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Impact of the 2014 Food and Drug Administration Warnings Against Power Morcellation

Published:January 28, 2016DOI:https://doi.org/10.1016/j.jmig.2016.01.019

      Abstract

      Study Objective

      To determine whether members of the AAGL Advancing Minimally Invasive Gynecologic Surgery Worldwide (AAGL) and members of the American College of Obstetricians and Gynecologists Collaborative Ambulatory Research Network (ACOG CARN) have changed their clinical practice based on the 2014 Food and Drug Administration (FDA) warnings against power morcellation.

      Design

      A survey study.

      Setting

      Participants were invited to complete this online survey (Canadian Task Force classification II-2).

      Patients

      AAGL and ACOG CARN members.

      Interventions

      An online anonymous survey with 24 questions regarding demographics and changes to clinical practice during minimally invasive myomectomies and hysterectomies based on the 2014 FDA warnings against power morcellation.

      Measurements and Main Results

      A total of 615 AAGL members and 54 ACOG CARN members responded (response rates of 8.2% and 60%, respectively). Before the FDA warnings, 85.8% and 86.9%, respectively, were using power morcellation during myomectomies and hysterectomies. After the FDA warnings, 71.1% and 75.8% of respondents reported stopping the use of power morcellation during myomectomies and hysterectomies. The most common reasons cited for discontinuing the use of power morcellation or using it less often were hospital mandate (45.6%), the concern for legal consequences (16.1%), and the April 2014 FDA warning (13.9%). Nearly half of the respondents (45.6%) reported an increase in their rate of laparotomy. Most (80.3%) believed that the 2014 FDA warnings have not led to an improvement in patient outcomes and have led to harming patients (55.1%).

      Conclusion

      AAGL and ACOG CARN respondents reported decreased use of power morcellation during minimally invasive gynecologic surgery after the 2014 FDA warnings, the most common reason cited being hospital mandate. Rates of laparotomy have increased. Most members surveyed believe that the FDA warnings have not improved patient outcomes.

      Keywords

      Morcellation, the division of tissue into fragments, is commonly used during a minimally invasive hysterectomy or myomectomy to facilitate removal of the uterus or leiomyomas. In 1995, the US Food and Drug Administration (FDA) approved the first power morcellator [

      US Food and Drug Administration. 1995. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K946147. Accessed December 31, 2015.

      ], a medical device that uses electromechanical energy to fragment tissue specimens.
      Leiomyomas are the most common pelvic tumor in women, occurring in up to 80% of women by age 50 years [
      • Baird D.D.
      • Dunson D.B.
      • Hill M.C.
      • Cousins D.
      • Schectman J.M.
      High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence.
      ]. They are a leading indication for hysterectomy, of which nearly half are performed through a minimally invasive approach [
      • Cohen S.L.
      • Vitonis A.F.
      • Einarsson J.I.
      Updated hysterectomy surveillance and factors associated with minimally invasive hysterectomy.
      ]. The benefits of a minimally invasive approach are well documented and include smaller scars, faster recovery, and fewer complications when compared with an open approach [
      • Nieboer T.E.
      • Johnson N.
      • Lethaby A.
      • et al.
      Surgical approach to hysterectomy for benign gynaecological disease.
      ,
      ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease.
      ,
      AAGL advancing minimally invasive gynecology worldwide
      AAGL position statement: route of hysterectomy to treat benign uterine disease.
      ]. Women undergoing an open hysterectomy have 3 times the risk of mortality compared with those undergoing a laparoscopic hysterectomy [
      • Wiser A.
      • Holcroft C.A.
      • Tulandi T.
      • Abenhaim H.A.
      Abdominal versus laparoscopic hysterectomies for benign diseases: evaluation of morbidity and mortality among 465,798 cases.
      ].
      In April and November 2014, the US FDA issued warnings against power morcellation, citing a potential risk of the spread of undiagnosed uterine sarcoma [

      US Food and Drug Administration. 2014. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Accessed December 31, 2015.

      ,

      US Food and Drug Administration. 2014. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm. Accessed December 31, 2015.

