Final Opinion on the safety of breast implants in relation to anaplastic large cell lymphoma

SCHEER WG on on the safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL)
SCHEER members: Wim H De Jong (Chair), Demosthenes Panagiotakos (Rapporteur), Ana Proykova, Theodoros Samaras
External experts: Mark Clemens, Daphne De Jong, Ingrid Hopper, Hinne Rakhorst, Fabio Santanelli di Pompeo, Suzanne Turner
Contact:SANTE-C2-SCHEERec [dot] europa [dot] eu (SANTE-C2-SCHEER[at]ec[dot]europa[dot]eu)
On request from: European Commission
Adopted on: 26 March 2021

The SCHEER was requested by the European Commission to provide a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL).

Literature searches were carried out using PubMed and Find-eR. The publication period covered was from 1 September 2016 to 31 August 2019, and an additional search was performed early in 2020 covering the period from 1 September 2019 to 30 April 2020. In addition, relevant sources and literature beyond this period was considered as well. After excluding all irrelevant papers and duplicate papers, a total of 605 papers remained and were evaluated for this Scientific Opinion.

BIA-ALCL is the occurrence of ALCL adjacent to a breast implant. Diagnosis of BIA-ALCL is achieved by analysis of seroma fluid or if a mass, core needle, incisional or excisional tissue biopsy. Radical en bloc surgical resection (i.e. implant including seroma and intact capsule) with safe margins, including healthy tissue, is recommended as the standard of care treatment, with a very good prognosis. The incidence of BIA-ALCL is considered low, varies by implant type, and is mainly associated with macro-textured implants. However, estimates of incidence have significant limitations related to the frequent use of ad hoc reporting of cases compared with systematic reporting, and the use of sales data provided by manufacturers. Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and ALCL, particularly in relation to implants with an intermediate to high surface roughness.

At this point it should be noted that i) there are several types of textured implants ii) surface textures of breast implants are not all manufactured in the same way, and iii) implants with diverse surface textures may also present different benefits. The magnitude of the risk per type of textured implant is difficult to establish due to the low incidence of the BIA-ALCL. Even with macro-textured implants, BIA-ALCL has a very low incidence. Therefore, risk assessments per implant type are needed. Furthermore, the risk should be weighed against the benefits. There is also a need for an unambiguous, clinically validated classification system for breast implants including more parameters than just “surface roughness”. A history of textured breast implants/expanders appears to be necessary but not sufficient for the development of BIA-ALCL.

The pathogenic mechanisms of the induction of BIA - ALCL are not well understood; current hypotheses include genetic predisposition, bacterial contamination resulting in chronic inflammation, shell shedding of particulates resulting in chronic inflammation, shell surface characteristics leading to friction resulting in inflammation, and implant associated reactive compounds. The disease latency varies between a few to 20 or even more years. There are several alternatives to breast implants that involve plastic surgery techniques, either using autologous flap tissue or autologous fat transfer. However, patients’ characteristics may limit the application of these techniques.

There is a need for further research to better understand the aetiology and pathogenesis of BIA-ALCL. Reporting of new BIA-ALCL cases by the relevant registries is also of major importance to obtain a better estimate of the risk of BIA-ALCL for patients with a breast implant.

Keywords:

breast implants, anaplastic large cell lymphoma, cancer, BIA-ALCL

Opinion to be cited as:

SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Scientific Opinion on the safety of breast implants in relation to anaplastic large cell lymphoma, 26 March 2021.