Mr. Chair, a number of issues were raised, and I'll try to make sure we go through all of them.
I'd like to start with the last comment. With 100% certainty, I can say categorically that this review was independent, impartial, evidence-based, and scientific. If there is an insinuation that in any way, shape, or form there was undue influence on the review, nothing could be further from the truth.
To give you a little bit of context, a normal medical device review in terms of our performance targets takes 90 days on average. That's our maximum. A lot of them will take less than that. These products have been under review for four years. As I mentioned before, these are the most intensively studied medical devices in history, and as I said, none of them are without risks.
The idea of doing a review is to ask if these medical devices, under the regulatory framework under which we are working, made by parliamentarians, meet the safety, effectiveness, and quality standards that are outlined. Do we know what the risks are? If we could have minimized those risks, have we minimized them? Have we quantified those risks? Are we able to provide information to the Canadian public, so they can make informed decisions about their health?
I cannot underscore that more. It really is up to the patient and his or her practitioner to have that dialogue about the risks and benefits of any treatment. It's the same whether you are taking an aspirin or whether you are having silicone gel-filled breast implants. It depends on knowing what those risks and benefits are.
Because these products have been so intensively studied, we know the risks and benefits and we feel they have met the criteria of the Food and Drugs Act and regulations. Having said that, we wanted to make sure they continue to meet those standards, and that's why those post-market conditions were put in place.
In terms of the FDA decision, you'd have to go back to the FDA to decide why they announced it at the time they did. When we made our decision, we made sure we made the announcement in the morning to allow people to comment and for officials to be present on the Hill to brief anybody who wanted to be briefed. We made a conscious decision to make sure we did that early in the day.
On the subject of MRIs, the products are really well labelled for the decisions. We asked our expert advisory panel what their opinion was on the use of MRIs and they gave specific recommendations.
They did not feel MRI follow-up was the best way to follow them up, and that's clearly outlined in the labelling. So if you read the labelling for the products, it goes through the debate and it explains what the FDA opinion was. The FDA had conflicting opinions as well. They had one expert advisory panel recommend it every two years, and they had another expert panel that did not recommend it every two years.
So the recommendations now are to look for clinical signs and symptoms, to go for a mammogram, and to go for ultrasound, and if there is any suspicion, then to sit down with a physician and decide at that point.
If you are going for an MRI, there may be a wait for an MRI, so the decision might be to go and remove them. If not, you can wait for an MRI and do that. But we specifically asked the question on MRI. We've specifically received an expert opinion on it, and the recommendation was not to have an MRI follow-up every two years.
In terms of Public Citizen, that is a consumer advocacy group. In the United States they have a public petition process. Public Citizen has come before the FDA with their concerns and they've had their hearings, and the FDA have cleared all the issues they've had with Public Citizen.
Another part of the question was speaking to wait times for having implants removed. Again, if there is a health risk, if there is a health reason for them to be removed, it's a priority, but individual surgeons will be making their own decisions in terms of their own lists. If it is due to health, then the public health system covers it. If it is not due to health concerns, then it is not covered.
The practice of medicine is regulated at the provincial and territorial level. It's not regulated at the federal level and it's not under the jurisdiction of Health Canada.