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Originally published Wednesday, April 17, 2013 at 5:38 PM

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French maker of faulty breast implants goes on trial

Hundreds of women who crowded into a makeshift courtroom claimed they were cheated by Poly Implant Prothèse, which is accused of using cheap silicone to fill tens of thousands of implants that were prone to ruptures and leaking.

The New York Times and The Associated Press

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PARIS — The founder of a French company accused of selling hundreds of thousands of defective breast implants to more than 65 countries appeared Wednesday in a courthouse in Marseille, with more than 300 victims in attendance.

The founder, Jean-Claude Mas, and four of his former employees are accused of aggravated fraud after their company, Poly Implant Prothèse (PIP), used an inferior, industrial-grade silicone to fill implants for a decade. The trial is expected to last a month. If convicted, Mas and his colleagues could face up to five years in prison.

The company, founded in 1991, was closed by the French authorities in March 2010. In 2012, Mas acknowledged that he had used a cheaper, unapproved product, but he argued that it was not harmful. The implants ruptured at a much higher rate than the industry norm, leaking silicone into body tissues.

Many health authorities have failed to find evidence that the leakage causes cancer, but after a Frenchwoman whose implant had ruptured died from a rare cancer called anaplastic large-cell lymphoma, several countries, including France, Germany and the Netherlands, urged women to have the implants removed. About 300,000 women received them around the world. The implants were not approved for sale in the United States.

Mas’ lawyers said the number of women listed in the case as victims is the largest in French judicial history and argued that the trial was too unwieldy to continue. The packed hearing room had six large-screen televisions placed at even intervals to allow even those at the back to see, and judges frequently admonished spectators into silence.

A former employee, who attended the trial Wednesday but asked not to be named because of the criminal allegations, said those who worked at the plant were told not to ask too many questions, even when women complained directly about medical problems. The employee said he suffered lung problems he blamed on years of handling unknown chemicals.

As investigators began uncovering the fraud, he said workers at the plant grabbed tubs of toxic materials and dumped them into the sewers to avoid detection.

A lawyer for TUV Rheinland, the German company that cleared PIP for certification, said its inspectors were also victims of a companywide deception.

“The bad gel was taken away in trucks, the computer system was scrubbed of all references to it. Every employee lied. All the documentation was falsified,” said Olivier Gutkes, a lawyer for TUV.

Doctors and scientists who have followed the case say medical complications stemming from the ruptures and leaks appear to be limited: rashes and localized pain were the most common complaints. But lawyers for the women say the full effects will not be known for years.

According to various government estimates, more than 42,000 women in Britain received the implants, more than 30,000 in France, 25,000 in Brazil and 15,000 in Colombia. Venezuela, where PIP implants were hugely popular, offered free removals for the estimated 16,000 women with the implants, as did France.

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