title: Impact of the Food and Drug Administration Safety Communication on the Use of Power Morcellator in Daily Clinical Practice: An Italian Survey.
abstract: 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.
  
  
  METHODS
  Electronic survey mailed to the main gynecologic centers (Canadian Task Force Classification type III).
  
  
  METHODS
  Unit of Obstetrics and Gynecology, IRCCS - Arcispedale S. Maria Nuova di Reggio Emilia (Italy).
  
  
  METHODS
  The study did not include patient data.
  
  
  METHODS
  There was no intervention.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Unit of Obstetrics and Gynecology, IRCCS, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy. Electronic address: dariomandato@gmail.com.
authors.forename: Vincenzo Dario
authors.initials: VD
authors.lastname: Mandato
authors.affiliation: Laboratory of Molecular Biology, IRCCS, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Torricelli
authors.affiliation: Unit of Obstetrics and Gynecology, IRCCS, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy.
authors.forename: Debora
authors.initials: D
authors.lastname: Pirillo
authors.affiliation: Unit of Obstetrics and Gynecology, IRCCS, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Aguzzoli
authors.affiliation: Unit of Obstetrics and Gynecology, IRCCS, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy.
authors.forename: Martino
authors.initials: M
authors.lastname: Abrate
authors.affiliation: Unit of Obstetrics and Gynecology, IRCCS, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Palomba
authors.affiliation: Unit of Obstetrics and Gynecology, IRCCS, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy; Unit of Obstetrics and Gynecology, University of Modena and Reggio Emilia, Reggio Emilia, Italy.
authors.forename: Giovanni Battista
authors.initials: GB
authors.lastname: La Sala
mesh_terms: D002983:Clinical Competence / Q000331:legislation & jurisprudence*; D005260:Female; D006176:Gynecology / Q000331:legislation & jurisprudence; D019538:Health Care Surveys; D006801:Humans; D007044:Hysterectomy / Q000009:adverse effects* / Q000331:legislation & jurisprudence; D007558:Italy / Q000453:epidemiology; D007813:Laparotomy; D007889:Leiomyoma / Q000473:pathology / Q000601:surgery*; D007890:Leiomyosarcoma / Q000601:surgery; D009366:Neoplasm Seeding; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence; D063186:Uterine Myomectomy / Q000009:adverse effects* / Q000331:legislation & jurisprudence; D014594:Uterine Neoplasms / Q000517:prevention & control* / Q000601:surgery
keywords: Cancer; Dissemination; Laparoscopy; Medical liability; Morcellation; Uterine sarcoma