Faulty French Breast Implants May Upend U.S. Device Debate

Medical device makers have spent the last year urging U.S. officials to approve high-risk products faster, like their European counterparts. A scandal over leaking breast implants made in France may make the argument harder.

French and German officials last month recommended thousands of women have surgery to remove implants made by Poly Implants Protheses SA, after reports the products were leaking industrial silicone inside patients. The mishaps have heightened scrutiny of European Union rules for medical devices that already faced calls from doctors for an overhaul.