Improving the safety of breast implants: implant-associated lymphoma

Ingrid Hopper, Susannah Ahern, John J McNeil, Anand K Deva, Elisabeth Elder, Colin Moore and Rodney Cooter
Med J Aust 2017; 207 (5): . || doi: 10.5694/mja17.00005
Published online: 28 August 2017

A likely causal link between breast implants and lymphoma highlights the importance of a prospective registry

Breast 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.

  • 1 Monash University, Melbourne, VIC
  • 2 University of Melbourne, Melbourne, VIC
  • 3 Macquarie University, Sydney, NSW
  • 4 Integrated Specialist Healthcare, Sydney, NSW
  • 5 Westmead Breast Cancer Institute, Sydney, NSW
  • 6 Breast Surgeons of Australia and New Zealand, Sydney, NSW
  • 7 Australasian College of Cosmetic Surgery, Sydney, NSW
  • 8 Australasian Foundation for Plastic Surgery, Sydney, NSW



The Department of Health provides funding for the Australian Breast Device Registry. Ingrid Hopper is supported by a National Health and Medical Research Council early career fellowship.

Competing interests:

No relevant disclosures.

  • 1. Jeeves AE, Cooter RD. Transforming Australia’s Breast Implant Registry. Med J Aust 2012; 196: 232-234. <MJA full text>
  • 2. Therapeutic Goods Administration. Breast implants and anaplastic large cell lymphoma. (accessed July 2017).
  • 3. Brody GS, Deapen D, Taylor CR, et al. Anaplastic large cell lymphoma occurring in women with breast implants: analysis of 173 cases. Plast Reconstr Surg 2015; 135: 695-705.
  • 4. Prince HM, Johnstone R. Commentary on: biomarkers provide clues to early events in the pathogenesis of breast implant-associated anaplastic large cell lymphoma. Aesthet Surg J 2016; 36: 782-783.
  • 5. Loch-Wilkison A, Beath K, Knight RJW, et al. Breast implant associated anaplastic large cell lymphoma in Australia and New Zealand – high surface area textured implants are associated with increased risk. Plast Reconstr Surg 2017; doi: 10.1097/PRS.0000000000003654 [Epub ahead of print].
  • 6. Collis N, Coleman D, Foo IT, Sharpe DT. Ten-year review of a prospective randomized controlled trial of textured versus smooth subglandular silicone gel breast implants. Plast Reconstr Surg 2000; 106: 786-791.
  • 7. Jacombs A, Tahir S, Hu H, et al. In vitro and in vivo investigation of the influence of implant surface on the formation of bacterial biofilm in mammary implants. Plast Reconstr Surg 2014; 133: 471e-480e.
  • 8. Hu H, Jacombs A, Vickery K, et al. Chronic biofilm infection in breast implants is associated with an increased T-cell lymphocytic infiltrate: implications for breast implant-associated lymphoma. Plast Reconstr Surg 2015; 135: 319-329.
  • 9. Blombery P, Thompson ER, Jones K, et al. Whole exome sequencing reveals activating JAK1 and STAT3 mutations in breast-implant associated anaplastic large cell lymphoma. Haematologica 2016; 10: e387-e390.
  • 10. Hopper I, Ahern S, Best RL, et al. Australian Breast Device Registry: breast device safety transformed. ANZ J Surg 2017; 87: 9-10.
  • 11. Deva AK, Adams WP, Vickery K. The role of bacterial biofilms in device-associated infection. Plast Reconstr Surg 2013; 132: 1319-1328.
  • 12. de Steiger RN, Hang JR, Miller LN, et al. Five-year results of the ASR XL Acetabular System and the ASR Hip Resurfacing System: an analysis from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Joint Surg Am 2011; 93: 2287-2293.
  • 13. van der Veer SN, de Keizer NF, Ravelli AC, et al. Improving quality of care. A systematic review on how medical registries provide information feedback to health care providers. Int J Med Inform 2010; 79: 305-323.
  • 14. Sedrakyan A, Campbell B, Graves S, Cronenwett JL. Surgical registries for advancing quality and device surveillance. Lancet 2016; 388: 1358-1360.
  • 15. Cooter RD, Barker S, Carroll SM, et al. International importance of robust breast device registries. Plast Reconstr Surg 2015; 135: 330-336.


remove_circle_outline Delete Author
add_circle_outline Add Author

Do you have any competing interests to declare? *

I/we agree to assign copyright to the Medical Journal of Australia and agree to the Conditions of publication *
I/we agree to the Terms of use of the Medical Journal of Australia *
Email me when people comment on this article

Online responses are no longer available. Please refer to our instructions for authors page for more information.