      ]. The actual reported incidence of an occult uterine sarcoma is highly variable, ranging from 1 in 350 to 1 in 8,300 [
      • Seidman M.A.
      • Oduyebo T.
      • Muto M.G.
      • Crum C.P.
      • Nucci M.R.
      • Quade B.J.
      Peritoneal dissemination complicating morcellation of uterine mesenchymal neoplasms.
      ,
      • Leibsohn S.
      • d'Ablaing G.
      • Mishell Jr., D.R.
      • Schlaerth J.B.
      Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas.
      ,
      • Parker W.H.
      • Fu Y.S.
      • Berek J.S.
      Uterine sarcoma in patients operated on for presumed leiomyoma and rapidly growing leiomyoma.
      ,
      • Takamizawa S.
      • Minakami H.
      • Usui R.
      • et al.
      Risk of complications and uterine malignancies in women undergoing hysterectomy for presumed benign leiomyomas.
      ,
      • Pritts E.A.
      • Vanness D.J.
      • Berek J.S.
      • et al.
      The prevalence of occult leiomyosarcoma at surgery for presumed uterine fibroids: a meta-analysis.
      ]. There is no preoperative diagnostic test that can reliably detect a uterine sarcoma.
      Gynecologic surgeons face the dilemma of balancing the potential risk for seeding an undiagnosed uterine sarcoma associated with performing morcellation and the risk of morbidity associated with performing a laparotomy. The frequency of use for power morcellation among practicing gynecologic surgeons subsequent to the 2014 FDA warnings has not been well described. To assess the prevalence in clinical practice of power morcellation, we surveyed members of the AAGL Advancing Minimally Invasive Gynecologic Surgery Worldwide (AAGL) and the American College of Obstetricians and Gynecologists Collaborative Ambulatory Research Network (ACOG CARN). The objective of our study was to ascertain the frequency of the use of power morcellation among gynecologic surgeons and to assess any change in clinical practice generated by the 2014 FDA warnings.

      Methods

      AAGL and ACOG CARN members were invited via e-mail to participate in an Internet-based survey of power morcellation use during minimally invasive hysterectomy and myomectomy. A total of 3 e-mails (the maximum allowed by the AAGL) were sent to the mailing list of 7,500 AAGL members, and 5 e-mails were sent to 90 ACOG CARN members (until the response rate was over 50%). The CARN consists of a group of practicing obstetricians and gynecologists who volunteer to participate in survey-based research. The CARN has been described in depth elsewhere [
      ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease.
      ,
      AAGL advancing minimally invasive gynecology worldwide
      AAGL position statement: route of hysterectomy to treat benign uterine disease.
      ,
      • Wiser A.
      • Holcroft C.A.
      • Tulandi T.
      • Abenhaim H.A.
      Abdominal versus laparoscopic hysterectomies for benign diseases: evaluation of morbidity and mortality among 465,798 cases.
      ,

      US Food and Drug Administration. 2014. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Accessed December 31, 2015.

      ,

      US Food and Drug Administration. 2014. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm. Accessed December 31, 2015.

