Essure may have been related to more fetal deaths than previously reported by the FDA, per this article:
Madris Tomes, founder and chief executive officer of Device Events, said her analysis of thousands of adverse events from the agency’s website shows 303 fetal deaths were linked to Essure.
The response from Bayer:
“It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term,” she added.
I realize this is standard PR language to eschew any culpability, but something about the term “an undesired pregnancy” is really bothering me. Yes, the chances are that if someone becomes pregnant with Essure, they probably were not planning on that pregnancy. But the way it is framed, and the emphasis that the pregnancy may have been “undesired” (Which — how do we know that for sure? What if the woman changed her mind after conceiving?), suggests that because the woman had permanent birth control, the product causing fetal death isn’t a problem. Sort of like: “well, they didn’t want it anyway, so what’s the big deal if the fetus died?”
Something about that assumption and also implying that your product causing fetal death is not an issue, even if it was undesired, is bugging me. Even if the fetal death did come as a relief to the women who were pregnant, your product causing spontaneous abortion is still dangerous for women.