Impact of the Food and Drug Administration Safety Communication on the Use of Power Morcellator in Daily Clinical Practice: An Italian Survey.
J Minim Invasive Gynecol
; 23(2): 206-14, 2016 Feb 01.
Article
em En
| MEDLINE
| ID: mdl-26454195
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 MAINRESULTS:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
United States Food and Drug Administration
/
Neoplasias Uterinas
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Padrões de Prática Médica
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Competência Clínica
/
Miomectomia Uterina
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Histerectomia
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Leiomioma
Tipo de estudo:
Guideline
/
Prognostic_studies
Limite:
Female
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Humans
País/Região como assunto:
America do norte
/
Europa
Idioma:
En
Revista:
J Minim Invasive Gynecol
Assunto da revista:
GINECOLOGIA
Ano de publicação:
2016
Tipo de documento:
Article