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Special Report: The French breast implant scandal

SUMMARY: This special report from Reuters Health brings you the details of the PIP implant scandal. Investigators found the company using industrial-grade silicone. While the company that sold the faulty implants internationally is out of business, many of the implants have split open, endangering the health of the women who received them.
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MARSEILLE, France (Reuters) - In March 2010, a pair of health inspectors acting on a tip paid a three-day visit to a factory in this hilly town on the Mediterranean coast.

The factory was the headquarters of Poly Implant Prothese (PIP), a leading international maker of breast implants founded by French entrepreneur Jean-Claude Mas. The inspectors found something odd: six discarded plastic containers of Silopren, a liquid silicone designed for industrial, not medical use, lined up along the outside wall of the production site.

A week later, gendarmes descended on the plant. Mas skipped out just ahead of them, eluding interrogation for nearly eight months, but his game was up. In the nearly two years since, the cheap silicone used in PIP's fake breasts has continued to leach into women's bodies. In France, 1,262 of the roughly 300,000 breast implants the company sold worldwide have split open in the past two years. PIP has been closed down, Mas has been arrested and put under investigation for alleged bodily harm, and French and European safety regulators have been thrust into an uncomfortable spotlight.

Mas, 72, a grocer's son from the south of France, had no scientific training. Yet for the first decade of this century he was able to manufacture and sell faulty breast implants on international markets that he and some of his employees knew to be substandard, according to testimony given to French police and seen by Reuters.

The history of breast implants is littered with flawed devices, a colorful cast of intertwined players and billion-dollar lawsuits. Reuters reviewed hundreds of pages of police investigation transcripts and financial documents, and interviewed former PIP employees, the company's suppliers, customers and health experts, to piece together this latest chapter in that history.

It is a tale of a haphazardly run and cash-strapped company that allegedly took desperate and sometimes deceptive steps to shave costs and hide the true ingredients of its devices. PIP's efforts were made easier by a European regulatory regime that had been essentially outsourced to the very companies that are meant to be regulated.

Among the new details to emerge: PIP was able to save an estimated 1.2 million euros ($1.6 million) in one year by using the industrial-grade silicone in its implants, according to figures cited by police investigators. And it relied on crude, unscientific tests of product quality, such as judging silicone gel by sticking a finger in it, according to one former worker. Some 75 percent of its implants used the non-approved, cheaper gel, Mas told police.

"Maybe it's shameful, but there you go," Yves Haddad, a lawyer who represents both Mas and his now-defunct company, told Reuters at the end of December. "We live in a capitalist world."

Mas, who declined to comment for this story, has said his products are harmless. After the health ministry advised Frenchwomen to have the devices removed, he told French radio network RTL last month that the decision was "criminal" and the health minister "needs to be committed."


Development of the PIP formula

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