OBG Management

A 16-month multicenter study in which 73 patients underwent morcellation of the uterus or myomas within an insufflated isolation bag during minimally invasive (MI) hysterectomy or myomectomy recently has been published in Obstetrics & Gynecology. The researchers conclude that contained power morcellation using this technique is feasible.¹

Sarah L. Cohen, MD, MPH, and colleagues at Fairview Ridges Hospital, Burnsville, Minnesota; Johns Hopkins Hospital, Baltimore, Maryland; Massachusetts General Hospital, Boston; and Brigham and Women’s Hospital, Boston, Massachusetts are all high-volume surgeons experienced in advanced MI gynecologic surgical techniques.¹

Patients in whom morcellation was planned at the time of MI hysterectomy or myomectomy during the study period (January 2013 through April 2014) were offered in-bag morcellation and included in the study. Exclusion criteria were known or suspected malignancy. Preoperative testing was performed to evaluate risk of genital tract cancer. Perioperative information included mode of access, type of procedure(s) performed, operative time, estimated blood loss, specimen weight, intact status of isolation bag postmorcellation, length of hospital stay, intraoperative complications, postoperative complications, readmission, and reoperation.¹

The technique for morcellation within an insufflated isolation bag was developed by one of the authors, Tony Shibley, MD, for use during laparoendoscopic single-site hysterectomy (WATCH Dr. Shibley’s technique video here and listen to an interview with Dr. Shibley here.) The technique adapts to multiport laparoscopic and robot-assisted laparoscopic hysterectomy and myomectomy.¹

Based on the results of their study, the authors conclude: “Morcellation within an insufflated isolation bag is a feasible technique. Methods for morcellating uterine tissue in a contained manner may provide an option to minimize the risks of open power morcellation while preserving the benefits of minimally invasive surgery.”¹

In response to this study, Charles R. Rardin, MD, Associate Professor of Obstetrics and Gynecology at Brown Medical School and Women and Infants’ Hospital in Providence, Rhode Island, wrote an online editorial in Obstetrics & Gynecology.² Dr. Rardin pointed out that “Until there are more effective screening tools to detect these unusual cancers [leiomyosarcoma], surgeons and hospitals are required to develop responses to these issues.”

He suggests that one extreme reaction to the morcellation crisis is to ban any method of morcellation entirely, leaving laparotomy as the only option for tissue extraction. Finding that logic faulty—relative value to the few at greater cost to the many—he suggests that one might also question the safety of other strategies to treat leiomyomas, including ablation and embolization.

Institutions have responded in several different ways, he says:

He finds that Cohen and colleagues’ techniques lack formal investigation of bag integrity or tissue spread (as successful control of tissue spread was judged by a visual assessment by the surgeon). He also indicates that the technique described is better suited to single-port laparoscopy than multi-port, that single-site laparoscopy required additional training and skill, and that the incisions in single-site laparoscopy are fewer in number but larger in diameter, eliciting concern for increased hernia formation. The authors recognize that using the technique in multi-port surgery, because penetration of the bag by one or more trocars may cause a disruption in bag integrity, is in violation of the manufacturer’s recommendations.^1,2 Dr. Rardin additionally expresses concern about “the passage of trocars through the peritoneal cavity, out of direct visualization until the trocar pierces the bag”² where the camera resides. He is concerned about reducing one set of risks while increasing other risks, and suggests that vaginal hysterectomy would reduce the risk of dissemination while preserving the patient’s benefits from minimally invasive surgery.²

A 16-month multicenter study in which 73 patients underwent morcellation of the uterus or myomas within an insufflated isolation bag during minimally invasive (MI) hysterectomy or myomectomy recently has been published in Obstetrics & Gynecology. The researchers conclude that contained power morcellation using this technique is feasible.¹

Sarah L. Cohen, MD, MPH, and colleagues at Fairview Ridges Hospital, Burnsville, Minnesota; Johns Hopkins Hospital, Baltimore, Maryland; Massachusetts General Hospital, Boston; and Brigham and Women’s Hospital, Boston, Massachusetts are all high-volume surgeons experienced in advanced MI gynecologic surgical techniques.¹

Patients in whom morcellation was planned at the time of MI hysterectomy or myomectomy during the study period (January 2013 through April 2014) were offered in-bag morcellation and included in the study. Exclusion criteria were known or suspected malignancy. Preoperative testing was performed to evaluate risk of genital tract cancer. Perioperative information included mode of access, type of procedure(s) performed, operative time, estimated blood loss, specimen weight, intact status of isolation bag postmorcellation, length of hospital stay, intraoperative complications, postoperative complications, readmission, and reoperation.¹

The technique for morcellation within an insufflated isolation bag was developed by one of the authors, Tony Shibley, MD, for use during laparoendoscopic single-site hysterectomy (WATCH Dr. Shibley’s technique video here and listen to an interview with Dr. Shibley here.) The technique adapts to multiport laparoscopic and robot-assisted laparoscopic hysterectomy and myomectomy.¹

Based on the results of their study, the authors conclude: “Morcellation within an insufflated isolation bag is a feasible technique. Methods for morcellating uterine tissue in a contained manner may provide an option to minimize the risks of open power morcellation while preserving the benefits of minimally invasive surgery.”¹

In response to this study, Charles R. Rardin, MD, Associate Professor of Obstetrics and Gynecology at Brown Medical School and Women and Infants’ Hospital in Providence, Rhode Island, wrote an online editorial in Obstetrics & Gynecology.² Dr. Rardin pointed out that “Until there are more effective screening tools to detect these unusual cancers [leiomyosarcoma], surgeons and hospitals are required to develop responses to these issues.”

He suggests that one extreme reaction to the morcellation crisis is to ban any method of morcellation entirely, leaving laparotomy as the only option for tissue extraction. Finding that logic faulty—relative value to the few at greater cost to the many—he suggests that one might also question the safety of other strategies to treat leiomyomas, including ablation and embolization.

Institutions have responded in several different ways, he says:

He finds that Cohen and colleagues’ techniques lack formal investigation of bag integrity or tissue spread (as successful control of tissue spread was judged by a visual assessment by the surgeon). He also indicates that the technique described is better suited to single-port laparoscopy than multi-port, that single-site laparoscopy required additional training and skill, and that the incisions in single-site laparoscopy are fewer in number but larger in diameter, eliciting concern for increased hernia formation. The authors recognize that using the technique in multi-port surgery, because penetration of the bag by one or more trocars may cause a disruption in bag integrity, is in violation of the manufacturer’s recommendations.^1,2 Dr. Rardin additionally expresses concern about “the passage of trocars through the peritoneal cavity, out of direct visualization until the trocar pierces the bag”² where the camera resides. He is concerned about reducing one set of risks while increasing other risks, and suggests that vaginal hysterectomy would reduce the risk of dissemination while preserving the patient’s benefits from minimally invasive surgery.²

A 16-month multicenter study in which 73 patients underwent morcellation of the uterus or myomas within an insufflated isolation bag during minimally invasive (MI) hysterectomy or myomectomy recently has been published in Obstetrics & Gynecology. The researchers conclude that contained power morcellation using this technique is feasible.¹

Sarah L. Cohen, MD, MPH, and colleagues at Fairview Ridges Hospital, Burnsville, Minnesota; Johns Hopkins Hospital, Baltimore, Maryland; Massachusetts General Hospital, Boston; and Brigham and Women’s Hospital, Boston, Massachusetts are all high-volume surgeons experienced in advanced MI gynecologic surgical techniques.¹

Patients in whom morcellation was planned at the time of MI hysterectomy or myomectomy during the study period (January 2013 through April 2014) were offered in-bag morcellation and included in the study. Exclusion criteria were known or suspected malignancy. Preoperative testing was performed to evaluate risk of genital tract cancer. Perioperative information included mode of access, type of procedure(s) performed, operative time, estimated blood loss, specimen weight, intact status of isolation bag postmorcellation, length of hospital stay, intraoperative complications, postoperative complications, readmission, and reoperation.¹

The technique for morcellation within an insufflated isolation bag was developed by one of the authors, Tony Shibley, MD, for use during laparoendoscopic single-site hysterectomy (WATCH Dr. Shibley’s technique video here and listen to an interview with Dr. Shibley here.) The technique adapts to multiport laparoscopic and robot-assisted laparoscopic hysterectomy and myomectomy.¹

Based on the results of their study, the authors conclude: “Morcellation within an insufflated isolation bag is a feasible technique. Methods for morcellating uterine tissue in a contained manner may provide an option to minimize the risks of open power morcellation while preserving the benefits of minimally invasive surgery.”¹

In response to this study, Charles R. Rardin, MD, Associate Professor of Obstetrics and Gynecology at Brown Medical School and Women and Infants’ Hospital in Providence, Rhode Island, wrote an online editorial in Obstetrics & Gynecology.² Dr. Rardin pointed out that “Until there are more effective screening tools to detect these unusual cancers [leiomyosarcoma], surgeons and hospitals are required to develop responses to these issues.”

