Evidence of meeting #8 for Health in the 39th Parliament, 1st session. (The original version is on Parliament’s site, as are the minutes.) The winning word was women.
Associate Director General, Therapeutic Product Directorate, Health Products and Food Branch, Department of Health
I'm assuming that when you're asking about a regulatory policy decision, you're talking about a decision on licensure of these products.
Associate Director General, Therapeutic Product Directorate, Health Products and Food Branch, Department of Health
We're actually in the final stages of the scientific review, and as you've mentioned, it's been going on, for some of the applications, for approximately five years. Just to put that into context, normal review times for class III and class IV medical devices are either 75 or 90 days. So this examination is definitely more extensive and much more indepth than those for other medical devices.
We are coming to the end of that process. At the end of that process, there's a recommendation. The recommendation can take one of three forms. There's a recommendation to license. In that case, the implants would be available for general sale. It can be a recommendation to license with conditions, so there may be conditions placed on that licensure. Or the decision would be to not license. I said that we're in the final stages of that, but information that prolongs the process can come up in those final stages.
Conservative
Dave Batters Conservative Palliser, SK
Absolutely.
I have one more question for Dr. Sharma.
Right now, when we talk about the special access program--again, we're talking about thousands of applications here, many of which are granted--how extensively are the decision-makers looking at these applications? To my reading, that's the minister. We're talking thousands of applications.
I can't believe--maybe it's just my personal bias--that every time Dr. Brown or one of his professional colleagues makes an application, there's a detailed study done patient by patient. Or maybe that's the case. Can you tell me what kind of process this involves, every time one of these special access program requests is granted or denied?
Associate Director General, Therapeutic Product Directorate, Health Products and Food Branch, Department of Health
Absolutely, and here is a clarification on an earlier point.
We were talking about numbers. For breast implants, in the last fiscal year it was approximately 8,000. Although the number of requests for other medical devices is smaller, as Mr. Yeates said, sometimes they come through in batches. For instance, for a drug-eluding stent that goes into your heart, we would release about 8,000, so it's comparable to breast implants.
Every application that comes in through the special access program is from an individual physician making a request for an individual patient for breast implants. Each application is looked at, screened, and analyzed against four sets of criteria that must be fulfilled before the minister--and that's delegated down to the department--can authorize that request. Every application is like that.
Conservative
Dave Batters Conservative Palliser, SK
Thank you.
Dr. Brown, is this an absolute nightmare in terms of getting patients approved? Is it a long, arduous process to get patients approved?
Plastic, Reconstructive and Cosmetic Surgeon and Associate Professor, Department of Surgery, University of Toronto
No, it's not particularly long and arduous. I try to apply for special access only when I feel that it's very appropriate and when there's a specific indication for it. In those instances, when I've essentially pre-screened the process by not applying when there's not an appropriate indication, I have generally received approval.
Conservative
Dave Batters Conservative Palliser, SK
Thank you, sir.
Dr. Zuckerman, what's the experience in the United States regarding the process for patients to get silicone gel implants?
President, National Research Centre for Women & Families
The process is somewhat similar. Silicone is supposed to be restricted to women who need reconstruction after breast cancer or need an implant replaced. However, their idea of reconstruction in the United States includes women whose breasts don't look as young as they used to because they breastfed. I was surprised to find out that this was a deformity, but apparently it is. So a very large percentage of women in the United States are getting silicone gel breast implants because their breasts look like they're 35 years old instead of looking like they're 20 years old. It's very easy for those women to get breast implants, because all they need is a doctor to say this is reconstruction. And as I said, their definition of reconstruction is not what I think the women here would probably think of as reconstruction.
It is a problem in the sense that these women are supposed to be studied. In the United States, if they get implants through special access, they're supposed to be studied over a long period of time, and they are not. They're not studied at all, actually.
Conservative
The Chair Conservative Rob Merrifield
I'm sorry, your time is gone.
Madame Barbot, you have five minutes.
Bloc
Vivian Barbot Bloc Papineau, QC
Thank you.
How can you say that Dr. Brown, who has been using these implants since 2001, does not benefit directly from the decision that will be made? In fact, these breast implants are not covered by insurance.
Associate Director General, Therapeutic Product Directorate, Health Products and Food Branch, Department of Health
What I was saying is that because saline-filled implants are licensed for sale in Canada—and they have been basically since 1971—if somebody is seeking a breast implant and there's a fee charged for that service, there's no difference in remuneration, whether it is a saline implant or a gel-filled implant.
Bloc
Vivian Barbot Bloc Papineau, QC
I would like to know whether, at the present time, any class action have been launched against Health Canada and, if so, for what reason.
Associate Director General, Therapeutic Product Directorate, Health Products and Food Branch, Department of Health
There are a number of issues before the courts. Some of them have actually been dismissed and settled. There was no money paid by the Government of Canada in the settlement of those, and those were the ones that were happening in British Columbia. I can't comment on the rest of them because they're before the courts, but we maintain that the regulatory and scientific decisions that were made with those issues were scientifically sound.
Bloc
Vivian Barbot Bloc Papineau, QC
I have a question for Dr. Brown.
What would you say about the fact that cancer survivors with implant experience have more complications and are more likely to need additional surgery to correct those problems compared to augmentation patients?
Plastic, Reconstructive and Cosmetic Surgeon and Associate Professor, Department of Surgery, University of Toronto
Thank you.
That fact is not the least bit surprising. Breast reconstructive surgery is very complex and very difficult and very challenging surgery for the plastic surgeon, whether it is with the use of an implant or whether it is with the use of tissue taken from other areas of the body. Breast augmentation surgery is generally a fairly straightforward procedure, where we're dealing with a natural and normal part of anatomy and changing its feature. If done properly, it can be done with a very low complication rate.
Reconstructive surgery is trying to reconstruct, build, or create a new breast, essentially from nothing. It is a much more difficult and complex procedure, not to mention that it's often a unilateral procedure. Many of the re-operations that are quoted in these studies are re-operations to fine-tune balancing and symmetry issues, for example, lifting or reducing an opposite breast to try to make it look more like the breast that's been reconstructed.
So that data does not surprise me in the least.
Liberal
Bonnie Brown Liberal Oakville, ON
Thanks very much.
Dr. Sharma, of the over 8,000 applications for these devices, how many Health Canada employees are reviewing those applications, and what are their qualifications?
Associate Director General, Therapeutic Product Directorate, Health Products and Food Branch, Department of Health
You're referring to the special access program.
Associate Director General, Therapeutic Product Directorate, Health Products and Food Branch, Department of Health
At any given time, there's usually two or three people who are reviewing those. The special access program for medical devices is actually led by a physician, a health care practitioner, and the people who are reviewing them are chemists and people who have expertise in materials, primarily.
Liberal
Associate Director General, Therapeutic Product Directorate, Health Products and Food Branch, Department of Health
No. They're all ultimately reviewed by the physician, because that's the person in charge of that program.
Liberal
Bonnie Brown Liberal Oakville, ON
He's in charge of those staffers. They make a recommendation to him and he has to approve or not approve--or can they say yes on their own?
Associate Director General, Therapeutic Product Directorate, Health Products and Food Branch, Department of Health
No. He has to approve or not approve, and he actually reads every single special access form.