Who and what are PIP?
The French company Poly Implant Prosthese (PIP) were making silicone implants (known as PIPs) from as early as 2001, and it is estimated that approximately 45,000 women in the UK have received this particular type of implant (95% for purely cosmetic reasons). The scandal surrounding these implants centres on the fact that industrial grade silicone was used, rather than medical grade. The industrial silicone in this case was supplied by German retailer Brennan AG, who admitted that they would normally supply their silicone for sealing materials in construction and for electrical components. To acquire medical grade status (i.e. be fit for human implantation), rigorous testing of materials, which include mechanical, chemical, animal and clinical evaluations, must be carried out before the product is approved.
PIP did the testing and the implants were approved, so what’s the problem?
After such testing is complete, approval is given by a regulator known as a Notified Body. There are around 80 of these companies in Europe, mostly privately owned and the quality is very variable. The Notified Body who authorised PIP implants was a German company called TUV Rheinland. After the product was authorised, TUV were responsible for annual check-ups on the company -to make sure the manufacturing process, paper work and standards etc were in order. It is suspected that after approval for the implant was given, PIP decided to change the kind of silicone it was using and order the (cheaper) industrial silicone and failed to inform TUV, which they were required to do. TUV, for its part, took PIP at their word during audits and missed the huge paper trial indicating purchases of unauthorised raw materials. So far, this seems to be a French and German problem…
So, how did these implants get into the UK?
Unfortunately, there is no centralised process for approving medical devices and so approval can be sought in any EC member state and then placed on the market in any EC member state. The quality of the Notified Bodies is variable throughout Europe and the quality of the regulators of the Notified Bodies is also variable, which has allowed PIPs to slip through the net and into women, where they have no business being.