Thank you.
I'd like to thank the committee for today's invitation to testify with the aim of improving patient outcomes.
It's been eight years since I was introduced to the true risk profile of breast implants with my stage 4 diagnosis of breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. We do this gruelling and unpaid work in an effort to raise a patientcentric perspective among the giants of industry that continue to successfully control the narrative, mislead consumers and leverage the emotional plight of breast reconstruction and our prophylactic mastectomy patients.
A national registry will directly impact health outcomes for patients if, and only if, its architecture and oversight include the following.
First is accountability. Will there be consequences for not doing what's required?
Second is auditability. Will the data be subject to audit by a neutral party so that we will know and be able to vet its credibility?
Last is accessibility. Will advocacy groups, patients and doctors have free access to the data so that we can protect patients from misleading information?
The devil is in the deep-dive details. I empathize with the confusion and complexity for committee members attempting to wrap their comprehension around a 60-year culture of mismanagement and contradictions. We are here to help.
We are subject experts. We are solution-driven and can provide robust recommendations and resources if we are included in the planning stages. We trust that a robust opt-out registry can deliver real-time, real-world outcomes and address issues sooner, in addition to the standard track and trace for notifications.
Who controls the data controls process and the reported outcomes. The effects of undue influence permeate our existing registries, specifically the Canadian device registry I was given in 2009, the Canadian adverse event reporting registry, the NBIR and the Profile registry for ALCL patients.
My lived experience with Health Canada's registry is evidence of the denial and delay tactics of undue influence. Industry has succeeded to date, and the consequences have been disastrous, and not only for patients. We bear witness to the slander campaign directed at plastic surgeons who do not bend to the peer influence of their thought leaders.
What actions did manufacturers take to notify patients in 2011? Why didn't Health Canada invoke its authority to demand that patients be notified in 2011? What punitive consequences has Health Canada issued against device manufacturers that intentionally withheld our BIA-ALCL cancer reports to our governments?
Blind wilfulness is the only reasonable conclusion for implanting surgeons whose self-promoting websites are riddled with misleading, stale-dated and simply false statements. Commerce without ethical context is dangerous and continues to harm patients. I have provided a link for your interest.
Why do we not have answers to rudimentary questions? How many Canadians have breast implants? How many Canadians are affected by the recalled products? Simply put, we cannot manage what we don't measure.
Our recommendations include adopting breast MRI recommendations for implant surveillance in Canada, requiring that breast implant patients be notified of the need for a breast MRI, pausing or limiting the sale of breast implants until an effective registry is created, requiring the participation of—