Literature DB >> 25623369

A medical-legal review of power morcellation in the face of the recent FDA warning and litigation.

Raquel Ton1, Gokhan S Kilic1, John Y Phelps2.   

Abstract

Minimally invasive gynecologic surgeons who perform laparoscopic intraperitoneal morcellation should be aware of the recent US Food and Drug Administration (FDA) warning and litigation arising from use of morcellation devices with claims of intraperitoneal dissemination of cancerous cells. On November 24, 2014, the FDA issued a statement warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids. Despite the best intentions in regards to their patients, gynecologists who continue to use power morcellation devices expose themselves to liability. This article is not meant to further deter gynecologists from using laparoscopic power morcellators, but rather to provide an interpretation of the FDA statement as to the patients for whom the use of power morcellation may still be permitted under the FDA guidelines. This article also offers protective measures from a legal perspective for those who choose to continue to use power morcellation in the face of the recent FDA warning and litigation. Published by Elsevier Inc.

Entities:  

Keywords:  Boxed warning; Consent; FDA; Fibroids; Leiomyosarcoma; Liability; Litigation; Morcellation; Morcellator

Mesh:

Year:  2015        PMID: 25623369     DOI: 10.1016/j.jmig.2015.01.017

Source DB:  PubMed          Journal:  J Minim Invasive Gynecol        ISSN: 1553-4650            Impact factor:   4.137


  5 in total

1.  Surgical removal of multiple mesenteric fibroids (Kg 4,500) by abdominal spread of previous laparoscopic uterine myomectomy.

Authors:  V Leanza; F A Gulino; G Leanza; G Zarbo
Journal:  G Chir       Date:  2015 Jan-Feb

2.  Examination of the use of needle biopsy to perform laparoscopic surgery safely on uterine smooth muscle tumors.

Authors:  Makoto Murakami; Tomoyuki Ichimura; Mari Kasai; Makiko Matsuda; Naoki Kawamura; Takeshi Fukuda; Toshiyuki Sumi
Journal:  Oncol Lett       Date:  2018-04-04       Impact factor: 2.967

Review 3.  Medical Device Safety and Surgical Dissemination of Unrecognized Uterine Malignancy: Morcellation in Minimally Invasive Gynecologic Surgery.

Authors:  Tracilyn Hall; Susanna I Lee; David M Boruta; Annekathryn Goodman
Journal:  Oncologist       Date:  2015-09-17

4.  Myomectomy by Robotically Assisted Laparoscopic Surgery: Results at Foch Hospital, Paris.

Authors:  Jennifer Asmar; Marc Even; Marie Carbonnel; Julie Goetgheluck; Aurelie Revaux; Jean Marc Ayoubi
Journal:  Front Surg       Date:  2015-08-20

Review 5.  Uterine fibroid management: from the present to the future.

Authors:  Jacques Donnez; Marie-Madeleine Dolmans
Journal:  Hum Reprod Update       Date:  2016-07-27       Impact factor: 15.610

  5 in total

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