Faulty French breast implants may reverse US device approval debate.

Poly Implant Prothese

FDA And Breast Implants Standards Jan 19. 2012 U.S. medical device makers have complained for years about slow reviews and inconsistent standards at the Food and Drug Administration They have spent the last year urging U.S. officials to approve high-risk products faster, like their European counterparts. A recent scandal over leaking breast implants made in [...]

French Health Regulators Finally Acknowledge Safety Concerns Over PIP Breast Implants


Almost 11 years ago, the U.S. Food and Drug Administration sent an agency investigator to France in order to inspect a plant run by breast implant manufacturer, Poly Implant Prothese (PIP). After the inspection was completed, U.S. health authorities issued a warning letter to PIP’s founder in June of 2000, outlining more than 10 manufacturing [...]