He suggests that one extreme reaction to the morcellation crisis is to ban any method of morcellation entirely, leaving laparotomy as the only option for tissue extraction. Finding that logic faulty—relative value to the few at greater cost to the many—he suggests that one might also question the safety of other strategies to treat leiomyomas, including ablation and embolization.

Institutions have responded in several different ways, he says:

He finds that Cohen and colleagues’ techniques lack formal investigation of bag integrity or tissue spread (as successful control of tissue spread was judged by a visual assessment by the surgeon). He also indicates that the technique described is better suited to single-port laparoscopy than multi-port, that single-site laparoscopy required additional training and skill, and that the incisions in single-site laparoscopy are fewer in number but larger in diameter, eliciting concern for increased hernia formation. The authors recognize that using the technique in multi-port surgery, because penetration of the bag by one or more trocars may cause a disruption in bag integrity, is in violation of the manufacturer’s recommendations.^1,2 Dr. Rardin additionally expresses concern about “the passage of trocars through the peritoneal cavity, out of direct visualization until the trocar pierces the bag”² where the camera resides. He is concerned about reducing one set of risks while increasing other risks, and suggests that vaginal hysterectomy would reduce the risk of dissemination while preserving the patient’s benefits from minimally invasive surgery.²

Suddenly, indigo carmine is in short supply throughout the United States. One manufacturer has stopped production because of a raw materials shortage; another is experiencing manufacturing delays. Neither company can estimate a resupply or product return date.¹

Indigo carmine is approved by the US Food and Drug Administration (FDA) to localize ureteral orifices during cystoscopy and is commonly used in obstetrics and gynecology as a marker dye in the following additional situations:

• administered in a dilute solution via a catheter to back fill the bladder and test for bladder injury
• administered via a cannula in the uterine cavity to test the patency of the fallopian tubes
• injected into the amniotic fluid compartment to test for premature rupture of the membranes (PROM)
• injected into the amniotic fluid of a twin gestation to mark the amniotic fluid of one twin.

With this agent in short supply, we need to identify alternative marker dyes to use in our clinical practice. In this editorial, I provide a list of possible options to replace indigo carmine. Evidence supporting the use and safety of marker dyes in obstetrics and gynecology is based on small cohorts or case reports. The available evidence is of modest to low quality, and it is especially challenging to identify uncommon adverse effects. Consequently, expert opinion guides most practice recommendations.

Options to test the function of the ureters at cystoscopy
Given the lack of availability of indigo carmine, I recommend one of the following three options to test the function of the ureters at cystoscopy.

Partially fill the bladder with a solution of either sterile water or a 10% dextrose solution. (Experienced surgeons may prefer to use saline.) The turbulence of the interaction between the ureteral urine jet and instilled fluid in the bladder may permit visualization of the urine stream exiting the ureteral orifices as it swirls through the sterile water or dextrose solution. Both sterile water and a 10% dextrose solution offer a contrast in viscosity between the urine and the cystoscopy fluid, which may enhance the ability to detect the urine jet leaving the ureter.²

Administer IV methylene blue. Methylene blue is FDA approved for methemoglobinemia treatment. For this indication, it is administered intravenously at a dose of 1 to 2 mg/kgover 5 to 10 minutes. Paradoxically, when administered at a dose of >7 mg/kg, methylene blue can cause methemoglobinemia.³

Methylene blue often is provided as a 1% solution of 10 mg/mL in 10-mL vials. To use intravenous (IV) methylene blue to test ureteral function at cystoscopy, administer IV methylene blue 50 mg over 5 minutes. Use the cystoscope to view the colored urine exiting the ureteral orifices.^4,5 Administering a small dose of IV furosemide may accelerate the appearance of methylene blue in the urine.

When to use caution. Methylene blue blocks serotonin metabolism by inhibiting monoamine oxidase and may precipitate a serotonin syndrome in patients taking selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase inhibitors (MAOIs).

Common findings in the serotonin syndrome include: temperature above 38° C (100.4° F), anxiety, agitation, delirium, clonus, tremor, and hypertonia.⁶ I recommend that you DO NOT use IV methylene blue in patients taking these medications.^7,8

Great caution should be used before administering IV methylene blue in the presence of the following clinical situations:

• renal impairment  
• G6PD deficiency
• pediatric patients.

Methylene blue never should be given by a subcutaneous or intrathecal route. In pregnant women it should never be injected into the amniotic fluid compartment.

Use preoperative oral phenazo-pyridine. If the preoperative plan includes a cystoscopy procedure to test ureteral function, administering oral phenazopyridine in the preoperative holding area will result in colorization of the urine within 30 minutes, and it will persist for approximately 4 to 5 hours. To use this approach, administer one dose of phenazopyridine (Pyridium, Azo-Gesic), 100 mg or 200 mg orally, 30 minutes to 1 hour before the planned surgical start time, in the preoperative holding area.⁹ During cystoscopy, the urine from the ureteral jet will be colored orange.

When to use caution. Phenazo­pyridine should not be administered to patients with G6PD deficiency.

Option to test for bladder injury
Methylene blue. If methylene blue is used to test the integrity of the bladder, I recommend diluting 10 mg methylene blue in 1 L normal saline and then instilling the dilute solution through a catheter into the bladder.¹⁰

It is unlikely that this technique will be associated with sufficient methylene blue absorption to cause a serotonin syndrome. Therefore, this technique can be used in patients taking SSRIs, SNRIs, and MAOIs.

Option to test patency of the fallopian tubes (chromopertubation)
Methylene blue. If methylene blue is used via a cannula in the uterine cavity to test the patency of the fallopian tubes, I recommend diluting 10 mg methylene blue in 150 mL normal saline and using the dilute solution to test tubal patency.

It is unlikely that this process will lead to sufficient methylene blue absorption to cause a serotonin syndrome. Therefore, this technique can be used in patients taking SSRIs, SNRIs and MAOIs. However, if intrauterine injection of the dilute dye solution results in extravasation of the dye into the pelvic veins, a significant amount of dye can enter the circulation.¹¹ There are case reports of anaphylaxis following intrauterine injection of methylene blue to test tubal patency.^12,13

Options to diagnose PROM and to use for twin amniocentesis
None. Most experts recommend against the intra-amniotic injection of methylene blue to diagnose PROM or in twin amniocentesis procedures. Methylene blue injected into the intra-amniotic fluid during amniocentesis in multiple gestations has been reported to cause fetal bowel obstruction or atresia.^14,15 Fetal death also has been reported.¹⁶ Decades ago, indocyanine green, which is FDA approved to determine cardiac output, liver blood flow, and hepatic function, was reported to be useful to mark one sac of a twin gestation during amniocentesis.¹⁷ With modern ultrasonography technology, the need to rely on a dye to mark a sac of a twin has decreased significantly.

Our only option is to cope—effectively as possible Over decades, the medical community develops patterns of patient care that are critically dependent on the availability of key pharmaceuticals and devices. When a pharmaceutical or device suddenly becomes unavailable, it can disrupt important patterns of patient care. Imagine the impact on obstetrics practice if oxytocin became unavailable due to manufacturing shortages. Likely, both market forces and government regulation are the root cause of the shortfalls. Preventing the adverse consequences of the sudden loss of key pharmaceuticals and devices is an important priority to ensure optimal care of our patients.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Suddenly, indigo carmine is in short supply throughout the United States. One manufacturer has stopped production because of a raw materials shortage; another is experiencing manufacturing delays. Neither company can estimate a resupply or product return date.¹

Indigo carmine is approved by the US Food and Drug Administration (FDA) to localize ureteral orifices during cystoscopy and is commonly used in obstetrics and gynecology as a marker dye in the following additional situations:

• administered in a dilute solution via a catheter to back fill the bladder and test for bladder injury
• administered via a cannula in the uterine cavity to test the patency of the fallopian tubes
• injected into the amniotic fluid compartment to test for premature rupture of the membranes (PROM)
• injected into the amniotic fluid of a twin gestation to mark the amniotic fluid of one twin.

