FDA Recommends Further Limiting Use Of Laparoscopic Power Morcellation
The US FDA is updating its labeling guidance on laparoscopic power morcellation to reflect new evidence showing the treatment may pose a higher cancer risk in older women, as well as to add discussion of containment systems.
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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.
The agency will require 510(k) clearance for the devices, which can be used to isolate tissue removed from the uterus during morcellation. However, labeling will need to state that the systems have not been proven to reduce the risk of cancer.
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