Commentary: Recommendations for a Canadian Breast Implant Registry

Medical device registries exist on a global scale for a wide variety of surgically implanted products. Registries can be an important and invaluable tool to track product performance, follow epidemiologic trends and usage, monitor both positive and adverse outcomes, and provide a central point of contact should the need arise to reach out to individuals that have received a device. Breast implants, both saline filled, and silicone gel filled, are commonly used devices in aesthetic, revision and reconstructive breast surgery. Although breast implant registries (BIR) currently exist in multiple countries, Canada has yet to develop and implement such a registry. In this very important and timely paper, Recommendations for a Canadian Breast Implant Registry, ¹ the authors bring this issue to the forefront. Their thoughtful analysis of the strengths and weaknesses of other registries sets the foundation for a plan to move forward with a BIR in Canada.

Breast implants have been in use for almost 65 years, with multiple adaptations based on shell characteristics, filler material, shape, size and implant surface. Device evolution has been based on many factors, including a need to respond to implant performance and safety concerns. Performance issues such as implant rupture, silicone gel bleed, gel extravasation, capsular contracture and implant malposition have resulted in decades of adaptation and technologic change. The identification of these concerns was largely driven through industry led trials as well as surgeon outcome studies. The absence of robust registries most certainly contributed to a delay in identifying several device failures over the years.

Perhaps, the most significant event that stimulated elevated focus on the potential value of a BIR was the identification of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). When it became clear that BIA-ALCL was associated with a specific type of breast implant (textured surface), there was an important need to identify patients with these devices so that they could receive advice and counsel about their treatment options. In the absence of a centralized BIR, most surgical practices, both hospital-based and private out of hospital premises, relied on their own internal tracking to identify relevant patients. Although well intended, this tracking was certainly less accurate than what would have been possible with a robust registry. In addition, eventual tracking of Canadian cases of BIA-ALCL proved challenging without a centralized registry. To this date, an accurate estimate of incidence of BIA-ALCL in Canadian women is not possible, not only because of a question of total cases, but also due to an unknown denominator of number of textured breast implants that have been inserted.

Registries do not come without significant challenges. These include buy in from surgeons, co-operation with industry partners, privacy issues for patients, ongoing database management as well as financial cost. These issues have been successfully addressed in a growing number of countries that have implemented a BIR. The time has come for regulatory bodies, surgeons, industry partners and patient advocates to work together to form a Canadian Breast Implant Registry.