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

J Minim Invasive Gynecol

Department of Obstetrics and Gynecology, University of Texas Medical Branch at Galveston, Galveston, TX. Electronic address:

Published: September 2015

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.

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jmig.2015.01.017DOI Listing

Publication Analysis

Top Keywords

power morcellation
16
fda warning
12
warning litigation
12
morcellation face
8
face fda
8
morcellation devices
8
laparoscopic power
8
power morcellators
8
continue power
8
power
6

Similar Publications

Background: To decrease the risk of unsuspected malignancies disseminating, several studies have shown the safety of using a containment bag to limit tissue dissemination during manual or power morcellation. Furthermore, in 2020, the FDA recommended performing laparoscopic power morcellation for myomectomy or hysterectomy only within a tissue containment system.

Objective: To show step-by-step a new surgical technique using vaginal power morcellation within an endoscopic pouch without adding or extending other incisions.

View Article and Find Full Text PDF

Aim: Studies on parasitic myomas after laparoscopic morcellation are mainly limited to case reports, and the incidence and risk factors have not yet been well-understood. We aimed to clarify the actual incidence and risk factors of parasitic myoma after laparoscopic myomectomy using uncontained power morcellation by reviewing cases with subsequent laparoscopic surgery.

Methods: This retrospective study included 87 patients who had laparoscopic myomectomy using uncontained power morcellation, followed by subsequent second laparoscopic surgery for gynecological disease between 2008 and 2021.

View Article and Find Full Text PDF
Article Synopsis
  • The study aimed to compare the effects of high-power and low-power Holmium laser enucleation of the prostate (HoLEP) on coagulation in patients on antiplatelet therapy, analyzing data from 210 patients across three groups.
  • Results showed no significant differences in baseline characteristics, but notable variations in surgical times, hospital stay, and hemoglobin reduction were found; prostate volume was identified as a key risk factor for hematuria.
  • The conclusion indicates that low-power HoLEP can reduce surgical and recovery times as well as hemoglobin loss, making it a practical choice for patients on antiplatelet therapy without needing to stop their medication.
View Article and Find Full Text PDF

Background: The objective of the present study is to prospectively analyze the prostate enucleation procedure with Holmium Laser using the minimally invasive technique (MiLEP), comparing the outcomes and their variables pre- and postoperatively.

Methods: We studied men aged 40 years or over, with prostate volumes greater than or equal to 35 cm³ with lower urinary tract symptoms due to BPH. We performed flowmetry and administered the IPSS questionnaire before and 6 months after the MiLEP procedure.

View Article and Find Full Text PDF

Myomectomy: Choosing the Surgical Approach - A Systematic Review.

Gynecol Minim Invasive Ther

July 2024

Department of Obstetrics and Gynecology, Mahkota Medical Centre, Melaka, Malaysia.

Myomectomy has evolved from open laparotomy to laparoscopy, hysteroscopy, VNOTES and robotic myomectomy. The surgical approach in doing myomectomy depends on the type and location of the myoma and the surgeon's expertise. Minimally invasive surgery has been the preferred approach due to the benefit of shorter hospital stay, lesser postoperative pain, earlier recovery, minimal blood loss and the cosmetic appearance of the scar.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!