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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

 
• By Shawn M. Schmitt

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.

One big ball and many small ones. On wooden scales on a white background.
"Physicians should discuss the risks and benefits of all relevant treatment options with their patients," the FDA says

The US Food and Drug Administration stresses in a new final guidance document that physicians discuss with patients the benefits and risks of using a laparoscopic power morcellator (LPM) to remove uterine fibroids.

“As part of shared decision-making, physicians should discuss the risks and benefits of all relevant treatment options with their patients prior to undergoing the procedure,” the agency says in its...

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