(Reuters) — A French appeals court today overturned a negligence conviction against certification agency TUV Rheinland for its role in approving faulty breast implants produced with counterfeit silicone by manufacturer PIP until its 2010 closure.
In a statement, the Aix-en-Provence appeals court said the German agency had “respected the obligations incumbent upon it as a certifying organization”.
Poly Implant Prothèse, the French company at the centre of the scandal, sold implants globally over almost 2 decades until French regulators discovered it was passing off low-grade industrial silicone as a much pricier medical product.
The counterfeit substance was used in implants given to some 300,000 women. About one-quarter of those subsequently removed were found to have ruptured, regulators said, raising concerns over the long-term health effects of exposure to their contents.
Company founder Jean-Claude Mas was jailed for four years and fined €75,000 ($83,000) in 2013 after a police investigation revealed a sophisticated fraud.
PIP employees would remove evidence of the cheaper silicone gel before annual inspections by TUV Rheinland, it found.
“TUV Rheinland welcomes this verdict,” the agency’s lawyer, Cécile Derycke, said on Thursday.
“The fraud committed by PIP could not have been detected by TUV Rheinland with the tools granted to certification organisations under current regulations.”
($1 = €0.9036)