The Unintended Consequences of an FDA Warning: The Case of Power Morcellation in Myoma Surgery.
J Minim Invasive Gynecol
; 23(4): 597-602, 2016.
Article
em En
| MEDLINE
| ID: mdl-26898893
ABSTRACT
OBJECTIVE:
To study patients' perspectives regarding the risks and benefits of the use of power morcellation.DESIGN:
Cross-sectional survey (Canadian Task Force classification II-3).SETTING:
Academic tertiary referral hospital. PATIENTS Women waiting in gynecology waiting rooms.INTERVENTIONS:
Not applicable. MEASUREMENTS AND MAINRESULTS:
Of the 321 women invited, 310 (97%) responded to the survey; 19% of the participants had myomas requiring treatment, and the other 81% did not. Women with myomas were more likely to be aware of the risks of morcellation (32% vs 14%; p < .001); 29% obtained their information directly from their physicians, while 71% obtained it from other resources. After reading about the risks and benefits of open and MIS approaches to myoma removal, 65% would choose an MIS approach if the risk of cancer spread was up to 0.3% (1 in 350). The majority of women (75%) felt that the government should not have a role in surgical decision making, but should provide information to help patients make decisions.CONCLUSION:
Women have different risk tolerances. Most women would be willing to take the 1 in 350 (0.3%) risk of undiagnosed sarcoma spread to benefit from MIS approaches. FDA warnings may have unintended consequences by limiting the acceptable medical choices available for patients.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias Uterinas
/
Morcelação
/
Leiomioma
Tipo de estudo:
Etiology_studies
/
Observational_studies
/
Prevalence_studies
/
Prognostic_studies
/
Qualitative_research
/
Risk_factors_studies
Limite:
Adult
/
Aged
/
Female
/
Humans
/
Middle aged
País/Região como assunto:
America do norte
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article