With this agent in short supply, we need to identify alternative marker dyes to use in our clinical practice. In this editorial, I provide a list of possible options to replace indigo carmine. Evidence supporting the use and safety of marker dyes in obstetrics and gynecology is based on small cohorts or case reports. The available evidence is of modest to low quality, and it is especially challenging to identify uncommon adverse effects. Consequently, expert opinion guides most practice recommendations.

Options to test the function of the ureters at cystoscopy
Given the lack of availability of indigo carmine, I recommend one of the following three options to test the function of the ureters at cystoscopy.

Partially fill the bladder with a solution of either sterile water or a 10% dextrose solution. (Experienced surgeons may prefer to use saline.) The turbulence of the interaction between the ureteral urine jet and instilled fluid in the bladder may permit visualization of the urine stream exiting the ureteral orifices as it swirls through the sterile water or dextrose solution. Both sterile water and a 10% dextrose solution offer a contrast in viscosity between the urine and the cystoscopy fluid, which may enhance the ability to detect the urine jet leaving the ureter.²

Administer IV methylene blue. Methylene blue is FDA approved for methemoglobinemia treatment. For this indication, it is administered intravenously at a dose of 1 to 2 mg/kgover 5 to 10 minutes. Paradoxically, when administered at a dose of >7 mg/kg, methylene blue can cause methemoglobinemia.³

Methylene blue often is provided as a 1% solution of 10 mg/mL in 10-mL vials. To use intravenous (IV) methylene blue to test ureteral function at cystoscopy, administer IV methylene blue 50 mg over 5 minutes. Use the cystoscope to view the colored urine exiting the ureteral orifices.^4,5 Administering a small dose of IV furosemide may accelerate the appearance of methylene blue in the urine.

When to use caution. Methylene blue blocks serotonin metabolism by inhibiting monoamine oxidase and may precipitate a serotonin syndrome in patients taking selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase inhibitors (MAOIs).

Common findings in the serotonin syndrome include: temperature above 38° C (100.4° F), anxiety, agitation, delirium, clonus, tremor, and hypertonia.⁶ I recommend that you DO NOT use IV methylene blue in patients taking these medications.^7,8

Great caution should be used before administering IV methylene blue in the presence of the following clinical situations:

• renal impairment  
• G6PD deficiency
• pediatric patients.

Methylene blue never should be given by a subcutaneous or intrathecal route. In pregnant women it should never be injected into the amniotic fluid compartment.

Use preoperative oral phenazo-pyridine. If the preoperative plan includes a cystoscopy procedure to test ureteral function, administering oral phenazopyridine in the preoperative holding area will result in colorization of the urine within 30 minutes, and it will persist for approximately 4 to 5 hours. To use this approach, administer one dose of phenazopyridine (Pyridium, Azo-Gesic), 100 mg or 200 mg orally, 30 minutes to 1 hour before the planned surgical start time, in the preoperative holding area.⁹ During cystoscopy, the urine from the ureteral jet will be colored orange.

When to use caution. Phenazo­pyridine should not be administered to patients with G6PD deficiency.

Option to test for bladder injury
Methylene blue. If methylene blue is used to test the integrity of the bladder, I recommend diluting 10 mg methylene blue in 1 L normal saline and then instilling the dilute solution through a catheter into the bladder.¹⁰

It is unlikely that this technique will be associated with sufficient methylene blue absorption to cause a serotonin syndrome. Therefore, this technique can be used in patients taking SSRIs, SNRIs, and MAOIs.

Option to test patency of the fallopian tubes (chromopertubation)
Methylene blue. If methylene blue is used via a cannula in the uterine cavity to test the patency of the fallopian tubes, I recommend diluting 10 mg methylene blue in 150 mL normal saline and using the dilute solution to test tubal patency.

It is unlikely that this process will lead to sufficient methylene blue absorption to cause a serotonin syndrome. Therefore, this technique can be used in patients taking SSRIs, SNRIs and MAOIs. However, if intrauterine injection of the dilute dye solution results in extravasation of the dye into the pelvic veins, a significant amount of dye can enter the circulation.¹¹ There are case reports of anaphylaxis following intrauterine injection of methylene blue to test tubal patency.^12,13

Options to diagnose PROM and to use for twin amniocentesis
None. Most experts recommend against the intra-amniotic injection of methylene blue to diagnose PROM or in twin amniocentesis procedures. Methylene blue injected into the intra-amniotic fluid during amniocentesis in multiple gestations has been reported to cause fetal bowel obstruction or atresia.^14,15 Fetal death also has been reported.¹⁶ Decades ago, indocyanine green, which is FDA approved to determine cardiac output, liver blood flow, and hepatic function, was reported to be useful to mark one sac of a twin gestation during amniocentesis.¹⁷ With modern ultrasonography technology, the need to rely on a dye to mark a sac of a twin has decreased significantly.

Our only option is to cope—effectively as possible Over decades, the medical community develops patterns of patient care that are critically dependent on the availability of key pharmaceuticals and devices. When a pharmaceutical or device suddenly becomes unavailable, it can disrupt important patterns of patient care. Imagine the impact on obstetrics practice if oxytocin became unavailable due to manufacturing shortages. Likely, both market forces and government regulation are the root cause of the shortfalls. Preventing the adverse consequences of the sudden loss of key pharmaceuticals and devices is an important priority to ensure optimal care of our patients.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Suddenly, indigo carmine is in short supply throughout the United States. One manufacturer has stopped production because of a raw materials shortage; another is experiencing manufacturing delays. Neither company can estimate a resupply or product return date.¹

Indigo carmine is approved by the US Food and Drug Administration (FDA) to localize ureteral orifices during cystoscopy and is commonly used in obstetrics and gynecology as a marker dye in the following additional situations:

• administered in a dilute solution via a catheter to back fill the bladder and test for bladder injury
• administered via a cannula in the uterine cavity to test the patency of the fallopian tubes
• injected into the amniotic fluid compartment to test for premature rupture of the membranes (PROM)
• injected into the amniotic fluid of a twin gestation to mark the amniotic fluid of one twin.

With this agent in short supply, we need to identify alternative marker dyes to use in our clinical practice. In this editorial, I provide a list of possible options to replace indigo carmine. Evidence supporting the use and safety of marker dyes in obstetrics and gynecology is based on small cohorts or case reports. The available evidence is of modest to low quality, and it is especially challenging to identify uncommon adverse effects. Consequently, expert opinion guides most practice recommendations.

Options to test the function of the ureters at cystoscopy
Given the lack of availability of indigo carmine, I recommend one of the following three options to test the function of the ureters at cystoscopy.

Partially fill the bladder with a solution of either sterile water or a 10% dextrose solution. (Experienced surgeons may prefer to use saline.) The turbulence of the interaction between the ureteral urine jet and instilled fluid in the bladder may permit visualization of the urine stream exiting the ureteral orifices as it swirls through the sterile water or dextrose solution. Both sterile water and a 10% dextrose solution offer a contrast in viscosity between the urine and the cystoscopy fluid, which may enhance the ability to detect the urine jet leaving the ureter.²

Administer IV methylene blue. Methylene blue is FDA approved for methemoglobinemia treatment. For this indication, it is administered intravenously at a dose of 1 to 2 mg/kgover 5 to 10 minutes. Paradoxically, when administered at a dose of >7 mg/kg, methylene blue can cause methemoglobinemia.³

Methylene blue often is provided as a 1% solution of 10 mg/mL in 10-mL vials. To use intravenous (IV) methylene blue to test ureteral function at cystoscopy, administer IV methylene blue 50 mg over 5 minutes. Use the cystoscope to view the colored urine exiting the ureteral orifices.^4,5 Administering a small dose of IV furosemide may accelerate the appearance of methylene blue in the urine.

When to use caution. Methylene blue blocks serotonin metabolism by inhibiting monoamine oxidase and may precipitate a serotonin syndrome in patients taking selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase inhibitors (MAOIs).

Common findings in the serotonin syndrome include: temperature above 38° C (100.4° F), anxiety, agitation, delirium, clonus, tremor, and hypertonia.⁶ I recommend that you DO NOT use IV methylene blue in patients taking these medications.^7,8

Great caution should be used before administering IV methylene blue in the presence of the following clinical situations:

• renal impairment  
• G6PD deficiency
• pediatric patients.

Methylene blue never should be given by a subcutaneous or intrathecal route. In pregnant women it should never be injected into the amniotic fluid compartment.

Use preoperative oral phenazo-pyridine. If the preoperative plan includes a cystoscopy procedure to test ureteral function, administering oral phenazopyridine in the preoperative holding area will result in colorization of the urine within 30 minutes, and it will persist for approximately 4 to 5 hours. To use this approach, administer one dose of phenazopyridine (Pyridium, Azo-Gesic), 100 mg or 200 mg orally, 30 minutes to 1 hour before the planned surgical start time, in the preoperative holding area.⁹ During cystoscopy, the urine from the ureteral jet will be colored orange.

