FDA Emphasizes Benefits And Risks, Gives Containment System Warning In LPM Final Guidance
The US agency also updated its safety communication for laparoscopic power morcellators
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.
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Surgeons are opting for alternate hysterectomy methods since the FDA warned power morcellation may spread cancerous cells through the body.
The special controls are to include biocompatibility, sterility and performance testing, as well as physician training and warning labels.
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.