      ,
      • Seidman M.A.
      • Oduyebo T.
      • Muto M.G.
      • Crum C.P.
      • Nucci M.R.
      • Quade B.J.
      Peritoneal dissemination complicating morcellation of uterine mesenchymal neoplasms.
      ,
      • Leibsohn S.
      • d'Ablaing G.
      • Mishell Jr., D.R.
      • Schlaerth J.B.
      Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas.
      ,
      • Parker W.H.
      • Fu Y.S.
      • Berek J.S.
      Uterine sarcoma in patients operated on for presumed leiomyoma and rapidly growing leiomyoma.
      ,
      • Takamizawa S.
      • Minakami H.
      • Usui R.
      • et al.
      Risk of complications and uterine malignancies in women undergoing hysterectomy for presumed benign leiomyomas.
      ,
      • Pritts E.A.
      • Vanness D.J.
      • Berek J.S.
      • et al.
      The prevalence of occult leiomyosarcoma at surgery for presumed uterine fibroids: a meta-analysis.
      ,
      • Morgan M.A.
      • Anderson B.L.
      • Lawrence H.
      • Schulkin J.
      Well-woman care among obstetrician-gynecologists: opportunity for preconception care.
      ,
      • Matteson K.A.
      • Anderson B.L.
      • Pinto S.B.
      • Lopes V.
      • Schulkin J.
      • Clark M.A.
      Practice patterns and attitudes about treating abnormal uterine bleeding: a national survey of obstetricians and gynecologists.
      ,
      • Leddy M.A.
      • Lawrence H.
      • Schulkin J.
      Obstetrician-gynecologists and women's mental health: findings of the Collaborative Ambulatory Research Network 2005-2009.
      ]. The 90 members chosen expressed an interest or experience in surgery.
      Survey questions were developed based on the type of questions sent to members of the American Urogynecology Society to assess the impact of the 2011 FDA transvaginal mesh safety update regarding the use of synthetic mesh for pelvic reconstructive surgery [
      • Clemons J.L.
      • Weinstein M.
      • Guess M.K.
      • et al.
      AUGS Research Committee
      Impact of the 2011 FDA transvaginal mesh safety update on AUGS members' use of synthetic mesh and biologic grafts in pelvic reconstructive surgery.
      ]. The survey was pilot tested by experts in minimally invasive gynecology before final implementation. Exclusion criteria were members who reported practicing outside of the United States and those not performing gynecologic surgery.
      The survey collected basic demographic information including age, sex, type of practice, specialty, fellowship training, number of years in practice (in 5-year increments), and number of total gynecologic cases performed per year (in increments of 50). Respondents who reported performing myomectomies and hysterectomies were asked about their use of power morcellation before and after the FDA warnings. The primary objective of the survey was to assess change in clinical practice after the FDA warnings. Questions were asked regarding preoperative counseling, use of endometrial biopsies, and rates of laparotomy since the FDA warnings. Participants were asked whether their hospital banned power morcellation, their opinions on the accuracy of the FDA's risk estimate of an unsuspected uterine sarcoma, and whether the FDA warnings have yielded an overall improvement in patient outcomes.
      Data were reported descriptively. Differences between categoric variables were assessed using chi-square tests. All analyses were performed with SAS version 9.4 (SAS Institute Inc, Cary, NC). All statistical tests were 2-sided. A p value < .05 was considered statistically significant.

