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At the 2018 Pelvic Anatomy and Gynecologic Surgery Symposium meeting in Las Vegas, Nevada, Tommaso Falcone, MD, Chief of Staff, Chief Academic Officer, and Medical Director at Cleveland Clinic London, England, addressed the status of tissue morcellation in hysterectomy and myomectomy after several years’ controversy—noting that the specialty’s professional societies all support use of the technique, with precautions and in selected patients.
Morcellation history
Should electromechanical (‘power’) morcellation of tissue be a tool for performing minimally invasive hysterectomy and myomectomy? If so, what are the risks and benefits of using this tool, first approved by the US Food and Drug Administration (FDA) in 1995?
The matter came under intense scrutiny and debate in 2014 as concerns rose about the potential of power morcellation to disseminate intraperitoneal malignancy in women with occult cancer (an estimated 1 in 370 women who undergo power morcellation during a minimally invasive hysterectomy have uterine cancer1). Early that year, the FDA moved to strongly discourage use of power morcellators for removing uterine fibroids.2
The aftermath, however, was that there were problems with the FDA’s [2014] statement, Dr. Falcone pointed out. In a study by Siedhoff and colleagues of a hypothetical cohort of 100,000 women with fibroids, for example, an abdominal approach resulted in more hysterectomy-related deaths and surgery-related complications than did a laparoscopic procedure with morcellation.3
Balancing risks and benefits of MIS
After continuing study of the risks presented by morcellation, the question today is: How do we balance preventing dissemination of cancer against diminishing the significant benefits of minimally invasive surgery, as surgical technique has been modified to avoid morcellation—including, Dr. Falcone said, by increased use of mini lap (i.e., extending the laparoscopy incision) tissue extraction, decreased use of supracervical hysterectomy, and a move to open approaches.
In fact, Dr. Falcone noted, power morcellation is banned in many institutions, having been replaced by scalpel, extraperitoneal, or in-bag morcellation. Last year, after further analysis, the FDA reiterated its recommendation against use of power morcellators to remove fibroids in most women.4
Continue to: Morcellation decisions
Morcellation decisions
Dr. Falcone pointed out that, at the Cleveland Clinic, morcellation is not performed in postmenopausal women, and for several other contraindications, including a history of >2 years of tamoxifen therapy; history of pelvic radiation; history of childhood retinoblastoma; personal history of hereditary leiomyomatosis or renal cell carcinoma; and the presence of a cancer-positive tissue specimen. Morcellation is not performed unless endometrial adenocarcinoma has been ruled out. The decision-making process when electing to use tissue extraction includes whether to use contained or noncontained morcellation; whether to favor knife excision over power morcellation; and, when using a mini lap approach, whether to proceed via the umbilicus or suprapubically.
Complications of morcellation include direct injury by the morcellator; dissemination, as noted, of tissue; ‘upstaging’ of uterine sarcoma, with a worsening prognosis; seeding of parasitic fibroids; and reoperation with laparotomy and extensive multi-organ resection to clear disease (3 patients in a published report).5
An important advancement in the use of morcellation in minimally invasive hysterectomy or myomectomy has been the development of contained systems for morcellating—generally a plastic specimen bag, sometimes pulled through the port and insufflated. Dr. Falcone’s presentation included video presentations of this important, and still evolving, technology. Whether these contained systems improve survival, and whether using them in a vaginal approach makes any difference, remain uncertain, however. Furthermore, some spillage from bags is inevitable—although how much spillage is clinically significant is open to question.
Takeaways
Dr. Falcone concluded with key points to guide the surgeon’s decision on whether to proceed with morcellation:
- There are no comparative data on which technique [of tissue removal] is best.
- Tissue spill will occur in uncontained morcellation—this is intrinsic to the device.
- Even with the current generation of tissue bags, leakage is common and puncture is possible.
If you choose to continue to use power morcellation, your decision is supported by the fact that all the professional societies still support it, Dr. Falcone noted. Furthermore, he pointed out that it is important to look to the standard of care in your community regarding risks and benefits before proceeding.
Last, the advantages and risks of morcellation in hysterectomy and myomectomy should be part of an in-depth discussion between patient and surgeon prior to the procedure. And you must, Dr. Falcone emphasized, obtain specific informed consent.
- Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation. JAMA. Published online July 22, 2014. Accessed December 10, 2018.
- US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. November 24, 2014. http://wayback.archive-it.org/7993/20170722215727/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm. Updated June 6, 2017. Accessed December 10, 2018.
- Siedhoff MT, Wheeler SB, Rutstein SE, et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015;212:591.e1–e8.
- FDA In Brief: FDA releases new findings on the risks of spreading hidden uterine cancer through the use of laparoscopic power morcellators. https://www.fda.gov/newsevents/newsroom/fdainbrief/ucm589137.htm. Updated December 14, 2017. Accessed December 10, 2018.
- Ramos A, Fader AN, Roche KL. Surgical cytoreduction for disseminated benign disease after open power uterine morcellation. Obstet Gynecol. 2015;125:99-102.
