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Hysteroscopic Morcellation: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database
Original Article
Hysteroscopic Morcellation: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database Karina Haber, MD*, Eleanor Hawkins, MD, Mark Levie, MD, and Scott Chudnoff, MD From the Department of Obstetrics and Gynecology, Danbury Hospital, Danbury, Connecticut (Dr. Haber), and Department of Minimally Invasive Gynecological Surgery, Montefiore Medical Center, Bronx, New York (Drs. Hawkins, Levie, and Chudnoff).
ABSTRACT Study Objective: To investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease. Design: Systematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III). Setting: N/A. Patients: Women undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator. Interventions: The MAUDE database was searched for the key words ‘‘Hysteroscope,’’ ‘‘Hysteroscopic reciprocating morcellator,’’ ‘‘Interlace,’’ ‘‘MyoSure,’’ ‘‘Smith & Nephew,’’ and ‘‘TRUCLEAR,’’ to identify reported incidences of device malfunction, injury, or death. A total of 119 adverse events were analyzed. Reports were reviewed individually and categorized by date of occurrence, type of morcellation device, type of complication, and a brief description. Each company was contacted to provide an estimate of the number of procedures performed or units sold to date. Measurements and Main Results: From 2005 to June 2014, 119 adverse events were reported to the MAUDE database. On the basis of severity, adverse events were categorized as major or minor complications. Major events included intubation/admission to an intensive care unit (n 5 14), bowel damage (n 5 12), hysterectomy (n 5 6), and death (n 5 2). Minor events included uterine perforation requiring no other treatment (n 5 29), device failure (n 5 25), uncomplicated fluid overload (n 5 19), postoperative bleeding controlled using noninvasive measures (n 5 6), and pelvic infection (n 5 4). These events were then categorized according to manufacturer. The number of adverse events reported to the MAUDE database was divided by the total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicated hysteroscopic morcellation in ,0.1% cases. Conclusions: The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur during traditional resectoscopy. On the basis of acknowledged limited information from the MAUDE database, it seems that life-threatening complications such as fluid overload, uterine perforation, and bleeding do occur with hysteroscopic morcellation but less frequently than with traditional electrocautery. Journal of Minimally Invasive Gynecology (2015) 22, 110–114 Ó 2015 AAGL. All rights reserved. Keywords:
DISCUSS
Hysteroscope; hysteroscopic reciprocating morcellator; Interlace; MyoSure; Smith & Nephew; TRUCLEAR
You can discuss this article with its authors and with other AAGL members at http://www.AAGL.org/jmig-22-2-JMIG-D-14-00347
Use your Smartphone to scan this QR code and connect to the discussion forum for this article now* * Download a free QR Code scanner by searching for ‘‘QR scanner’’ in your smartphone’s app store or app marketplace.
Disclosures: None declared. Corresponding author: Karina Haber, MD, Department of Obstetrics and Gynecology, Danbury Hospital, 24 Hospital Ave, Danbury CT 06810. E-mail: [email protected] Submitted July 12, 2014. Accepted for publication August 8, 2014. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2015 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2014.08.008
Submucosal myomas and polyps often result in abnormal uterine bleeding, infertility, and possibly pelvic pain, which frequently lead to surgical intervention. Hysteroscopic resection via a loop electrode has been the contemporary treatment of choice for removal of intracavitary lesions. Normal saline solution is used universally in bipolar hysteroscopic resection and in hysteroscopic morcellation.
Haber et al.