      Results

      A total of 615 AAGL members and 54 ACOG CARN members responded to the survey (response rates of 8.2% and 60%, respectively). The demographic characteristics of responders are listed in Table 1. Three hundred eighty-nine AAGL members (64.7%) reported practicing in the United States. Both AAGL and CARN responders represented a wide range of ages, years of practice, and surgical volume. The groups were overall similar in demographics except AAGL responders reported performing more surgical cases per year, were more likely to have fellowship training in minimally invasive gynecologic surgery and were more likely to be in academic medicine than CARN responders.
      Table 1Demographic characteristics of the study population
      AAGL and ACOG CARN members
      n%
      Country
       United States45267.6
       Other21732.4
      Age
       26–354810.6
       36–4510924.1
       46–5513129.0
       >5515434.1
       Unknown102.2
      Sex
       Male26658.8
       Female18340.5
       Unknown30.7
      Years in practice
       0–1011024.3
       10–2013329.4
       20–3013329.4
       >307616.8
      Type of practice
       Private practice23151.1
       Academic hospital based12728.1
       Multispecialty group5512.2
       HMO204.4
       Other/unknown194.2
      Specialty
       General OB/GYN17037.6
       Gynecologist439.5
       Minimally invasive gynecologist15734.7
       Urogynecologist449.7
       Gynecologic oncologist102.2
       Reproductive endocrinology and infertility204.4
       Other/unknown81.8
      Fellowship trained
       No30367.0
       Yes14532.1
       Unknown40.9
      Fellowship
       Minimally invasive gynecologic surgery8117.9
       Urogynecology255.5
       Gynecologic oncology102.2
       Reproductive endocrinology and infertility214.6
       Other51.1
      Total surgical cases in 1 year
       0–10014031.0
       101–20019042.0
       201–3008318.4
       >300327.1
       Unknown71.5
      AAGL = American Association of Gynecologic Laparoscopists; ACOG = American College of Obstetricians and Gynecologists; CARN = ACOG's Collaborative Ambulatory Research Network; HMO = health maintenance organization; OB/GYN = obstetrician/gynecologist.
      Fig. 1 summarizes the reported use of power morcellation during myomectomy and hysterectomy before and after the 2014 FDA warnings. Most respondents (55.7%) reported using power morcellation in more than 80% of myomectomies before the FDA warnings, with 71.1% reporting 0% use after the FDA warnings. Similarly, 75.2% of respondents reported using power morcellation in up to 50% of hysterectomies before the FDA warnings, with 75.8% reporting 0% use after the FDA warnings.
      Figure thumbnail gr1
      Fig. 1The use of power morcellation during myomectomy and hysterectomy before and after the 2014 FDA warnings.
      Table 2 summarizes the changes in clinical practice since the 2014 FDA warnings. Approximately half of all responders (49.6%) reported that their hospital had banned power morcellation. The majority of responders (88.7%) thought that the FDA risk estimate of an unsuspected sarcoma was too high. Most respondents (79.6%) reported that they stopped using power morcellation or used it less often after the 2014 FDA warnings, using a range of alternate options. The most common reason for stopping or decreasing the use of power morcellation was hospital mandate (45.6%), followed by legal consequences (16.1%), the April 2014 FDA warning (13.9%), the November 2014 FDA warning (10.3%), and patient request (6.4%).
      Table 2Practice patterns and attitudes towards power morcellation since the 2014 Food and Drug Administration (FDA) warnings
      AAGL and ACOG CARN members
      n%
      Has your hospital banned power morcellation?
       Yes22449.6
       No20545.4
       Don't know194.2
       Unknown40.9
      The FDA estimates that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected sarcoma. Do you think the risk estimate is:
       Accurate419.1
       Too high40188.7
       Too low61.3
       Unknown40.9
      How has your use of power morcellation changed since the 2014 FDA warning?
       Stopped using power morcellation (used in past)27560.8
       Still using power morcellation but less often8518.8
       Still using power morcellation–no change to practice388.4
       Still using power morcellation but more often00
       No change–never used power morcellation4610.2
       New user of power morcellation20.4
       Unknown61.3
      If you have stopped using power morcellation or use it less often, what alternative method do you use for specimen retrieval? Check all that apply.
       Laparotomy with removal of intact specimen149
       Nonpower morcellation (uncontained)123
       Power morcellation inside a bag52
       Nonpower morcellation inside a bag180
       Other40
      If you have stopped using power morcellation or use it less often, what influenced you the most to change your practice?
       April 2014 FDA warning5013.9
       November 2014 FDA warning3710.3
       Patient request236.4
       Hospital mandate16445.6
       Legal consequences5816.1
       Personal experience82.2
       Other174.7
       Unknown30.8
      Before the 2014 FDA warnings, how often did you counsel patients preoperatively about the risk of power morcellation?
       Never13028.8
       Occasionally9220.4
       Usually8218.1
       Always14131.2
       Unknown71.5
      After the 2014 FDA warnings, how often do you counsel patients preoperatively about the risk of power morcellation?
