Non-Hodgkin's lymphoma

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). [7] US Food and Drug Administration. Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL): letter to health care providers. Feb 2019 [internet publication]. https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm630863.htm 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), [8] Loch-Wilkinson A, Beath KJ, Knight RJW, et al. Breast implant-associated anaplastic large cell lymphoma in Australia and New Zealand: high-surface-area textured implants are associated with increased risk. Plast Reconstr Surg. 2017 Oct;140(4):645-54. http://www.ncbi.nlm.nih.gov/pubmed/28481803?tool=bestpractice.com [9] Doren EL, Miranda RN, Selber JC, et al. US epidemiology of breast implant-associated anaplastic large cell lymphoma. Plast Reconstr Surg. 2017 May;139(5):1042-50. http://www.ncbi.nlm.nih.gov/pubmed/28157769?tool=bestpractice.com [10] de Boer M, van Leeuwen FE, Hauptmann M, et al. Breast implants and the risk of anaplastic large-cell lymphoma in the breast. JAMA Oncol. 2018 Mar 1;4(3):335-41. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5885827/ http://www.ncbi.nlm.nih.gov/pubmed/29302687?tool=bestpractice.com 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 labelling, including the patient-specific labelling, 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 individualised 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 programme) and the PROFILE (Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma etiology and Epidemiology) Registry.

Original source of update