As women’s healthcare experts, we fight hard every day for the health of our patients. And when political agendas supersede the health of our patients, it is our responsibility to speak up. The FDA’s announcement yesterday that they plan to lift safety restrictions that govern the dispensing of medication abortions makes women’s health simply a pawn in the effort to push for more abortion. The American Association of Prolife Obstetricians and Gynecologists (AAPLOG) represents approximately 7,000 women’s healthcare practitioners who will not allow our patients’ lives to be put in jeopardy in order to appease the abortion industry and their allies.
When Mifepristone was first approved in 2000, it was only approved with safety regulations in place (known later as REMS) that would attempt to minimize the significant risk of hemorrhage, tissue not removed, and infection. These REMS were relaxed in 2016 by the FDA, without any further safety testing and despite evidence of significant adverse events, as well as maternal deaths. Inexplicably in 2016, the FDA stopped collecting data on non-fatal adverse events and has only collected data on maternal deaths related to Mifepristone. They have chosen to completely ignore the thousands of women who are showing up in their local emergency rooms due to heavy bleeding, retained tissue, infection, or other complications as a result of medication abortions. A recent analysis of the Adverse Events submitted to the FDA with the REMS in place shows over 3000 women suffering with complications, of which 24 of these women died, and another 500 would have died if they had not reached emergency medical care in time. These numbers will only increase if the current REMS, which require that a woman be seen and evaluated by a licensed healthcare practitioner prior to receiving the medications for an abortion, are removed. This requirement is not restrictive – it is protective.