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Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)

3 June 2019

The TGA has commenced its review and laboratory testing of samples received from the sponsors of breast implants in Australia. Read the update.

Information for health professionals

This page provides information for health professionals on breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). 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, data analysts, public-health practitioners and consumers from around Australia. The last working group meeting was held on 30 January 2019 and determined that further evidence is required before any regulatory or clinical changes. 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.

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. The TGA has been monitoring issues related to BIA-ALCL since 2011 when an association between breast implants and ALCL was first identified.

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.

Inform patients of the benefits and risks

Patients who are considering breast implants should be made aware of the benefits and risks of the different types of implants. They should also be provided with educational material to ensure they can give informed and educated consent. You should provide patients with the breast implant manufacturer's labelling, patient information leaflet, and the patient-specific implant card.

The possibility of BIA-ALCL should be included in informed consent. The disease is rare. A one-number estimate of the risk is not possible with the currently available data, however current expert opinion is that the risk is between 1-in-1000 and 1-in-10,000 women with implants. Most cases occur between 3 and 14 years after insertion of the implant (median: 8 years; range: 1-37 years).[1]

Based on the currently available data, BIA-ALCL does not seem to occur when only smooth implants are used. All Australian cases to date have occurred in women with textured or polyurethane implants.

Women with implants should be made aware of the common presenting symptoms including asymmetry, pain, delayed effusion/seroma or, less commonly, a mass or lymphadenopathy. Women with implants should be encouraged to have regular follow up appointments and to present for immediate clinical assessment should there be any change in size, shape or symptoms related to the breast and/or implant.

Based on the current epidemiological evidence, the expert working group advised the TGA that breast implants were likely to be a necessary, but not solely-sufficient, to cause BIA-ALCL. The expert working group's reasoning included:

  • the ALCL cells occur in close proximity to the implant
  • BIA-ALCL is a distinct clinical entity, separate from other categories of ALCL[2]
  • ALCL, with the distinct features of BIA-ALCL (e.g., ALK-negative, CD30-positive, typical clinical course), has not been reported in the absence of an implant.

The expert panel emphasised that, as with other cancers, the complete set of causal factors is unknown. To date, no patient-specific susceptibility factors, which might help predict risk, have been identified.

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 (hardening of tissue around the implant), movement or rupture of the implant.

Take steps to reduce the risks for your patients where possible

The currently available data suggest that the risk might be reduced by using smooth implants.

In addition, 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.

For women who already have implants, the current consensus of expert opinion is that screening or prophylactic removal in asymptomatic patients is not recommended.

Investigate 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. Patients in Australia are able to have samples tested through national insurance, which means the patient does not bear any cost.

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 cases; there is a medical benefit schedule (MBS) item that relates to MRI for patients diagnosed with BIA-ALCL (item 63547 There does not appear to be a role for mammography.

Removal of the implant is usually curative

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.[3]

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 (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, three deaths have occurred in Australia.

Contribute to the Australian Breast Device Registry (ABDR)

The Australian Government has provided funding to establish the Australian Breast Device Register (ABDR) to track the long-term safety and performance of breast implants as well as identify best surgical practice 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 are encouraged to report problems with medical devices 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's breast implant expert working group met on 8 April 2019 to discuss the current data on BIA-ALCL rates and correlation with type of implant. This followed decisions taken by regulators in France and to remove selected textured implants from their market. The TGA has since commenced its review and laboratory testing of samples. Read the update.

On 28 May 2019, Health Canada released an update to the safety review that was being undertaken in relation to BIA-ALCL. The outcome has been the suspension of Allergan Biocell implants from the market in Canada due to the increased risk of BIA-ALCL with textured implants. The Allergan Biocell implants are the only textured implants available in Canada.

The National Institute for Public Health and the Environment (RIVM) in the Netherlands published the findings of their review of BIA-ALCL on 17 May 2019. As a result, the Minister has decided that the devices will not be subject to further regulatory action in the Netherlands, at this time.

The United States Food and Drug Administration (FDA) released a statement on 2 May 2019 detailing the steps that they will take following a public meeting held by the FDA on 25 and 26 March 2019. The meeting discussed the benefits and risks of breast implants indicated for breast augmentation and reconstruction, including:

  1. breast implant associated anaplastic large cell lymphoma (BIA-ALCL)
  2. systemic symptoms reported in patients receiving breast implants
  3. the use of registries for breast implant surveillance
  4. magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants
  5. the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy
  6. the use of real-world data and patient perspectives in regulatory decision making
  7. best practices for informed consent discussions between patients and clinicians.

A letter was sent by the FDA to health professionals on 6 February 2019 to increase the awareness of BIA-ALCL.

The FDA has acknowledged the latest developments and will publish more information as it becomes available.

The Agency of Medicine and Health Products Safety (known as ANSM; the French Regulator) held a public forum on 7 and 8 February 2019 to hear submissions relating to breast implants. The minutes from this meeting, along with the information from the FDA public meeting, peer-reviewed publications, and their legislation, are the basis for the decision by the ANSM, published on 4 April 2019, that macro-textured and polyurethane-coated implants would no longer be supplied in France.

The Allergan textured breast implants and tissue expanders have been withdrawn from Europe due to a lapse in the EC certification. We have published a statement relating to this matter, which will be updated as new information becomes available.

References and published articles