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FDA now discourages use of morcellator

by Medical Staff Office on May 1, 2014

By Henry Sobel, MD, Chair, Women’s and Children’s Services

The FDA recently issued an advisory strongly discouraging the use of uterine power morcellators. Read the MedPage article with the advisory and ACOG comment here.  The FDA’s specific recommendation to physicians is highlighted. Leading hospitals around the country are taking either of two approaches: banning use of the morcellator or having its use restricted to within bags in the abdomen to protect against the risk of spread of potentially malignant tissue. This controversy was the subject of our February Women and Children’s M&M Conference.

Since that discussion efforts have been made to assure that we have the necessary high quality surgical bags, and we do. The use of the power morcellator, the incidence of leiomyosarcoma, and the impact of surgical technique on survival are each of some small increment.  Balanced against that risk is the benefit of the decreased morbidity of the minimally invasive techniques allowed by the use of morcellation.  More informed high level conversation is coming from national medical thought leaders, including ACOG.

With that expectation, having seen different responses at other hospitals, and having gotten differing opinions within our service, at this time I see the prudent action to be the more conservative one of requiring the use of collection bags to isolate the tissue from spread within the abdomen at time of morcellation.

Further, the FDA’s discussion points (highlighted in yellow within the attachment) should be considered as imperatives in any pre-operative discussion where morcellation may be a possibility.  And that should be documented.

Due to the small number of patients impacted by this controversy, the potential for stirring up fear and worry and the fact that we are simply responding to published recommendations, I do not view this as something justifying increased local publicity.  It is a subject you should be familiar with, expect questions about and be able to discuss in an informed manner.  If contacted by a reporter, the best response is to refer them to the AAMC PR  department for comment.

Your comments are welcome.  Thank you.

1 comment

  1. pat smale

    Dr. Sobel-
    Thanks for this interesting article. I emailed Dr. Walton last week wondering if this affects surgery here as I am unfamiliar with the morcellator and read an article about the FDA ban. I would refer back to surgeon with questions but just wondered if this affects surgery here and was nice to see this article. Thanks!

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