ALCL risk from breast implants

September 2018

BAPRAS Position

BAPRAS supports the MHRA in exploring links between breast implants and a rare type of immune system cell cancer called Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Members must warn prospective patients of the potential risk when counselling them and provide both verbal and written information.

It is estimated that between 5 and 10 million women have breast implants. Since the initial MHRA medical device alert in the UK in 2011 57 cases of Anaplastic Large Cell Lymphoma (ALCL) have been reported (correct at September 2018). Due to the rarity of a diagnosis of ALCL (believed to be in the order of 1:50,000-300,000) a worldwide collaboration is required to provide robust data to investigate the link. This need reinforces BAPRAS’ commitment to the International Collaboration on Breast Registry Activities (ICOBRA).

BIA-ALCL is a lymphoma and not cancer of the breast tissue. When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Over time, a fibrous scar called a capsule develops around the implant, separating it from the rest of the breast. In women with breast implants, the ALCL was generally found adjacent to the implant itself and contained within the fibrous capsule. BIA-ALCL presets with late onset (>1year post implantation), rapid swelling of one breast and it is diagnosed on cytology of the periprosthetic fluid and the CD30 cell count in particular.

BIA-ALCL appears to be related to textured breast implants and it appears to have occurred with textured implants made by every manufacturer. International collation of these cases should allow more information on these links in coming months and years.

It should be noted that ALCL is extremely rare and treatable by excision of the capsule and adjunctive treatment on the recommendation of the appropriate MDT. This is evidenced in particular by a recent paper.

'Breast implant-associated anaplastic large-cell lymphoma: long-term follow-up of 60 patients' (reference 1) concluded that: “most patients with breast implant-associated ALCL, who had disease confined within the fibrous capsule achieved complete remission. Proper management for these patients may be limited to capsulectomy and implant removal. Patients who present with a mass have a more aggressive clinical course that may be fatal, justifying cytotoxic chemotherapy in addition to removal of implants.”

The MHRA currently advises no change to current practice and all patients should be advised that ALCL is a very rare condition. BAPRAS remains in close communication with the MHRA and, if their advice changes, we will pass that on to our members as soon as possible.

BAPRAS maintains that until further evidence is presented there is no need to routinely remove breast implants as a matter of course. We continue to advise that any women with breast implants who experience any sudden unexplained changes, lumps or swelling should speak to their surgeon.

BAPRAS, BAAPS and ABS have been working closely with the Department of Health in setting up of the new national Breast Implant Registry. Surgeons must make sure their patients are registered on it so that any future issues raised by events, such as PIP and BIA-ALCL, can be quickly investigated and patients contacted as is needed

Further advice for clinicians

Where there is clinical evidence (usually late onset, rapid swelling of one breast) of potential ALCL, clinicians need to be aware that diagnosis requires fresh seroma fluid to be sent for cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation (CD) and Anaplastic Lymphoma Kinase (ALK) markers. We recommend you discuss your concerns with haematology and histopathology colleagues so that appropriate specialist diagnostic services can be involved.

Please also inform BAPRAS secretariat of the details of the case so that we can collate the numbers of cases.


1- Breast implants and anaplastic large-cell lymphoma: a danish population-based cohort study
Vase MØ, Friis S, Bautz A, Bendix K, Sørensen HT, d'Amore F.
Cancer Epidemiol Biomarkers Prev. 2013 Nov;22(11):2126-9. doi: 10.1158/1055-9965.EPI-13-0633. Epub 2013 Aug 16.
PMID: 23956025 [PubMed - in process]