title: The Unintended Consequences of an FDA Warning: The Case of Power Morcellation in Myoma Surgery.
abstract: To study patients' perspectives regarding the risks and benefits of the use of power morcellation.
  
  
  
  Cross-sectional survey (Canadian Task Force classification II-3).
  
  
  
  Academic tertiary referral hospital.
  
  
  
  Women waiting in gynecology waiting rooms.
  
  
  
  Not applicable.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Division of Urogynecology, Department of Obstetrics and Gynecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
authors.forename: Leslie
authors.initials: L
authors.lastname: Po
authors.affiliation: Division of Urogynecology, Department of Obstetrics and Gynecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada. Electronic address: pel.lee@utoronto.ca.
authors.forename: Patricia E
authors.initials: PE
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D002170:Canada; D003430:Cross-Sectional Studies; D018450:Disease Progression; D005260:Female; D006176:Gynecology; D006801:Humans; D007044:Hysterectomy / Q000379:methods / Q000523:psychology; D010535:Laparoscopy / Q000379:methods / Q000523:psychology; D007889:Leiomyoma / Q000523:psychology / Q000601:surgery*; D008875:Middle Aged; D000069577:Morcellation / Q000523:psychology*; D017060:Patient Satisfaction; D012307:Risk Factors; D012509:Sarcoma / Q000601:surgery; D014594:Uterine Neoplasms / Q000523:psychology / Q000601:surgery*
keywords: Gynecology; Minimally invasive surgery; Morcellation; Myoma; Patient advocacy; Risk tolerance