Weekly Vitals: The Power of Defective Breast Implants, Newt Gingrich vs. FDA, and More

Posted by Shana Leonard on January 20, 2012

This week in medtech, experts began to ponder the potential impact that the French breast implant scandal could have on U.S. regulation. The industry and its supporters often point to the quicker device clearance process in the European Union (EU) when criticizing FDA, for example. But the controversy that has erupted from a company's breast implants that leaked industrial silicone into patients has provided FDA and its supporters with a sizeable stock of ammo. “All the industry guys in the U.S. say, ‘we should have access to these products much sooner, like in Europe,'" Carl Heneghan, an Oxford University teacher who has studied device recalls, told Bloomberg recently. “The flip side is, the European people are being used as guinea pigs.” In addition to the breast implant controversy, presidential hopeful Newt Gingrich nabbed headlines and the interest of the industry this week when he stated that he wants to whip the agency into shape and create a "21st century FDA." Read about these stories and more in the weekly medtech roundup below.