Editorial
Mitigating Risks of Specimen Extraction Is In-Bag Power Morcellation an Answer?
M
Charles R. Rardin, MD
See related article on page 491.
Dr. Rardin is from the Department of Obstetrics and Gynecology, Division of Urogynecology, at the Women and Infants’ Hospital, Brown Medical School, Providence, Rhode Island; e-mail: [email protected]. Financial Disclosure The author did not report any potential conflicts of interest. © 2014 by The American College of Obstetricians and Gynecologists. Published by Lippincott Williams & Wilkins. ISSN: 0029-7844/14
VOL. 124, NO. 3, SEPTEMBER 2014
edicine has a long history of recognizing and coping with the unintended consequences of its own developments. Sometimes the detected risks turn out to be real (eg, thalidomide, diethylstilbestrol, weekly rounds of steroids for prematurity), and sometimes a scientific second look quiets the initial furor (eg, silicone implants, immunizations associated with autism). Despite the rich history of medicine’s reassessment of the risks of its interventions, it typically remains a difficult and often painful process. In use for more than 20 years, the technique of power morcellation has brought minimally invasive surgery to women with gynecologic issues requiring surgery. The rate of laparotomy in the treatment of women with uterine pathology has decreased over that time, with an increasing proportion of women benefiting from minimally invasive surgery, including reduced postoperative pain and recuperation time, and, by many studies’ estimation, reduced rates of pelvic infection, incisional hernia, thromboembolic disease, and adhesion formation. Few would argue that tissue morcellation of a known malignancy is a poor surgical strategy. Although much of the support for the concept that mechanically spread tissue can remain viable is in the setting of benign (leiomyomatosis or endometriosis) rather than malignant disease, there are data to support the biologically plausible notion that morcellating malignancy can negatively affect tumor staging or clinical outcomes. In cases where leiomyosarcoma is detected, those with uteri delivered intact seem to fare better than those whose surgery involves tumor disruption (myomectomy, either abdominal or hysteroscopic, and laparoscopic hysterectomy with knife morcellation).1 The issue, of course, has been that these rare cancers are as yet largely undetectable before surgery. Therefore, the surgical strategy in minimally invasive surgery often has involved, whether statistically tenable or not, assuming the absence of pathology based on the patient characteristics and available preoperative data. A recent case of an unfortunate individual who underwent morcellation of what was subsequently found to be leiomyosarcoma, and the media coverage around this case, has intensified the scrutiny around the process of tissue morcellation.2 Whether around vaginal mesh, robotic surgery, or power morcellation, there is an attraction for the press to portray a “gotcha” story of doctors who appeared to be making mistakes, using poor judgment, profiting personally, and the like. This sensationalism, along with the suggestion that some surgeons are more interested in their own reputations or relations with industry than with their patients’ well-being, have fueled much of the emotional intensity around this debate. Until there are more effective screening tools to detect these unusual cancers, surgeons and hospitals are required to develop responses to these issues. One extreme response might be to proscribe any form of tissue morcellation whatsoever. If such were the case, the only approach in which en-bloc extraction can be assured is through laparotomy. In this
OBSTETRICS & GYNECOLOGY
489
scenario, even using the most pessimistic estimates of prevalence, many hundreds of women would need to undergo laparotomy to avoid acquiring the poor prognosis of a single woman with leiomyosarcoma. This logic, of course, forces the uncomfortable collective discussion about relative value to the many, at the cost to the few. Taken even further, this argument about the potential for leiomyomas to harbor undetected malignancy forces questions about other management strategies for leiomyomas, including ablation, embolization, or even expectant management. Some institutions have opted to proscribe power morcellation entirely, whereas others have chosen to allow continued use of the power morcellator, often with additional layers in the informed-consent or caseapproval process. Another response to these concerns is to attempt to mitigate the risk of tissue spread during power morcellation procedures. One university was reported to have adopted the policy that power morcellation could be done only in cases of uteri sized less than 18 weeks of gestation, and, in those cases, the power morcellation was permitted only within the confines of an endoscopic bag device.3 Although this may appear to be a tempting solution, there are several issues and questions regarding the plausibility, safety, and efficacy of in-bag morcellation. This month’s issue of Obstetrics & Gynecology includes a study titled “Contained Power Morcellation Within an Insufflated Isolation Bag” by Dr. Cohen and her colleagues (see page 491), which seeks to address these concerns as a first scientific step toward understanding whether this is a viable answer.4 Cohen et al’s article addresses primarily the technical plausibility of in-bag morcellation during laparoscopic myomectomy or hysterectomy (supracervical or total). Formal investigations of bag integrity or tissue spread are not included; successful control of tissue spread was essentially assessed by a visual judgment by the surgeon. In addition, the techniques described seem particularly well-suited to single-site laparoscopic or robotic surgery with unclear applicability to traditional multiport laparoscopy. Single-site laparoscopy requires additional training and skill, and, because the
