Last reviewed: March 2019
Last updated: March  2019
15 Mar 2019

FDA issues alert over link between breast implants and anaplastic large cell lymphoma

The US Food and Drug Administration (FDA) has issued a letter to alert healthcare providers to the increased risk of anaplastic large cell lymphoma associated with all types of breast implant (BIA-ALCL). [6] Although the absolute risk of developing BIA-ALCL is small (estimated incidence rate ranging from 1 in 3817 patients to around 1 in 30,000), [7] [8] [9] the FDA wants to ensure healthcare providers expedite diagnosis and reporting of BIA-ALCL.

BIA-ALCL usually develops within the scar tissue (capsule) around implants. In most cases reported to the FDA, diagnosis was made following treatment of implant-related symptoms (e.g., pain, lumps, swelling) at the initial surgical site when fully healed. Most cases of BIA-ALCL have occurred with textured implants, but there have been reports of BIA-ALCL occurring with smooth-surface implants.

The FDA letter includes the following recommendations for healthcare providers in the US:

  • Ensure patients are aware of the benefits and risks of different types of implants by providing the breast implant manufacturer's labeling, including the patient-specific labeling, and other educational material prior to surgery

  • Suspect BIA-ALCL in patients with late-onset, peri-implant seroma (some patients may present with a mass or masses adjacent to the implant) and refer to a multidisciplinary team for evaluation

  • Collect fresh seroma and representative portions of the capsule for pathology testing and cytological evaluation

  • Develop an individualized treatment plan with the patient's multidisciplinary team, and consider current clinical practice treatment guidelines

  • Report confirmed cases to MedWatch (the FDA safety information and adverse event reporting program) and the PROFILE (Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma etiology and Epidemiology) Registry.

Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • night sweats
  • weight loss
  • fatigue/malaise
  • fever

Other diagnostic factors

  • lymphadenopathy
  • massive splenomegaly in marginal zone lymphoma
  • hepatomegaly
  • shortness of breath
  • cough
  • abdominal discomfort
  • headache
  • change in mental status
  • dizziness, ataxia
  • chest pain
  • bone pain, back pain (bone involvement)
  • jaundice
  • pallor
  • purpura
  • skin lesions
  • neurologic abnormalities on exam

Risk factors

  • age >50 years
  • male sex
  • immunocompromised host
  • Epstein-Barr virus (EBV)
  • human T-lymphocytotrophic virus-1 (HTLV-1)
  • human herpesvirus-8
  • Helicobacter pylori
  • celiac disease
  • HIV
  • organ transplant
  • hepatitis C virus (HCV)
  • Borrelia burgdorferi¬†
  • Sjogren syndrome
  • rheumatoid arthritis
  • systemic lupus erythematosus (SLE)
  • common variable immunodeficiency
  • Wiskott-Aldrich syndrome
  • ataxia-telangiectasia
  • Chediak-Higashi syndrome
  • Klinefelter syndrome
  • pesticides
  • phenoxyherbicides
  • breast implants

Diagnostic investigations

1st investigations to order

  • CBC with differential
  • blood smear
  • lymph node biopsy
  • skin biopsy
  • bone marrow biopsy
  • basic metabolic panel
  • liver function tests
  • LDH
Full details

Investigations to consider

  • flow cytometry
  • immunohistochemistry
  • polymerase chain reaction for tumor markers
  • immunoglobulin gene rearrangement studies
  • cytogenetics studies with or without fluorescence in situ hybridization (FISH)
  • hepatitis B and C serology
  • HIV antibody
  • lumbar puncture
  • colonoscopy
  • CT scan
  • multiple-gated acquisition scan
  • echocardiography
  • PET scan
Full details

Emerging tests

  • gene expression profiling
Full details

Treatment algorithm

Contributors

Authors VIEW ALL

Consultant

Department of Haematology-Oncology

National University Cancer Institute

Singapore

Disclosures

EC declares that she has no competing interests.

Consultant

Department of Haematology-Oncology

National University Cancer Institute

Singapore

Disclosures

CHN declares that he has no competing interests.

Consultant

Department of Haematology-Oncology

National University Cancer Institute

Singapore

Disclosures

MO declares that she has no competing interests.

Senior Consultant

Department of Haematology-Oncology

National University Cancer Institute

Singapore

Disclosures

MP has received sponsorship from Sanofi and Janssen to attend conferences.

Dr Esther Chan, Dr Chin Hin Ng, Dr Melissa Ooi, and Dr Michelle Poon would like to gratefully acknowledge Dr Boris Kobrinsky and Dr Kenneth B. Hymes, previous contributors to this topic.

Peer reviewers VIEW ALL

Associate Professor Surgery

Department of Cell Biology and Anatomy

University of Miami School of Medicine

Coral Gables

FL

Disclosures

LGK declares that he has no competing interests.

Consultant Haematologist

Department of Haematology and Stem Cell Transplantation

Heartlands Hospital

Birmingham

UK

Disclosures

SP declares that he has no competing interests.

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