Directorate General Health & Consumers
A public consultation on the preliminary opinion was open from 29 October 2013 to 3 January 2014. Submissions received during the public consultation were carefully examined by the SCENIHR and, when relevant, taken into account in the final opinion. The text of the comments received and the response provided by the SCENIHR is available here.
Content of the opinion:
The silicone Poly Implant Prothèse (PIP), which has been produced in France since 2001, had been found to contain non-medical grade silicone and had thus not been produced according to legal requirements to achieve CE marking. It is estimated that worldwide about 400.000 women have received these implants.
PIP breast implants are reported to have a higher prevalence and incidence of implant ruptures than other silicone breast implants, and that ruptures also tend to occur earlier in the implant life than is the case with other implants.
Since the previous SCENIHR opinion on PIP breast implants in February 2012 several cyclic siloxanes (known as D4, D5 and D6) have been identified in PIP devices at higher concentrations than in other silicone breast implants. This has led to investigate the possible toxicological consequences of cyclic siloxanes release from damaged PIP implants. It became apparent that these chemicals are commonly present in the bodies of women even without breast implants. This is a consequence of the widespread use of siloxanes in many domestic products. Cyclic siloxanes D4, D5 and D6 are non-toxic and not irritant in standard tests.
In some cases, implant gel-bleed or rupture has been associated with an inflammatory reaction either locally or in regional lymph nodes. In other cases, ruptures were free of symptoms. Neither implant rupture, nor local inflammation, has been found to be associated with breast cancer or anaplastic large cell lymphoma. While there are differences in rupture rates, there is no reliable evidence that ruptured PIP implants create a greater health risk than a ruptured silicone breast implant from another manufacturer.
SCENIHR confirms that PIP silicone breast implants have far higher rupture rates than breast implants by other manufacturers. However, to date, no increased health risk has been associated with exposure to silicone gel emanating from a ruptured PIP implant, as compared with a conventional implant from another manufacturer.
SCENIHR concluded that explantation is advised in the case of implant rupture; however, there are no convincing medical, toxicological or other data to justify routine removal of intact PIP implants. However, the decision to remove an intact PIP implant for this reason should be based on an individual assessment of the woman's condition by her surgeon or other treating physician after consultation.