TY - JOUR
T1 - Improving the safety of breast implants
T2 - implant-associated lymphoma
AU - Hopper, Ingrid
AU - Ahern, Susannah
AU - McNeil, John J
AU - Deva, Anand K
AU - Elder, Elilsabeth
AU - Moore, Colin
AU - Cooter, Rodney
PY - 2017/8
Y1 - 2017/8
N2 - A likely causal link between breast implants and lymphoma highlights the importance of a prospective registryBreast devices, including implants and tissue expanders, are classified as class III (high risk) medical devices by the Therapeutic Goods Administration, and are subject to the highest level of regulatory control. They have been associated with highly publicised health scares in the past, particularly, the Poly Implant Prothèse crisis.1 More recently, breast implants have again created national concern, with the Therapeutic Goods Administration confirming in late 2016 that there were 46 reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in Australia, including three cases that resulted in death. This number has since increased to 53.2 Most breast implants are used in young women and in women who have had breast cancer, thus long term exposure to these devices can be anticipated. It is therefore imperative to identify serious adverse effects at the earliest opportunity. The Australian Breast Device Registry is ideally positioned to do this, but it requires sufficient resources and engagement to ensure that it remains fit for purpose.
AB - A likely causal link between breast implants and lymphoma highlights the importance of a prospective registryBreast devices, including implants and tissue expanders, are classified as class III (high risk) medical devices by the Therapeutic Goods Administration, and are subject to the highest level of regulatory control. They have been associated with highly publicised health scares in the past, particularly, the Poly Implant Prothèse crisis.1 More recently, breast implants have again created national concern, with the Therapeutic Goods Administration confirming in late 2016 that there were 46 reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in Australia, including three cases that resulted in death. This number has since increased to 53.2 Most breast implants are used in young women and in women who have had breast cancer, thus long term exposure to these devices can be anticipated. It is therefore imperative to identify serious adverse effects at the earliest opportunity. The Australian Breast Device Registry is ideally positioned to do this, but it requires sufficient resources and engagement to ensure that it remains fit for purpose.
UR - http://www.scopus.com/inward/record.url?scp=85032378773&partnerID=8YFLogxK
U2 - 10.5694/mja17.00005
DO - 10.5694/mja17.00005
M3 - Comment / Debate
AN - SCOPUS:85032378773
SN - 0025-729X
VL - 207
SP - 185-186.e1
JO - The Medical Journal of Australia
JF - The Medical Journal of Australia
IS - 5
ER -