Breast implant associated anaplastic large cell lymphoma (ALCL)

Breast Implant Associated-ALCL (BIA-ALCL)

In 2016, the World Health Organisation (WHO) defined a new type of anaplastic large cell lymphoma (ALCL), which is, itself, an uncommon type of non-Hodgkin lymphoma with several subtypes

• WHO labelled this new variant as breast implant associated anaplastic large cell lymphoma or BIA-ALCL*
• has specific diagnostic criteria, which include positive expression of the marker CD30, negative for ALK, and a distinct cell morphology
• most common symptom for people with BIA-ALCL around breast implants, is fluid collecting around the implant ('late' seroma)
  • the patient may notice a fairly quick, but painless, increase in size of the affected breast, usually over a few weeks. In some cases, it can affect both sides at the same time
  • most cases have happened years after surgery
  • very rarely BIA-ALCL has been found when a lump develops next to an implant, or within the tough fibrous tissue that can build up around an implant (termed the capsule)
• in the UK, the current estimated incidence of BIA-ALCL, based on confirmed cases, is 1 per 14,200 implants sold
  • as of 31 December 2023, we had received 106 reports of confirmed BIA-ALCL where the surgery occurred in the UK and 6 reports where the surgery occurred outside of the UK
    • the current estimated incidence of BIA-ALCL, based on confirmed cases where surgery occurred in the UK, is 1 per 14,200 implants sold
  • estimate is based on data for all types of breast implants, including breast tissue expanders
  • of the confirmed cases of BIA-ALCL in people with breast implants in the UK, there has been one death reported to the MHRA
    • three deaths from ALCL were reported to the MHRA which did not meet the WHO diagnostic criteria for BIA-ALCL
  • overall survival rate for patients diagnosed with BIA-ALCL is 89% at 5 years
    • rate is significantly higher for patients with Stage I disease who undergo complete capsulectomy and implant removal

Information for healthcare professionals

Clinicians have a legal obligation to discuss the potential risk of BIA-ALCL when seeking informed consent of new patients, and with any patient returning for review of their breast implants.

When reporting a case of BIA-ALCL in patients with breast implants, surgeons are reminded to include (where it is known):

• the patient’s CD30+/-, ALK +/- status
• full details of the device, including manufacturer, model, surface texture (as identified by the manufacturer)
• the presenting clinical features and the subsequent management
• other information including the dates of initial implantation, revision, and explantation
• information on previous implants, particularly whether tissue expanders have been used and for how long

Reference:

• MRHA. Breast Implant Associated-ALCL (BIA-ALCL) (Accessed 30/08/25)
• Joint statement between ABS, BAAPS, BAPRAS & MHRA on BIA-ALCL, July 2018