The trial in the case of PIP fraudulent breast prostheses (Poly Implant Prothesis) has been held in Marseille since Wednesday April 17th. In question, implants containing an unauthorized industrial gel. More than 5,200 women have filed a complaint against the Var company of Jean-Claude Mas, who admits to having replaced the approved gel with another, less expensive, but not dangerous according to him.
However, the French Agency for the Safety of Health Products (Afssaps) has proven that PIP gel has an irritant power that is not found with approved gels. In the case of breast prostheses, an elastic silicone envelope envelops a liquid silicone gel. It is the latter which is called into question, because, not being compliant, it would have weakened the envelope of the implants and caused a high rate of rupture.
Moreover, in the decision of March 29, 2010 concerning the withdrawal of PIP implants from the market, Afssaps affirms that “the diffusion of silicone through the envelope can generate an embrittlement of the latter and could therefore explain the rate of rupture observed in materiovigilance. A rupture requires an additional surgical intervention whose risk for the patients n ‘is not negligible. In addition, the diffusion of silicone in the organism can also lead to the occurrence of locoregional complications. ” This is because the body does not eliminate the silicone, which ends up accumulating in areas of the body thus forming lymph nodes under the armpits, which causes painful inflammation.
While breast implants have a typical lifespan of 10 years and more, rupture of PIP implants occurs on average at 6.3 years. According to the National Medicines Safety Agency (Ansm), the rate of failed PIP implants currently stands at 25.9%. Among the malfunctions recorded, 85% concern ruptures and perspiration (oozing from the gel). “All breast implants can be affected by these anomalies, but their frequency and precocity are more important in the case of PIP breast implants”, specifies the Ansm in its inventory of April 11, 2013.
