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.

Impact of the Food and Drug Administration Safety Communication on the Use of Power Morcellator in Daily Clinical Practice: An Italian Survey / Mandato, Vincenzo Dario; Torricelli, Federica; Pirillo, Debora; Aguzzoli, Lorenzo; Abrate, Martino; Palomba, Stefano; LA SALA, Giovanni Battista. - In: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. - ISSN 1553-4650. - 23:2(2016), pp. 206-214. [10.1016/j.jmig.2015.09.021]

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

TORRICELLI, FEDERICA;PIRILLO, Debora;Palomba, Stefano;LA SALA, Giovanni Battista
2016

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.
2016
23
2
206
214
Impact of the Food and Drug Administration Safety Communication on the Use of Power Morcellator in Daily Clinical Practice: An Italian Survey / Mandato, Vincenzo Dario; Torricelli, Federica; Pirillo, Debora; Aguzzoli, Lorenzo; Abrate, Martino; Palomba, Stefano; LA SALA, Giovanni Battista. - In: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. - ISSN 1553-4650. - 23:2(2016), pp. 206-214. [10.1016/j.jmig.2015.09.021]
Mandato, Vincenzo Dario; Torricelli, Federica; Pirillo, Debora; Aguzzoli, Lorenzo; Abrate, Martino; Palomba, Stefano; LA SALA, Giovanni Battista
File in questo prodotto:
File Dimensione Formato  
Mandato VD 2016 J Minim Invasive Gynecol.pdf

Accesso riservato

Tipologia: Versione pubblicata dall'editore
Dimensione 394.39 kB
Formato Adobe PDF
394.39 kB Adobe PDF   Visualizza/Apri   Richiedi una copia
Pubblicazioni consigliate

Licenza Creative Commons
I metadati presenti in IRIS UNIMORE sono rilasciati con licenza Creative Commons CC0 1.0 Universal, mentre i file delle pubblicazioni sono rilasciati con licenza Attribuzione 4.0 Internazionale (CC BY 4.0), salvo diversa indicazione.
In caso di violazione di copyright, contattare Supporto Iris

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1117125
Citazioni
  • ???jsp.display-item.citation.pmc??? 9
  • Scopus 20
  • ???jsp.display-item.citation.isi??? 20
social impact