       Never9621.2
       Occasionally214.6
       Usually286.2
       Always29765.7
       Unknown102.2
      What percentage of your patients has heard about the FDA warnings against power morcellation?
       0%214.6
       10%7115.7
       20%7416.4
       30%6915.3
       40%184.0
       50%8418.6
       60%184.0
       70%316.9
       80%408.8
       90%153.3
       100%40.9
       Unknown71.5
      Since the 2014 FDA warnings, has your use of preoperative endometrial biopsies changed if morcellation is anticipated?
       No change29364.8
       More likely to perform an endometrial biopsy6414.2
       Always perform an endometrial biopsy8619.0
       Less likely to perform an endometrial biopsy10.2
       Unknown81.8
      Since the FDA warnings, has your counseling changed about laparoscopic total versus supracervical hysterectomy in regards to morcellation?
       No change21447.3
       More likely to counsel a patient towards total hysterectomy to potentially avoid morcellation13229.2
       Always counsel a patient towards total hysterectomy to potentially avoid morcellation9921.9
       Less likely to counsel a patient towards total hysterectomy20.4
       Unknown51.1
      Since the 2014 FDA warnings, has your rate of laparotomy increased due to these warnings?
       No24153.3
       Yes20645.6
       Unknown51.1
      If yes, by what percentage?
       0%21.0
       10%4823.1
       20%4823.1
       30%4119.7
       40%125.8
       50%2813.5
       60%62.9
       70%31.4
       80%62.9
       90%136.3
       100%10.5
      Do you think the 2014 FDA warnings have led to an overall improvement in patient outcomes?
       Yes–significant improvement in patient outcomes112.4
       Yes–some improvement in patient outcomes but not significant224.9
       Neutral5011.1
       No–no improvement in patient outcomes11425.2
       No–no improvement in patient outcomes and have led to harming patients24955.1
       Unknown61.3
      AAGL = American Association of Gynecologic Laparoscopists; ACOG = American College of Obstetricians and Gynecologists; CARN = ACOG's Collaborative Ambulatory Research Network.
      Before the 2014 FDA warnings, approximately half of all responders (49.3%) reported usually or always counseling patients preoperatively about the risk of power morcellation compared with 71.9% doing so after the 2014 FDA warnings. The majority of responders (74.6%) reported that only 50% or less of their patients had heard about the FDA warnings against power morcellation. Most responders reported no change in the use of preoperative endometrial biopsies or counseling for total laparoscopic hysterectomy after the FDA warnings (64.8% and 47.3%, respectively). Forty-six percent of responders reported that their rate of laparotomy had increased. The majority of responders (80.3%) answered that they thought the FDA warnings have not led to an overall improvement in patient care, with 55.1% believing that the FDA warnings have led to harming patients.
      Associations between surgeon characteristics and change in the use of power morcellation after the 2014 FDA warnings are presented in Table 3. Factors associated with stopping use or decreasing the use of power morcellation included age older than 45 years, private practice setting, surgeons in practice for 10 or more years, and surgeons who considered themselves generalists (p < .05 for all). Surgeons who considered themselves minimally invasive gynecologists were more likely to continue the use of power morcellation (p = .02).
      Table 3Surgeon characteristics associated with change in the use of power morcellation
      No change (still using)Stopped using or use less oftenNo change (never used)p value
      n%n%n%
      388.636081.14610.4
      Age.002
       26–3500.04593.836.3
       36–4565.58678.91715.6
       46–5586.311085.9107.8
       >552416.111073.81510.1
       Unknown00.0990.0110.0
      Sex.05
       Male3111.820377.22911.0
       Female73.915486.5179.6
       Other00.03100.000.0
      Years in practice.001
       0–1021.89384.61513.6
       10–20139.911083.396.8
       20–3096.910983.9129.2
       >301419.44866.71013.9
      Type of practice.02
       Private practice2511.118080.0208.9
       Academic hospital based43.210784.91511.9
       Multispecialty group59.34583.347.4
       HMO210.01785.015.0
       Other/unknown210.51157.9631.6
      Specialty<.001
       General OB/GYN148.313982.7158.9
       Gynecologist00.03995.124.9
       Minimally invasive gynecologist1811.712379.9138.4
       Urogynecologist24.63477.3818.2
       Gynecologic oncologist00.0660.0440.0
       Reproductive oncologist420.01575.015.0
       Other/unknown00.0457.1342.9
      Total surgical cases in 1 year0.18
       0–10096.511683.51410.1
       101–200115.915382.32211.8
       201–3001214.56274.7910.8
       >300516.12580.713.2
       Unknown120.0480.000.0
      HMO = health maintenance organization; OB/GYN = obstetrician/gynecologist.
      Open-ended responses were reviewed to the following question: “Any other changes in your practice that you have noticed since the 2014 FDA warnings against power morcellation?” Themes that emerged included increased operating room time, increased preoperative counseling, increased patient anxiety, increased rate of laparotomy with associated risk, change in referrals and surgical volume, and overall anger with the FDA's warnings (Fig. 2).
      Figure thumbnail gr2
      Fig. 2Themes identified from open-ended responses.

