BISA advocates urgently called to testify in front of Parliament about breast implant registry in Canada

Advocates in Canada and the U.S. have long stressed the urgent need for improved data to protect public safety. As a result, the federal committee is studying the feasibility of a database that doctors, patients, and regulators can regularly access to better inform the public of emerging safety signals (i.e., patterns of problems) with breast implants.

On May 11th, 2023, patient advocates will testify to Parliament at the nation’s capital in Ottawa in favor of creating a national breast implant registry for Canadians. The federal House of Commons Standing Committee on Health heard from representatives from Health Canada on April 25, 2023 and from plastic surgeons on May 4, 2023.

Breast Implant Safety Alliance (BISA) is proud to have two of our esteemed Canadian patient advocate representatives,Terri McGregor and Julie Elliott, along with one of our advisors, Dr. Stephen Nicolaidis, among the presenting groups on this topic.

Terri McGregor is a BIA-ALCL survivor, and Julie Elliott is a French-Canadian patient advocate. Both are recognized for their advocacy efforts on a global scale. They will be joined by Canadian Nancy Pratt, a long-time advocate and founder of the BIFI Society of Canada and co-founder of the Canadian Breast Implant Failure and Illness support group. Both Julie Elliott and Nancy Pratt suffered from Systemic Symptoms of Breast Implants (SSBI), commonly called Breast Implant Illness (BII), and were quoted in a recent CBC News article, ”National breast implant registry much needed but long overdue, patients and doctors say.” 

These hearings are finally happening because of the relentless work of Mr. Luc Thériault, Member of the Parliament for Montcalm and Vice-Chair of the Standing Committee on Health. The committee's study is called Oversight of Medical Devices (Breast Implants) and the healthcare professionals testifying in favor of the registry will include:

Dr. Peter Lennox - Plastic Surgeon, Head of the University of British Columbia’s Division of Plastic Surgery, BIA-ALCL Specialist
Dr. Stephen Nicolaidis - Plastic Surgeon, Researcher, Explant Expert, Assistant Professor of Surgery at the University of Montreal, BISA Advisory Council Member
Dr. Jan Willem Cohen Tervaert - Immunologist, Rheumatologist, Professor of Rheumatology at Edmonton University, and ASIA Syndrome Specialist. 

Breast Implant Registry Concerns

In the recent CBC article published on April 26, 2023, Dr. Jan Willem Cohen Tervaert stated, "It's clear that the medical device industry and especially the breast implant medical device industry need more supervising, and authorities are failing to do so.

BISA advocates and advisors will highlight patient experiences and historical facts in making a case for a long overdue robust Canadian breast implant registry with adequate safeguards. Unfortunately, the current system, which relies heavily on self-interested manufacturers and industry for collecting, interpreting, and disseminating data, has failed to identify and timely alert patients to health and safety problems harming both patients and taxpayers. “We need third-party oversight and patient advocate involvement. We cannot expect device manufacturers to prioritize patient safety; they have demonstrated their mandate is to shareholders not patients.” says Terri McGregor.

Director of BIA-ALCL Advocacy for BISA Jennifer Cook focused on accountability, auditability, and accessibility with these concerns:

Accountability: Will there be consequences for not doing what is required?
Auditability: Will the data be subject to audit by a neutral party so we will know it is credible? 
Accessibility: Will advocacy groups, patients, and doctors have free access to the data so we can protect patients from misleading information?

Madris Kinard, founder of Device Events and a member of BISA’s Advisory Council, expressed additional concerns. Kinard stated, “In the U.S., we’ve had trouble getting physicians to report adverse events to the FDA because they think using the registry satisfies that requirement, but it does not. The FDA does not own device registries, leaving the industry and associations to collect and disseminate data. There is no mandate that registries must share data with the FDA or even share it with the participating physicians.”

“Will the data from the registry be publicly viewable at no cost? In the U.S. our registries are not free. Physicians who participate can only view the reports they submit, not all the reports submitted. Canada can learn from the mistakes made with respect to registries in the U.S. and set this up correctly from the outset. There is the potential to do this right and do it well.”
-Madris Kinard, Device Events

“BISA appreciates the opportunity to collaborate for better patient safety regarding breast implant registries. These registries are long overdue and the current registries need improvement, especially in the areas of transparency, accessibility and accountability. Registries are only good for those who have access to data and we believe creating an effective one can be accomplished,” says BISA President Maria Gmitro.

The Breast Implant Safety Alliance (BISA) is a patient-centered nonprofit organization dedicated to improving breast implant safety—through direct collaboration with consumers, plastic surgeons, manufacturers, regulators, and advocates. The BISA team consists of volunteers who do not draw a salary and the organization does not accept money from breast implant manufacturers. BISA is a go-to resource for journalists looking for patient stories, advocate and expert interviews and connection to the latest research. Our team has been cited in high-quality publications. Please contact us for media inquiries.

Resources & Additional Reading

CBC NEWS | April 2023
National breast implant registry much needed but long overdue, patients and doctors say

CBC News | January 2022
Thousands of suspected injuries tied to breast implants revealed in manufacturer data dump, CBC analysis finds

CBC News | January 2022
Thousands of Hidden Breast Implant Injury Incident Reports In Canada

AMA Journal of Ethics | September 2021
Is the FDA Failing Women?

Annals of Plastic Surgery | March 2021
The Case Against the National Breast Implant Registry

BMJ: Journal of Medical Ethics | February 2021
Informed consent and compulsory medical device registries: ethics and opportunities

JPRAS | October 2020
Moving breast implant registries forward: Are they FAIR and Functional?

Medicina | August 2020
A Systematic Review of the National Breast Implant Registry for Application in Korea: Can We Predict “Unpredictable” Complications?

Journal of Rheumatic Disease and Treatment | 2019
The Clever Deception by Silicone Gel-filled Breast Implant Manufacturers Regarding the Phenomenon of Gel Bleed

CBC News | December 2018
Canadian advocates call for all medical implants to be registered

CBC News | November 2018
'We're guinea pigs': Canada's oversight process for implanted medical devices stuns suffering patients

Associated Press | November 2018
Breast implants reveal problems in tracking device safety

CBC News | August 2019
Women's lives upended after cancer diagnosis linked to BIOCELL breast implants

Safety in Health | June 2015
Medical device registries for breast implants - where to?

ASPS | March 2015
ASPS Responds to France's National Cancer Institute Statement on ALCL & Silicone Breast Implants

Canada.ca | Oct 2006
Health Canada grants manufacturers Class IV licences with conditions to market silicone gel-filled breast implants