FDA Dinged French Implants Maker in 2000

Called out 'adulterated' implants
By Kate Seamons,  Newser Staff
Posted Dec 27, 2011 9:48 AM CST
In this photo taken Thursday, Dec. 22, 2011, Chantal Guerin, a 46-year-old accountant and mother of three, displays a breast implant made by Poly Implant Prothese.   (AP Photo/Christophe Ena)

(Newser) – Interpol wants to arrest Poly Implant Protheses' founder, and a Dutch company that bought its implants is now cautioning women ... how could things get uglier for PIP? Maybe by way of the revelation that US health authorities expressed worry about PIP in May ... of the year 2000. That's nearly a full decade before European regulators began eyeing the company, whose silicone gel-filled implants were yanked off the market last year following accusations that they were filled with industrial-grade silicone. France has since advised 30,000 women to have their implants removed, over fears that they might rupture.

Reuters reports that after an FDA investigator visited a PIP plant in southeastern France in 2000, the agency sent founder Jean-Claude Mas a letter that pointed a finger at the company's "adulterated" implants and detailed 11 deviations from proper manufacturing actions. The FDA was reviewing saline implants, not the silicone ones currently under fire, though the plant it visited also produced the latter type. Reuters notes that it's unclear why the FDA's finding didn't lead French or other regulators to inspect PIP or its plant. (Read more breast implants stories.)

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