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BIA-ALCL: Information for health professionals

11 July 2019

The TGA has published Allergan’s independent decision to initiate a Medical Device Recall and Implant Hazard Alert, regarding its macro-textured breast implants and tissue expanders. Read the update.

This page provides information for health professionals on breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). If you are a consumer, please visit our consumer BIA-ALCL information page.

The information on this page is based on advice from an expert working group on BIA-ALCL that is convened by the Therapeutic Goods Administration (TGA). The working group includes representation from plastic surgeons, cosmetic surgeons, breast cancer surgeons, cancer epidemiologists, pathologists and haematologists, data analysts, public-health practitioners and consumers from around Australia. The last working group meeting was held on 8 April 2019. They acknowledged a requirement to improve information provided to consumers, and importantly the value of reporting all cases of BIA-ALCL to the TGA and the Australian Breast Device Registry (ABDR).

As BIA-ALCL is rare, various aspects of this disease are not fully characterised. A more complete picture is expected over coming years. Health professionals should keep informed of the latest evidence.

The TGA has been monitoring issues related to BIA-ALCL since 2011 when an association between breast implants and ALCL was first identified. The TGA continues to monitor the safety of breast implants and urges health professionals to report any problems associated with these devices to the TGA.

What is breast implant associated ALCL?

BIA-ALCL is a rare form of non-Hodgkin lymphoma. In 2016, the World Health Organisation (WHO) classified BIA-ALCL as a distinct clinical entity, separate from other categories of ALCL.  

Unique characteristics include:

  • being purely T-cell
  • having no anaplastic lymphoma kinase gene translocation (ALK-)
  • being CD30 receptor protein positive on immunohistochemistry (CD30+)
  • being in close anatomical association with a breast implant.

The aetiology of BIA-ALCL appears complex and multi-factorial. The expert panel emphasised that, as with other cancers, the complete set of causal factors is unknown. Breast implants are likely to be a necessary, but not solely-sufficient, to cause BIA-ALCL. Inter-related factors have been proposed that include:

  • textured implants (with a higher risk for high surface area textures)
  • bacterial contamination at the time of surgery to cause inflammation
  • patient genetic predisposition
  • time for the process to develop.  

Most cases occur between three and 14 years after insertion of the implant (median: 8 years; range: 1-37 years). The risk appears to be between 1-in-1000 and 1-in-10,000 patients with implants, and the risk increases with increasing texturing of the implant.

The number of BIA-ALCL cases in Australia (about 1 in 7 of all cases reported globally) are much higher than would be expected on a relative population basis. To date in Australia there have been no cases of BIA-ALCL in patients who have a history of implantation with only smooth implants; all Australian cases to date have occurred in women with textured or polyurethane implants. Until 2-3 years ago, about 85% of implants used in Australia were textured whereas in the United States, 70-90% of implants are smooth. The United States Food and Drug Administration (FDA) believes that the association with smooth implants cannot be ruled out as full details of the history of implants in cases are unknown.

Discuss the risk of BIA-ALCL with your patients

The risk of BIA-ALCL must be discussed with the patient as part of obtaining their informed consent. Patients who are considering breast implants should be made aware of the benefits and risks of the different types of implants for their clinical circumstance. They should also be provided with educational material to read and consider at leisure. After implantation, you should provide patients with written details about the name and type of implant and the procedure performed. You should give the patient the breast implant manufacturer's labelling, patient information leaflet, and the patient-specific implant card if they are available.

All patients with breast implants should be advised to become familiar with the usual features of their breasts and conduct regular self-examination as they would for routine breast cancer awareness.

Women with implants should be made aware of the common presenting symptoms including asymmetry, pain, delayed effusion or seroma, or, less commonly, a mass or lymphadenopathy. They should be encouraged to present for immediate clinical assessment should there be any change in size, shape or symptoms related to the breast and/or implant, as surgery as a result of early diagnosis can be curative. Disease which has spread through the capsule, forms a mass or spreads to local lymph nodes carries a worse prognosis.

Women should be reminded that generally, breast implants are not lifetime devices regardless of BIA-ALCL. Typically they are removed after 10-15 years. The longer the implant, the more likely it will need to be removed. Common reasons for removal are contracture, rippling, movement or rupture of the implant.