When to use caution. Phenazo­pyridine should not be administered to patients with G6PD deficiency.

Option to test for bladder injury
Methylene blue. If methylene blue is used to test the integrity of the bladder, I recommend diluting 10 mg methylene blue in 1 L normal saline and then instilling the dilute solution through a catheter into the bladder.¹⁰

It is unlikely that this technique will be associated with sufficient methylene blue absorption to cause a serotonin syndrome. Therefore, this technique can be used in patients taking SSRIs, SNRIs, and MAOIs.

Option to test patency of the fallopian tubes (chromopertubation)
Methylene blue. If methylene blue is used via a cannula in the uterine cavity to test the patency of the fallopian tubes, I recommend diluting 10 mg methylene blue in 150 mL normal saline and using the dilute solution to test tubal patency.

It is unlikely that this process will lead to sufficient methylene blue absorption to cause a serotonin syndrome. Therefore, this technique can be used in patients taking SSRIs, SNRIs and MAOIs. However, if intrauterine injection of the dilute dye solution results in extravasation of the dye into the pelvic veins, a significant amount of dye can enter the circulation.¹¹ There are case reports of anaphylaxis following intrauterine injection of methylene blue to test tubal patency.^12,13

Options to diagnose PROM and to use for twin amniocentesis
None. Most experts recommend against the intra-amniotic injection of methylene blue to diagnose PROM or in twin amniocentesis procedures. Methylene blue injected into the intra-amniotic fluid during amniocentesis in multiple gestations has been reported to cause fetal bowel obstruction or atresia.^14,15 Fetal death also has been reported.¹⁶ Decades ago, indocyanine green, which is FDA approved to determine cardiac output, liver blood flow, and hepatic function, was reported to be useful to mark one sac of a twin gestation during amniocentesis.¹⁷ With modern ultrasonography technology, the need to rely on a dye to mark a sac of a twin has decreased significantly.

Our only option is to cope—effectively as possible Over decades, the medical community develops patterns of patient care that are critically dependent on the availability of key pharmaceuticals and devices. When a pharmaceutical or device suddenly becomes unavailable, it can disrupt important patterns of patient care. Imagine the impact on obstetrics practice if oxytocin became unavailable due to manufacturing shortages. Likely, both market forces and government regulation are the root cause of the shortfalls. Preventing the adverse consequences of the sudden loss of key pharmaceuticals and devices is an important priority to ensure optimal care of our patients.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Minimally invasive surgery utilizing laparoscopy for hysterectomy and myomectomy has become more common in women with gynecologic pathology. The benefits of this approach compared with laparotomy include decreased hospital stay, shorter recovery and, in experienced hands, significantly decreased morbidity.^1–3

Approximately 600,000 hysterectomies are performed annually in the United States—30% of which are performed laparoscopically.⁴ The primary indication for surgical intervention is uterine leiomyoma. This pathology accounts for 40% of procedures.⁵ During these surgeries, electromechanical morcellation (EMM), or open “power” morcellation, is commonly used to cut large tissue specimens into small pieces for removal and thereby avoid a larger incision. Concerns have been raised regarding the use of open power morcellation because of the risk of spreading an unrecognized malignancy.

Based on case reports and retrospective studies, the FDA issued a statement in April of this year discouraging the use of EMM for hysterectomy and myomectomy in women with uterine fibroids.⁶ The concern for inadvertent spread of an occult malignancy was the reasoning for the communication. Since that time, the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee held a public meeting in which the panel heard comments from patients, societies, and industry regarding their positions on the safety of laparoscopic power morcellation. The panel made several recommendations to the FDA but, at the time of this writing, the FDA has yet to issue a final decision.

Reaction to FDA’s action/inaction
The FDA’s “safety” communication was in response to the concern of a few who experienced a bad outcome believed to be secondary to open power morcellation of enlarged uteri or fibroid tumors. In its statement, the FDA estimated the risk of an occult sarcoma to be about 1 in 350 and stated that the risk of disseminating a sarcoma with morcellation is substantial. The FDA discouraged the use of the power morcellator during hysterectomy or myomectomy for uterine fibroids.

Many organizations, including the Society of Gynecologic Oncology, The American Association of Gynecologic Laparoscopists (AAGL), and the American College of Obstetricians and Gynecologists, issued less stringent statements regarding this technology.^7–9 These organizations stated generally that there were too few data to make a statement at that time, advocated the collection of more data, and encouraged detailed informed consent to be given to patients undergoing these procedures.

However, the FDA’s statement, and lack of a timely follow-up to clarify the role of the laparoscopic power morcellator in gynecologic surgery, has effectively stopped the use of this technology in its current form. In fact, in response to the statement, Ethicon Endosurgery has discontinued the distribution and sales of its power morcellator and many institutions have severely or completely restricted the use of this technology. The reason for these restrictions is that the medicolegal consequences of an adverse outcome would be very difficult to defend given the current, albeit premature, recommendations of the FDA. This statement makes it difficult to defend any adverse outcome that may occur in association with the use of the laparoscopic power morcellator. Furthermore, this statement by the FDA has largely prevented the medical community at large from collecting additional useful information to allow for a data-driven determination.

Power morcellation is not without risks. In fact, we outline them in this article. However, we believe that minimally invasive surgery should be allowed to continue to advance. In that vein, here we describe a technique of dual-port contained EMM. This surgical approach is performed under direct visualization—which solves the problem of poor visualization that hinders other contained EMM techniques.

Risks of power morcellation
The potential for inadvertent spread of occult malignancy is not the only risk of open EMM. Reports of disseminated leiomyomatosis, adenomyosis, and endometriosis also have been described from inadvertent tissue dispersion during open EMM with resulting ectopic reperitonealization.^10–12

The procedure itself is not without risks. A recent systematic review documented 55 major and minor complications from EMM.¹³ Multiple organ systems were injured including bowel, urinary, vascular, and others, resulting in six deaths from these complications. The investigators concluded that “laparoscopic morcellator–related injuries continue to increase and short- and long-term complications are emerging in both the medical literature and device-related databases. Surgeon inexperience is descriptively identified as one of the most common contributing factors.”

All of the above risks must be weighed against the known benefits of laparoscopic surgery and presented to each patient to assist in deciding which route of surgery should be performed.

Tissue extraction options for large specimens
Large specimen extraction options during gynecologic surgery include:

Vaginal coring. Delivery through the vagina or colpotomy during vaginal or laparoscopic hysterectomy uses the technique of coring, which has long been established in our field.

Manual morcellation through a single incision. Mini-laparotomy or laparoendoscopic single-site surgery (LESS) incisions provide another option of removal with manual morcellation after laparoscopic hysterectomy or myomectomy. One study revealed that specimens up to 22 weeks in size can be placed in a large EndoCatch bag and morcellated extracorporeally by circumferentially coring with a scalpel.¹⁴

Contained power morcellation through a single port. Finally, the technique of contained EMM was recently described.¹⁵ This technique uses a large containment bag placed through a LESS incision with EMM being performed in an artificially created pneumoperitoneum. This technique isolates the specimen so that it can be morcellated without risk of exposing the patient to any malignant cells that might be unrecognized within the specimen.

Each of these techniques allows many patients to consider a minimally invasive option for their surgery. However, the ability to safely morcellate a very large uterus or myoma may be limited by visualization, and the experience of the surgeon is often critical in the successful performance of these procedures.¹⁶

Therefore, at Washington Universitywe have developed a technique using dual ports, with isolation of the uterus or myomas to improve visualization and prevent spillage of malignant tumor or dispersion of other benign tissue.

Dual-port EMM: Technique, tips, and tricks
Our technique of dual-port contained EMM allows the removal of large fibroids or uteri much larger than 20 weeks in size safely under direct visualization through a 15-mm incision. The technique uses:

• Karl Storz Rotocut tissue morcellator with spacers (FIGURE 1)
• 15-mm trocar
• 5-mm balloon trocar
• 20320-inch containment bag (FIGURE 2).

Containment bag placement
Once the specimen is free, we place it to the right or left side of the abdomen. The 15-mm trocar is placed through the umbilicus while visualizing from a lateral trocar site. We then fan-fold the containment bag and introduce it through the 15-mm trocar, keeping the bag oriented with the opening anterior (FIGURE 3). The bag is then grasped at the opening along the drawstring with an atraumatic grasper.

