A new study found that rates of adverse events with embryo transfer catheters ― including contamination and patient harm ― may be higher than previously reported to the FDA.
Please confirm that you would like to log out of Medscape. If you log out, you will be required to enter your username and password the next time you visit.Adverse events related to the use of embryo transfer catheters may be underreported to the US Food and Drug Administration , according to a new study presented at the 2023 annual meeting of the American Society for Reproductive Medicine.
Although the number of reported adverse events associated with ETCs is relatively small, the problems can significantly affect patient care, the researchers said. Problems with devices included contamination, packaging problems, malfunction, mechanical flaws, and material separation. Patient-level adverse events included retaining of foreign body, trauma, malfunction, or failed embryo transfer.
Because the majority of these adverse event reports were submitted by manufacturers and were rarely submitted by end users , the researchers said their findings likely underestimate such problems. "In two of these reports, they failed to transfer the embryo; they actually lost the embryo," Pomeroy added."That's drastic for those patients; it's a serious problem that needs to be addressed."
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