A history of device oversight by the US Food and Drug Administration traces regulatory changes in response to injuries caused by Dalkon Shield intrauterine devices.
AMA J Ethics. 2021;23(9):E712-720. doi:
10.1001/amajethics.2021.712.
When deciding whether a pregnant woman will take antidepressants that pose a slight risk to the fetus, the patient and doctor must each make value-based determinations about whether absolute protection of the fetus is more important than preventing the mother’s probable suffering.