WASHINGTON (Reuters) As early as 2000, U.S. health authorities raised concerns about the French breast implant maker at the heart of a scandal affecting hundreds of thousands of women worldwide. That was almost ten years before the company came under scrutiny from European regulators.
The Food and Drug Administration sent an investigator to inspect a plant run by the manufacturer, Poly Implant Prothese (PIP), at La Seyne Sur Mer in southeastern France in May 2000. Shortly afterwards, the FDA sent the company's founder, Jean-Claude Mas, a warning letter saying the implants were "adulterated" and citing at least 11 deviations from good manufacturing practices.
The problems had to do with PIP's saline implants, a different line from the silicone implants that French authorities ordered off the market in 2010 for using industrial-grade silicone instead of medical-grade silicone, leading to the French firm's bankruptcy. Still, the plant inspected by the FDA was used to manufacture the silicone implants for PIP.
The French government last week recommended that women in France who have PIP's silicone gel-filled implants get them removed by their surgeons after the implants appeared to have an unusually high rupture rate. Other countries, including Britain and Brazil, said women should visit their surgeons for checks.
A critical question is why the FDA's warning didn't trigger greater scrutiny of PIP's activities by regulators in France and elsewhere. Officials at the FDA and France's health regulator were not available for comment on Monday on whether the FDA shared information about its inspection of the PIP plant, though the warning letter was made public in 2000.
POOR HEALTH
No one has been charged in the case.
Sources said a Marseilles court could soon announce fraud charges against four to six ex-PIP employees.
There is also an investigation into involuntary homicide by French authorities, following the death from cancer of a woman last year. She had received PIP implants. The French government has not presented any evidence of an increased cancer risk from the product.
Mas' lawyer Yves Haddad told Reuters on Monday that his 72-year-old client is in poor health but ready to respond to any court summons. Haddad denied that Mas was in hiding, reiterating that he was still in southern France's Var region.
"He's currently in very bad health because he has just undergone a difficult surgery that prevents him from walking," Haddad said. "He is worried by the importance this matter is taking on. He is angry at those who pointlessly add to people's suffering," the lawyer added.
Reuters didn't subsequently reach him to ask about the FDA's findings.
The U.S. concerns about PIP's saline implants more than 11 years ago could mean that there are safety issues for more women than the 300,000 worldwide who received the company's silicone implants . The number of women with PIP saline implants worldwide and the safety record of the device could not be immediately verified.
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