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European Commission Publishes Scientific Advices Related to Breast Implants and Health

Insufficient scientific information available to establish a methodologically robust risk assessment on the potential association of breast implants with the development of ALCL
11 Apr 2017
Bioethical Principles and GCP

On 7 April 2017, the European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published two Scientific Advices related to breast implants and health, requested by the European Commission. These are on 1) new scientific information on the safety of PIP breast implants and 2) the possible association between breast implants and anaplastic large cell lymphoma (ALCL).

The first piece of advice concerns whether there is sufficient new scientific information on the safety of PIP breast implants to warrant an update of the 2014 Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) Opinion. Based on the scientific information it has gathered and evaluated, the SCHEER concludes that this is not the case at present. See full advice.

The second piece of advice is on the state of scientific knowledge on a possible association between breast implants and ALCL. The SCHEER was asked to determine whether sufficient scientific information is available for conducting a full risk assessment. The SCHEER concluded that, at present, there is insufficient scientific information available to establish a methodologically robust risk assessment on the potential association of breast implants with the development of ALCL. See full advice.

A Public Hearing on these two Scientific Advices will be organised on 29 May in Luxembourg, which aims to present and discuss the scientific basis of these two. Candidates must have appropriate expertise in the field, be able to present and understand the scientific arguments and meet other criteria. Interested parties are invited to register by 7 May 2017.

Last update: 11 Apr 2017

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