Call for information
A call for information on possible association between breast implants and anaplastic large cell lymphoma is also available here.
Call for Information – Safety of PIP silicone breast implants
The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has received a request to organize a call for data and a literature review to monitor the publication of new and valid scientific information related to the safety of PIP silicone breast implants and to carry out a scientific evaluation of the said scientific information.
As a result of this review, the SCHEER should indicate if there is sufficient new scientific information to warrant for an update of the previous Opinion on the PIP silicone breast implants.
Scope of the call for information:
This call for information is being launched according to the stakeholders dialogue procedures laid down in the Rules of procedure of the Scientific Committees.
The objective of this call for information is to ensure that all relevant scientific information is available to the Scientific Committee for its assessment.
The new scientific data should relate to every field needed to assess the safety of PIP silicone breast implants and especially those covered by the previous Opinion, such as the physiochemical properties of PIP implants, their toxicology, the clinical impact and recommendations.
Interested parties are invited to submit the following information:
1) Scientific peer-reviewed research papers and reviews concerning the safety of PIP silicone breast implants;
2) Other publicly available scientific information that may not be easily accessible and which is directly relevant to this issue.
Studies will be considered by the SCHEER following the criteria defined by the "Memorandum on the use of the scientific literature for human health risk assessment purposes – weighing of evidence and expression of uncertainty"
Only submissions directly related to the call and complying with its specifications will be considered.
Submission of information:
All information should be submitted in electronic form to SANTE-C2-SCHEER@ec.europa.eu specifying “Call for Information - Safety of PIP silicone breast implants” in the subject line of the e-mail.
All information is considered public unless otherwise stated by the provider.
A document on guidelines for submission of contributions, containing criteria for the call for information and guidance for submission can be found here.
The deadline for submitting information is 4 September 2016, 23:59. However the call for information remains open after this date, until 20 November 2016, and additional studies (e.g. on-going studies and research that are not completed by the deadline) were passed to the working group.
More information about SCHEER and the other Scientific Committees of the European Commission can be found here.