490
Rardin
Mitigating Risks of Specimen Extraction
incisions are fewer in number but larger in diameter, there is some concern for increased hernia formation.5 The authors also appropriately recognize the concerns about the technique in multiport surgery, which require the penetration of the bag by one or more trocars or instruments. In addition to possible disruption of bag integrity, violation of the manufacturer’s recommendations, or both, this also involves the passage of trocars through the peritoneal cavity, out of direct visualization until the trocar pierces the bag wherein the camera resides. All of these issues raise the concern for reducing one set of risks while increasing other risks. Regardless of how surgeons and institutions seek to engage in safer power morcellation techniques, it behooves us all to remember and retain our knowledge and skill in other forms of minimally invasive surgery, including vaginal hysterectomy with extraction techniques. Although comparative data are lacking, techniques of vaginal tissue extraction—maintaining contact of the uterine serosa to the vaginal cuff and avoiding spread of tissue throughout the peritoneal cavity— should keep any risk of dissemination to a minimum while preserving the patient’s benefits from the original minimally invasive surgery. REFERENCES 1. Perri T, Korach J, Sadetzki S, Oberman B, Fridman E, BenBaruch G. Uterine leiomyosarcoma: does the primary surgical procedure matter? Int J Gynecol Cancer 2009;19:257–60. 2. Levitz J. Doctors eye cancer risk in uterine procedure: popular technique to remove growths comes under question. The Wall Street Journal 2013. Available at: http://online.wsj.com/news/ articles/SB10001424052702304173704579264673929862850. Retrieved June 21, 2014. 3. Kamp J, Levitz J. Philadelphia hospital restricts “morcellation” procedure. The Wall Street Journal 2014. Available at: http://online.wsj.com/news/articles/ SB10001424052702303775504579394771688705300. Retrieved June 21, 2014. 4. Cohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, et al. Contained power morcellation within an insufflated isolation bag. Obstet Gynecol 2014;124:491–7. 5. Gunderson CC, Knight J, Ybanez-Morano J, Ritter C, Escobar PF, Ibeanu O, et al. The risk of umbilical hernia and other complications with laparoendoscopic single-site surgery. J Minim Invasive Gynecol 2012;19:40–5.
OBSTETRICS & GYNECOLOGY
Mitigating Risks of Specimen Extraction Is In-Bag Power Morcellation an Answer?
M
Charles R. Rardin, MD
See related article on page 491.
Dr. Rardin is from the Department of Obstetrics and Gynecology, Division of Urogynecology, at the Women and Infants’ Hospital, Brown Medical School, Providence, Rhode Island; e-mail: [email protected]. Financial Disclosure The author did not report any potential conflicts of interest. © 2014 by The American College of Obstetricians and Gynecologists. Published by Lippincott Williams & Wilkins. ISSN: 0029-7844/14
VOL. 124, NO. 3, SEPTEMBER 2014
edicine has a long history of recognizing and coping with the unintended consequences of its own developments. Sometimes the detected risks turn out to be real (eg, thalidomide, diethylstilbestrol, weekly rounds of steroids for prematurity), and sometimes a scientific second look quiets the initial furor (eg, silicone implants, immunizations associated with autism). Despite the rich history of medicine’s reassessment of the risks of its interventions, it typically remains a difficult and often painful process. In use for more than 20 years, the technique of power morcellation has brought minimally invasive surgery to women with gynecologic issues requiring surgery. The rate of laparotomy in the treatment of women with uterine pathology has decreased over that time, with an increasing proportion of women benefiting from minimally invasive surgery, including reduced postoperative pain and recuperation time, and, by many studies’ estimation, reduced rates of pelvic infection, incisional hernia, thromboembolic disease, and adhesion formation. Few would argue that tissue morcellation of a known malignancy is a poor surgical strategy. Although much of the support for the concept that mechanically spread tissue can remain viable is in the setting of benign (leiomyomatosis or endometriosis) rather than malignant disease, there are data to support the biologically plausible notion that morcellating malignancy can negatively affect tumor staging or clinical outcomes. In cases where leiomyosarcoma is detected, those with uteri delivered intact seem to fare better than those whose surgery involves tumor disruption (myomectomy, either abdominal or hysteroscopic, and laparoscopic hysterectomy with knife morcellation).1 The issue, of course, has been that these rare cancers are as yet largely undetectable before surgery. Therefore, the surgical strategy in minimally invasive surgery often has involved, whether statistically tenable or not, assuming the absence of pathology based on the patient characteristics and available preoperative data. A recent case of an unfortunate individual who underwent morcellation of what was subsequently found to be leiomyosarcoma, and the media coverage