At the 2018 Pelvic Anatomy and Gynecologic Surgery Symposium meeting in Las Vegas, Nevada, Tommaso Falcone, MD, Chief of Staff, Chief Academic Officer, and Medical Director at Cleveland Clinic London, England, addressed the status of tissue morcellation in hysterectomy and myomectomy after several years’ controversy—noting that the specialty’s professional societies all support use of the technique, with precautions and in selected patients.
Morcellation history
Should electromechanical (‘power’) morcellation of tissue be a tool for performing minimally invasive hysterectomy and myomectomy? If so, what are the risks and benefits of using this tool, first approved by the US Food and Drug Administration (FDA) in 1995?
The matter came under intense scrutiny and debate in 2014 as concerns rose about the potential of power morcellation to disseminate intraperitoneal malignancy in women with occult cancer (an estimated 1 in 370 women who undergo power morcellation during a minimally invasive hysterectomy have uterine cancer1). Early that year, the FDA moved to strongly discourage use of power morcellators for removing uterine fibroids.2
The aftermath, however, was that there were problems with the FDA’s [2014] statement, Dr. Falcone pointed out. In a study by Siedhoff and colleagues of a hypothetical cohort of 100,000 women with fibroids, for example, an abdominal approach resulted in more hysterectomy-related deaths and surgery-related complications than did a laparoscopic procedure with morcellation.3
Balancing risks and benefits of MIS
After continuing study of the risks presented by morcellation, the question today is: How do we balance preventing dissemination of cancer against diminishing the significant benefits of minimally invasive surgery, as surgical technique has been modified to avoid morcellation—including, Dr. Falcone said, by increased use of mini lap (i.e., extending the laparoscopy incision) tissue extraction, decreased use of supracervical hysterectomy, and a move to open approaches.
In fact, Dr. Falcone noted, power morcellation is banned in many institutions, having been replaced by scalpel, extraperitoneal, or in-bag morcellation. Last year, after further analysis, the FDA reiterated its recommendation against use of power morcellators to remove fibroids in most women.4
Continue to: Morcellation decisions
Morcellation decisions
Dr. Falcone pointed out that, at the Cleveland Clinic, morcellation is not performed in postmenopausal women, and for several other contraindications, including a history of >2 years of tamoxifen therapy; history of pelvic radiation; history of childhood retinoblastoma; personal history of hereditary leiomyomatosis or renal cell carcinoma; and the presence of a cancer-positive tissue specimen. Morcellation is not performed unless endometrial adenocarcinoma has been ruled out. The decision-making process when electing to use tissue extraction includes whether to use contained or noncontained morcellation; whether to favor knife excision over power morcellation; and, when using a mini lap approach, whether to proceed via the umbilicus or suprapubically.
Complications of morcellation include direct injury by the morcellator; dissemination, as noted, of tissue; ‘upstaging’ of uterine sarcoma, with a worsening prognosis; seeding of parasitic fibroids; and reoperation with laparotomy and extensive multi-organ resection to clear disease (3 patients in a published report).5
An important advancement in the use of morcellation in minimally invasive hysterectomy or myomectomy has been the development of contained systems for morcellating—generally a plastic specimen bag, sometimes pulled through the port and insufflated. Dr. Falcone’s presentation included video presentations of this important, and still evolving, technology. Whether these contained systems improve survival, and whether using them in a vaginal approach makes any difference, remain uncertain, however. Furthermore, some spillage from bags is inevitable—although how much spillage is clinically significant is open to question.
Takeaways
Dr. Falcone concluded with key points to guide the surgeon’s decision on whether to proceed with morcellation:
- There are no comparative data on which technique [of tissue removal] is best.
- Tissue spill will occur in uncontained morcellation—this is intrinsic to the device.
- Even with the current generation of tissue bags, leakage is common and puncture is possible.
If you choose to continue to use power morcellation, your decision is supported by the fact that all the professional societies still support it, Dr. Falcone noted. Furthermore, he pointed out that it is important to look to the standard of care in your community regarding risks and benefits before proceeding.
Last, the advantages and risks of morcellation in hysterectomy and myomectomy should be part of an in-depth discussion between patient and surgeon prior to the procedure. And you must, Dr. Falcone emphasized, obtain specific informed consent.
At the 2018 Pelvic Anatomy and Gynecologic Surgery Symposium meeting in Las Vegas, Nevada, Tommaso Falcone, MD, Chief of Staff, Chief Academic Officer, and Medical Director at Cleveland Clinic London, England, addressed the status of tissue morcellation in hysterectomy and myomectomy after several years’ controversy—noting that the specialty’s professional societies all support use of the technique, with precautions and in selected patients.
Morcellation history
Should electromechanical (‘power’) morcellation of tissue be a tool for performing minimally invasive hysterectomy and myomectomy? If so, what are the risks and benefits of using this tool, first approved by the US Food and Drug Administration (FDA) in 1995?
