Evidence of meeting #9 for Health in the 39th Parliament, 1st session. (The original version is on Parliament’s site, as are the minutes.) The winning word was silicone.
Liberal
Ruby Dhalla Liberal Brampton—Springdale, ON
Perhaps Madame Demers can accept what I had originally stated in regard to a friendly amendment. It would just basically read as follows:
We are asking the Minister of Health to tighten the conditions for the special access program by allowing surgeons to obtain silicone gel implants for purposes other than breast augmentation.
Conservative
The Chair Conservative Rob Merrifield
We have a motion, a friendly one. We've got a motion that's acceptable as amended.
Conservative
The Chair Conservative Rob Merrifield
All right, we understand what we're doing. Let us have debate on that motion.
Mr. Fletcher.
Conservative
Steven Fletcher Conservative Charleswood—St. James—Assiniboia, MB
Mr. Chair, I think it's really important that this committee focus on the science. They're either safe or they're not. If they're safe, this committee shouldn't be making moral judgments on what is appropriate or inappropriate.
I would like to say some things for the record. Silicone-gel-filled breast implants were voluntarily withdrawn from the Canadian market in January 1992 to allow Health Canada time to review new evidence of the safety and effectiveness of these implants.
The moratorium was lifted in January 1993, when manufacturers were informed that they would need to reapply for market authorizations and provide additional clinical evidence of the safety and effectiveness.
Health Canada is nearing the end of an extensive, thorough, and lengthy review of several licence applications for silicone gel breast implants. The results of this review will have an impact on the need for special access authorizations of these medical devices.
The requirements of the medical devices special access program are clearly stated in part 2 of the medical device regulations. During the review of special access authorization requests, Health Canada reviews the risks and benefits as determined by health care professionals for individual patients.
Health Canada cannot legally refuse a licence or special access authorization to a medical device that meets the regulatory requirements set out for its sale and importation in the Food and Drugs Act and in the medical device regulations. If a silicone-gel-filled breast implant is safe and effective for use in a cancer survivor, it is equally safe and effective for the same indicators in a person seeking augmentation or replacement of an existing device.
In summary, it is not Health Canada's role to determine the appropriateness of specific treatment for specific patients; these decisions are made by the treating physicians in consultation with their patients.
If we can make an amendment that would agree with that principle--that it's a relationship between the patient and the physician--I think we could support it, but it's not the role of this committee to go beyond that.
Conservative
The Chair Conservative Rob Merrifield
Okay.
Is there any other discussion on the motion?
Mr. Batters.
Conservative
Dave Batters Conservative Palliser, SK
Well, Mr. Chair, I agree with everything that Mr. Fletcher has just said, which really runs contrary to the entire spirit of this motion. I don't know if this is amendable so I could support it. I'm not going to support the motion, but I want to explain to Ms. Demers and this committee why not.
Just very simply, I agree with the parliamentary secretary. It needs to be determined whether or not these implants are safe or unsafe, rather than getting into the validity of who should qualify and for what reasons, whether they be for reconstructive surgery or for augmentation.
Madam Demers, I see from your body language that you don't agree with me—but I think their safety is the key, and that needs to be determined. Perhaps you agree with this point, that we need a decision from the department, yes or no. Granted, you're saying that in the meantime, before that decision is made, and along the lines of Ms. Dhalla's comments, that it be approvable other than for augmentation.
I guess what I'm pushing for here is: let's have a decision, and get away from this special access program altogether. Let's have a decision: they're safe or they're not safe. That's why I'm not going to support it, but I wanted you to know why.
Conservative
Bloc
Nicole Demers Bloc Laval, QC
Yes, Mr. Chairman. I don't know where the parliamentary secretary comes up with his figures get his ideas. I have a document that I received from Health Canada advising me that the sale of silicone gel breast implants is currently outlawed in Canada and that there is no experimental testing under way in Canada involving this type of breast implants.
It's incorrect to state that the moratorium was lifted in 1993. In 1996 and 1997, silicone gel breast implants were no longer available through the Special Access Program for Medical Devices because the United States had deemed them to be too great a health risk and had banned their use, even for breast reconstructions. Despite this ban, a total of 24,000 requests were approved and requests from women continue to be approved, although they are not given any information and made aware of the risks. They are only informed after the fact, once they are ill and experiencing problems. A program initially developed to help people maintain their health should not normally be used for this purpose. This has to stop.
Conservative
The Chair Conservative Rob Merrifield
Okay.
So we have the amended motion; it is a friendly amendment.
Do we have the exact wording, Ms. Dhalla?
Liberal
Ruby Dhalla Liberal Brampton—Springdale, ON
Yes, I just gave it to you. Do you want me to just read it out?
Conservative
The Chair Conservative Rob Merrifield
Yes, read that out, so everybody knows what we're voting on. We've seen it as a friendly amendment.
Liberal
Ruby Dhalla Liberal Brampton—Springdale, ON
The friendly amendment would read as follows:
We are asking the Minister of Health to tighten the conditions for the special access program by allowing surgeons to obtain silicone gel implants only for the purposes other than breast augmentations that are medically necessary.
(Motion agreed to)
