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.
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http://dx.doi.org/10.1016/j.jmig.2015.01.017 | DOI Listing |
Facts Views Vis Obgyn
December 2024
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.
J Obstet Gynaecol Res
November 2024
Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Tokyo, Japan.
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.
Ther Clin Risk Manag
September 2024
Department of Urology, Affiliated Hospital 2 of Nantong University, Nantong, Jiangsu Province, 226200, People's Republic of China.
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.
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.
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