title: A medical-legal review of power morcellation in the face of the recent FDA warning and litigation.
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.
authors.affiliation: Department of Obstetrics and Gynecology, University of Texas Medical Branch at Galveston, Galveston, TX.
authors.forename: Raquel
authors.initials: R
authors.lastname: Ton
authors.affiliation: Department of Obstetrics and Gynecology, University of Texas Medical Branch at Galveston, Galveston, TX.
authors.forename: Gokhan S
authors.initials: GS
authors.lastname: Kilic
authors.affiliation: Department of Obstetrics and Gynecology, University of Texas Medical Branch at Galveston, Galveston, TX. Electronic address: jyphelps@utm.edu.
authors.forename: John Y
authors.initials: JY
authors.lastname: Phelps
mesh_terms: D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000009:adverse effects* / Q000331:legislation & jurisprudence; D010535:Laparoscopy / Q000009:adverse effects* / Q000331:legislation & jurisprudence; D007889:Leiomyoma / Q000601:surgery*; D009366:Neoplasm Seeding; D014481:United States; D014486:United States Food and Drug Administration; D063186:Uterine Myomectomy / Q000009:adverse effects* / Q000331:legislation & jurisprudence; D014594:Uterine Neoplasms / Q000517:prevention & control*
keywords: Boxed warning; Consent; FDA; Fibroids; Leiomyosarcoma; Liability; Litigation; Morcellation; Morcellator