Regulatory Focus™ > News Articles > French Device Manufacturer Marketed Unapproved Device for Decades: Lawyer

French Device Manufacturer Marketed Unapproved Device for Decades: Lawyer

Posted 28 December 2011 | By Alexander Gaffney, RAC 

A French company under investigation for selling substandard silicone breast implants used unapproved industrial-grade silicone for implants, according to the company's lawyer.  In an interview with Reuters, Poly Implant Prothese's lawyer, Yves Haddad, said that the company had sold the unapproved version of the device since 1991, while manufacturing an approved version of the prosthetic that was sold to their more affluent clients.  

"There is a product made by PIP which did not formally receive the (regulators') approval and in this regard there was a violation of regulations," said Haddad in his interview with Reuters.  Haddad further said that the company had done so to meet economic objectives by shaving down on costs.  The industrial grade silicone represented a five-fold decrease in costs over the approved medical-grade silicone.

The revelations could prove to be embarrassing for the French regulatory authority, which is still reeling after the Mediator scandal earlier this year exposed lax oversight and potentially thousands of premature deaths.  Haddad further claimed that PIP's manufacturing plant had gone without inspection until 2010, when the French regulatory authority received an anonymous tip regarding the company's actions.

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