Steps to reduce the risk for your patients

Current data suggest that the lower the surface area texture of the implant, the lower the risk of ALCL.

A hypothesis currently in favour, but not proven, is that T-cell stimulation due to a chronic bacterial biofilm infection increases the risk of ALCL developing. Therefore, standard-of-care precautions, such as antibiotic prophylaxis, pocket irrigation, sterility, and skin preparation should be maintained when placing an implant. It is also hypothesised that such precautions would have the additional benefit of reducing the risk of contracture.

A group of Australian breast implant researchers have made the following recommendations:

  1. Use intravenous antibiotic prophylaxis at the time of anaesthetic induction
  2. Avoid periareolar incisions; these have been shown in both laboratory and clinical studies to lead to a higher rate of contracture as the pocket dissection is contaminated directly by bacteria within the breast tissue.
  3. Use nipple shields to prevent spillage of bacteria into the pocket.
  4. Perform careful atraumatic dissection to minimise devascularised tissue.
  5. Perform careful haemostasis.
  6. Avoid dissection into the breast parenchyma. The use of a dual-plane, subfascial pocket has anatomic advantages.
  7. Perform pocket irrigation (refer to hospital or health department guidelines).
  8. Use an introduction sleeve. We have recommended the use of a cut-off surgical glove to minimise skin contact.
  9. Use new instruments and drapes, and change surgical gloves prior to handling the implant.
  10. Minimise the time of implant opening.
  11. Minimise repositioning and replacement of the implant.
  12. Use a layered closure.
  13. Avoid using a drainage tube, which can be a potential site of entry for bacteria.
  14. Use antibiotic prophylaxis to cover subsequent procedures that breach skin or mucosa.

Routine monitoring of breast implants

Routine monitoring of patients with breast implants is a clinical decision for the surgeon and patient guided by consideration of the recommendations of the relevant surgical specialist college or association. Similarly the option of explantation of breast implants in the absence of symptoms requires discussion of risks versus benefits, and would be a clinical decision to be made in partnership with a fully informed patient.

Investigation of suspected cases of BIA-ALCL

The diagnosis of BIA-ALCL has improved through identifying characteristics of samples taken of fluid and tissue around the breast implant.

The main method of investigation is ultrasound evaluation to confirm the presence and extent of an effusion, determine if there is presence of a mass, and evaluate regional lymph node basins for lymphadenopathy. Fine needle aspiration (+/- or core biopsy) of an effusion (mass) is performed and the aspirate (tissue) is sent for cytology (histology) and flow cytometry +/- molecular studies for confirmation of the diagnosis of BIA-ALCL. Positron emission tomography/computed tomography (PET/CT) scans and magnetic resonance imaging (MRI) are reserved for confirmed case, there is a Medicare Benefit Schedule (MBS) item for MRI for investigation of patients diagnosed with BIA-ALCL (MBS item 63547).

There does not appear to be a role for mammography in the detection or investigation of BIA-ALCL.

Management of BIA-ALCL

The management of this condition is multidisciplinary. All patients require a referral to a surgeon experienced with breast implants and the involvement of a haematologist who specialises in lymphoma for initial and ongoing investigations and management.

Curative treatment for most women is removal of the implant and oncological capsulectomy, which includes complete resection of any mass associated with the capsule. Contralateral breast implants should be removed with complete capsulectomy because several bilateral cases have been detected incidentally. Both the capsule and fluid should be sent for pathology.

The disease can be categorised into stages, with approximately 63% of reported Australian BIA-ALCL cases having cancerous cells that are limited to the fluid (effusion/seroma) surrounding the breast implant and not present in the tissue surrounding the implant, and a further 23% of cases having cancerous cells limited to the seroma and the tissue capsule that is removed upon explant of the breast implants.

Most diagnosed cases are adequately treated with complete capsulectomy and implant removal. However, aggressive variants have been reported. To date, four deaths have occurred in Australia.

