The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has issued its preliminary report into the recent scandal and its findings are here.
The questions asked of the expert committee who assembled this report were:
- Are the breast implants manufactured by PIP more prone to failure than those of other manufacturers?
- What are the consequences to health, if any, from PIP implant failures?
The full report is 74 pages long, but for brevity can be summarised as follows:
- It is noted in the report that PIP silicone breast implants vary considerably in composition and, as a result they are likely to vary substantially in performance.
- Tests conducted by the French Authorities on the physical integrity of a sample of PIP silicone breast implants indicated weaknesses in PIP shells not found in other commercially available implants.
- Contents of the PIP implants show no signs of Genotoxicity or Cytotoxicity, but do display an irritant effect not seen in other implants.
Finally, and representative of a form of conclusion, the report states; “The limited clinical data, along with the absence of epidemiologic data on PIP silicone breast implants provide insufficient evidence to warrant a conclusion that women with PIP silicone breast implants have a greater risk to their health than women with breast implants from other manufacturers. In regard to breast implants in general, there is a reasonable number of large, good-quality studies showing no increase in any cancer type or connective tissue disease among women with standard silicone breast implants (including women with ruptured implants). However, in the case of PIP implants, when the limited available clinical information is taken together with the findings from tests of the physical and chemical properties of the shell and silicone, and of the in vivo irritancy test, some concerns are raised about the safety of PIP silicone such breast implants as the possibility for health effects cannot be ruled out.”
Bottom line: Further work needs to be carried out to fully characterise the extent and type of problems likely to be encountered.
Source: European Commission