FDA Warned About French Implants

    Dr. Maurice Mimoun, a plastic surgeon at the St Louis hospital, holds silicone gel breast implants made by French company Poly Implant Prothese, or PIP, that he removed from a patient because of concerns that they are unsafe, Paris, Wednesday, Dec. 21, 2011. French health authorities are considering whether to suggest that an estimated 30,000 women in France get their breast implants removed, amid warnings by leading doctors about risks of rupture and possible cancer risks. (AP Photo/Michel Euler)

    Michel Euler / AP Photo

    You can thank your regulators for a change: the FDA expressed concern about defective French implants in 2000, a full 10 years before European regulators began to worry. The FDA sent an inspector to the implants’ manufacturer, Poly Implant Prothese, and then sent its founder a letter saying the implants were “adulterated” and listing at least 11 problems with the manufacturing process. PIP, it turns out, was using computer-grade silicone in the implants. Thousands of European women have received them, and the French government has recommended that its citizens have them removed due to their high rupture rate.

    Read it at Reuters