ALCL risk from breast implants

BAPRAS Position

BAPRAS supports the MHRA in exploring a possible link between breast implants and a rare type of immune system cell cancer called Anaplastic Large Cell Lymphoma (ALCL).

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 only three cases of Anaplastic Large Cell Lymphoma (ALCL) have been reported. Due to the rarity of a diagnosis of ALCL (3 in 100 million per year in the USA diagnosed with ALCL in the breast) a worldwide collaboration is required to provide robust data to investigate this possible link. This need reinforces BAPRAS’ commitment to the International Collaboration on Breast Registry Activities (ICOBRA).

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. ALCL is a lymphoma which is a type of cancer involving cells of the immune system. It is not cancer of the breast tissue.

The most recent clinical studies state that it is not possible to confirm with any certainty whether breast implants have any relation to an increased likelihood of developing Anaplastic Large Cell Lymphoma (ALCL), and particularly whether any one type of implant can create a higher or lower risk than another of developing the disease.

It should be noted that ALCL is extremely rare and treatable. This is evidenced in particular by two recent papers.
•A Danish nationwide study – ’Breast implants and anaplastic large-cell lymphoma: a Danish population-based cohort study’ (reference 1 below) – concluded that in a nationwide cohort of 19,885 women who underwent breast implant surgery between 1973 and 2010, no cases of ALCL were identified.
•A review of cases within another recent comprehensive article, ’Breast implant-associated anaplastic large-cell lymphoma: long-term follow-up of 60 patients’ (reference 2) 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 advises no change to current practice and patients should be advised that ALCL is a very rare condition.

BAPRAS maintains that until any further evidence is presented there is no need to 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 GP or their surgeon.

Further advice for clinicians

Where there is clinical evidence of a possibility of ALCL clinicians need to be aware that implant 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. Discuss your concerns with haematology and histopathology colleagues so that appropriate specialist diagnostic services can be involved.

Where operative intervention is performed the capsule or representative portions of the capsule should be sent for pathological tests to rule out ALCL.

Definitive management of an established case of ALCL must be with the involvement of a specialist Lymphoma MDT.

All cases of ALCL must be reported to the MHRA and information should include
1. Patient age, gender, race/ethnicity.
2. ALCL diagnosis: date of diagnosis, anatomic site of ALCL, whether ALCL was primary in this site and pathologically confirmed
3. Clinical presentation
4. Detailed pathology findings
5. Breast implant exposure: date implanted, brand and type of implant (saline or silicone-filled), type of implant surface (smooth or textured), complications, length of time from implant insertion, and history of subsequent revision surgeries
6. Treatment(s) the patient received
7. Name, contact information and medical specialty of reporter

The practitioner/hospital should keep a secure copy of this information for ease of future audit purposes and in anticipation of a registry of cases.

Where possible the costs of further investigations and operative interventions should be minimised where there is a significant risk of ALCL

References

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]

2-Breast implant-associated anaplastic large-cell lymphoma: long-term follow-up of 60 patients