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.