The Unintended Consequences of an FDA Warning: The Case of Power Morcellation in Myoma Surgery

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 Main Results: 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. (C) 2016 AAGL. All rights reserved.