Insight: FDA warned PIP on breast implant safety in 2000

Tue Dec 27, 2011 1:20pm EST
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By Anna Yukhananov

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 10 years before the company came under scrutiny from European regulators.

The U.S. 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 afterward, 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 company'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 did not trigger greater scrutiny of PIP's activities by regulators in France and elsewhere.

France's drug and medical device regulator, AFSSAPS, told Reuters on Tuesday that it had not found evidence that the FDA had informed them of the 2000 letter sent to PIP.

"The FDA wouldn't be obliged to send it to us if there wasn't a health risk," said a spokeswoman. "Therefore there doesn't seem to be a reason why we would have been informed."

The FDA warning letter was made public in 2000. The agency said it also routinely exchanges non-public information with foreign regulators with whom it has confidentiality commitments, including France. But the FDA could not immediately comment on whether it had shared information with France in 2000.   Continued...

<p>The locked entrance of French company Poly Implant Prothese (PIP) building is seen in La Seyne-sur-Mer near Toulon December 27, 2011. France's health minister tried to calm women's fears over potentially dangerous breast implants on Tuesday, saying there was no medical need to remove them immediately. The implants at the center of the global scandal were made by now-defunct French company Poly Implant Prothese (PIP) and appear to have an unusually high rupture rate. REUTERS/Jean-Paul Pelissier</p>