FDA has approved devices for obstetrics and gynecology without sufficient data, according to a study by Northwestern University.
Of the 18 high-risk OB-GYN devices approved from January 2000 to December 2015, 42% passed muster on the basis of nonrandomized controlled trials, according to research published in Obstetrics & Gynecology. Medical residents from Northwestern University conducted the study. The approved devices included highly controversial pelvic meshes, laparoscopic morcellators, and the Essure birth control device.
