FDA underestimated fetal deaths linked to Bayer's Essure contraceptive: Analyst

Essure--Screenshot courtesy of Bayer

It's more bad news for Bayer in the safety saga over its contraceptive implant, Essure. The FDA in the past has cited 5 fetal deaths linked to the device. But now one analyst is pegging this number much higher. After scouring the agency's side effects reporting database, Madris Tomes, founder and chief executive of data analysis company Device Events, found 303 fetal deaths associated with the product. The news comes as the FDA decides whether to beef up its oversight of Essure after receiving thousands of reports of serious problems from women who used the implant. More from FierceMedicalDevices