Evidence of meeting #68 for Health in the 44th Parliament, 1st session. (The original version is on Parliament’s site, as are the minutes.) The winning word was information.
A recording is available from Parliament.
Conservative
Robert Gordon Kitchen Conservative Souris—Moose Mountain, SK
—ask you whether you would provide to the committee your thoughts on what should be included in the registry? That would be greatly appreciated.
I'm sorry, and thank you, Mr. Chair.
Liberal
Liberal
Marcus Powlowski Liberal Thunder Bay—Rainy River, ON
My understanding is that in 2019, Allergan issued a voluntary recall of its breast implants.
Maybe I have this all wrong here. I went to the Health Canada website. There is a recall policy for health products. I would have thought this policy would apply to breast implants, but correct me if I'm wrong. It requires that the responsible party, which I assume is Allergan, is expected to take action in a manner that is prompt. They are expected to have a recall procedure. They are expected to maintain distribution records that allow tracing of the devices.
To Ms. Elliott specifically, I think you said that there were 15,000 people in Quebec who had implants. A lot of them hadn't been contacted. What exactly did Allergan do? Perhaps I'm wrong in my interpretation of the medical devices regulations and our recall policy for health products, but it would seem to me that they have an obligation to be doing that. What, if anything, did they do, to your knowledge?
I know they're not here, but you can say it from your perspective?
Patient Advocate, Breast Implant Safety Alliance
My perspective is based on my experience of having a group of close to 2,500 women in Quebec. There are a few dozen who have textured devices and should have received some kind of information about the fact that their implants were recalled. Very few of those patients who received textured implants as part of a reconstruction following mastectomy received a letter from the health care centre where they had their surgery. It's very few of them.
I asked the women in my group, “If you receive a letter, please let us know. We want to know how many of you got that letter.” I think that among all those patients, there was only one who had textured implants for aesthetic reasons only—not part of a reconstruction—who got a letter from.... I don't remember whether it was from her plastic surgeon or Allergan, but there was only one.
Of course, not all women with breast implants or textured breast implants are part of the French-Canadian group. It represents only a small portion of the women with textured implants and breast implants in general. A minority were contacted. Close to 0% were contacted by the manufacturer to let them know they had a defective device implanted.
Liberal
Marcus Powlowski Liberal Thunder Bay—Rainy River, ON
Do any of the other witnesses know whether women who received these implants were contacted by the manufacturers?
Patient Advocate, Breast Implant Safety Alliance
I can answer that.
Public commentary from manufacturers, specifically Allergan, says they have taken robust—I believe that's the term they used—activity to try to contact us. What I know as a patient, whether I'm silicone or saline, or smooth or textured, is that implant manufacturers have very robust warranty data. If you look at my Canadian device registry, it was dual-purpose. It was their warranty.
We can't get an answer from the Canadian sales and distribution teams for Allergan and Mentor on exactly what actions they took to reach out and contact women. That question has landed on crickets.
What I can tell you is that this committee will be receiving a copy of my 2009 Canadian device registry. The black-box warning at the bottom of my registry specifically sets that responsibility with Allergan—that Allergan will contact me if there's a safety, efficacy or performance issue. Why cancer didn't raise somebody's alarm bell to say that it was a material change.... I wanted to know—
Patient Advocate, Breast Implant Safety Alliance
Who was the trigger for that? Where is the trigger point from Health Canada to get them to issue those warnings?
Liberal
Marcus Powlowski Liberal Thunder Bay—Rainy River, ON
Well, I'd like to jump in there, because the recall policy for health products on the Health Canada website says that the regulatory operations and enforcement branch of Health Canada monitors recalls and assesses the effectiveness of responsible parties. It also says that should a responsible party fail to effectively conduct a recall, the branch may take compliance and enforcement actions.
To your knowledge, did they take any such action, and have they monitored this recall?
Patient Advocate, Breast Implant Safety Alliance
That was part of our recommendations. What consequences has that department levied on these manufacturers that have completely defied any of the conditions, the laws put in place to protect us? Thanks for the question.
Liberal
The Chair Liberal Sean Casey
Thank you, Ms. McGregor.
We will go to Mr. Aboultaif for five minutes, please.
Conservative
Ziad Aboultaif Conservative Edmonton Manning, AB
Thank you. I have three short questions for each one of you to answer, and then one question.
How would you rate the quality of information you received when consulting with professionals prior to the operation?
Let's start with Ms. McGregor.
Conservative
Ziad Aboultaif Conservative Edmonton Manning, AB
How would you rate the quality of information received from the surgeon prior to the operation?
Patient Advocate, Breast Implant Safety Alliance
What I would suggest is that the surgeon is also motivated to sell me, and there are a lot glossy products—
Conservative
Ziad Aboultaif Conservative Edmonton Manning, AB
I am asking about the quality of information received. How do you rate it? Good? Bad?
Conservative
Patient Advocate, Breast Implant Safety Alliance
Are you asking about quality of information about the breast implants?
Conservative
Ziad Aboultaif Conservative Edmonton Manning, AB
Yes, I'm asking about the information received prior to the operation.
Patient Advocate, Breast Implant Safety Alliance
Do you mean information about the actual device?
Patient Advocate, Breast Implant Safety Alliance
Okay. He told me—and I remember—“Do your homework.” This was in 2007. What tools did I have in 2007?
I went on Google or whatever, and what did I find out about that? I found that there could be post-op complications, so I came back to him and said, “Well, there's a slight chance I can die from the surgery. I can have post-op complications,” and he said, “Well, you did your homework.”
Conservative
Patient Advocate, Breast Implant Failure and Illness Society Canada
I got my implants back in 1991, and I was told when I got mine that they would be lifetime devices. The plastic surgeon actually said that when I died, my body would decay, but my breast implants would be shiny new in the casket.
Today I would say that there's really mixed messaging when Canadians go to consult with plastic surgeons about implants. A lot of them—not all plastic surgeons—do double-talk and say, “Oh, but, you know, the risk is really low,” so the messaging is not adequate.