Safety of Poly Implant Prothèse (PIP) Silicone Breast Implants (2013 update)

WG on PIP2 (Breast implants)
SCENIHR members: Hartemann
External experts: Jim Bridges, Wim De Jong, Marita Eisenmann-Klein, Jorge Garcia, Ian Kimber, Lisbet Rosenkrantz Hölmich, Dirk W . Schubert, Carlos Vázquez Albaladejo
Acknowledgement: Members of the Working Group are acknowledged for their valuable contribution to this opinion.
Contact: SANCO-C2-SCENIHRec [dot] europa [dot] eu (SANCO-C2-SCENIHR[at]ec[dot]europa[dot]eu)
On request from: European Commission
Doi: 10.2772/66097
Adopted on: 12 May 2014

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. 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. The 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. The 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.

Keywords:

SCENIHR, PIP breast implants, implant failure, safety evaluation, toxicity, silicone

Opinion to be cited as:

SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), Scientific opinion on the Safety of Poly Implant Prothèse (PIP) Silicone Breast Implants (2013 update), 12 May 2014.