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Expert opinion

Scientific advice on Evaluation of the availability of new scientific information on the safety of PIP breast implants

Final Opinion

Details

Publication date
28 September 2017
Author
Scientific Committee on Health, Environmental and Emerging Risks (SCHEER)

Description

WG on PIP breast implants
SCHEER members: Wim de Jong, Demosthenes Panagiotakos, Theodoros Samaras
Contact:SANTE-C2-SCHEER@ec.europa.eu
On request from: European Commission
Adopted on: 28 September 2017

Conclusion of the scientific advice:

Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) hereby provides an inventory of new information available on the safety of Poly Implant Prothèse (PIP) silicone breast implants to evaluate whether an update of the 2014 SCENIHR Opinion on the safety of the PIP breast implants (2014 Opinion) is warranted.

In addition to conducting a literature review, a public call for scientific information was launched. The literature review showed that new information is available regarding the possible health effects of PIP breast implants, but this information is rather limited. Also, the public call for information did not result in the submission of scientific papers regarding health effects specific to PIP implants, but rather on breast implants in general. Therefore, on the basis of the new scientific information gathered, the SCHEER concludes that an update of the 2014 Opinion is not warranted.

New scientific information was found relating to the early and increased PIP implant rupture risk, which suggested that the risk was probably due to the low quality of the implant’s shell as already reported in 2014 Opinion. Based on new data, the rupture rate of PIP silicone breast implants was calculated to about 23%, which is similar to the 25% - 30% rupture rate indicated in the 2014 Opinion.

Keywords:

PIP breast implants, implant failure, safety evaluation, toxicity, silicone, risk assessment

Scientific Advice to be cited as:

SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Evaluation of the availability of new scientific information on the safety of PIP breast implants, 28 September 2017.

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