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Public consultation on BIA-ALCL

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

 Preliminary Opinion

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

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).

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 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.

In line with the Stakeholder Dialogue Procedures (Annex V to the Rules of Procedures of the Scientific Committees), the Scientific Committees are now seeking feedback from the scientific community and stakeholders on this Opinion.

All interested parties are invited to submit written comments on the Preliminary Opinion by 07 December 2020 in view of gathering specific comments, suggestions, explanations or contributions on the scientific basis of the Opinion, as well as any other scientific information regarding the questions addressed, to enable the Scientific Committees to focus on issues that need to be further investigated.

The electronic template provided with the documents should be used exclusively for the submission of comments, with reference made to the line and page numbers. Please note that comments submitted by email or post cannot be taken into account.

As stated in the Rules of Procedures (Annex V), a submission will not be considered if:

  • it is submitted after the deadline set out in the call,
  • it is presented in any other form than the template provided,
  • it exceeds the maximum length indicated for each section, or contains comments which do not correspond to the indicated title of that particular section,
  • it contains information on individual cases or any other material not included in published reports,
  • it contains complaints against institutions, personal accusations or irrelevant or offensive statements or material. Complaints should be made according to the existing procedures,
  • it is related to policy or risk management aspects.

The Scientific Committee will assess all comments from interested parties which are submitted in line with the criteria above and will take them into consideration if they are found relevant.

The European Commission reserves the right to publish all comments received on the Scientific Committees' website. Please read the Privacy statement before submitting comments.

 Submit comments (deadline: 07 December 2020 23:59 CET)
 

For more information