ROME (Reuters) - Italy’s plastic surgeons association on Wednesday sued the French company that made substandard breast implants and the German certification company that checked its products for fraud and said its members would consider themselves injured parties.
The association said its lawyers had filed the suit in a Rome court against the now defunct company Poly Implant Prothese (PIP) and Germany’s TUV Rheinland.
“Surgeons who used the incriminating implants were as much the objects of fraud as were the patients,” the association’s vice president, Mario Pelle Ceravolo, said.
He said the surgeons had been “tricked” by a product that had the European Union’s mark of approval and had all the physical characteristics of a bonafide product.
“Doctors who used the PIP implant cannot be blamed ...” he said.
French inspectors ordered them off the market in March 2010, due to concerns over their quality.
But only last month did officials in Paris recommend their surgical removal, drawing attention to the problem for patients worldwide who had been fitted with products from the company, which was at one time the third biggest global supplier.
PIP enjoyed years of success with international sales but the company was hiding from certification agencies the fact they were using cheap, industrial silicone, not approved for medical use.
In December, the French government advised women with PIP implants to have them removed, and said it would pay for the operations in France, sparking alarm around the world.
Officials in several other countries, including Britain and Brazil, have asked women to visit their doctors for checks.
TUV Rheinland, the German certification body that checked PIP’s products until March 2010, has said its remit was to look into the manufacturing process but not the content of the silicone used in the implants.
Some 4,300 women in Italy may have been fitted, with the sub-standard implants, a spokeswoman for the association, which represents more than 100 doctors, said.
The health ministry has asked doctors, hospitals and clinics to provide the names of woman who have received the implants.
About 300,000 PIP implants were sold worldwide before the French company went out of business last year.
Reporting By Philip Pullella; Editing by Giles Elgood