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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FDA Emphasizes Benefits And Risks, Gives Containment System Warning In LPM Final Guidance
The new guidance from the US FDA urges physicians to discuss with patients the benefits and risks of using a laparoscopic power morcellator to remove uterine fibroids, and adds some language around LPM containment systems that wasn’t included in the draft of the document.
Priority Lane: Guidances On Risky Devices, 510(k) Reform Top FDA’s To-Do List
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Power Morcellator Use Increases Cancer Risk, FDA Verifies
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.