Journal of minimally invasive gynecology · 2016
The Unintended Consequences of an FDA Warning: The Case of Power Morcellation in Myoma Surgery.
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Po Leslie, Lee Patricia E
Аннотация
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.
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.