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.
Consultant
Department of Haematology-Oncology
National University Cancer Institute
Singapore
EC declares that she has no competing interests.
Consultant
Department of Haematology-Oncology
National University Cancer Institute
Singapore
CHN declares that he has no competing interests.
Consultant
Department of Haematology-Oncology
National University Cancer Institute
Singapore
MO declares that she has no competing interests.
Senior Consultant
Department of Haematology-Oncology
National University Cancer Institute
Singapore
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.
Associate Professor Surgery
Department of Cell Biology and Anatomy
University of Miami School of Medicine
Coral Gables
FL
LGK declares that he has no competing interests.
Consultant Haematologist
Department of Haematology and Stem Cell Transplantation
Heartlands Hospital
Birmingham
UK
SP declares that he has no competing interests.
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