Great. Thank you.
I would like to thank the committee for the opportunity to appear here today and provide some information regarding breast implants. I agree with my colleague that the regulation of surgical implants is key to patient safety.
I'm Steve Morris. I am a plastic and reconstructive surgeon. I've been working in Halifax for 30 years. I have a research lab, and I've been doing laboratory research for the last 25 or so years. Currently, I am president of the Canadian Society of Plastic Surgeons.
I started my residency in the 1980s. At the time, breast implants were flawed. Results were poor and unpredictable. Gradually, the implant manufacturers improved the devices and results improved. Due to concerns about safety, in 1992 there was a moratorium placed on silicone gel implants. In order to do any kind of reconstruction, we had to use saline-filled implants for a period of time. The problem with saline-filled implants is that there's a 1% failure rate per implant per year. Spontaneous rupture is a consistent issue. Gradually, silicone implants were allowed back on the market, and Health Canada basically put the onus on the implant manufacturers to collect data.
Just to back up a bit, what do we use breast implants for? I do a lot of breast reconstructive surgeries using implants. There are congenital causes for breast deformity, such as hypoplasia, asymmetry or other more unusual breast deformities. Transgender patients require breast implants. Finally, there's cosmetic breast augmentation. The number of these procedures varies from surgeon to surgeon in different practices.
There's always been some level of concern about breast implant safety. In the 1980s-style implant, there was an unacceptably high rate of implant rupture. As the manufacturers tried to achieve a better implant, they made the capsule thinner and thinner and the silicone more viscous. This ended up causing a lot of ruptures.
Silicone has been of concern because of what it could do in the body. Generally, silicone was first selected because it's relatively biologically inert, but there is always a capsule around any implanted device. Whatever the type of implant in the body, there's always a capsule around it. That seems to cause a lot of the problems in a certain subset of the patients.
When the moratorium was announced in 1992, there were hundreds of research projects looking at the safety, particularly looking at the autoimmune. At that time, there was no convincing evidence. That's why Health Canada allowed the implants back on the market, with the understanding that the implant manufacturers were going to study the data. That's why we're here today.
It's said that the best time to plant a tree is 30 years ago, and the second-best time to plant a tree is today. It's the same with this registry. Today is the best time to start moving forward with this issue: We would have excellent data by now.
BIA, or breast implant-associated, ALCL is a large, very serious tumour caused by breast implants. Again, textured implants were associated with it in the highest numbers, but there's no doubt that there's a relationship between anaplastic large cell lymphoma, which is a form of non-Hodgkin's lymphoma, and the implants. That's the reason they were taken off the market in 2019. If we'd had that data, when we first got an inkling of ALCL, we could have alerted all those patients and all those surgeons, explanted those implants and stopped the production of them, setting back the clock about 10 years. We lost that opportunity—or more.
Unfortunately, right now there is no good way to track the number of patients who have received these types of implants. A registry would have accomplished this easily. In every surgical procedure, the surgeon is required to disclose to the patient the cost-benefit analysis of the operation. What are the risks? What's the financial cost? What pain and suffering will be associated with this? What's the goal of the operation? If we do not have adequate data on breast implants, we can't correctly advise our patients. As surgeons, we want to achieve excellent results every day, but we want to do it safely.
In this patient population, believe it or not, after what you've just heard, we get great results very consistently. I've been practising for 30 years. If I'd had terrible results and patients who were badly affected, I would have stopped doing these types of surgeries a long time ago. Clearly, we're getting great results most of the time.
Then there are cases we don't know about. We've lost them to follow-up or what have you.
In order to provide optimal and safe patient care, I think we need to create a national breast implant registry. I had a quote from one of the papers I read in preparation for this, which is that the obligation for patient safety lies not with the doctor who uses the medical device, but with the government that regulates the medical device.