Reasonable and safe alternatives exist

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 year 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 concerned about the conflict of interest

that characterizes research supporting 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.

Name: Shea ; Member - Breast Cancer Action Montreal

Mandate: Breast Cancer Action Montreal (BCAM) is a non-profit

organization dedicated to raising awareness about the issues

surrounding breast cancer.

Relationship, Interest or Affiliation: none