There are a few things.
Regarding the opt-out system, the dataset that can be used should be the same as the one in Australia and the Netherlands, but there should also be a PROMs dataset. That's patient-reported outcome measures.
Compliance with the mandatory registry could be an issue. In the Netherlands, it's arranged that all hospitals and private clinics have the legal responsibility for the registration. In addition, compliance to the registry is a requirement for renewing the licences of plastic surgeons.
To facilitate the registry, manufacturers should be asked to develop bar codes on the implants, so that with bar code scanning modules, the registry can be done without mistakes.
The funding of a registry could be an issue. In the Netherlands, it's established that patients pay $40 Canadian extra for the surgery. Patients with breast reconstruction get this reimbursed by their health insurance.
In conclusion, breast implants are high-risk medical devices. Long-term sound epidemiological data are not available, despite the fact these breast implants have been on the market for more than 60 years.
Recalls have been made in the past, and are probably needed in the future. Recalls are not successful if there's no good registry. It is my opinion that there's an urgent need to start a national breast registry. The registry should be used by all surgeons that place implants. The registry will provide us with better information about the diseases that are associated and/or caused by these implants.
Thank you very much, Mr. Chairman.