      Discussion

      According to our survey results, AAGL and ACOG CARN respondents report that their use of power morcellation has declined substantially since the 2014 FDA warnings. It appears that this dramatic decrease in the use of power morcellation is not caused by physicians' perceptions of improved patient outcomes; instead, hospital mandates and fear of legal consequences have dictated clinical practice. Subspecialists in minimally invasive gynecologic surgery seem to retain the belief that power morcellation is of use because they were more likely to report continuing its use in their practice. The majority of respondents (88.7%) believed that the FDA risk estimate of an unsuspected sarcoma was too high, an issue that is highlighted in a current commentary [
      • Parker W.H.
      • Kaunitz A.M.
      • Pritts E.A.
      • et al.
      The FDA's guidance regarding morcellation of leiomyomata: well intentioned, but is it harmful for women?.
      ].
      Some data exist regarding practice patterns of gynecologic surgeons after the 2014 FDA warnings. A survey of 46 AAGL affiliated Fellowship in Minimally Invasive Gynecologic Surgery (FMIGS) fellowship directors by Desai et al [
      • Desai V.B.
      • Guo X.M.
      • Xu X.
      Alterations in surgical technique after FDA statement on power morcellation.
      ], similar to our study, showed that 84% changed their surgical approach for hysterectomies and myomectomies after the November 2014 FDA warning. In their study, 25% reported changing to an open approach for hysterectomy, and in our study, 46% reported an increased rate of laparotomy. In a retrospective cohort study by Harris et al [
      • Harris J.A.
      • Swenson C.W.
      • Uppal S.
      • et al.
      Practice patterns and postoperative complications before and after Food and Drug Administration safety communication on power morcellation.
      ] reviewing 18,299 hysterectomies, they found that utilization of laparoscopic hysterectomies decreased by 4.1%, whereas both abdominal and vaginal hysterectomies increased. They showed an increase in major surgical complications and hospital readmission, mirroring a concern from the open-ended responses in our study.
      Although the intent of the FDA's warnings was to protect patients from dissemination of unsuspected uterine sarcomas, our study shows that other concerns have emerged from the resulting changes in clinical practice. In addition to the increased rate of laparotomy with the associated surgical morbidity, respondents noted longer operating room times and increased patient anxiety. These concerns must be balanced with the overall risk of an occult uterine sarcoma, which is reported to range from 0.01% to 0.49% in studies [

      US Food and Drug Administration. 2014. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Accessed December 31, 2015.

      ,

      US Food and Drug Administration. 2014. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm. Accessed December 31, 2015.

      ,
      • Seidman M.A.
      • Oduyebo T.
      • Muto M.G.
      • Crum C.P.
      • Nucci M.R.
      • Quade B.J.
      Peritoneal dissemination complicating morcellation of uterine mesenchymal neoplasms.
      ,
      • Leibsohn S.
      • d'Ablaing G.
      • Mishell Jr., D.R.
      • Schlaerth J.B.
      Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas.
      ,
      • Parker W.H.
      • Fu Y.S.
      • Berek J.S.
      Uterine sarcoma in patients operated on for presumed leiomyoma and rapidly growing leiomyoma.
      ,
      • Takamizawa S.
      • Minakami H.
      • Usui R.
      • et al.
      Risk of complications and uterine malignancies in women undergoing hysterectomy for presumed benign leiomyomas.
      ,
      • Pritts E.A.
      • Vanness D.J.
      • Berek J.S.
      • et al.
      The prevalence of occult leiomyosarcoma at surgery for presumed uterine fibroids: a meta-analysis.
      ,
      • Rowland M.
      • Lesnock J.
      • Edwards R.
      • et al.
      Occult uterine cancer in patients undergoing laparoscopic hysterectomy with morcellation.
      ]. A decision analysis from Siedhoff et al [
      • Siedhoff M.T.
      • Wheeler S.B.
      • Rutstein S.E.
      • et al.
      Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis.
      ] predicted fewer overall deaths from laparoscopic hysterectomy with morcellation than with abdominal hysterectomy, which is associated with increased postoperative complications and lower quality of life.
      Respondents did report a range of alternative morcellation techniques, including in-bag morcellation. These techniques have yet to be studied in depth but represent creative and potentially safer methods of tissue specimen extraction using a minimally invasive approach. In-bag power morcellation has been noted to increase operating time by 20 to 26 minutes [
      • Winner B.
      • Porter A.
      • Velloze S.
      • Biest S.
      Uncontained compared with contained power morcellation in total laparoscopic hysterectomy.
      ,
      • Vargas M.V.
      • Cohen S.L.
      • Fuchs-Weizman N.
      • et al.
      Open power morcellation versus contained power morcellation within an insufflated isolation bag: comparison of perioperative outcomes.
      ]. The purpose of contained morcellation is to avoid dissemination of an occult malignancy, parasitic fibroids, and direct visceral injuries from morcellation. Two studies looking at bag integrity after morcellation showed that 9.2% and 33% showed spillage of dye [
      • Cohen S.L.
      • Morris S.N.
      • Brown D.N.
      • et al.
      Contained tissue extraction using power morcellation: prospective evaluation of leakage parameters.
      ,
      • Solima E.
      • Scagnelli G.
      • Austoni V.
      • et al.
      Vaginal uterine morcellation within a specimen containment system: a study of bag integrity.
      ], indicating a defect in this containment system.
      Older and more experienced surgeons in private practice were more likely to reduce or discontinue using power morcellation. It may be that older private practitioners have a declining surgical practice or may be reluctant to incur the risk at this junction in their career. Surgeons who considered themselves experts in minimally invasive gynecology were more likely to continue using power morcellation, possibly indicating that power morcellation is trending toward subspecialist care.
      Both AAGL and ACOG have position statements regarding power morcellation [

