UK Guidelines on the Diagnosis and Treatment of Breast Implant‐Associated Anaplastic Large Cell Lymphoma on behalf of the Medicines and Healthcare products Regulatory Agency Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group

Abstract

Summary Breast implant‐associated anaplastic large cell lymphoma (BIA‐ALCL) is an uncommon T‐cell non‐Hodgkin Lymphoma (NHL) associated with breast implants. Raising awareness of the possibility of BIA‐ALCL in anyone with breast implants and new breast symptoms is crucial to early diagnosis. The tumour begins on the inner aspect of the peri‐implant capsule causing an effusion, or less commonly a tissue mass to form within the capsule, which may spread locally or to more distant sites in the body. Diagnosis is usually made by cytological, immunohistochemical and immunophenotypic evaluation of the aspirated peri‐implant fluid: pleomorphic lymphocytes are characteristically anaplastic lymphoma kinase (ALK)‐negative and strongly positive for CD30. BIA‐ALCL is indolent in most patients but can progress rapidly. Surgical removal of the implant with the intact surrounding capsule (total en‐bloc capsulectomy) is usually curative. Late diagnosis may require more radical surgery and systemic therapies and although these are usually successful, poor outcomes and deaths have been reported. By adopting a structured approach, as suggested in these guidelines, early diagnosis and successful treatment will minimise the need for systemic treatments, reduce morbidity and the risk of poor outcomes.

Current Challenges in Breast Implantation

“…Nevertheless, the incidence of this condition is more prevalent than expected, as shown in recent Review by Santanelli di Pompeo et al [50] Although most cases are indolent, the clinical features may include redness, breast pain and swelling, asymmetry, palpable tumour, seroma or ulceration [52][53][54]. Diagnosis is verified by cytological, immunohistochemical and immunophenotypic assessment of the aspirated peri-implant fluid [54]. Reports indicate that the ALCL affects patients with silicone and saline breast implants with a textured surface or tissue expanders [24,46,55].…”

“…Until now, the American Society of Plastic Surgeons Patient Registry has already collected 518 cases of BIA-ALCL from 25 countries [46], with the incidence defined at approximately one to three per million per year [46,51]. Nevertheless, the incidence of this condition is more prevalent than expected, as shown in recent Review by Santanelli di Pompeo et al [50] Although most cases are indolent, the clinical features may include redness, breast pain and swelling, asymmetry, palpable tumour, seroma or ulceration [52][53][54]. Diagnosis is verified by cytological, immunohistochemical and immunophenotypic assessment of the aspirated peri-implant fluid [54].…”

“…Research into the genetic factors predisposing to the development of a BIA-ALCL is still ongoing, emphasising the activation of the JAK/STAT path among patients with confirmed lymphoma [52,58]. Total en-bloc capsulectomy is recommended in symptomatic patients as usually curative treatment [53,54,59]. However, late diagnosis may indicate a necessity of more invasive therapy [54].…”

“…Total en-bloc capsulectomy is recommended in symptomatic patients as usually curative treatment [53,54,59]. However, late diagnosis may indicate a necessity of more invasive therapy [54]. Adjuvant chemotherapy, based on anthracycline with brentuximab vedotin following the ECHELON II trial results, is dedicated to patients with advanced disease [60,61].…”

“…Currently, there are no studies that could confirm this theory [63,65,66]. However, a constantly increasing percentage of patients report symptoms negatively affecting their mental and physical functioning [54]. Chronic pain and fatigue, memory and concentration disorders, panic attacks, and depression [64].…”