Impact of the Food and Drug Administration Safety Communication on the Use of Power Morcellator in Daily Clinical Practice: An Italian Survey

Vincenzo Dario Mandato, Federica Torricelli, Debora Pirillo, Lorenzo Aguzzoli, Martino Abrate, Stefano Palomba, Giovanni Battista La Sala

Research output: Contribution to journalArticle

Abstract

Study Objective: To assess the impact of the Food and Drug Administration (FDA) warning about power morcellation use on the daily clinical practice of Italian gynecologists. Design: Electronic survey mailed to the main gynecologic centers (Canadian Task Force Classification type III). Setting: Unit of Obstetrics and Gynecology, IRCCS - Arcispedale S. Maria Nuova di Reggio Emilia (Italy). Patients: The study did not include patient data. Intervention: There was no intervention. Measurements and Main Results: From 490 surveys sent out, 426 replies were included in the final analysis (return rate = 86.9%). Four hundred of the 426 (93.9%) gynecologists were aware of the FDA warning. One hundred fifty of 302 (49.7%) of experienced gynecologists and 176 of 349 (50.4%) of oncology gynecologists considered laparoscopy the best approach for myomectomy. The FDA communication was considered overly restrictive by experienced and oncology gynecologists who declared that they had no intention of changing their surgical approach. Two hundred fifty of the 426 (58.7%) gynecologists declared that they would change their surgical approach only to prevent legal litigation. Conclusion: The FDA warning also affected Italian gynecologists. Particularly, less experienced gynecologists and those without oncologic practice seem to be more interested in avoiding legal litigation rather than a real clinical risk of upstaging an unexpected leiomyosarcoma. Fear of undiagnosed sarcoma could increase the number of laparotomies.

Original languageEnglish
Pages (from-to)206-214
Number of pages9
JournalJournal of Minimally Invasive Gynecology
Volume23
Issue number2
DOIs
Publication statusPublished - Feb 1 2016

Keywords

  • Cancer
  • Dissemination
  • Laparoscopy
  • Medical liability
  • Morcellation
  • Uterine sarcoma

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Fingerprint Dive into the research topics of 'Impact of the Food and Drug Administration Safety Communication on the Use of Power Morcellator in Daily Clinical Practice: An Italian Survey'. Together they form a unique fingerprint.

  • Cite this