The identification of more than 50 cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has highlighted the importance of the Australian Breast Device Registry.
A Perspective piece in the Medical Journal of Australia said the TGA was the first regulatory authority in the world to confirm the likely casual link between textured breast implants and the rare lymphoma.
The authors, lead by physician Dr Ingrid Hopper from Drug and Device Registries at Monash University’s School of Public Health and Preventive Medicine, called for further strengthening of the registry to ensure adequate case ascertainment in future implant-related risks.
Suggestions to increase engagement with and resourcing to the registry were:
- contribution to the registry should be a requirement of membership to collaborating surgical societies;
- the TGA should obligate device manufacturers to contribute to the financial sustainability of the registry
- industry should be mandated to provide sales data to the registry to help validate its case capture rate.
“The emergence of BIA-ALCL highlights the importance of systematic post-market surveillance of breast devices,” they said in the MJA.
“The Australian Breast Device Registry has a pivotal role to play in furthering our understanding of BIA-ALCL, as well as monitoring the occurrence of other known and unanticipated adverse events.”
As reported previously in the limbic, the high surface area of the textured implants facilitates the creation of a bacterial biofilm, which can trigger immune activation in some women.
While the absolute risk of BIA-ALCL is low, more cases are expected given the average eight-year lead-time for its development.
The authors said because most breast implants were in young women, long-term exposure could be anticipated.
“It is therefore imperative to identify serious adverse events at the earliest opportunity.”
They said the registry could also help evaluate strategies in place to reduce implant-related risks such as the 14-point plan to reduce the risk of biofilm formation.