Association Between Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Risk and Polyurethane Breast Implants: Clinical Evidence and European Perspective

: This article aims to present an overview on the use of polyurethane (PU) breast implants and the possible association with the risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), with a special look at the current situation in Europe. It is well known that the real cause of BIA-ALCL remains unknown. Although this is a rare disease, many interesting theories surrounding its development have been advanced; however, none of these theories has been able to demonstrate with statistical significance, as required by the criteria of evidence-based medicine, definitive clinical proof as to why BIA-ALCL develops. It is widely assumed that the implant surface plays a crucial role. Most BIA-ALCL cases are associated with macro-textured implants, but from a strictly scientific point of view, this link is not supported by any clear clinical evidence. A deeper discussion of the various implant surfaces indicates that adding further categories to the existing surface classification (smooth, micro-, and macro-textured) should be avoided. Moreover, one of the most common misunderstandings should be clarified: PU breast implants cannot be classified as macro-textured implants. The PU foam that covers breast implants provides a completely different surface, and the mechanisms of action related to tissue adhesion, as well as to fibrous capsule formation, differ substantially from those of smooth or textured implants.