Medicare benefits and BIA-ALCL

Even if the breast implants were inserted for purely cosmetic purposes and so the implantation surgery did not attract a Medicare benefit at the time, services for investigation and treatment of breast implant associated cancer, as with any other cancer, are eligible for payment of Medicare benefits.  In addition to benefits for diagnostic imaging and pathology services, there is also a Medicare benefit specific for MRI investigation of patients diagnosed with BIA-ALCL (MBS item 63547).

A Medicare benefit is payable under MBS item 45551 for removal of each breast implant and its surrounding capsule. Other MBS items are available for lymph node procedures and for other types of breast surgery if required. As with any other service eligible for payment of Medicare benefits, the MBS item billed should be appropriate for  the procedure that is clinically necessary for the treatment of the patient.

Contribute to the Australian Breast Device Registry (ABDR)

The Australian Government established the Australian Breast Device Register (ABDR) to track the long-term safety and performance of breast implants to help safeguard health outcomes for patients. The registry is independently managed by Monash University and is endorsed by Australian surgical societies representing plastic and reconstructive surgeons, cosmetic surgeons and general breast surgeons.

The ABDR is the central repository of data for all breast device issues, including BIA-ALCL. The registry collects comprehensive information about breast implants, breast tissue expanders and dermal mesh. Currently, the registry holds breast device details for more than 36,000 patients, which has been provided by more than 460 surgeons from public and private hospitals and day surgeries in all states and territories.

The expert working group, in conjunction with the TGA, strongly endorses the ABDR as the repository of all information relating to breasts implants, including BIA-ALCL.

Report adverse events

In conjunction with reporting to the ABDR, health professionals should report problems with breast implants to the TGA. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

Further information

The TGA regulates breast implants and other medical devices in Australia. We regulate breast implants as high risk medical devices. This means that we evaluate these products for safety, quality and performance before they can be used in surgery. The TGA also works closely with the Australian Breast Device Registry to monitor the ongoing safety and performance of breast implants.

Visit our alert webpage for the latest updates, and the breast implant hub for more detailed information about our role, and actions taken by international and national regulators.

Further reading

Loch-Wilkinson A, Beath KJ, 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. Journal of Plastic and Reconstructive Surgery 2017; 140(4): 645-654. doi: 10.1097/PRS.0000000000003654

Swerdlow SH, Campo E, Pileri SA et al. The 2016 revision of the World Health Organisation classification of lymphoid neoplasms. Blood 2016; 127(2): 2375-2390. doi:10.1182/blood-2016-01-643569

Clemens MW, Medeiros LJ, Cutler CE et al. Complete surgical excision is essential for the management of patients with breast implant-associated anaplastic large-cell lymphoma. J Clin Oncol 2016; 34(2) 160–168. doi: 10.1200/JCO.2015.63.3412

American Society of Plastic Surgeons. BIA-ALCL resources. Retrieved from https://www.plasticsurgery.org/patient-safety/bia-alcl-summary

Clemens MK, Jacobsen ED, Horwitz MD. 2019 NCCN consensus guidelines on the diagnosis and treatment of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Aesthet Surg J 2019; 39(S1): S3–S13. doi: 10.1093/asj/sjy331

Deva AK, Adams WP, Jr., Vickery K. The role of bacterial biofilms in device-associated infection. Plast Reconstr Surg 2013; 132(5):1319-1328. doi: 10.1097/PRS.0b013e3182a3c105

Fleming D, Stone J, Tansley P. Spontaneous regression and resolution of breast implant-associated anaplastic large cell lymphoma: Implications for research, diagnosis and clinical management. Aesthetic Plast Surg 2018; 42(3): 672–678. doi:10.1007/s00266-017-1064-z

Knight R et al. Epidemiology and risk factors for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in Australia & New Zealand. Plast Reconstr Surg Glob Open 2016; 4(9S): 94–95. doi: 10.1097/01.GOX.0000502995.75344.8e

Magnusson M, Beath K, Cooter R et al. The epidemiology of breast implant associated large cell lymphoma in Australia and New Zealand confirms the highest risk for grade 4 surface breast implants. Plast Reconstr Surg 2019. doi: 10.1097/PRS.0000000000005500

Rothman KJ, Greenland S. Causation and causal inference in epidemiology. Am J Public Health 2005; 95(S1): S144-S150. doi: 10.2105/AJPH.2004.059204