Swissmedic Update on BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma)


Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare sub type of non-Hodgkin's lymphoma. In 2016 World Health Organisation (WHO) defined specific diagnostic criteria including expression of the maker CD30+ and negative for ALK. 

Swissmedic is a member of the European and international task force on BIA-ALCL. The task force was established to enable members to pool data and share information on this rare disease. 

The investigation into BIA-ALCL is ongoing and as with all issues, an evidence-based approach is being taken. Research into this area is yet to provide a definitive answer as to how BIA-ALCL develops although there are several competing theories available. In this context, we participated in a workshop of an international expert group consisting of authorities, manufacturer representatives and representatives of the scientific medical societies on BIA-ALCL on Monday, November 19, 2018 (Expert Meeting). 

Although a predominance of the BIA-ALCL cases have been reported in patients treated with textured implants, to date, no controlled clinical trials that compare homogenous samples of patients implanted with smooth and textured implants have been carried out. Scientific proof of causal relationships has not been established and the mechanism for the development of BIA-ALCL is yet to be determined. 

In conformance with the SCHEER expert advice "Scientific advice on the state of scientific knowledge regarding a possible connection between breast implants and anaplastic large cell lymphoma" of October 2017 (SCHEER Report), there is currently insufficient scientific information available to establish a methodologically robust risk assessment to investigate a possible association of breast implants with ALCL development. It was therefore seen as necessary to intensify research in the field of BIA-ALCL and to continue to devote greater attention to better understand this disease. 

As awareness and the number of internationally confirmed cases of BIA-ALCL increase, Swissmedic would like to reiterate the importance for anyone considering breast implant surgery to discuss the risks and benefits with their surgeon. Clinicians should discuss the potential risk of BIA-ALCL when consenting new patient, and with any patient returning for review of their breast implants. If you have any health concerns relating to breast implants, please consult your healthcare professional.