Perspective
Morcellation in Canada: Perspectives on Current Practices and Future Implications DISCUSS
You can discuss this article with its authors and with other AAGL members at http:// www.AAGL.org/jmig-22-6-JMIG-D-15-00395.
Use your Smartphone to scan this QR code and connect to the discussion forum for this article now* * Download a free QR Code scanner by searching for ‘‘QR scanner’’ in your smartphone’s app store or app marketplace.
Compared with traditional laparotomy, minimally invasive surgical management of uterine fibroids offers patients faster recovery and fewer complications [1–3]. Extraction of tissue through smaller incisions has traditionally included the use of laparoscopic power morcellators, however. Power morcellators have come under considerable scrutiny recently. Because of the difficulty in clinically differentiating a sarcoma from a benign fibroid at laparoscopy, morcellation of an undiagnosed sarcoma may result in intra-abdominal dissemination of malignant tissue. In December 2013, The Wall Street Journal publicized a case in which an unexpected uterine sarcoma was morcellated during a routine hysterectomy for ‘‘fibroids’’ [4]. Considerable media attention followed. In the spring of 2014, the US Food and Drug Administration (FDA) and Health Canada released statements discouraging the use of power morcellators in gynecology [5,6]. In November 2014, the FDA issued a black box warning specifying that laparoscopic power morcellation should be contraindicated in perimenopausal and menopausal women [7]. In December 2014, Health Canada followed suit, echoing the FDA recommendations [8]. The Society of Obstetricians and Gynecologists of Canada (SOGC) recently released a technical update, providing a more tempered approach for Canadian gynecologists [9]. Based on these recent events, there has been wide variation in practice and opinions in the gynecology community. We conducted an electronic survey of practicing physician members of the SOGC to examine the use of power morcellation in surgery, complications experienced with morcellator use, and factors influencing patient selection for procedures involving morcellation. This survey, like many others of its kind, is limited by the response rate, resulting in the potential for responder bias. Nonetheless, we strongly 1553-4650/$ - see front matter Ó 2015 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2015.07.001
believe that these data are important to share, providing valuable insights into current national practices and ideas for the future. We received 203 responses from the SOGC members invited to participate, for a 28.2% response rate. All Canadian provinces and various practice settings (rural, urbancommunity, urban-academic) were represented. More than one-half of the respondents (116; 57%) reported using laparoscopic power morcellation in their practice, mostly for laparoscopic subtotal hysterectomy, laparoscopic myomectomy, and laparoscopic total hysterectomy. In what follows, we discuss the most important findings from our study. Current Events Have Resulted in a Distinct Shift in Practice In light of the FDA and Health Canada statements, 14% of Canadian gynecologists reported that they have abandoned laparoscopic morcellation. An additional 11% indicated that their hospital now restricts the use of power morcellation. It is possible that more gynecologists may abandon laparoscopic morcellation given the recent FDA and Health Canada black box warnings. This change in practice will definitely have profound implications on women’s health. Access to minimally invasive options may become increasingly limited for Canadian women, and, consequently, fewer women will receive the proven benefits of minimally invasive approaches, such as shorter hospital stay and fewer postoperative complications [1–3]. In addition, current events are likely to result in women receiving a fulsome conversation about the risks and benefits of laparoscopic morcellation before undergoing surgery. Our survey results indicate that before the FDA warning about the power morcellator, only 62% of the respondents (58 of
Perspective
94) reported that they always informed patients when a laparoscopic power morcellator was to be used in their surgery, and 13.8% (13 of 94) would never do so. There Is Confusion About the Risks of Encountering Occult Malignancy During Fibroid Surgery The risk of occult sarcoma is controversial. The FDA reports that 1 in 350 women who undergo fibroid surgery will have an unsuspected sarcoma [5]; however, other reported estimates of this risk range from 1 in 200 to 1 in 1000 [10–14]. The FDA’s risk estimate, derived from 9 retrospective studies, is limited by referral and reporting bias. In our survey, 52% of Canadian gynecologists would quote a risk of occult sarcoma at the time of fibroid surgery of \1/1000, 30% would quote a risk between 1/ 300 and 1/500, and 18% would quote a risk of .1/300. This finding highlights the variation in patient counseling and a lack of consensus regarding the risk of malignancy. Our results emphasize the need for further research in this area. We also need to develop standardized and accurate approaches to communicating preoperative risks with patients. Given that patient age and uterine size are known risk factors for sarcoma, we need to stratify risk estimates by age, type of surgery (hysterectomy vs myomectomy), and surgical approach (minimally invasive vs traditional laparotomy). Presumably the risk of occult sarcoma differs between a 30-year-old undergoing laparoscopic myomectomy and a 60 year-old undergoing hysterectomy. There Are Opportunities for Provider Education on Indications, Use, and Complications of Morcellation Devices/Techniques We asked the respondents whether they would consider using a power morcellator in various clinical scenarios. Some 35% of the respondents reported offering laparoscopic morcellation in women over age 50. When asked specifically about potential risk factors of uterine sarcoma, 11% responded that they would consider morcellation in a patient with rapid fibroid growth over the past year, 7% would consider morcellation in a patient with a previous gynecologic malignancy, 22% would consider morcellation for risk-reducing surgery (i.e., in BRCA carriers), and 6% would consider morcellation in a surgical procedure performed for a premalignant condition (e.g., endometrial hyperplasia with atypia). Patient selection and preoperative evaluation and counseling are fundamental aspects of preoperative planning for any physician anticipating to perform laparoscopic power morcellation. Given all of the recent warnings and guidelines, providers should not offer morcellation in patients at high risk for malignancy (e.g., perimenopausal
1143
and postmenompausal women, those undergoing riskreducing surgery, history of gynecologic premalignancy). Risks of Morcellation Are Not Limited to Inadvertent Morcellation of Undiagnosed Malignancy Our respondents reported 5 cases of malignancy diagnoses following morcellation of a uterine specimen and 9 cases of major intra-abdominal organ injury. The true rate of complications associated with power morcellation is difficult to ascertain, however. In a systematic review of morcellatorrelated injuries in the United States between 1993 and 2013, Milad and Milad [15] reported 55 injuries and 6 deaths attributed to morcellator use. The authors concluded that surgeon experience likely confers some advantage for protection against injuries. Users of the laparoscopic morcellator must receive appropriate training in techniques and technology before performing this technique. Health Canada has recommended closed morcellation in a bag as a way to reduce the risk of ‘‘inadvertent spread of uterine tissue’’ [8]. The recent SOGC technical update also discuss ‘‘contained morcellation techniques’’ [9]. Many practicing gynecologists are unfamiliar with these techniques. Only 10% of respondents reported performing power morcellation in a bag. Ten percent were familiar with vaginal morcellation in a bag, and 29% were familiar with manual morcellation in a bag. Keep in mind, however, that at present there is no evidence that in-bag morcellation changes the natural course of the disease and/or improves clinical outcomes. Furthermore, potential complications inherent to in-bag morcellation have not yet been assessed. Although it is important to explore these risk-reducing morcellation alternatives, gynecologists must undergo training before performing these procedures, to reduce the risk of unintended complications. In summary, laparoscopic power morcellation can provide patients considerable benefits in terms of facilitating a minimally invasive approach when uterine and/or fibroid size is large, thereby decreasing recovery time and perioperative risks. However, patients need to be carefully selected and counseled when morcellation is planned. Physicians using the power morcellator should be encouraged to obtain appropriate training in this surgical technique, along with education with respect to the potential risks of morcellation and knowledge of alternative techniques. Additional surgical training may be needed to improve operator skills with the morcellator and other techniques. Sukhbir S. Singh, MD, FRCSC Olga Bougie, MD, FRCSC The Ottawa Hospital, Obstetrics Gynecology and Newborn Care Ottawa, Ontario, Canada
1144
Journal of Minimally Invasive Gynecology, Vol 22, No 7, November/December 2015
Mount Sinai Department of Obstetrics and Gynecology Toronto, Ontario, Canada
The Ottawa Hospital Research Institute Ottawa, Ontario, Canada University of Ottawa Faculty of Medicine Ottawa, Ontario, Canada Kristina Arendas, MD, FRCSC McMaster University Obstetrics & Gynecology Hamilton, Ontario, Canada George Vilos, MD, FRCSC, FACOG, FSOGC St Joseph’s Health Centre London, Ontario, Canada University of Western Ontario London, Ontario, Canada Catherine Allaire, MD, FRCSC University of British Columbia Obstetrics and Gynaecology Vancouver, British Columbia, Canada Philippe Y. Laberge, MD, FRCSC, ACGE Universite Laval Departement d’obstetrique-gynecologie Quebec Quebec, Canada Nicholas Leyland, MD, MHCM, FRCSC McMaster University Obstetrics & Gynecology Hamilton, Ontario, Canada Innie Chen, MD, FRCSC The Ottawa Hospital, Obstetrics Gynecology and Newborn Care Ottawa, Ontario, Canada The Ottawa Hospital Research Institute Ottawa, Ontario, Canada University of Ottawa Faculty of Medicine Ottawa, Ontario, Canada Ally Murji, MD, MPH, FRCSC University of Toronto Toronto, Ontario, Canada
REFERENCES 1. AAGL. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011;18:1–3. 2. Laberge PY, Singh SS. Surgical approach to hysterectomy: introducing the concept of technicity. J Obstet Gynaecol Can. 2009;31:1050–1053. 3. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Databae of Syst Rev. 2009:CD003677. 4. Fibroid Surgery Puts Doctor Fighting Cancer Diagnosis in Spotlight. 2013. (Accessed February 15, 2015) 5. Laparoscopic Electric Morcellators - Risk of Spread of Unsuspected Uterine Sarcoma - Notice to Hospitals. 2014. (Accessed July 8, 2014) 6. Quantitative assessment of the prevalence ofunsuspected uterine sarcoma in women undergoing treatment of uterine fibroids: summary and key findings. 2014. (Accessed July 8 2014) 7. Laparoscopic Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication - Use Discouraged Due to Increased Risk in Women With Uterine Fibroids.. FDA; 2014 (Accessed February 15, 2015). 8. Laparoscopic Electric Morcellators - Update on the Risk of Spread of Unsuspected Uterine Cancer - Notice to Hospitals 2014. (Accessed February 15, 2015). 9. Singh SS, Scott S, Bougie O, et al. Technical Update on Tissue Morcellation DuringGynaecologic Surgery: Its Uses, Complications,and Risks of Unsuspected Malignancy. J Obstet Gynaecol Can. 2015;31:68–78. 10. Leibsohn S, D’Ablaing G, Mishell Jr DR, et al. Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas. AJOG. 1990;162:968–976. 11. Parker WHM, Fu YSM, Berek JSM. Uterine Sarcoma in Patients Operated on for Presumed Leiomyoma and Rapidly Growing Leiomyoma. Obstet Gynecol. 1994;83:414–418. 12. Takamizawa S, Minakami H, Usui R, et al. Risk of complications and uterine malignancies in women undergoing hysterectomy for presumed benign leiomyomas. Gynecol Obstet Invest. 1999;48:193–196. 13. Theben JU, Schellong ARM, Altgassen C, et al. Unexpected malignancies after laparoscopic-assisted supracervical hysterectomies (LASH): An analysis of 1,584 LASH cases. Arch Gynecol Obstet. 2013;287:455–462. 14. Wright JD, Tergas AI, Burke WM, et al. Uterine Pathology in Women Undergoing Minimally Invasive Hysterectomy Using Morcellation. Obstet Gynecol Surv. 2014;69:653–654. 15. Milad MP, Milad EA. Laparoscopic morcellator-related complications. J Minim Invasive Gynecol. 2014;21:486–491.
Morcellation in Canada: Perspectives on Current Practices and Future Implications DISCUSS
You can discuss this article with its authors and with other AAGL members at http:// www.AAGL.org/jmig-22-6-JMIG-D-15-00395.
Use your Smartphone to scan this QR code and connect to the discussion forum for this article now* * Download a free QR Code scanner by searching for ‘‘QR scanner’’ in your smartphone’s app store or app marketplace.
Compared with traditional laparotomy, minimally invasive surgical management of uterine fibroids offers patients faster recovery and fewer complications [1–3]. Extraction of tissue through smaller incisions has traditionally included the use of laparoscopic power morcellators, however. Power morcellators have come under considerable scrutiny recently. Because of the difficulty in clinically differentiating a sarcoma from a benign fibroid at laparoscopy, morcellation of an undiagnosed sarcoma may result in intra-abdominal dissemination of malignant tissue. In December 2013, The Wall Street Journal publicized a case in which an unexpected uterine sarcoma was morcellated during a routine hysterectomy for ‘‘fibroids’’ [4]. Considerable media attention followed. In the spring of 2014, the US Food and Drug Administration (FDA) and Health Canada released statements discouraging the use of power morcellators in gynecology [5,6]. In November 2014, the FDA issued a black box warning specifying that laparoscopic power morcellation should be contraindicated in perimenopausal and menopausal women [7]. In December 2014, Health Canada followed suit, echoing the FDA recommendations [8]. The Society of Obstetricians and Gynecologists of Canada (SOGC) recently released a technical update, providing a more tempered approach for Canadian gynecologists [9]. Based on these recent events, there has been wide variation in practice and opinions in the gynecology community. We conducted an electronic survey of practicing physician members of the SOGC to examine the use of power morcellation in surgery, complications experienced with morcellator use, and factors influencing patient selection for procedures involving morcellation. This survey, like many others of its kind, is limited by the response rate, resulting in the potential for responder bias. Nonetheless, we strongly 1553-4650/$ - see front matter Ó 2015 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2015.07.001
believe that these data are important to share, providing valuable insights into current national practices and ideas for the future. We received 203 responses from the SOGC members invited to participate, for a 28.2% response rate. All Canadian provinces and various practice settings (rural, urbancommunity, urban-academic) were represented. More than one-half of the respondents (116; 57%) reported using laparoscopic power morcellation in their practice, mostly for laparoscopic subtotal hysterectomy, laparoscopic myomectomy, and laparoscopic total hysterectomy. In what follows, we discuss the most important findings from our study. Current Events Have Resulted in a Distinct Shift in Practice In light of the FDA and Health Canada statements, 14% of Canadian gynecologists reported that they have abandoned laparoscopic morcellation. An additional 11% indicated that their hospital now restricts the use of power morcellation. It is possible that more gynecologists may abandon laparoscopic morcellation given the recent FDA and Health Canada black box warnings. This change in practice will definitely have profound implications on women’s health. Access to minimally invasive options may become increasingly limited for Canadian women, and, consequently, fewer women will receive the proven benefits of minimally invasive approaches, such as shorter hospital stay and fewer postoperative complications [1–3]. In addition, current events are likely to result in women receiving a fulsome conversation about the risks and benefits of laparoscopic morcellation before undergoing surgery. Our survey results indicate that before the FDA warning about the power morcellator, only 62% of the respondents (58 of
Perspective
94) reported that they always informed patients when a laparoscopic power morcellator was to be used in their surgery, and 13.8% (13 of 94) would never do so. There Is Confusion About the Risks of Encountering Occult Malignancy During Fibroid Surgery The risk of occult sarcoma is controversial. The FDA reports that 1 in 350 women who undergo fibroid surgery will have an unsuspected sarcoma [5]; however, other reported estimates of this risk range from 1 in 200 to 1 in 1000 [10–14]. The FDA’s risk estimate, derived from 9 retrospective studies, is limited by referral and reporting bias. In our survey, 52% of Canadian gynecologists would quote a risk of occult sarcoma at the time of fibroid surgery of \1/1000, 30% would quote a risk between 1/ 300 and 1/500, and 18% would quote a risk of .1/300. This finding highlights the variation in patient counseling and a lack of consensus regarding the risk of malignancy. Our results emphasize the need for further research in this area. We also need to develop standardized and accurate approaches to communicating preoperative risks with patients. Given that patient age and uterine size are known risk factors for sarcoma, we need to stratify risk estimates by age, type of surgery (hysterectomy vs myomectomy), and surgical approach (minimally invasive vs traditional laparotomy). Presumably the risk of occult sarcoma differs between a 30-year-old undergoing laparoscopic myomectomy and a 60 year-old undergoing hysterectomy. There Are Opportunities for Provider Education on Indications, Use, and Complications of Morcellation Devices/Techniques We asked the respondents whether they would consider using a power morcellator in various clinical scenarios. Some 35% of the respondents reported offering laparoscopic morcellation in women over age 50. When asked specifically about potential risk factors of uterine sarcoma, 11% responded that they would consider morcellation in a patient with rapid fibroid growth over the past year, 7% would consider morcellation in a patient with a previous gynecologic malignancy, 22% would consider morcellation for risk-reducing surgery (i.e., in BRCA carriers), and 6% would consider morcellation in a surgical procedure performed for a premalignant condition (e.g., endometrial hyperplasia with atypia). Patient selection and preoperative evaluation and counseling are fundamental aspects of preoperative planning for any physician anticipating to perform laparoscopic power morcellation. Given all of the recent warnings and guidelines, providers should not offer morcellation in patients at high risk for malignancy (e.g., perimenopausal
1143
and postmenompausal women, those undergoing riskreducing surgery, history of gynecologic premalignancy). Risks of Morcellation Are Not Limited to Inadvertent Morcellation of Undiagnosed Malignancy Our respondents reported 5 cases of malignancy diagnoses following morcellation of a uterine specimen and 9 cases of major intra-abdominal organ injury. The true rate of complications associated with power morcellation is difficult to ascertain, however. In a systematic review of morcellatorrelated injuries in the United States between 1993 and 2013, Milad and Milad [15] reported 55 injuries and 6 deaths attributed to morcellator use. The authors concluded that surgeon experience likely confers some advantage for protection against injuries. Users of the laparoscopic morcellator must receive appropriate training in techniques and technology before performing this technique. Health Canada has recommended closed morcellation in a bag as a way to reduce the risk of ‘‘inadvertent spread of uterine tissue’’ [8]. The recent SOGC technical update also discuss ‘‘contained morcellation techniques’’ [9]. Many practicing gynecologists are unfamiliar with these techniques. Only 10% of respondents reported performing power morcellation in a bag. Ten percent were familiar with vaginal morcellation in a bag, and 29% were familiar with manual morcellation in a bag. Keep in mind, however, that at present there is no evidence that in-bag morcellation changes the natural course of the disease and/or improves clinical outcomes. Furthermore, potential complications inherent to in-bag morcellation have not yet been assessed. Although it is important to explore these risk-reducing morcellation alternatives, gynecologists must undergo training before performing these procedures, to reduce the risk of unintended complications. In summary, laparoscopic power morcellation can provide patients considerable benefits in terms of facilitating a minimally invasive approach when uterine and/or fibroid size is large, thereby decreasing recovery time and perioperative risks. However, patients need to be carefully selected and counseled when morcellation is planned. Physicians using the power morcellator should be encouraged to obtain appropriate training in this surgical technique, along with education with respect to the potential risks of morcellation and knowledge of alternative techniques. Additional surgical training may be needed to improve operator skills with the morcellator and other techniques. Sukhbir S. Singh, MD, FRCSC Olga Bougie, MD, FRCSC The Ottawa Hospital, Obstetrics Gynecology and Newborn Care Ottawa, Ontario, Canada
1144
Journal of Minimally Invasive Gynecology, Vol 22, No 7, November/December 2015
Mount Sinai Department of Obstetrics and Gynecology Toronto, Ontario, Canada
The Ottawa Hospital Research Institute Ottawa, Ontario, Canada University of Ottawa Faculty of Medicine Ottawa, Ontario, Canada Kristina Arendas, MD, FRCSC McMaster University Obstetrics & Gynecology Hamilton, Ontario, Canada George Vilos, MD, FRCSC, FACOG, FSOGC St Joseph’s Health Centre London, Ontario, Canada University of Western Ontario London, Ontario, Canada Catherine Allaire, MD, FRCSC University of British Columbia Obstetrics and Gynaecology Vancouver, British Columbia, Canada Philippe Y. Laberge, MD, FRCSC, ACGE Universite Laval Departement d’obstetrique-gynecologie Quebec Quebec, Canada Nicholas Leyland, MD, MHCM, FRCSC McMaster University Obstetrics & Gynecology Hamilton, Ontario, Canada Innie Chen, MD, FRCSC The Ottawa Hospital, Obstetrics Gynecology and Newborn Care Ottawa, Ontario, Canada The Ottawa Hospital Research Institute Ottawa, Ontario, Canada University of Ottawa Faculty of Medicine Ottawa, Ontario, Canada Ally Murji, MD, MPH, FRCSC University of Toronto Toronto, Ontario, Canada
REFERENCES 1. AAGL. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011;18:1–3. 2. Laberge PY, Singh SS. Surgical approach to hysterectomy: introducing the concept of technicity. J Obstet Gynaecol Can. 2009;31:1050–1053. 3. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Databae of Syst Rev. 2009:CD003677. 4. Fibroid Surgery Puts Doctor Fighting Cancer Diagnosis in Spotlight. 2013. (Accessed February 15, 2015) 5. Laparoscopic Electric Morcellators - Risk of Spread of Unsuspected Uterine Sarcoma - Notice to Hospitals. 2014. (Accessed July 8, 2014) 6. Quantitative assessment of the prevalence ofunsuspected uterine sarcoma in women undergoing treatment of uterine fibroids: summary and key findings. 2014. (Accessed July 8 2014) 7. Laparoscopic Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication - Use Discouraged Due to Increased Risk in Women With Uterine Fibroids.. FDA; 2014 (Accessed February 15, 2015). 8. Laparoscopic Electric Morcellators - Update on the Risk of Spread of Unsuspected Uterine Cancer - Notice to Hospitals 2014. (Accessed February 15, 2015). 9. Singh SS, Scott S, Bougie O, et al. Technical Update on Tissue Morcellation DuringGynaecologic Surgery: Its Uses, Complications,and Risks of Unsuspected Malignancy. J Obstet Gynaecol Can. 2015;31:68–78. 10. Leibsohn S, D’Ablaing G, Mishell Jr DR, et al. Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas. AJOG. 1990;162:968–976. 11. Parker WHM, Fu YSM, Berek JSM. Uterine Sarcoma in Patients Operated on for Presumed Leiomyoma and Rapidly Growing Leiomyoma. Obstet Gynecol. 1994;83:414–418. 12. Takamizawa S, Minakami H, Usui R, et al. Risk of complications and uterine malignancies in women undergoing hysterectomy for presumed benign leiomyomas. Gynecol Obstet Invest. 1999;48:193–196. 13. Theben JU, Schellong ARM, Altgassen C, et al. Unexpected malignancies after laparoscopic-assisted supracervical hysterectomies (LASH): An analysis of 1,584 LASH cases. Arch Gynecol Obstet. 2013;287:455–462. 14. Wright JD, Tergas AI, Burke WM, et al. Uterine Pathology in Women Undergoing Minimally Invasive Hysterectomy Using Morcellation. Obstet Gynecol Surv. 2014;69:653–654. 15. Milad MP, Milad EA. Laparoscopic morcellator-related complications. J Minim Invasive Gynecol. 2014;21:486–491.
