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

Interested parties are invited to submit their comments on the scientific evidence online until 07 December 2020.

The main purpose of the scientific opinion is to assist the Commission in assessing the most recent scientific and technical information on breast implants in relation to anaplastic large cell lymphoma (BIA-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 state of the art 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 explantation 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 should cover both reconstructive and augmentation use of breast implants.

More information:

• On the work of the Commission's independent scientific committees