SCHEER - Public consultation on the Preliminary Opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL)

Public health community

Final Opinion
on the safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL)

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) publish the Final Opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL).

Final Opinion

Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided an opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL).

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. In addition, SCHEER recognises that there are several types of textured implants, that surface textures of breast implants are not all manufactured in the same way, and that implants with diverse surface textures may also present different benefits.

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.

The main purpose of the scientific opinion is to support the Commission by assessing the most recent scientific and technical information on breast implants in relation to ALCL.

In particular, the SCHEER has been asked:

1. To briefly describe the specific clinical indications and uses for various types of breast implants.
2. To briefly describe what BIA-ALCL is, the specific diagnostic criteria, the state of the art treatment, and the prognosis of the disease. In relation to ALCL, the good clinical practices for the follow-up of women with breast implants should also be described.
3. To indicate what knowledge there is in terms of incidence of BIA-ALCL.
4. To describe the most recent knowledge regarding the characterisation and classification of textures of the breast implant shells (e.g. is classification possible).
5. To indicate whether a causal relationship between breast implants and ALCL can be established, based on the evidence available to date. To discuss what may be the potential and if possible, the most plausible pathogenesis mechanisms. To evaluate the available information on incubation time, and in relation to this, discuss the importance of knowledge on previous implants’ history of women developing BIA-ALCL. To evaluate if preventive removal of the implant is warranted, in case reasons for concern related to breast implants or specific subcategories of breast implants are identified.
6. To describe the factors that may determine the risk of BIA-ALCL. To identify criteria regarding the characterisation of breast implants in relation to ALCL and control measures to reduce the identified risk.
7. In the context of ALCL to briefly describe alternatives to breast implants.
8. Where relevant to identify needs for further research and the best ways to collect the missing data regarding breast implants and ALCL.

The considerations covered both reconstructive and augmentation use of breast implants.

On the basis of the preliminary version, the Commission launched a public consultation from 26 October to 07 December 2020 inviting interested parties to submit their comments on the scientific evidence.

Results of the public consultation

In addition, a hearing was organised on 16 November 2020.