Tip: Care must be taken when introducing the bag in order to avoid tearing or making a small hole in it.

The leading edge is then introduced into the deepest part of the pelvis, and the remainder of the bag (left outside of the abdomen) is then fed cephalad into the abdomen.

Once the bag is completely in the abdomen, we orient the bag with the opening as wide as possible. This allows placement of a very large specimen. Once the specimen is within the containment bag, the drawstring is pulled tight and the mouth of the bag is removed through the 15-mm trocar site at the umbilicus.

The abdominal lateral gas port is opened to allow the intra-abdominal pneumoperitoneum to escape. A 5-mm trocar is placed into the bag through the opening at the umbilicus and the containment bag is insufflated with carbon dioxide and the insufflation pressure is set to 30 mm. The laparoscope placed through this trocar allows the artificial pneumoperitoneum being created to be observed (VIDEO).

Vidyard Video

Tip: The containment bag covers the entire abdominal cavity and should be fully distended. If it does not distend fully, a hole in the bag may be present and the bag must be replaced.

At this point, we place a balloon trocar at the lateral trocar site and into the bag under direct visualization. The balloon tip is inflated and pulled up tightly against the bag and abdominal wall (FIGURE 4). This allows a tight seal so there is no gas leak or spillage of the morcellated specimen. The laparoscope is placed through this trocar and the insufflation tubing is moved to this port.

Morcellator insertion
The morcellator is introduced through the umbilicus under direct visualization using the short morcellator blade in most instances. Spacers are used to set the length of the morcellator within the containment bag. The tip of the morcellator should be approximately 3 cm to 4 cm within the bag but well away from the retroperitoneum. Remember, any bag will be cut easily by the morcellator and should be thought of as peritoneum only and not a tough barrier. Serious injuries could otherwise develop.

At this point, place the patient flat or out of Trendelenburg position. Morcellation may now proceed.

Tip: Morcellation is best performed with the morcellator perpendicular to the abdomen under direct visualization using a 30° laparoscope to optimize the view. Morcellation in this position uses gravity to facilitate “peeling” of the specimen during morcellation and allows for faster removal.

Before removing the morcellator, inspect the containment bag for any large pieces that may have been dispersed during the morcellation process and remove them. Once there are only small fragments remaining, remove the morcellator, allowing the carbon dioxide to escape. Deflate the balloon tip on the trocar.

Now the containment bag with the remaining specimen may be removed through the umbilicus, while simultaneously removing the balloon-tip trocar from the bag.

A safe minimally invasive approach
This technique has allowed us to safely remove specimens larger than 1,500 g while keeping them in a contained environment with no spill of tissue within the abdomen.

Tracking and adaptation needed
The FDA safety communication has severely limited the practice of morcellation in the minimally invasive gynecologic surgical setting. Many hospitals around the country have reacted by placing significant restrictions on the use of EMM or banned it outright. This action may reverse the national trend of increasing rates of laparoscopic hysterectomy and force many practitioners to return to open surgery.

Currently, it is unclear what the true risk of tissue extraction is whether it is performed via EMM or manually. Large national databases including the BOLD database from the Surgical Review Corporation, as well as AAGL, must be utilized to track these cases and their outcomes to guide therapy. In the meantime, in order to continue to offer a minimally invasive approach to gynecologic surgery, new techniques and instrumentation in the operating room will need to be modified to adapt to these new guidelines. This is vital to maintain or even reduce the rates of open hysterectomy and associated morbidity while diminishing the potential risks of inadvertent benign as well as malignant tissue dispersion with tissue extraction.

Share your thoughts on this article! Send your Letter to the Editor to: [email protected]

Minimally invasive surgery utilizing laparoscopy for hysterectomy and myomectomy has become more common in women with gynecologic pathology. The benefits of this approach compared with laparotomy include decreased hospital stay, shorter recovery and, in experienced hands, significantly decreased morbidity.^1–3

Approximately 600,000 hysterectomies are performed annually in the United States—30% of which are performed laparoscopically.⁴ The primary indication for surgical intervention is uterine leiomyoma. This pathology accounts for 40% of procedures.⁵ During these surgeries, electromechanical morcellation (EMM), or open “power” morcellation, is commonly used to cut large tissue specimens into small pieces for removal and thereby avoid a larger incision. Concerns have been raised regarding the use of open power morcellation because of the risk of spreading an unrecognized malignancy.

Based on case reports and retrospective studies, the FDA issued a statement in April of this year discouraging the use of EMM for hysterectomy and myomectomy in women with uterine fibroids.⁶ The concern for inadvertent spread of an occult malignancy was the reasoning for the communication. Since that time, the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee held a public meeting in which the panel heard comments from patients, societies, and industry regarding their positions on the safety of laparoscopic power morcellation. The panel made several recommendations to the FDA but, at the time of this writing, the FDA has yet to issue a final decision.

Reaction to FDA’s action/inaction
The FDA’s “safety” communication was in response to the concern of a few who experienced a bad outcome believed to be secondary to open power morcellation of enlarged uteri or fibroid tumors. In its statement, the FDA estimated the risk of an occult sarcoma to be about 1 in 350 and stated that the risk of disseminating a sarcoma with morcellation is substantial. The FDA discouraged the use of the power morcellator during hysterectomy or myomectomy for uterine fibroids.

Many organizations, including the Society of Gynecologic Oncology, The American Association of Gynecologic Laparoscopists (AAGL), and the American College of Obstetricians and Gynecologists, issued less stringent statements regarding this technology.^7–9 These organizations stated generally that there were too few data to make a statement at that time, advocated the collection of more data, and encouraged detailed informed consent to be given to patients undergoing these procedures.

However, the FDA’s statement, and lack of a timely follow-up to clarify the role of the laparoscopic power morcellator in gynecologic surgery, has effectively stopped the use of this technology in its current form. In fact, in response to the statement, Ethicon Endosurgery has discontinued the distribution and sales of its power morcellator and many institutions have severely or completely restricted the use of this technology. The reason for these restrictions is that the medicolegal consequences of an adverse outcome would be very difficult to defend given the current, albeit premature, recommendations of the FDA. This statement makes it difficult to defend any adverse outcome that may occur in association with the use of the laparoscopic power morcellator. Furthermore, this statement by the FDA has largely prevented the medical community at large from collecting additional useful information to allow for a data-driven determination.

Power morcellation is not without risks. In fact, we outline them in this article. However, we believe that minimally invasive surgery should be allowed to continue to advance. In that vein, here we describe a technique of dual-port contained EMM. This surgical approach is performed under direct visualization—which solves the problem of poor visualization that hinders other contained EMM techniques.

Risks of power morcellation
The potential for inadvertent spread of occult malignancy is not the only risk of open EMM. Reports of disseminated leiomyomatosis, adenomyosis, and endometriosis also have been described from inadvertent tissue dispersion during open EMM with resulting ectopic reperitonealization.^10–12

The procedure itself is not without risks. A recent systematic review documented 55 major and minor complications from EMM.¹³ Multiple organ systems were injured including bowel, urinary, vascular, and others, resulting in six deaths from these complications. The investigators concluded that “laparoscopic morcellator–related injuries continue to increase and short- and long-term complications are emerging in both the medical literature and device-related databases. Surgeon inexperience is descriptively identified as one of the most common contributing factors.”

All of the above risks must be weighed against the known benefits of laparoscopic surgery and presented to each patient to assist in deciding which route of surgery should be performed.

Tissue extraction options for large specimens
Large specimen extraction options during gynecologic surgery include:

Vaginal coring. Delivery through the vagina or colpotomy during vaginal or laparoscopic hysterectomy uses the technique of coring, which has long been established in our field.

Manual morcellation through a single incision. Mini-laparotomy or laparoendoscopic single-site surgery (LESS) incisions provide another option of removal with manual morcellation after laparoscopic hysterectomy or myomectomy. One study revealed that specimens up to 22 weeks in size can be placed in a large EndoCatch bag and morcellated extracorporeally by circumferentially coring with a scalpel.¹⁴

Contained power morcellation through a single port. Finally, the technique of contained EMM was recently described.¹⁵ This technique uses a large containment bag placed through a LESS incision with EMM being performed in an artificially created pneumoperitoneum. This technique isolates the specimen so that it can be morcellated without risk of exposing the patient to any malignant cells that might be unrecognized within the specimen.

Each of these techniques allows many patients to consider a minimally invasive option for their surgery. However, the ability to safely morcellate a very large uterus or myoma may be limited by visualization, and the experience of the surgeon is often critical in the successful performance of these procedures.¹⁶

Therefore, at Washington Universitywe have developed a technique using dual ports, with isolation of the uterus or myomas to improve visualization and prevent spillage of malignant tumor or dispersion of other benign tissue.

