NEWS The PIP Breast Implant Scandal
Chronology:
As early as in May 2000 the US Food and Drug Administration performed an inspection of the PIP production site in Southern France. As a result of this inspection the sale of PIP implants was stopped in the US. In a letter to Jean-Claude Mas, the owner of PIP, the FDA stated that the implants were "adulterated" along with eleven other deviations from good manufacturing practices such as lack of sufficient investigation of deflation rate and failure of reporting 120 complaints.
Whether the French Health Authority AFSSAPS was informed by the FDA, about the results of their inspection or not, is unclear.
PIP must have started to exchange the medical grade silicone for industrial silicone probably in 2003. For a while, PIP used both types of gel but probably stopped using medical grade gel around 2005. From that time on, most likely they only used industrial silicone. Roughly estimated: there must have been around 200 000 kilograms of industrial silicone delivered to PIP and nobody considered this suspicious!
Inspections were performed by TÜV Rheinland regularly but they all were announced ten days prior to their visit, which is in accordance with the requirements of the European Medical Device Law.
Starting in 2008, more and more plastic surgeons reported a high failure rate in PIP implants. After an investigation by AFSSAPS, the French Health Authorities banned PIP implants in spring of 2010.
Obviously the PIP implant stock or at least part of it was sold to the Netherlands and the distribution was continued by Rofil Medical under the name "M-implant". When the Dutch health authorities found out that PIP and M were identical, M-implants were banned in June 2010.
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