around this case, has intensified the scrutiny around the process of tissue morcellation.2 Whether around vaginal mesh, robotic surgery, or power morcellation, there is an attraction for the press to portray a “gotcha” story of doctors who appeared to be making mistakes, using poor judgment, profiting personally, and the like. This sensationalism, along with the suggestion that some surgeons are more interested in their own reputations or relations with industry than with their patients’ well-being, have fueled much of the emotional intensity around this debate. Until there are more effective screening tools to detect these unusual cancers, surgeons and hospitals are required to develop responses to these issues. One extreme response might be to proscribe any form of tissue morcellation whatsoever. If such were the case, the only approach in which en-bloc extraction can be assured is through laparotomy. In this
OBSTETRICS & GYNECOLOGY
489
scenario, even using the most pessimistic estimates of prevalence, many hundreds of women would need to undergo laparotomy to avoid acquiring the poor prognosis of a single woman with leiomyosarcoma. This logic, of course, forces the uncomfortable collective discussion about relative value to the many, at the cost to the few. Taken even further, this argument about the potential for leiomyomas to harbor undetected malignancy forces questions about other management strategies for leiomyomas, including ablation, embolization, or even expectant management. Some institutions have opted to proscribe power morcellation entirely, whereas others have chosen to allow continued use of the power morcellator, often with additional layers in the informed-consent or caseapproval process. Another response to these concerns is to attempt to mitigate the risk of tissue spread during power morcellation procedures. One university was reported to have adopted the policy that power morcellation could be done only in cases of uteri sized less than 18 weeks of gestation, and, in those cases, the power morcellation was permitted only within the confines of an endoscopic bag device.3 Although this may appear to be a tempting solution, there are several issues and questions regarding the plausibility, safety, and efficacy of in-bag morcellation. This month’s issue of Obstetrics & Gynecology includes a study titled “Contained Power Morcellation Within an Insufflated Isolation Bag” by Dr. Cohen and her colleagues (see page 491), which seeks to address these concerns as a first scientific step toward understanding whether this is a viable answer.4 Cohen et al’s article addresses primarily the technical plausibility of in-bag morcellation during laparoscopic myomectomy or hysterectomy (supracervical or total). Formal investigations of bag integrity or tissue spread are not included; successful control of tissue spread was essentially assessed by a visual judgment by the surgeon. In addition, the techniques described seem particularly well-suited to single-site laparoscopic or robotic surgery with unclear applicability to traditional multiport laparoscopy. Single-site laparoscopy requires additional training and skill, and, because the
490
Rardin
Mitigating Risks of Specimen Extraction
incisions are fewer in number but larger in diameter, there is some concern for increased hernia formation.5 The authors also appropriately recognize the concerns about the technique in multiport surgery, which require the penetration of the bag by one or more trocars or instruments. In addition to possible disruption of bag integrity, violation of the manufacturer’s recommendations, or both, this also involves the passage of trocars through the peritoneal cavity, out of direct visualization until the trocar pierces the bag wherein the camera resides. All of these issues raise the concern for reducing one set of risks while increasing other risks. Regardless of how surgeons and institutions seek to engage in safer power morcellation techniques, it behooves us all to remember and retain our knowledge and skill in other forms of minimally invasive surgery, including vaginal hysterectomy with extraction techniques. Although comparative data are lacking, techniques of vaginal tissue extraction—maintaining contact of the uterine serosa to the vaginal cuff and avoiding spread of tissue throughout the peritoneal cavity— should keep any risk of dissemination to a minimum while preserving the patient’s benefits from the original minimally invasive surgery. REFERENCES 1. Perri T, Korach J, Sadetzki S, Oberman B, Fridman E, BenBaruch G. Uterine leiomyosarcoma: does the primary surgical procedure matter? Int J Gynecol Cancer 2009;19:257–60. 2. Levitz J. Doctors eye cancer risk in uterine procedure: popular technique to remove growths comes under question. The Wall Street Journal 2013. Available at: http://online.wsj.com/news/ articles/SB10001424052702304173704579264673929862850. Retrieved June 21, 2014. 3. Kamp J, Levitz J. Philadelphia hospital restricts “morcellation” procedure. The Wall Street Journal 2014. Available at: http://online.wsj.com/news/articles/ SB10001424052702303775504579394771688705300. Retrieved June 21, 2014. 4. Cohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, et al. Contained power morcellation within an insufflated isolation bag. Obstet Gynecol 2014;124:491–7. 5. Gunderson CC, Knight J, Ybanez-Morano J, Ritter C, Escobar PF, Ibeanu O, et al. The risk of umbilical hernia and other complications with laparoendoscopic single-site surgery. J Minim Invasive Gynecol 2012;19:40–5.
OBSTETRICS & GYNECOLOGY
