Health Committee on June 8th, 2006

[Penny Priddy, NDP, Surrey North, BC]

Thanks. That's helpful.

Do I have some more time?

[The Chair, Conservative, Rob Merrifield]

For a short one.

[Penny Priddy, NDP, Surrey North, BC]

All right.

I have a point about the expert panel. Maybe it's just a comment, but I will waste my time on the comment.

Three people were listed as patient experts and they were all nurses. Do I assume that they were also patients who had breast implants? Was there a real patient as a patient expert on the panel? When somebody said “patient expert”, I expected that they had been a patient of that particular procedure.

[Dr. Paula Chidwick]

Nobody on the panel openly discussed their medical status. The people who I--

[Penny Priddy, NDP, Surrey North, BC]

The people who were listed as patient experts were actually nurses with additional training who worked with patients.

[Dr. Paula Chidwick]

They were people who worked with patients. Whether they had personal experience as a patient was not discussed at the panel.

[Penny Priddy, NDP, Surrey North, BC]

So there may very well not have been a patient as part of this patient-centred study.

Thank you.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Ms. Davidson, you have five minutes.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

I wanted to ask Dr. Brown a question.

In order to obtain the silicone gel-filled breast implants, physicians are required to seek authorization through special access. Special access is defined as “access to a medical device for emergency use, or if conventional therapies have failed, are unavailable, or are unsuitable”.

With respect to the silicone gel breast implants, could you explain the meaning of “emergency use” and “conventional therapies”? Further, do you apply for special access for breast implants? Could you provide the committee with some estimate of how often your special access requests are for replacement of a failed implant, for reconstruction, or for cosmetic augmentation?

[Dr. Mitchell Brown]

Thank you.

Yes, through the special access program, I do apply for silicone gel-filled breast implants. I would estimate that approximately 40% to 50% are for reconstructive breast surgery for women who have undergone mastectomies or lumpectomies, and that the remaining 50% to 60% are divided between women undergoing implant replacement, who have likely had silicone gel breast implants in the past, and women undergoing primary breast augmentation with specific indications, such as an abnormal tuberous shape to the breast where defined devices that are presently available—i.e., saline breast implants—would likely cause significant problems and elevate the re-operation rate in those particular patients.

Examples would be patients who have very minimal tissue in certain areas, such as in a tuberous breast patient or in a patient who has undergone mastectomy, where there is little tissue to cover an implant in a certain area or where a salient implant would be extremely palpable, and so unnatural to the feel and look. Those are circumstances where conventional devices that are presently available would not be suitable.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Thank you.

In your experience, how long are these implants lasting? When you see your patients, how long is it before some of them are experiencing a problem, and what seems to be the percentage of people who do experience that problem?

[Dr. Mitchell Brown]

We've just finished looking at our data in the first five years since I started using these devices in 2001. Of course, I would like and hope to have longer data as the years go by.

At the present time, my re-operation rate for any indication—which would be for any patient, whether for reconstruction because a patient had changes to the breast because of breast feeding or for replacement on an implant—is 5.7% over the period of the study, and that could be for a variety of reasons. It could be for mal-positioning, such as turning or changing in the position of the implant. It could be for asymmetry, which is a common potential problem, especially when you're reconstructing a single breast and trying to match it to a natural breast on the opposite side. It could be for issues related to scar tissue or contracture around the implant.

I have not identified a ruptured gel implant that I've used in my practice. There may be some I have not identified, which would only be identified through longer follow-up or MRIs of every single patient, but I have not seen a ruptured device yet.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Thank you.

Do I still have some time?

[The Chair, Conservative, Rob Merrifield]

You can have a very short one, if you want.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Okay, very quickly, I'd like to please ask Dr. Zuckerman about testicular implants made of similar substances, which are also on the market. Could you comment on those from the FDA? How do they assess the clinical data regarding their safety?

[Dr. Diana Zuckerman]

Much less is known about them, but I believe that the testicular one is a harder silicone. I don't believe it's gel, but if it were, the amount of gel would be much less.

One of the problems with breast implants is that there is so much silicone. If it breaks and leaks, there is an enormous amount of silicone that can get into the body, whereas if you have a very small implant, like a testicular one, even if it were gel and did break, the amount of silicone the body would be exposed to is much less. Therefore the chances for problems would be fewer.

Also, the number of men who get testicular implants is very small compared to the number of women who get breast implants, so we know much less about them. When you have millions of women getting a product in the United States, you see a lot more problems. Even if the proportion is the same, it's easier to keep track.

Also, for women with breast implants, it's taken 40 or 30 years to start talking openly about it. I don't think men with testicular implants are speaking very openly about it yet.

[The Chair, Conservative, Rob Merrifield]

Thank you. This is getting to be a very sensitive area.

Ruby Dhalla. You have five minutes.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

Thank you very much.

Thank you to all of the people who have taken the time to come today. It's an extremely important issue to a number of my constituents in Brampton—Springdale, along with many of the colleagues around this table, and to women in general across this country.

There a couple of concerns I have on how Canada could best address them. They took a look at establishing a panel to consider scientific, medical, and clinical evidence, and put the panel together. Perhaps answering with a yes or no, in light of the time, were the individuals appointed to this panel required to declare a conflict of interest?

[Neil Yeates]

They were required to identify any conflict of interest, yes.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

Thank you.

I find it quite alarming, then, in light of the fact that we know that they were required to declare a conflict of interest, that three of the nine members did identify a conflict of interest, and a couple of the individuals actually acted as paid advisers to companies that actually produce these medial devices. Why was no action taken by Health Canada to ensure that this panel would provide objective and unbiased advice?

[Neil Yeates]

We felt that it was very important that we have access to people who are involved in the field. So some of these interests and affiliations are unavoidable if we're going to get people who have real-world experience. We feel that we need that. The expert panel report actually was delivered with a very high degree of consensus and represented a very wide spectrum of views. So given the nature of what we were dealing with here, we think it was very important to have people who had that real-world experience.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

With all due respect, though, when we look at the number of plastic surgeons that exist in this country and in the U.S., if we had to go there, which I wouldn't imagine we would, could Health Canada not go beyond the individuals they had on that panel to find other individuals who did not have a conflict of interest?

You can imagine that for colleagues around this table, it's very difficult for us to have recommendations put forward by an advisory panel that had a declared conflict of interest, which Health Canada did nothing to address. When individuals are paid by a company that has been producing those silicone implants, many women around this country are going to question the validity of the recommendations they put forward.

[Neil Yeates]

We felt that these people who served on the panel served the panel well. They had affiliations, but we didn't feel that they had a conflict of interest. To some extent this is unavoidable, given the nature of what we're dealing with. We feel that the experience of experts such as Dr. Brown, who is also presenting today, is very important, and we need to hear from them about what is used here in Canada. I think we need to know that.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

With all due respect to Dr. Brown and the great work he's done for women, I'm sure there are many other plastic surgeons around this country who did not have that conflict of interest. Were any efforts made by Health Canada to look to individuals who perhaps didn't have a conflict of interest? If so, what types of efforts were made by Health Canada?

[Neil Yeates]

I'll ask Dr. Sharma to speak a little further about what went into the selection of panel members.