Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
SCHEER Scientific Advice on
breast implants and health
The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published two pieces of Scientific Advice related to breast implants and health. These are on 1) new scientific information on the safety of PIP breast implants; and 2) the state of scientific knowledge regarding a possible connection between breast implants and anaplastic large cell lymphoma.
Content of the advices:
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 SCENIHR Opinion. Based on the newest scientific information evaluated, the SCHEER concluded that there is new scientific information available. It relates to the early and increased PIP implant rupture risk, which suggests that the risk is probably the result of the low quality of the implant’s shell, as already reported in the 2014 Opinion. Based on the new data, the rupture rate of PIP silicone breast implants is calculated as about 23%, which is similar to the 25% - 30% rupture rate indicated in the 2014 Opinion. Based on the new scientific information gathered, the SCHEER concludes that an update of the 2014 Opinion is not warranted.
The second piece of advice is on the current state of scientific knowledge on the possible association between breast implants and anaplastic large cell lymphoma (ALCL). The SCHEER was asked to determine whether sufficient scientific information was available for conducting a full risk assessment. A search of scientific literature has retrieved mostly case reports and case series; as well as several epidemiological studies. The available information suggests that breast implants may be associated with an increased risk of ALCL.
Although the very low incidence of ALCL and the methodological limitations of the available information/studies do not currently allow for a robust risk assessment, the SCHEER recommends that a more in-depth evaluation be conducted on the possible association of breast implants with the development of ALCL.