Dual-port EMM: Technique, tips, and tricks
Our technique of dual-port contained EMM allows the removal of large fibroids or uteri much larger than 20 weeks in size safely under direct visualization through a 15-mm incision. The technique uses:

• Karl Storz Rotocut tissue morcellator with spacers (FIGURE 1)
• 15-mm trocar
• 5-mm balloon trocar
• 20320-inch containment bag (FIGURE 2).

Containment bag placement
Once the specimen is free, we place it to the right or left side of the abdomen. The 15-mm trocar is placed through the umbilicus while visualizing from a lateral trocar site. We then fan-fold the containment bag and introduce it through the 15-mm trocar, keeping the bag oriented with the opening anterior (FIGURE 3). The bag is then grasped at the opening along the drawstring with an atraumatic grasper.

Tip: Care must be taken when introducing the bag in order to avoid tearing or making a small hole in it.

The leading edge is then introduced into the deepest part of the pelvis, and the remainder of the bag (left outside of the abdomen) is then fed cephalad into the abdomen.

Once the bag is completely in the abdomen, we orient the bag with the opening as wide as possible. This allows placement of a very large specimen. Once the specimen is within the containment bag, the drawstring is pulled tight and the mouth of the bag is removed through the 15-mm trocar site at the umbilicus.

The abdominal lateral gas port is opened to allow the intra-abdominal pneumoperitoneum to escape. A 5-mm trocar is placed into the bag through the opening at the umbilicus and the containment bag is insufflated with carbon dioxide and the insufflation pressure is set to 30 mm. The laparoscope placed through this trocar allows the artificial pneumoperitoneum being created to be observed (VIDEO).

Vidyard Video

Tip: The containment bag covers the entire abdominal cavity and should be fully distended. If it does not distend fully, a hole in the bag may be present and the bag must be replaced.

At this point, we place a balloon trocar at the lateral trocar site and into the bag under direct visualization. The balloon tip is inflated and pulled up tightly against the bag and abdominal wall (FIGURE 4). This allows a tight seal so there is no gas leak or spillage of the morcellated specimen. The laparoscope is placed through this trocar and the insufflation tubing is moved to this port.

Morcellator insertion
The morcellator is introduced through the umbilicus under direct visualization using the short morcellator blade in most instances. Spacers are used to set the length of the morcellator within the containment bag. The tip of the morcellator should be approximately 3 cm to 4 cm within the bag but well away from the retroperitoneum. Remember, any bag will be cut easily by the morcellator and should be thought of as peritoneum only and not a tough barrier. Serious injuries could otherwise develop.

At this point, place the patient flat or out of Trendelenburg position. Morcellation may now proceed.

Tip: Morcellation is best performed with the morcellator perpendicular to the abdomen under direct visualization using a 30° laparoscope to optimize the view. Morcellation in this position uses gravity to facilitate “peeling” of the specimen during morcellation and allows for faster removal.

Before removing the morcellator, inspect the containment bag for any large pieces that may have been dispersed during the morcellation process and remove them. Once there are only small fragments remaining, remove the morcellator, allowing the carbon dioxide to escape. Deflate the balloon tip on the trocar.

Now the containment bag with the remaining specimen may be removed through the umbilicus, while simultaneously removing the balloon-tip trocar from the bag.

A safe minimally invasive approach
This technique has allowed us to safely remove specimens larger than 1,500 g while keeping them in a contained environment with no spill of tissue within the abdomen.

Tracking and adaptation needed
The FDA safety communication has severely limited the practice of morcellation in the minimally invasive gynecologic surgical setting. Many hospitals around the country have reacted by placing significant restrictions on the use of EMM or banned it outright. This action may reverse the national trend of increasing rates of laparoscopic hysterectomy and force many practitioners to return to open surgery.

Currently, it is unclear what the true risk of tissue extraction is whether it is performed via EMM or manually. Large national databases including the BOLD database from the Surgical Review Corporation, as well as AAGL, must be utilized to track these cases and their outcomes to guide therapy. In the meantime, in order to continue to offer a minimally invasive approach to gynecologic surgery, new techniques and instrumentation in the operating room will need to be modified to adapt to these new guidelines. This is vital to maintain or even reduce the rates of open hysterectomy and associated morbidity while diminishing the potential risks of inadvertent benign as well as malignant tissue dispersion with tissue extraction.

Share your thoughts on this article! Send your Letter to the Editor to: [email protected]

Minimally invasive surgery utilizing laparoscopy for hysterectomy and myomectomy has become more common in women with gynecologic pathology. The benefits of this approach compared with laparotomy include decreased hospital stay, shorter recovery and, in experienced hands, significantly decreased morbidity.^1–3

Approximately 600,000 hysterectomies are performed annually in the United States—30% of which are performed laparoscopically.⁴ The primary indication for surgical intervention is uterine leiomyoma. This pathology accounts for 40% of procedures.⁵ During these surgeries, electromechanical morcellation (EMM), or open “power” morcellation, is commonly used to cut large tissue specimens into small pieces for removal and thereby avoid a larger incision. Concerns have been raised regarding the use of open power morcellation because of the risk of spreading an unrecognized malignancy.

Based on case reports and retrospective studies, the FDA issued a statement in April of this year discouraging the use of EMM for hysterectomy and myomectomy in women with uterine fibroids.⁶ The concern for inadvertent spread of an occult malignancy was the reasoning for the communication. Since that time, the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee held a public meeting in which the panel heard comments from patients, societies, and industry regarding their positions on the safety of laparoscopic power morcellation. The panel made several recommendations to the FDA but, at the time of this writing, the FDA has yet to issue a final decision.

Reaction to FDA’s action/inaction
The FDA’s “safety” communication was in response to the concern of a few who experienced a bad outcome believed to be secondary to open power morcellation of enlarged uteri or fibroid tumors. In its statement, the FDA estimated the risk of an occult sarcoma to be about 1 in 350 and stated that the risk of disseminating a sarcoma with morcellation is substantial. The FDA discouraged the use of the power morcellator during hysterectomy or myomectomy for uterine fibroids.

Many organizations, including the Society of Gynecologic Oncology, The American Association of Gynecologic Laparoscopists (AAGL), and the American College of Obstetricians and Gynecologists, issued less stringent statements regarding this technology.^7–9 These organizations stated generally that there were too few data to make a statement at that time, advocated the collection of more data, and encouraged detailed informed consent to be given to patients undergoing these procedures.

However, the FDA’s statement, and lack of a timely follow-up to clarify the role of the laparoscopic power morcellator in gynecologic surgery, has effectively stopped the use of this technology in its current form. In fact, in response to the statement, Ethicon Endosurgery has discontinued the distribution and sales of its power morcellator and many institutions have severely or completely restricted the use of this technology. The reason for these restrictions is that the medicolegal consequences of an adverse outcome would be very difficult to defend given the current, albeit premature, recommendations of the FDA. This statement makes it difficult to defend any adverse outcome that may occur in association with the use of the laparoscopic power morcellator. Furthermore, this statement by the FDA has largely prevented the medical community at large from collecting additional useful information to allow for a data-driven determination.

Power morcellation is not without risks. In fact, we outline them in this article. However, we believe that minimally invasive surgery should be allowed to continue to advance. In that vein, here we describe a technique of dual-port contained EMM. This surgical approach is performed under direct visualization—which solves the problem of poor visualization that hinders other contained EMM techniques.

Risks of power morcellation
The potential for inadvertent spread of occult malignancy is not the only risk of open EMM. Reports of disseminated leiomyomatosis, adenomyosis, and endometriosis also have been described from inadvertent tissue dispersion during open EMM with resulting ectopic reperitonealization.^10–12

The procedure itself is not without risks. A recent systematic review documented 55 major and minor complications from EMM.¹³ Multiple organ systems were injured including bowel, urinary, vascular, and others, resulting in six deaths from these complications. The investigators concluded that “laparoscopic morcellator–related injuries continue to increase and short- and long-term complications are emerging in both the medical literature and device-related databases. Surgeon inexperience is descriptively identified as one of the most common contributing factors.”

All of the above risks must be weighed against the known benefits of laparoscopic surgery and presented to each patient to assist in deciding which route of surgery should be performed.

Tissue extraction options for large specimens
Large specimen extraction options during gynecologic surgery include:

Vaginal coring. Delivery through the vagina or colpotomy during vaginal or laparoscopic hysterectomy uses the technique of coring, which has long been established in our field.

