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Regulators had not approved most PIP implants: lawyer
December 27, 2011 / 7:25 PM / 6 years ago

Regulators had not approved most PIP implants: lawyer

The locked entrance of the French company Poly Implant Prothese (PIP) building is seen in La Seyne-sur-Mer near Toulon, December 27, 2011.Jean-Paul Pelissier

TOULON, France (Reuters) - The lawyer for the French company at the heart of an escalating global breast implant health scare told Reuters on Tuesday that most of the prostheses sold by the firm since 1991 were produced using a silicone that was not approved by health authorities.

Lawyer Yves Haddad, who represents now-shuttered Poly Implant Prothese (PIP) and its founder Jean-Claude Mas, said the company sold both so-called "simple" prostheses made with silicone that was not approved by health authorities and a high-end product using approved silicone for wealthier 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," Haddad told Reuters in an interview in his office.

No charges have been filed in the case that could potentially affect 300,000 women around the world who purchased implants made by the firm.

An involuntary homicide investigation was opened this month after the 2010 death of a French woman from cancer who had PIP implants.

PIP, which began selling implants in 1991, was once the third-largest breast implant maker in the world. It went bankrupt and its doors shut in 2010 after an official inspection revealed it was using industrial-grade silicone in some of its products that was not approved by health authorities, but that was cheaper.

"Why did this company use this kind of product? Because it was a corporation with economic objectives and because of corporate management that tried to get the best cost," he said.

The "house gel" version of the PIP implants was "just as effective but five times cheaper" as the high-end version, according to PIP, Haddad said, noting the company, which employed 120 workers had "sales and results targets".

"There was a basic product and a high-end product, for people in the 16th (arrondissement of Paris) for example," said Haddad, referring to a up market area of Paris.

The company never asked France's medical device safety regulators to approve its house-made product, but expected it would have been, Haddad said.

Haddad said that health regulator AFSSAPS only inspected the PIP factory in La Seyne Sur Mer, an industrial town outside the southern city of Toulon, in March 2010 after receiving an anonymous letter denouncing PIP's practices.

The French government has advised that the 30,000 women in France who bought PIP's implants have them removed. Authorities have said there is no link to cancer, but have cited higher rates of rupture than in other brands. Rupture can cause inflammation and irritation.

Mas has not spoken publicly about the affair and has not been seen since the scandal broke.

"He will express himself in front of the courts," said Haddad.

Philippe Courtois, a lawyer for 1,300 women in France with PIP implants, told Reuters he was stunned that Mas had not yet been charged.

Another lawyer, Laurent Gaudon, who represents four women who have PIP implants, said he planned to file civil complaints against some of the surgeons who implanted the devices.

"A surgeon has a duty of inform his patients, not only about the risks associated with the operation, but also about the advantages and disadvantages of the implants he will insert," Gaudon said.

Earlier on Tuesday, France's health minister tried to calm women's fears over the PIP implants, saying there was no medical need to remove them immediately.

"It's true this is not of an urgent nature," Health Minister Xavier Bertrand told French radio RTL.

Bertrand said the exact number of Frenchwomen with the implants was unknown, but a government hotline set up over the last month had received 9,500 calls and two-thirds of the callers had the implants.

Reporting by Marc Joanny, Jean-Francois Rosnoblet and Natalie Huet; Writing by Alexandria Sage; Editing by Geert De Clercq and Matthew Jones

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