The Therapeutic Goods Administration has confirmed 46 cases of breast implant-associated anaplastic large cell lymphoma (ALCL) in Australia since 2007.
In a recent alert (20 December) to consumers and health professionals, the TGA estimated about one woman in 5000 with breast implants would develop the rare form of non-Hodgkin lymphoma between 3 and 14 years after surgery.
This represents a significant increase in risk compared to the previous estimate of 3 in 100 million women, as reported by the TGA in 2011.
All Australian cases of breast implant-associated ALCL have occurred in women with textured or polyurethane implants.
“Most cases of breast implant-associated ALCL are cured by removal of the implants and the capsule surrounding the implant, however a small number are more aggressive,” the TGA Alert said.
Three deaths have been reported and a small number of unconfirmed cases are still being investigated.
Given the rare nature of the condition, there has been no recommendation for screening or prophylactic removal of implants in women without symptoms.
However women should be advised to monitor their breasts for effusion, seroma, a mass or lymphadenopathy.
The unique characteristics of breast implant-associated ALCL include:
- being purely T-cell
- having no anaplastic lymphoma kinase gene translocation (ALK-)
- being CD30 receptor protein positive on immunohistochemistry
- being in close anatomical association with a breast implant.
Chronic bacterial biofilm infection on the surface of breast implants has been suggested as a contributing factor to the development of breast implant-associated ALCL.