Manual morcellation through a single incision. Mini-laparotomy or laparoendoscopic single-site surgery (LESS) incisions provide another option of removal with manual morcellation after laparoscopic hysterectomy or myomectomy. One study revealed that specimens up to 22 weeks in size can be placed in a large EndoCatch bag and morcellated extracorporeally by circumferentially coring with a scalpel.¹⁴

Contained power morcellation through a single port. Finally, the technique of contained EMM was recently described.¹⁵ This technique uses a large containment bag placed through a LESS incision with EMM being performed in an artificially created pneumoperitoneum. This technique isolates the specimen so that it can be morcellated without risk of exposing the patient to any malignant cells that might be unrecognized within the specimen.

Each of these techniques allows many patients to consider a minimally invasive option for their surgery. However, the ability to safely morcellate a very large uterus or myoma may be limited by visualization, and the experience of the surgeon is often critical in the successful performance of these procedures.¹⁶

Therefore, at Washington Universitywe have developed a technique using dual ports, with isolation of the uterus or myomas to improve visualization and prevent spillage of malignant tumor or dispersion of other benign tissue.

Dual-port EMM: Technique, tips, and tricks
Our technique of dual-port contained EMM allows the removal of large fibroids or uteri much larger than 20 weeks in size safely under direct visualization through a 15-mm incision. The technique uses:

• Karl Storz Rotocut tissue morcellator with spacers (FIGURE 1)
• 15-mm trocar
• 5-mm balloon trocar
• 20320-inch containment bag (FIGURE 2).

Containment bag placement
Once the specimen is free, we place it to the right or left side of the abdomen. The 15-mm trocar is placed through the umbilicus while visualizing from a lateral trocar site. We then fan-fold the containment bag and introduce it through the 15-mm trocar, keeping the bag oriented with the opening anterior (FIGURE 3). The bag is then grasped at the opening along the drawstring with an atraumatic grasper.

Tip: Care must be taken when introducing the bag in order to avoid tearing or making a small hole in it.

The leading edge is then introduced into the deepest part of the pelvis, and the remainder of the bag (left outside of the abdomen) is then fed cephalad into the abdomen.

Once the bag is completely in the abdomen, we orient the bag with the opening as wide as possible. This allows placement of a very large specimen. Once the specimen is within the containment bag, the drawstring is pulled tight and the mouth of the bag is removed through the 15-mm trocar site at the umbilicus.

The abdominal lateral gas port is opened to allow the intra-abdominal pneumoperitoneum to escape. A 5-mm trocar is placed into the bag through the opening at the umbilicus and the containment bag is insufflated with carbon dioxide and the insufflation pressure is set to 30 mm. The laparoscope placed through this trocar allows the artificial pneumoperitoneum being created to be observed (VIDEO).

Vidyard Video

Tip: The containment bag covers the entire abdominal cavity and should be fully distended. If it does not distend fully, a hole in the bag may be present and the bag must be replaced.

At this point, we place a balloon trocar at the lateral trocar site and into the bag under direct visualization. The balloon tip is inflated and pulled up tightly against the bag and abdominal wall (FIGURE 4). This allows a tight seal so there is no gas leak or spillage of the morcellated specimen. The laparoscope is placed through this trocar and the insufflation tubing is moved to this port.

Morcellator insertion
The morcellator is introduced through the umbilicus under direct visualization using the short morcellator blade in most instances. Spacers are used to set the length of the morcellator within the containment bag. The tip of the morcellator should be approximately 3 cm to 4 cm within the bag but well away from the retroperitoneum. Remember, any bag will be cut easily by the morcellator and should be thought of as peritoneum only and not a tough barrier. Serious injuries could otherwise develop.

At this point, place the patient flat or out of Trendelenburg position. Morcellation may now proceed.

Tip: Morcellation is best performed with the morcellator perpendicular to the abdomen under direct visualization using a 30° laparoscope to optimize the view. Morcellation in this position uses gravity to facilitate “peeling” of the specimen during morcellation and allows for faster removal.

Before removing the morcellator, inspect the containment bag for any large pieces that may have been dispersed during the morcellation process and remove them. Once there are only small fragments remaining, remove the morcellator, allowing the carbon dioxide to escape. Deflate the balloon tip on the trocar.

Now the containment bag with the remaining specimen may be removed through the umbilicus, while simultaneously removing the balloon-tip trocar from the bag.

A safe minimally invasive approach
This technique has allowed us to safely remove specimens larger than 1,500 g while keeping them in a contained environment with no spill of tissue within the abdomen.

Tracking and adaptation needed
The FDA safety communication has severely limited the practice of morcellation in the minimally invasive gynecologic surgical setting. Many hospitals around the country have reacted by placing significant restrictions on the use of EMM or banned it outright. This action may reverse the national trend of increasing rates of laparoscopic hysterectomy and force many practitioners to return to open surgery.

Currently, it is unclear what the true risk of tissue extraction is whether it is performed via EMM or manually. Large national databases including the BOLD database from the Surgical Review Corporation, as well as AAGL, must be utilized to track these cases and their outcomes to guide therapy. In the meantime, in order to continue to offer a minimally invasive approach to gynecologic surgery, new techniques and instrumentation in the operating room will need to be modified to adapt to these new guidelines. This is vital to maintain or even reduce the rates of open hysterectomy and associated morbidity while diminishing the potential risks of inadvertent benign as well as malignant tissue dispersion with tissue extraction.

Share your thoughts on this article! Send your Letter to the Editor to: [email protected]

About 5.2 million people insured by Highmark Inc, a Blue Cross and Blue Shield (BCBS)–affiliated company in Pennsylvania, Delaware, and West Virginia will be denied coverage for laparoscopic power morcellation used in gynecologic surgery. Highmark is the fourth-largest BCBS affiliate.¹

On August 2, spokesman Aaron Billger announced by email that, in the best interest of their members, Highmark is halting coverage as of September 1, 2014.² This decision comes in response to the US Food and Drug Administration (FDA) Safety Communication of April 17, 2014, that discouraged the use of power morcellation during hysterectomy and myomectomy because of the increased risk of dispersion of benign myoma tissue and occult malignant tissue through the abdominal cavity.^2,3

University of Pittsburgh Medical Center (UPMC), the largest hospital group in western Pennsylvania, publicized that it will stop performing laparoscopic power morcellation as of September 1. UPMC spokesperson Gloria Kreps said the decision was an “appropriate and prudent course of action,” and that the hospital was “looking to the FDA for further guidance.”⁴ Other medical centers and hospitals have banned the use of power morcellation, beginning with Brigham and Women’s and Massachusetts General in April.⁵

In April 2014, Ethicon, a unit of Johnson & Johnson, suspended sales of all its morcellation devices. In an urgent Medical Device Market Withdrawal dated July 30, 2014, Ethicon initiated a “worldwide voluntary market withdrawal of all Ethicon Morcellation Devices that currently remain on the market.”⁶ Ethicon will issue prorated credit for morcellation devices returned by December 30, 2014, with full credit issued for unopened, unexpired disposable products.⁶

The FDA Obstetrics and Gynecology Devices Panel Advisory Committee held a 2-day hearing in July 2014 to weigh the risks and benefits of power morcellation. The panel will send recommendations to the FDA, and a final decision on the use of laparoscopic power morcellation will be forthcoming.⁷

About 5.2 million people insured by Highmark Inc, a Blue Cross and Blue Shield (BCBS)–affiliated company in Pennsylvania, Delaware, and West Virginia will be denied coverage for laparoscopic power morcellation used in gynecologic surgery. Highmark is the fourth-largest BCBS affiliate.¹

On August 2, spokesman Aaron Billger announced by email that, in the best interest of their members, Highmark is halting coverage as of September 1, 2014.² This decision comes in response to the US Food and Drug Administration (FDA) Safety Communication of April 17, 2014, that discouraged the use of power morcellation during hysterectomy and myomectomy because of the increased risk of dispersion of benign myoma tissue and occult malignant tissue through the abdominal cavity.^2,3

University of Pittsburgh Medical Center (UPMC), the largest hospital group in western Pennsylvania, publicized that it will stop performing laparoscopic power morcellation as of September 1. UPMC spokesperson Gloria Kreps said the decision was an “appropriate and prudent course of action,” and that the hospital was “looking to the FDA for further guidance.”⁴ Other medical centers and hospitals have banned the use of power morcellation, beginning with Brigham and Women’s and Massachusetts General in April.⁵

In April 2014, Ethicon, a unit of Johnson & Johnson, suspended sales of all its morcellation devices. In an urgent Medical Device Market Withdrawal dated July 30, 2014, Ethicon initiated a “worldwide voluntary market withdrawal of all Ethicon Morcellation Devices that currently remain on the market.”⁶ Ethicon will issue prorated credit for morcellation devices returned by December 30, 2014, with full credit issued for unopened, unexpired disposable products.⁶

The FDA Obstetrics and Gynecology Devices Panel Advisory Committee held a 2-day hearing in July 2014 to weigh the risks and benefits of power morcellation. The panel will send recommendations to the FDA, and a final decision on the use of laparoscopic power morcellation will be forthcoming.⁷

About 5.2 million people insured by Highmark Inc, a Blue Cross and Blue Shield (BCBS)–affiliated company in Pennsylvania, Delaware, and West Virginia will be denied coverage for laparoscopic power morcellation used in gynecologic surgery. Highmark is the fourth-largest BCBS affiliate.¹

On August 2, spokesman Aaron Billger announced by email that, in the best interest of their members, Highmark is halting coverage as of September 1, 2014.² This decision comes in response to the US Food and Drug Administration (FDA) Safety Communication of April 17, 2014, that discouraged the use of power morcellation during hysterectomy and myomectomy because of the increased risk of dispersion of benign myoma tissue and occult malignant tissue through the abdominal cavity.^2,3

University of Pittsburgh Medical Center (UPMC), the largest hospital group in western Pennsylvania, publicized that it will stop performing laparoscopic power morcellation as of September 1. UPMC spokesperson Gloria Kreps said the decision was an “appropriate and prudent course of action,” and that the hospital was “looking to the FDA for further guidance.”⁴ Other medical centers and hospitals have banned the use of power morcellation, beginning with Brigham and Women’s and Massachusetts General in April.⁵

In April 2014, Ethicon, a unit of Johnson & Johnson, suspended sales of all its morcellation devices. In an urgent Medical Device Market Withdrawal dated July 30, 2014, Ethicon initiated a “worldwide voluntary market withdrawal of all Ethicon Morcellation Devices that currently remain on the market.”⁶ Ethicon will issue prorated credit for morcellation devices returned by December 30, 2014, with full credit issued for unopened, unexpired disposable products.⁶

The FDA Obstetrics and Gynecology Devices Panel Advisory Committee held a 2-day hearing in July 2014 to weigh the risks and benefits of power morcellation. The panel will send recommendations to the FDA, and a final decision on the use of laparoscopic power morcellation will be forthcoming.⁷

Among women who undergo minimally invasive hysterectomy with electric power morcellation, the rate of uterine cancer is 27 cases per 10,000 women at the time of the procedure, according to a recent study published in the Journal of the American Medical Association.¹ That figure translates into approximately one case of undetected uterine cancer in every 368 women undergoing hysterectomy. Earlier this year the US Food and Drug Administration (FDA) estimated the prevalence of uterine sarcoma at one case in every 352 women.²

Leading up to publication of this study in late July, there had been concern and considerable discussion—including a 2-day hearing convened by the FDA— about whether power morcellation may result in the spread of undetected malignancies and, if so, how often that may occur.

Although power morcellators have been available commercially for two decades, accurate estimates of the prevalence of malignancy at the time of power morcellation have been lacking.

Jason D. Wright, MD, and colleagues from Columbia University used the Perspective database, a large insurance database, to investigate the prevalence of underlying cancer in women who underwent uterine morcellation during minimally invasive hysterectomy from 2006 to 2012. This database is an “all-payer” database that includes more than 500 hospitals in the United States, many of them urban teaching centers.

The cohort included 232,882 women who underwent minimally invasive hysterectomy, including 36,470 (15.7%) who had uterine morcellation during the procedure. Among women who underwent morcellation, 99 cases of uterine cancer were identified, a prevalence of 27 cases per 10,000 women (95% confidence interval [CI], 22–32).

Among women who underwent power morcellation, the prevalence of underlying cancer and endometrial hyperplasia increased with age. For example, compared with women younger than 40 years, the prevalence ratio for uterine malignancy was:

• 4.97 (95% CI, 1.91–12.93) in women aged 50 to 54 years
• 19.37 (95% CI, 7.66–48.95) in those aged 55 to 59 years
• 21.36 (95% CI, 7.22–63.21) in women aged 60 to 64
• 35.97 (95% CI, 14.14–91.53) in women aged 65 or older. 

“Prevalence information is the first step in determining the risk of spreading cancer with morcellation,” Wright and colleagues observe. “Patients considering morcellation should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure.”

Among women who undergo minimally invasive hysterectomy with electric power morcellation, the rate of uterine cancer is 27 cases per 10,000 women at the time of the procedure, according to a recent study published in the Journal of the American Medical Association.¹ That figure translates into approximately one case of undetected uterine cancer in every 368 women undergoing hysterectomy. Earlier this year the US Food and Drug Administration (FDA) estimated the prevalence of uterine sarcoma at one case in every 352 women.²

Leading up to publication of this study in late July, there had been concern and considerable discussion—including a 2-day hearing convened by the FDA— about whether power morcellation may result in the spread of undetected malignancies and, if so, how often that may occur.

Although power morcellators have been available commercially for two decades, accurate estimates of the prevalence of malignancy at the time of power morcellation have been lacking.

Jason D. Wright, MD, and colleagues from Columbia University used the Perspective database, a large insurance database, to investigate the prevalence of underlying cancer in women who underwent uterine morcellation during minimally invasive hysterectomy from 2006 to 2012. This database is an “all-payer” database that includes more than 500 hospitals in the United States, many of them urban teaching centers.

The cohort included 232,882 women who underwent minimally invasive hysterectomy, including 36,470 (15.7%) who had uterine morcellation during the procedure. Among women who underwent morcellation, 99 cases of uterine cancer were identified, a prevalence of 27 cases per 10,000 women (95% confidence interval [CI], 22–32).

Among women who underwent power morcellation, the prevalence of underlying cancer and endometrial hyperplasia increased with age. For example, compared with women younger than 40 years, the prevalence ratio for uterine malignancy was:

• 4.97 (95% CI, 1.91–12.93) in women aged 50 to 54 years
• 19.37 (95% CI, 7.66–48.95) in those aged 55 to 59 years
• 21.36 (95% CI, 7.22–63.21) in women aged 60 to 64
• 35.97 (95% CI, 14.14–91.53) in women aged 65 or older. 

“Prevalence information is the first step in determining the risk of spreading cancer with morcellation,” Wright and colleagues observe. “Patients considering morcellation should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure.”

Among women who undergo minimally invasive hysterectomy with electric power morcellation, the rate of uterine cancer is 27 cases per 10,000 women at the time of the procedure, according to a recent study published in the Journal of the American Medical Association.¹ That figure translates into approximately one case of undetected uterine cancer in every 368 women undergoing hysterectomy. Earlier this year the US Food and Drug Administration (FDA) estimated the prevalence of uterine sarcoma at one case in every 352 women.²

Leading up to publication of this study in late July, there had been concern and considerable discussion—including a 2-day hearing convened by the FDA— about whether power morcellation may result in the spread of undetected malignancies and, if so, how often that may occur.

Although power morcellators have been available commercially for two decades, accurate estimates of the prevalence of malignancy at the time of power morcellation have been lacking.

Jason D. Wright, MD, and colleagues from Columbia University used the Perspective database, a large insurance database, to investigate the prevalence of underlying cancer in women who underwent uterine morcellation during minimally invasive hysterectomy from 2006 to 2012. This database is an “all-payer” database that includes more than 500 hospitals in the United States, many of them urban teaching centers.

The cohort included 232,882 women who underwent minimally invasive hysterectomy, including 36,470 (15.7%) who had uterine morcellation during the procedure. Among women who underwent morcellation, 99 cases of uterine cancer were identified, a prevalence of 27 cases per 10,000 women (95% confidence interval [CI], 22–32).

Among women who underwent power morcellation, the prevalence of underlying cancer and endometrial hyperplasia increased with age. For example, compared with women younger than 40 years, the prevalence ratio for uterine malignancy was:

• 4.97 (95% CI, 1.91–12.93) in women aged 50 to 54 years
• 19.37 (95% CI, 7.66–48.95) in those aged 55 to 59 years
• 21.36 (95% CI, 7.22–63.21) in women aged 60 to 64
• 35.97 (95% CI, 14.14–91.53) in women aged 65 or older. 

“Prevalence information is the first step in determining the risk of spreading cancer with morcellation,” Wright and colleagues observe. “Patients considering morcellation should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure.”