Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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

Executive Summary

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.

You may also be interested in...



Power Morcellation Containment Devices Placed In FDA Class II

The special controls are to include biocompatibility, sterility and performance testing, as well as physician training and warning labels.

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.

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.

Topics

UsernamePublicRestriction

Register

MT143269

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel