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Should We Bag Tissue Morcellation? Looking Backward and Forward
Editorial
Should We Bag Tissue Morcellation? Looking Backward and Forward DISCUSS
You can discuss this article with its authors and with other AAGL members at http://www.AAGL.org/jmig-22-1-JMIG-D-14-00322
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.
In this issue of The Journal of Minimally Invasive Gynecology several articles are dedicated to topics surrounding tissue extraction and power morcellation. These studies reflect the membership of the AAGL and JMIG in both their international origins and their cutting-edge research geared toward refining surgical practice. Each study asks questions from a different perspective on how to improve the safety of minimally invasive gynecologic surgery and tissue extraction. Independent of these innovative studies, there is much to be learned from the introduction and subsequent limitations placed on power morcellation that culminated with the US Food and Drug Administration recommendation in April that surgeons ‘‘be aware that based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids’’ [1]. Although power morcellation contributed to the revolution within minimally invasive gynecologic surgery that enabled surgeons to remove large tissue specimens through keyhole incisions, in retrospect there were potential missed opportunities. This is a key point because our surgical field is continually and rapidly evolving, taking advantage of the continual developments in new technology and equipment to increase the options we can offer to our patients. One lesson is that consideration should be given to prospective registries when new technology is introduced. The AAGL is a leader in this regard, with a long history of conducting surveys among its members and establishing registries to study these types of issues. Much of the current debate on the safety of power morcellation ultimately centers around numerators and denominators, in particular the true likelihood of an unanticipated pathologic finding. A prospectively entered database inclusive of all types of centers and surgeons would clarify the actual incidence of both unexpected malignancy and the effect of morcellation 1553-4650/$ - see front matter Ó 2014 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2014.06.012
on prognosis. Although registries such as the MAUDE (Manufacturer and User Facility Device Experience) database are helpful, they primarily reflect device-related malfunctions, injuries, and deaths. Gynecologists have been using morcellators since their initial approval in 1995 [2]. Thus, had the ideal approach been taken from the beginning, there would have been ample time for widespread data collection. Another lesson is that case reports can serve as the canary in the coal mine and should lead to consideration for a larger perspective and more detailed investigation. Even independent of the potential risk of upstaging cancers, no nationwide attempts have been undertaken to quantify the risk of spreading benign tissue (e.g., myomas) via power morcellation, although this has become an accepted phenomenon [3,4]. In addition, we have observed the ability of a motivated resourceful individual to affect and influence health care in a large arena. In this case, the surgeon husband of the affected patient launched a campaign to halt morcellation [5]. Our societies had a missed opportunity to attempt to contribute to and help guide this dialogue early on. Instead, much of the discussion has been one-sided, with the spotlight on morcellation and not on the relative risks and the broader perspective. If one accepts the principle that no surgeon would intentionally morcellate a known cancer via any route (e.g., open abdominal procedure, vaginal or endoscopic approach), the dialogue moves away from the sole emphasis on banning morcellation as the solution and instead focuses on how to improve patient safety while maintaining the benefits of a minimally invasive approach. Parallel to this, there has been essentially no discussion of the negative effect of stepping backward to laparotomy in the vast majority of women who will not be found to have a malignant lesion despite the known increased costs, pain, blood loss, hospital stay and recovery time, wound and
714
Journal of Minimally Invasive Gynecology, Vol 21, No 5, September/October 2014
abdominal wall infections, and other issues associated with open procedures [6]. Rather, the entire discourse has been focused on those truly unfortunate patients in whom sarcomas were morcellated and on how irresponsible and ignorant their surgeons were, including placing a desire to partner with surgical manufacturing companies to make a profit at the expense of spreading cancer in women. Contributing to this discussion is our responsibility, given our insights, knowledge, and expertise specific to this arena. The AAGL is to be congratulated on a well thought out and clear report [7]. In addition, the AAGL went a step farther early in this process by calling for members to share their techniques for tissue extraction, providing a dedicated E-mail link [8]. Ideally, these statements should be developed and released early in this process before public and government opinions have already been formed. We can, and should, only move forward with power morcellation if we can do so safely. In this issue of JMIG 3 different approaches are described. Cohen et al [9] prospectively evaluated a simple in vitro system, assessing the risk of leakage from morcellation systems performed within different containment bags. It is ideal to perform these preclinical evaluation assessments of surgical techniques in a laboratory setting before studying or using them on our patients. Cohen and colleagues note that all tissue extraction, even during laparotomy without morcellation, is associated with the theoretical risk of dissemination of cells including potentially malignant ones. Bogani et al [10] retrospectively compared 100 women undergoing laparoscopic myomectomy with myomas with mean largest diameter 6 cm extracted via either power morcellation or transvaginally, in the latter case morcellated within a bag if necessary. Although operative times and complication rates were similar, the vaginal route averted the need to dilate the trocar, given no abdominal tissue extraction, and required less rescue analgesia. While a hypothesis-generating study only, that report paves the way for prospective evaluations and highlights the value of the vaginal approach, the original and most ideal minimally invasive gynecologic surgery. Tulandi and Ferenczy [11] reported on 2 women in whom an intraoperative core needle biopsy of their myomas was obtained and frozen section analysis was then immediately performed. With no malignancy observed, traditional morcellation was performed. Of note, these additional steps
added only several minutes to the procedure. If future feasibility and confirmatory studies are positive, this innovative approach could potentially substantially alter the management algorithm for our patients. Core needle biopsy could potentially be performed preoperatively or, if cancer is diagnosed via the intraoperative biopsy, the appropriate surgery could then be immediately performed through the ideal incision and approach or the patient could be awakened and undergo treatment later when the appropriate personnel and resources are in place. Gary N. Frishman, MD The Warren Alpert Medical School of Brown University Women and Infants Hospital Providence, RI, USA References 1. Available at: http://www.fda.gov/medicaldevices/safety/alertsandnotices/ ucm393576.htm. 2. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/ pmn.cfm?ID5K946147. 3. Larrain D, Rabischong B, Khoo CK, Botchorishvili R, Canis M, Mage G. ‘‘Iatrogenic’’ parasitic myomas: unusual late complication of laparoscopic morcellation procedures. J Minim Invasive Gynecol. 2010;17:719–724. 4. Takeda A, Mori M, Sakai K, Mitsui T, Nakamura H. Parasitic peritoneal leiomyomatosis diagnosed 6 years after laparoscopic myomectomy with electric tissue morcellation: report of a case and review of the literature. J Minim Invasive Gynecol. 2007;14:770–775. 5. Available at: http://www.change.org/petitions/women-s-health-alertdeadly-cancers-of-the-uterus-spread-by-gynecologists-stop-morcellatingthe-uterus-in-minimally-invasive-and-robot-assisted-hysterectomy. 6. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;(3):CD003677. 7. Available at: http://www.aagl.org/wp-content/uploads/2014/05/Tissue_ Extraction_TFR.pdf. 8. Available at: http://www.aagl.org/aaglnews/aagl-member-updatedisseminated-leiomyosarcoma-with-power-morcellation. 9. Cohen SL, Greenberg JA, Wang KC, et al. Risk of leakage and tissue dissemination with various contained tissue extraction (CTE) techniques: an in vitro pilot study. J Minim Invasive Gynecol. 2014;935–939. 10. Bogani G, Uccella S, Cromi A, et al. Electric motorized morcellator versus transvaginal extraction for myoma retrieval after laparoscopic myomectomy: a propensity-matched analysis. J Minim Invasive Gynecol. 2014;928–934. 11. Tulandi T, Ferenczy A. Biopsy of uterine leiomyomata and frozen sections before laparoscopic morcellation. J Minim Invasive Gynecol. 2014;963–966.
Should We Bag Tissue Morcellation? Looking Backward and Forward DISCUSS
You can discuss this article with its authors and with other AAGL members at http://www.AAGL.org/jmig-22-1-JMIG-D-14-00322
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.
In this issue of The Journal of Minimally Invasive Gynecology several articles are dedicated to topics surrounding tissue extraction and power morcellation. These studies reflect the membership of the AAGL and JMIG in both their international origins and their cutting-edge research geared toward refining surgical practice. Each study asks questions from a different perspective on how to improve the safety of minimally invasive gynecologic surgery and tissue extraction. Independent of these innovative studies, there is much to be learned from the introduction and subsequent limitations placed on power morcellation that culminated with the US Food and Drug Administration recommendation in April that surgeons ‘‘be aware that based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids’’ [1]. Although power morcellation contributed to the revolution within minimally invasive gynecologic surgery that enabled surgeons to remove large tissue specimens through keyhole incisions, in retrospect there were potential missed opportunities. This is a key point because our surgical field is continually and rapidly evolving, taking advantage of the continual developments in new technology and equipment to increase the options we can offer to our patients. One lesson is that consideration should be given to prospective registries when new technology is introduced. The AAGL is a leader in this regard, with a long history of conducting surveys among its members and establishing registries to study these types of issues. Much of the current debate on the safety of power morcellation ultimately centers around numerators and denominators, in particular the true likelihood of an unanticipated pathologic finding. A prospectively entered database inclusive of all types of centers and surgeons would clarify the actual incidence of both unexpected malignancy and the effect of morcellation 1553-4650/$ - see front matter Ó 2014 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2014.06.012
on prognosis. Although registries such as the MAUDE (Manufacturer and User Facility Device Experience) database are helpful, they primarily reflect device-related malfunctions, injuries, and deaths. Gynecologists have been using morcellators since their initial approval in 1995 [2]. Thus, had the ideal approach been taken from the beginning, there would have been ample time for widespread data collection. Another lesson is that case reports can serve as the canary in the coal mine and should lead to consideration for a larger perspective and more detailed investigation. Even independent of the potential risk of upstaging cancers, no nationwide attempts have been undertaken to quantify the risk of spreading benign tissue (e.g., myomas) via power morcellation, although this has become an accepted phenomenon [3,4]. In addition, we have observed the ability of a motivated resourceful individual to affect and influence health care in a large arena. In this case, the surgeon husband of the affected patient launched a campaign to halt morcellation [5]. Our societies had a missed opportunity to attempt to contribute to and help guide this dialogue early on. Instead, much of the discussion has been one-sided, with the spotlight on morcellation and not on the relative risks and the broader perspective. If one accepts the principle that no surgeon would intentionally morcellate a known cancer via any route (e.g., open abdominal procedure, vaginal or endoscopic approach), the dialogue moves away from the sole emphasis on banning morcellation as the solution and instead focuses on how to improve patient safety while maintaining the benefits of a minimally invasive approach. Parallel to this, there has been essentially no discussion of the negative effect of stepping backward to laparotomy in the vast majority of women who will not be found to have a malignant lesion despite the known increased costs, pain, blood loss, hospital stay and recovery time, wound and
714
Journal of Minimally Invasive Gynecology, Vol 21, No 5, September/October 2014
abdominal wall infections, and other issues associated with open procedures [6]. Rather, the entire discourse has been focused on those truly unfortunate patients in whom sarcomas were morcellated and on how irresponsible and ignorant their surgeons were, including placing a desire to partner with surgical manufacturing companies to make a profit at the expense of spreading cancer in women. Contributing to this discussion is our responsibility, given our insights, knowledge, and expertise specific to this arena. The AAGL is to be congratulated on a well thought out and clear report [7]. In addition, the AAGL went a step farther early in this process by calling for members to share their techniques for tissue extraction, providing a dedicated E-mail link [8]. Ideally, these statements should be developed and released early in this process before public and government opinions have already been formed. We can, and should, only move forward with power morcellation if we can do so safely. In this issue of JMIG 3 different approaches are described. Cohen et al [9] prospectively evaluated a simple in vitro system, assessing the risk of leakage from morcellation systems performed within different containment bags. It is ideal to perform these preclinical evaluation assessments of surgical techniques in a laboratory setting before studying or using them on our patients. Cohen and colleagues note that all tissue extraction, even during laparotomy without morcellation, is associated with the theoretical risk of dissemination of cells including potentially malignant ones. Bogani et al [10] retrospectively compared 100 women undergoing laparoscopic myomectomy with myomas with mean largest diameter 6 cm extracted via either power morcellation or transvaginally, in the latter case morcellated within a bag if necessary. Although operative times and complication rates were similar, the vaginal route averted the need to dilate the trocar, given no abdominal tissue extraction, and required less rescue analgesia. While a hypothesis-generating study only, that report paves the way for prospective evaluations and highlights the value of the vaginal approach, the original and most ideal minimally invasive gynecologic surgery. Tulandi and Ferenczy [11] reported on 2 women in whom an intraoperative core needle biopsy of their myomas was obtained and frozen section analysis was then immediately performed. With no malignancy observed, traditional morcellation was performed. Of note, these additional steps
added only several minutes to the procedure. If future feasibility and confirmatory studies are positive, this innovative approach could potentially substantially alter the management algorithm for our patients. Core needle biopsy could potentially be performed preoperatively or, if cancer is diagnosed via the intraoperative biopsy, the appropriate surgery could then be immediately performed through the ideal incision and approach or the patient could be awakened and undergo treatment later when the appropriate personnel and resources are in place. Gary N. Frishman, MD The Warren Alpert Medical School of Brown University Women and Infants Hospital Providence, RI, USA References 1. Available at: http://www.fda.gov/medicaldevices/safety/alertsandnotices/ ucm393576.htm. 2. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/ pmn.cfm?ID5K946147. 3. Larrain D, Rabischong B, Khoo CK, Botchorishvili R, Canis M, Mage G. ‘‘Iatrogenic’’ parasitic myomas: unusual late complication of laparoscopic morcellation procedures. J Minim Invasive Gynecol. 2010;17:719–724. 4. Takeda A, Mori M, Sakai K, Mitsui T, Nakamura H. Parasitic peritoneal leiomyomatosis diagnosed 6 years after laparoscopic myomectomy with electric tissue morcellation: report of a case and review of the literature. J Minim Invasive Gynecol. 2007;14:770–775. 5. Available at: http://www.change.org/petitions/women-s-health-alertdeadly-cancers-of-the-uterus-spread-by-gynecologists-stop-morcellatingthe-uterus-in-minimally-invasive-and-robot-assisted-hysterectomy. 6. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;(3):CD003677. 7. Available at: http://www.aagl.org/wp-content/uploads/2014/05/Tissue_ Extraction_TFR.pdf. 8. Available at: http://www.aagl.org/aaglnews/aagl-member-updatedisseminated-leiomyosarcoma-with-power-morcellation. 9. Cohen SL, Greenberg JA, Wang KC, et al. Risk of leakage and tissue dissemination with various contained tissue extraction (CTE) techniques: an in vitro pilot study. J Minim Invasive Gynecol. 2014;935–939. 10. Bogani G, Uccella S, Cromi A, et al. Electric motorized morcellator versus transvaginal extraction for myoma retrieval after laparoscopic myomectomy: a propensity-matched analysis. J Minim Invasive Gynecol. 2014;928–934. 11. Tulandi T, Ferenczy A. Biopsy of uterine leiomyomata and frozen sections before laparoscopic morcellation. J Minim Invasive Gynecol. 2014;963–966.