Health Committee on June 8th, 2006

[Bonnie Brown, Liberal, Oakville, ON]

Of the more than 8,000 requests, how many were turned down last year?

[Dr. Supriya Sharma]

I actually don't have the statistics, but it's a very small number. Less than 100 would have been turned down.

[Bonnie Brown, Liberal, Oakville, ON]

Considering the expert panel and its report, it seems to me that, at least in those discussions that I'm sure you monitored, there was a lot of negativity about saline implants. Certainly at the public hearing I attended I heard a lot about the negative effects of using saline. That's why the plastic surgeons want to get approval for this newer silicone.

Because of all the negative conversation about saline, is Health Canada considering removing saline from the marketplace?

[Dr. Supriya Sharma]

There are probably two separate points in that.

Most of the commentary around saline implants was in comparison to gel-filled implants for specific indications. As a result, the conversations were fairly negative. For instance, patients with very thin chest walls don't do very well with saline implants. Patients have a higher risk of contracture, for example. So it didn't really reflect the body of knowledge we have on saline implants in general.

Saline implants have been available since 1971 and they are continuously monitored, as are other class-4 medical devices. So there's a program by which we look at risk and adverse events that have been associated with it. There is a re-review. So that is continuing, and at this moment there hasn't been enough evidence to warrant the withdrawal of saline implants from the market.

[Bonnie Brown, Liberal, Oakville, ON]

Dr. Sharma, do you know how many plastic surgeons there are in Canada?

[Dr. Supriya Sharma]

I do not.

[Bonnie Brown, Liberal, Oakville, ON]

But however many there are, you're saying that in trying to select two or three for your panel, your choice was so limited that you had to pick two who already had a monetary connection to the two companies applying for the device to be approved, to be licensed.

[Dr. Supriya Sharma]

A number of plastic surgeons were approached and they declined, either because of availability or because of lack of availability for an honorarium to be provided. But we did look extensively for plastic surgeons to sit on the panel.

[Bonnie Brown, Liberal, Oakville, ON]

How many did you invite before you settled on these few?

[Dr. Supriya Sharma]

I would have to go back and look at that.

[Bonnie Brown, Liberal, Oakville, ON]

Could you get that information to us?

[Dr. Supriya Sharma]

Sure.

[Bonnie Brown, Liberal, Oakville, ON]

Thanks very much.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

We have two more questioners, and I ask that we split the time. We have five minutes left, so each can have two and a half minutes.

Mr. Dykstra is next, and then Madam Demers.

[Rick Dykstra, Conservative, St. Catharines, ON]

Thanks, Mr. Chair. I'll be specific. I have a couple of questions and I'll try to get to them as quickly as possible.

One is on the process, and I'm not sure who to direct this to. If a leak is found in a woman's breast, what is the process to deal with it? How does it work through? The indication is that there are extensive wait times that are damaging to the health of women. What specific guidelines do we use to deal with it, from either an Ontario perspective or, better yet, from a federal perspective? Are there guidelines?

[Dr. Supriya Sharma]

I can just speak to the special access program if we're talking about gel-filled implants. If a gel-filled implant is accessed through the special access program, there's a requirement to report any adverse event associated with it to Health Canada within 72 hours. So there is a requirement to get that information on the device.

In terms of how it's dealt with at the practitional level for removal, that's actually a practice of medicine issue, so I would probably direct that to Dr. Brown.

[The Chair, Conservative, Rob Merrifield]

Dr. Brown, do you have any comments on that?

[Dr. Mitchell Brown]

The issue is to have a discussion with your patient about what you've found and lay out the options for them. There is not general consensus that even in the presence of a known leaking implant it is necessarily an indication for removal. So options are presented to women about observation; the likelihood of there really being a leak, even if it's been identified potentially on a mammogram, MRI, or ultrasound; and the options for removal and replacement. They are laid out, and then the procedure is scheduled for the patient if it's required.

I try to triage my patients as best as I can. If a woman has a very noticeable leak of an implant and it looks like it may have come out from the capsule that forms around the implant, I try to move surgery and get that woman in as quickly as possible to deal with it. It's essentially done on a case-by-case basis.

[The Chair, Conservative, Rob Merrifield]

Dr. Zuckerman.

[Dr. Diana Zuckerman]

At the FDA meeting the decision was clear that leaking implants should be removed as soon as possible, and that almost always it isn't obvious that an implant is leaking. That's why the MRIs are so important. I guess that's one difference between the Health Canada panel and the FDA panel. They felt very strongly that once it starts leaking...well, even if it's broken, it's going to start leaking and it should be removed right away.

[The Chair, Conservative, Rob Merrifield]

Thank you.

Madame Demers.

[Nicole Demers, Bloc, Laval, QC]

Thank you very much, Mr. Chairman.

Dr. Sharma, I would like to know, first of all, whether in your view Health Canada has some responsibility regarding the health and well-being of Canadians and Quebeckers in general.

Also, among the requirements in order to make a special access application for breast implants, the physician and the patient must both sign the application form. Such being the case, how is it that there is no particular space on the form for the patient's signature?

Moreover, we have seen in a news story broadcast by Radio-Canada that physicians do not advise the patient that she must sign an application to obtain breast implants. How do you explain this?

[Dr. Supriya Sharma]

To the first part of the question, I'll speak specifically to the mandate of the health products and food branch and how it relates to health products.

We absolutely have a mandate. Our mandate is to maximize the safety of the products we regulate while minimizing those risks. That contributes to the health and safety of Canadians, so that is absolutely our raison d'être.

On the signing, the requirement is that the practitioner, the requester, sign the form. It's a declaration that the practitioner has actually discussed the risks and benefits of the device with the patient, but there is no requirement for the patient to sign the actual form.

[Nicole Demers, Bloc, Laval, QC]

Yes, but there is a requirement that the patient must sign the application form. I am sorry, Ms. Sharma, but it says so in the documents issued by the Department of Health, more particularly in the special access program's guidelines. In the case of breast implants, both the patient and the physician must sign the form. It is on page 3 of your own document. These are the guidelines for the industry.

[Dr. Supriya Sharma]

I'm actually referring to the regulations that govern the special access program for medical devices. In section 22 of the Medical Devices Regulations, it stipulates only that the practitioner sign a declaration that says he or she has discussed the risks and benefits to the patient. I can take a look at the document you're referring to, but that's not in the regulations.