Ob/Gyn Specialists Ask FDA To Soften Power Morcellation Warning
This article was originally published in The Gray Sheet
Dozens of gynecology experts asked FDA to scale back its November 2014 warning against use of power morcellation for most women undergoing myomectomy or hysterectomy.
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There is a 1-in-225 to 1-in-580 risk that women getting fibroid removal surgery through hysterectomies or myomectomies may have hidden uterine sarcomas, US FDA said Dec. 14, and verified that power morcellation use during the surgeries will result in higher rates of cancer recurrence.
Several US House lawmakers are drafting a bill in response to a Government Accountability Office report finding that FDA's Medical Device Reporting system has shortcomings that may have missed adverse events for laparoscopic power morcellators. The devices have been linked to an increased risk of spreading cancer in women undergoing fibroid surgery.
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