The matter came under intense scrutiny and debate in 2014 as concerns rose about the potential of power morcellation to disseminate intraperitoneal malignancy in women with occult cancer (an estimated 1 in 370 women who undergo power morcellation during a minimally invasive hysterectomy have uterine cancer1). Early that year, the FDA moved to strongly discourage use of power morcellators for removing uterine fibroids.2
The aftermath, however, was that there were problems with the FDA’s [2014] statement, Dr. Falcone pointed out. In a study by Siedhoff and colleagues of a hypothetical cohort of 100,000 women with fibroids, for example, an abdominal approach resulted in more hysterectomy-related deaths and surgery-related complications than did a laparoscopic procedure with morcellation.3
Balancing risks and benefits of MIS
After continuing study of the risks presented by morcellation, the question today is: How do we balance preventing dissemination of cancer against diminishing the significant benefits of minimally invasive surgery, as surgical technique has been modified to avoid morcellation—including, Dr. Falcone said, by increased use of mini lap (i.e., extending the laparoscopy incision) tissue extraction, decreased use of supracervical hysterectomy, and a move to open approaches.
In fact, Dr. Falcone noted, power morcellation is banned in many institutions, having been replaced by scalpel, extraperitoneal, or in-bag morcellation. Last year, after further analysis, the FDA reiterated its recommendation against use of power morcellators to remove fibroids in most women.4
Continue to: Morcellation decisions
Morcellation decisions
Dr. Falcone pointed out that, at the Cleveland Clinic, morcellation is not performed in postmenopausal women, and for several other contraindications, including a history of >2 years of tamoxifen therapy; history of pelvic radiation; history of childhood retinoblastoma; personal history of hereditary leiomyomatosis or renal cell carcinoma; and the presence of a cancer-positive tissue specimen. Morcellation is not performed unless endometrial adenocarcinoma has been ruled out. The decision-making process when electing to use tissue extraction includes whether to use contained or noncontained morcellation; whether to favor knife excision over power morcellation; and, when using a mini lap approach, whether to proceed via the umbilicus or suprapubically.
Complications of morcellation include direct injury by the morcellator; dissemination, as noted, of tissue; ‘upstaging’ of uterine sarcoma, with a worsening prognosis; seeding of parasitic fibroids; and reoperation with laparotomy and extensive multi-organ resection to clear disease (3 patients in a published report).5
An important advancement in the use of morcellation in minimally invasive hysterectomy or myomectomy has been the development of contained systems for morcellating—generally a plastic specimen bag, sometimes pulled through the port and insufflated. Dr. Falcone’s presentation included video presentations of this important, and still evolving, technology. Whether these contained systems improve survival, and whether using them in a vaginal approach makes any difference, remain uncertain, however. Furthermore, some spillage from bags is inevitable—although how much spillage is clinically significant is open to question.
Takeaways
Dr. Falcone concluded with key points to guide the surgeon’s decision on whether to proceed with morcellation:
- There are no comparative data on which technique [of tissue removal] is best.
- Tissue spill will occur in uncontained morcellation—this is intrinsic to the device.
- Even with the current generation of tissue bags, leakage is common and puncture is possible.
If you choose to continue to use power morcellation, your decision is supported by the fact that all the professional societies still support it, Dr. Falcone noted. Furthermore, he pointed out that it is important to look to the standard of care in your community regarding risks and benefits before proceeding.
Last, the advantages and risks of morcellation in hysterectomy and myomectomy should be part of an in-depth discussion between patient and surgeon prior to the procedure. And you must, Dr. Falcone emphasized, obtain specific informed consent.
- Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation. JAMA. Published online July 22, 2014. Accessed December 10, 2018.
- US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. November 24, 2014. http://wayback.archive-it.org/7993/20170722215727/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm. Updated June 6, 2017. Accessed December 10, 2018.
- Siedhoff MT, Wheeler SB, Rutstein SE, et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015;212:591.e1–e8.
- FDA In Brief: FDA releases new findings on the risks of spreading hidden uterine cancer through the use of laparoscopic power morcellators. https://www.fda.gov/newsevents/newsroom/fdainbrief/ucm589137.htm. Updated December 14, 2017. Accessed December 10, 2018.
- Ramos A, Fader AN, Roche KL. Surgical cytoreduction for disseminated benign disease after open power uterine morcellation. Obstet Gynecol. 2015;125:99-102.
- Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation. JAMA. Published online July 22, 2014. Accessed December 10, 2018.
- US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. November 24, 2014. http://wayback.archive-it.org/7993/20170722215727/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm. Updated June 6, 2017. Accessed December 10, 2018.
- Siedhoff MT, Wheeler SB, Rutstein SE, et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015;212:591.e1–e8.
- FDA In Brief: FDA releases new findings on the risks of spreading hidden uterine cancer through the use of laparoscopic power morcellators. https://www.fda.gov/newsevents/newsroom/fdainbrief/ucm589137.htm. Updated December 14, 2017. Accessed December 10, 2018.
- Ramos A, Fader AN, Roche KL. Surgical cytoreduction for disseminated benign disease after open power uterine morcellation. Obstet Gynecol. 2015;125:99-102.