Evidence of meeting #67 for Health in the 44th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was implants.
A recording is available from Parliament.
11:45 a.m.
Bloc
Luc Thériault Bloc Montcalm, QC
Mr. Cohen Tervaert will be pleased, because on February 21, you recommended the creation of research funds to improve the evidence collected on implant-related adverse events.
Since February 2021, has work started on that recommendation?
11:45 a.m.
Chair, Scientific Advisory Committee on Health Products for Women
Not to my knowledge.
11:45 a.m.
Bloc
Luc Thériault Bloc Montcalm, QC
Health Canada is considering the creation of a fund to cover the costs of damages. Has there been any progress on this front since February 2021?
11:45 a.m.
Chair, Scientific Advisory Committee on Health Products for Women
Not to my knowledge, although we did recommend that.
11:45 a.m.
Bloc
Luc Thériault Bloc Montcalm, QC
The retrospective case study you mentioned a little earlier is ongoing, isn't it?
11:45 a.m.
Chair, Scientific Advisory Committee on Health Products for Women
Not to my knowledge.
11:45 a.m.
Liberal
The Chair Liberal Sean Casey
Your time is up. Thank you very much, Mr. Thériault.
Next we have Mr. Davies for six minutes, please.
11:45 a.m.
NDP
Don Davies NDP Vancouver Kingsway, BC
Thank you, Mr. Chair.
Thank you to all the witnesses for being here.
Can any of you give our committee a general idea of how many Canadian women have been injured by breast implants?
11:45 a.m.
Professor of Medicine, University of Alberta, As an Individual
I tried to calculate that. From the other experiments in other countries, it's calculated that about 25% of the patients with breast implants have issues that might be due to the implants.
11:45 a.m.
NDP
Don Davies NDP Vancouver Kingsway, BC
For those of us who aren't used to medical epidemiology and risk factors, is that considered a high risk for what can sometimes be, I guess, an elective surgery?
11:45 a.m.
Professor of Medicine, University of Alberta, As an Individual
It's an extremely high risk.
11:45 a.m.
NDP
Don Davies NDP Vancouver Kingsway, BC
Thank you.
Dr. Cohen Tervaert, staying with you, if I had your words correct, you said there were some issues with implant trials. I imagine these were the clinical trials that were probably done by the manufacturers.
Can you expand a little bit on that? What were the issues with the implant trials?
11:45 a.m.
Professor of Medicine, University of Alberta, As an Individual
The FDA recommended trials when the ban was lifted. However, these trials were not done and were not done properly.
We had an FDA meeting, I think, three or four years ago where I was also a witness. There, many patients came forward and said they participated in these trials, but as soon as they developed complications, they were sent out of the trial because they had complications. Those are not proper trials.
11:45 a.m.
Professor of Medicine, University of Alberta, As an Individual
It was Mentor and Allergan.
11:45 a.m.
NDP
Don Davies NDP Vancouver Kingsway, BC
You've identified three major potential negative problems from breast implants: one, malignant disease breast implant ALCL; two, autoimmune disorders; and three, so-called breast implant illness.
Is there an implant on the market today that significantly avoids these three risks?
11:50 a.m.
Professor of Medicine, University of Alberta, As an Individual
No. We did do a comparative study, where we compared the modern implants with the implants that were in place 20 years ago, and we saw the same symptoms occurring in the patients. There was no difference in implant quality. Although the manufacturers always state that their implants are better and better, we don't see that from the rheumatological or autoimmune field.
11:50 a.m.
NDP
Don Davies NDP Vancouver Kingsway, BC
I'm going to ask an obvious question as a lay person.
We have a device that causes an extremely high rate of serious problems. I take it that you would agree with me that the cancer, the autoimmune disorders and the autoimmune nervous disorders are fairly serious—are they not?
11:50 a.m.
Professor of Medicine, University of Alberta, As an Individual
Causality is an issue here always. The malignant disease is clearly caused by a specific mutation that occurs that is not seen in other forms of ALCL. The causality of breast implant illness by breast implants is still debated. I recently put up research where we showed with current Bradford Hill criteria—which are the criteria that we use to support causality—that breast implant illness is, indeed, caused by the breast implants.
Let's go back to the discussion about smoking. In the late 19th century, it was already clear that some patients who smoked did get lung cancer. However, it lasted until 1960 when causality was proven, and that was Dr. Bradford Hill who did that. It is very difficult to fight against the manufacturers.
11:50 a.m.
NDP
Don Davies NDP Vancouver Kingsway, BC
Sure.
Then, if I understand you correctly, the BIA-ALCL is one version. There is a causative aspect established. The Israeli study, a large-scale study, said that there's a 45% higher risk in women with breast implants to get AI disorders over those who don't have implants, and 25% of women would have three symptoms or more after 10 years after their breast implants in terms of autoimmune disorders.
The question I'd ask is this: Should we be allowing these to be implanted at all, given those health impacts, at least for people who don't have a medical indication for one?
11:50 a.m.
Professor of Medicine, University of Alberta, As an Individual
I'm not the one who decides that, but clearly my statement is always this: If we are continuing to give breast implants to healthy people, they should be well informed. Preferably, I would say, “You are a guinea pig, and if you want to participate in this study, yes, you're allowed.”
11:50 a.m.
NDP
11:50 a.m.
Professor of Medicine, University of Alberta, As an Individual
11:50 a.m.
NDP