Hysteroscopic Morcellation
Excessive absorption of distention medium can create fluid and electrolyte imbalances and ultimately lead to hyponatremia, heart failure, and pulmonary and cerebral edema [1]. Use of an isotonic distention medium substantially diminishes the complications of fluid overload that are observed with hypertonic solutions [1]. Jansen et al [2] demonstrated that the risk of fluid overload is a complication in only 0.2% of traditional resectoscopy cases. In the same study, uterine perforation was the most common complication of traditional operative and diagnostic hysteroscopy, occurring in approximately 0.76% of cases [2]. During traditional resectoscopy, visual field limitations are created by the orientation of the protruding resectoscope as well as the resected chips, increasing the risk of uterine perforation and other complications. In an attempt to overcome these issues, intrauterine morcellation was developed. Intrauterine morcellation is a non-cautery– dependent mechanical device that simultaneously cuts and aspirates polyp and/or myoma tissue [3,4]. In theory, the lack of electrocautery decreases the risk of thermal injury, and the ability to both cut and retrieve polyps improves visualization and averts the need for additional instrumentation [5,6]. Both of these concepts have been theorized to decrease potential adverse events. Although the concept of hysteroscopic morcellation is appealing, sufficient data have not been reported to well characterize the incidence of major complications. Material and Methods In 2005, the US Food and Drug Administration (FDA) approved the TRUCLEAR hysteroscopic morcellator (Smith & Nephew, Andover, MA) as the first mechanical morcellator for resection of intrauterine disease [5]. The TRUCLEAR ULTRA has a reciprocating and rotating style blade that operates at 357 bites/minute at 2500 RPM. It has a bevel on both the inner and outer sheath and has continuous outflow. When the device is turned on, both the blade and the suctioning device are activated. The removed tissue is discharged through the device, collected in a pouch, and made available for pathologic analysis [6]. The TRUCLEAR device functions with most fluid management systems [5]. The FDA approved a second hysteroscopic morcellation device in 2009, the MyoSure R Tissue Removal System (Hologic, Bedford, MA). Similar to the TRUCLEAR device, the MyoSure system relies on a suction-based, mechanical energy, rotating tubular cutting system rather than highfrequency electrical energy. The blade on the MyoSure system is a reciprocating style that operates at 157 bites/minute at 6000 RPM. The MyoSure system is compatible with all fluid management systems [6]. This review includes all adverse events reported to the FDA Manufacturer and User Device Experience (MAUDE) database from development of the first hysteroscopic morcellator in 2005 to June 2014. Information included in the MAUDE database is publically available and not individu-
111
ally identifiable; therefore, it is exempt from institutional review board review. The database was searched for the key words ‘‘hysteroscope,’’ ‘‘hysteroscopic reciprocating morcellator,’’ ‘‘Interlace,’’ ‘‘MyoSure,’’ ‘‘Smith & Nephew,’’ and ‘‘TRUCLEAR,’’ to identify reported cases of device malfunction, injury, or death. Reports were reviewed individually for annotations of patient injury or death and were categorized by date reported, date of occurrence, type of morcellation device, type of complication, a brief description, and who reported the incident. Duplicate reports identified when the various search terms were used were removed. Each company was then contacted to provide an estimate of the number of units sold to date in the United States as a surrogate of the number of procedures performed. Results From 2005 to June 2014, 119 adverse events secondary to hysteroscopic intrauterine morcellation were reported to the MAUDE database in the United States. Table 1 gives the number of complications that occurred with each device, noting that TRUCLEAR was the only intrauterine morcellator available until 2009, when the MyoSure was approved by the FDA. On the basis of severity, adverse events are categorized as major or minor complications (Table 2). Major events included death, bowel injury, admission to an intensive care unit, and hysterectomy. Minor events included uterine perforation requiring no additional surgery or treatment, uncomplicated fluid overload that resolved spontaneously or with intravenous administration of furosemide (Lasix), endometritis, postoperative bleeding that was controlled via uterine tamponade, and device failure. Adverse events were then categorized according to manufacturer. Uterine perforation was the most commonly reported adverse event. In 28 of 40 cases, the information reported Table 1 Total number of adverse events reported to MAUDE database per year for each hysteroscopic morcellation device Variable
TRUCLEAR
MyoSure
Total cases, 110 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
23 NA 2 1 0 2 4 6 3 3 2
87 NA NA NA NA NA 3 11 23 44 6
MAUDE 5 Manufacturer and User Facility Device Experience database; NA 5 not applicable.
