What chemicals & what manufacturing procedures were used by PIP in manufacturing fraudulent implants? ANYONE KNOW?
Doctor Brawer in the USA says:
The Australian Regulator (TGA) did some tests on PIP
|From TGA Australia|
TGA on Cyclic Siloxanes D4, D5, D6
Presence of D4, D5 and D6 siloxanes
AFSSAPS noted that some batches of unauthorised gels contained higher amounts of small silicone molecules (called low molecular weight siloxanes) than the authorised gel. Thus, the TGA is testing the gels to determine the presence of D4, D5 and D6 siloxanes. Test results from GC-MS analyses indicate D4 is present in the gels of PIP breast implants at between 0 and 261ppm, with a median of 136ppm. D5 is present between 0-710ppm, with a median of 434ppm. D5 is present between 0 and 1005, with a median of 470ppm. There does not seem to be any relationship between the year of manufacture of the gel and the presence of D4, D5 and D6 siloxanes. These values could change with the testing of further samples.
Information provided by the suppliers of the raw materials, which were used to produce the gel used in PIP breast implants, together with more recent detailed information provided to the TGA by AFSSAPS, does suggest that the TGA findings are a reasonable estimate of the content of these siloxanes.
The SCENIHR report reproduced this table showing the concentrations of D4, D5 and D6