      AAGL statement to the FDA on power morcellation. 2014. Available at: https://www.aagl.org/aaglnews/aagl-statement-to-the-fda-on-power-morcellation/. Accessed December 31, 2015.

      ,

      ACOG statement on power morcellation. 2014. Available at: http://www.acog.org/About-ACOG/News-Room/Statements/2014/ACOG-Statement-on-Power-Morcellation. Accessed December 31, 2015.

      ]. Both national societies support power morcellation in patients who are appropriately selected and informed of the potential risks. Despite these position statements, it appears that many hospitals and surgeons have interpreted the FDA warnings as a complete ban of power morcellation. It should be recognized that all morcellation techniques have the potential of spreading an underlying malignancy. Even though ACOG recommends a vaginal hysterectomy as the approach of choice for a hysterectomy [
      Choosing the route of hysterectomy for benign disease. ACOG Committee Opinion No. 444. American College of Obstetricians and Gynecologists.
      ], vaginal specimen removal for a large uterus would require morcellation. Long-term evidence is needed to guide clinical practice.
      Even though our study was aimed at gynecologic surgeons practicing in the United States, 35.3% of our AAGL respondents were surgeons from countries outside the United States, and 16.6% reported that their hospitals had banned power morcellation (data not reported). This is consistent with a Canadian survey that showed 14% of Canadian gynecologists have stopped using power morcellation and 11% reported restricted use at their hospital [
      • Singh S.S.
      • Bougie O.
      • Arendas K.
      • et al.
      Morcellation in Canada: perspectives on current practices and future implications.
      ]. The heightened media coverage and discussion within the medical community regarding this controversial topic demonstrates the far-reaching effects of the FDA warnings.
      Although our study benefits from a large number of respondents, the response rate from AAGL members was low at 8.2%. It is unclear why our response rate was so low given that morcellation is considered a trending topic. Reasons include de-personalization and lack of follow-up emails, lack of incentive, and a large, diverse membership. While there are approximately 7,500 AAGL members, it is estimated that only 75% are practicing physicians. The first survey link was distributed within the electronic newsletter, and only 39 members clicked on the survey link with 29 members completing the survey. The second and third email requests revealed that approximately 50% of members opened the email each time, with only 12% clicking on the survey link. Responses may not be representative of the majority of members' practice patterns, and our results may be affected by response bias. Another limitation of our study is its cross-sectional design. This survey was released in April 2015, 1 year after the April 2014 warning and 5 months after the November 2014 warning. It is possible that there has been a further change in clinical practice since that time.
      In summary, our survey shows that AAGL and ACOG CARN respondents have stopped or decreased use of power morcellation since the 2014 FDA warnings. Based on their responses, it appears that the driving force behind this change in practice is not a consensus that a ban on morcellation will lead to improved patient outcomes but rather that surgeons are governed by a hospital mandate or fear of medical legal action. It is difficult to know whether this change in practice will be a short-term or a long-term trend. Clinical practice is always evolving, and physicians have a duty to provide their patients with accurately evidence-based care. Our survey is a first step in understanding how physicians have adapted their clinical practice in response to the FDA safety communication. The next step includes conducting large population-based prospective research to precisely define the incidence and risks of an undiagnosed uterine sarcoma to ensure that healthcare stakeholders are aligned in providing the best care to patients.

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