Accepted Manuscript The Unintended Consequences of an FDA Warning: The Case of Power Morcellation in Fibroid Surgery Leslie Po, MD, Patricia Lee, MD, CM PII:
S1553-4650(16)00083-2
DOI:
10.1016/j.jmig.2016.02.004
Reference:
JMIG 2786
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 4 December 2015 Revised Date:
3 February 2016
Accepted Date: 4 February 2016
Please cite this article as: Po L, Lee P, The Unintended Consequences of an FDA Warning: The Case of Power Morcellation in Fibroid Surgery, The Journal of Minimally Invasive Gynecology (2016), doi: 10.1016/j.jmig.2016.02.004. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1 THE UNINTENDED CONSEQUENCES OF AN FDA WARNING: THE CASE OF POWER MORCELLATION IN FIBROID SURGERY Leslie Po MD (1), Patricia Lee MD, CM (1)
RI PT
(1) Department of Obstetrics and Gynecology, Division of Urogynecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada
SC
Corresponding Author: Patricia Lee, MD CM LLM FRCSC FACOG Department of Obstetrics & Gynecology, Division of Urogynecology Sunnybrook Health Sciences Centre 2075 Bayview Avenue, Room B732 Toronto, Ontario, Canada M4N 3M5 Phone: 416-480-6740 Fax: 416-480-6741 Email: [email protected]
M AN U
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
Key Words: myoma, gynecology, morcellation, patient advocacy, risk tolerance, minimally invasive surgery
PRECIS:
25
Most women are willing to accept the risks of power morcellation used in minimally invasive
26
surgery for fibroids, yet access has been limited by an FDA warning.
EP AC C
27
TE D
24
ACCEPTED MANUSCRIPT 2 ABSTRACT
29
Objective: While the benefits of a minimally invasive surgical (MIS) approach to treating
30
fibroids include faster recovery, less pain and better cosmetics, the risks of spreading an
31
undiagnosed sarcoma from power morcellation of the fibroid is approximately 1/350. Because of
32
this risk, the FDA has recommended that power morcellators should not be used. This has the de
33
facto effect of limiting the patient’s access to minimally invasive surgery to manage fibroids.
34
The objective is to study patients’ perspectives on the risks and benefits of the use of power
35
morcellation.
36
Design: A cross-sectional survey.
37
Design Classification: II-3
38
Setting: Academic tertiary referral hospital.
39
Patients: Women waiting in gynecology waiting rooms.
40
Interventions: N/A.
41
Measurements & Main Results: 310 of 321 (97%) of women approached responded to the
42
survey. 19% of all respondents had fibroids requiring treatment while 81% did not. Women with
43
fibroids were more likely to be aware of the risks of morcellation (32% vs. 14%, p
S1553-4650(16)00083-2
DOI:
10.1016/j.jmig.2016.02.004
Reference:
JMIG 2786
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 4 December 2015 Revised Date:
3 February 2016
Accepted Date: 4 February 2016
Please cite this article as: Po L, Lee P, The Unintended Consequences of an FDA Warning: The Case of Power Morcellation in Fibroid Surgery, The Journal of Minimally Invasive Gynecology (2016), doi: 10.1016/j.jmig.2016.02.004. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1 THE UNINTENDED CONSEQUENCES OF AN FDA WARNING: THE CASE OF POWER MORCELLATION IN FIBROID SURGERY Leslie Po MD (1), Patricia Lee MD, CM (1)
RI PT
(1) Department of Obstetrics and Gynecology, Division of Urogynecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada
SC
Corresponding Author: Patricia Lee, MD CM LLM FRCSC FACOG Department of Obstetrics & Gynecology, Division of Urogynecology Sunnybrook Health Sciences Centre 2075 Bayview Avenue, Room B732 Toronto, Ontario, Canada M4N 3M5 Phone: 416-480-6740 Fax: 416-480-6741 Email: [email protected]
M AN U
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
Key Words: myoma, gynecology, morcellation, patient advocacy, risk tolerance, minimally invasive surgery
PRECIS:
25
Most women are willing to accept the risks of power morcellation used in minimally invasive
26
surgery for fibroids, yet access has been limited by an FDA warning.
EP AC C
27
TE D
24
ACCEPTED MANUSCRIPT 2 ABSTRACT
29
Objective: While the benefits of a minimally invasive surgical (MIS) approach to treating
30
fibroids include faster recovery, less pain and better cosmetics, the risks of spreading an
31
undiagnosed sarcoma from power morcellation of the fibroid is approximately 1/350. Because of
32
this risk, the FDA has recommended that power morcellators should not be used. This has the de
33
facto effect of limiting the patient’s access to minimally invasive surgery to manage fibroids.
34
The objective is to study patients’ perspectives on the risks and benefits of the use of power
35
morcellation.
36
Design: A cross-sectional survey.
37
Design Classification: II-3
38
Setting: Academic tertiary referral hospital.
39
Patients: Women waiting in gynecology waiting rooms.
40
Interventions: N/A.
41
Measurements & Main Results: 310 of 321 (97%) of women approached responded to the
42
survey. 19% of all respondents had fibroids requiring treatment while 81% did not. Women with
43
fibroids were more likely to be aware of the risks of morcellation (32% vs. 14%, p
