Updated information on BIA-ALCL

Affected products: Breast implants, all types, makes and models of all manufacturers

Background:
Swissmedic has repeatedly published information on BIA-ALCL:

Version dated 12/2024

Breast implants are medical devices^[1] that are used to increase the size of or reconstruct the breast. They can have various surface structures (usually smooth or textured) and are made from various materials.

In the past, there was uncertainty regarding the occurrence of breast implant-associated diseases, particularly a certain type of lymphoma (breast implant-associated-anaplastic large cell lymphoma (BIA-ALCL)).

Over the 12 years from 2012 to the end of July 2024, Swissmedic received reports of a total of 21 cases of BIA-ALCL that were detected in Switzerland.

More than 10 million women worldwide have breast implants. Recent investigations estimate that 1 in 3,000 to 30,000 women with breast implants develop BIA-ALCL, although certain studies indicate higher incidence rates.^[2][3][4]

Please note: It is important that specialists and patients are informed of the risk of BIA-ALCL and that all suspected and confirmed cases of BIA-ALCL are reported to Swissmedic (using the user report form), with the aim of improving breast implant safety over the long term.

Patient information:

• If you have health concerns connected with your implants, please consult a healthcare professional.
• Symptoms of BIA-ALCL include severe swelling of the breast, changes to the skin or palpable lumps. In cases of BIA-ALCL, the symptoms usually only appear years after implantation.
• It is important to seek medical advice quickly if you notice such symptoms.

Additional information for specialists:

• BIA-ALCL is the rare occurrence of a lymphoma in the tissue surrounding the breast implant. Since 2016, it has been defined as a separate disease by WHO and its morphological and immunophenotypic features are indistinguishable from ALK-negative anaplastic large cell lymphoma (ALCL).^[5]
• Only around 1/3 of patients have axillary lymphadenopathy4.
• BIA-ALCL usually has an indolent clinical course and a good prognosis if it is diagnosed and treated at an early stage.^[6],[7]
• It is usually diagnosed by the presence of fluid in the tissue (seroma) around the implant and biopsy.
• While the content of the implant (saline solution or silicone) appears to play no role in pathogenesis, the surface structure does.^[8]
• The suspected pathogenic triggers include the biofilm and the silicone envelope, which have a direct or indirect immunogenic effect. ^[9],[10]
• Regular follow-up examinations are important after a breast implant is placed to detect complications at an early stage.
• There is clear evidence that the risk of BIA-ALCL is greater with textured breast implants than with implants with a smooth surface^[11]. The FDA (Food and Drug Administration) found the following figures in a random sample of BIA-ALCL from 520 reports in 2019 and 733 reports in 2020. Of the implants concerned, 67% and 68% respectively were textured implants and 5% and 4% respectively were smooth-walled.^[12]
• Swissmedic recommends that specialists communicate the risks and benefits of breast implants clearly and carefully weigh up the alternatives before carrying out such procedures.

^[1] _{MedDO Art. 3 Medical device and accessories}

^[2] _{Doren EL, Miranda RN, Selber JC, et al. U.S. Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Plastic and reconstructive surgery. 2017;139(5):1042-1050.}

^[3] _{Cordeiro PG, Ghione P, Ni A, et al. Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants. Journal of plastic, reconstructive & aesthetic surgery: JPRAS. 2020;73(5):841-846}

^[4] _{Nelson JA, Dabic S, Mehara BJ, et al. Breast Implant-associated Anaplastic Large Cell Lymphoma Incidence: Determining an Accurate Risk. Annals of surgery. 2020;272(3):403-409}

^[5] _{WHO Classification of Tumors of Haematopoietic and Lymphoid Tissues, revised 4^th Edition, Edited by Steven H.Swerdlow et al., International Agency for Research on Cancer, Lyon, 2017. P.421}

^[6] _{WHO Classification of Tumors of Haematopoietic and Lymphoid Tissues, revised 4^th Edition, Edited by Steven H.Swerdlow et al., International Agency for Research on Cancer, Lyon, 2017. P.422}

^[7] _{The Crucial Role of Surgical Treatment in BIA-ALCL Prognosis in Early- and Advanced-Stage Patients; Campanale, Antonella M.D. et al, Plastic and Reconstructive Surgery 146(5):p 530e-538e, November 2020.}

^[8] _{Miranda RN, et al. Breast implant-associated anaplastic large-cell lymphoma: long-term follow-up of 60 patients. J Clin Oncol. 2014 Jan 10;32(2):114-20.}

^[9] _{Malcolm TI, et al. Challenging perspectives on the cellular origins of lymphoma. Open Biol. 2016 Sep;6(9):160232.}

^[10] _{Institute of Medicine (US) Committee on the Safety of Silicone Breast Implants. Safety of Silicone Breast Implants. Bondurant S, Ernster V, Herdman R, editors. Washington (DC): National Academies Press (US); 1999.}

^[11] _{Scientific Committee on Health, Environmental and Emerging Risks (SCHEER); Final Opinion on the safety of breast implants in relation to anaplastic large cell lymphoma, p.31f}

^[12] _{https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma}