Some high-risk women’s health devices were approved without proper data, according to a recent study. The findings point to a need for increased oversight from the agency, researchers said.
Scientists at Northwestern University looked at 18 high-risk devices approved by the FDA from 2000 to 2015, including those for menstrual flow reduction, contraception and fetal monitoring. Four of the devices were approved even though they did not show efficacy in clinical trials, according to results published recently in the journal Obstetrics and Gynecology.
Six of the devices included in the study were not required to undergo post-market studies to monitor their safety. Three devices were eventually withdrawn from the market, and of those three, two were not reviewed by experts on the FDA’s obstetrics and gynecology advisory committee. The other product was reviewed but not recommended for approval by the panel.