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Journal of Minimally Invasive Gynecology, Vol 22, No 1, January 2015
Table 2 Adverse events by complication and manufacturer
Major complications Death Bowel injury Intensive care unit admission Hysterectomy Unknown cause of admission Minor complications Uncomplicated fluid overload Pelvic infection Uterine perforation Postoperative bleeding, controlled Device failure
TRUCLEAR
MyoSure
6 0 3 1 1 1 17 1 0 6 1 9
31 2 9 13 5 2 65 18 4 22 5 16
to the MAUDE database included that perforation was confirmed via diagnostic hysteroscopy or laparoscopy and that no further intervention was required. In 12 patients, the reported case stated that uterine perforation was suspected because of a large fluid deficit, but did not specify that the site of perforation was visualized. More than half of reported cases mentioned that the injury was suspected during uterine sounding. Injury to the bowel was noted in 11 patients and required additional surgery (Table 3). Two patients required temporary colostomy bags and admission to the intensive care unit. Two women underwent hysterectomy ‘‘per patient request’’ after the diagnoses of uterine perforation and failed NovaSure ablation. Overall, our search produced 30 reports of fluid overload. Eight cases resolved spontaneously, 10 required intravenous furosemide therapy and no further intervention, and 11 required intubation and admission to the intensive care unit. In all reported intrauterine morcellation cases, normal saline solution was used as the distention medium. Device failure was reported in 25 cases. This included metal shavings and broken pieces of the device visualized in the uterine cavity, poor visualization, failure of outflow, and a defective device that could not be activated. In one reported case, the blade fell into the uterine cavity and could not be retrieved. Hysterectomy was performed, and the patient did well after the surgery. Bleeding was reported in 8 cases. In 5 the bleeding was controlled via uterine tamponade with the use of a Bakari balloon, and no further intervention was required. Three hysterectomies were performed as a result of excessive blood loss. There were no reports of blood transfusion. Two deaths were reported in association with the use hysteroscopic morcellation. The first patient had multiple comorbidities including chronic hypertension and obesity. While the patient was under anesthesia, desaturation occurred. Subsequent intubation and transesophageal echocardiography were performed. A pulmonary embolism was diagnosed, and the patient died. The second patient was an
elderly woman who was not well. Per the report, the hysteroscopic morcellation procedure was uncomplicated, and the patient was discharged on the same day. She was readmitted the following day, and died shortly after. An exact cause of death was not reported. As reported by the medical director of MyoSure, approximately 80 000 hysteroscopic morcellation devices have been sold since FDA approval in 2009. A TRUCLEAR representative estimated that approximately 100 000 procedures have been performed since 2004. The number of adverse events reported to the MAUDE database was divided by total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicate 1 per 1000 cases using the MyoSure hysteroscopic morcellator and 1 of 5000 cases using the TRUCLEAR device. Discussion Current literature suggests that mechanical morcellation offers advantages over traditional resectoscopy for treatment of myomas that lie entirely in uterine cavity (type 0) and those that extend ,50% into the myometrium (type I) [4,6]. If .50% of a tumor penetrates the myometrium (type II) the risk of excessive intraoperative fluid absorption is increased, along with the risk of bleeding [4]. Hysteroscopic morcellators use mechanical energy and rely on the power of uterine contraction to adequately achieve hemostasis. If excessive bleeding does occur, the intrauterine morcellator does not have electrocoagulation or a way to cauterize open vessels, increasing the risk of excessive bleeding and intravasation of fluid. Of adverse events reported to the MAUDE database insofar as hysteroscopic morcellation, 6% were secondary to bleeding. Excessive intravasation of fluid can occur with all hysteroscopic resection techniques. Using normal saline solution as distention medium decreases the risk of pulmonary edema, hyponatremia, hypo-osmolarity, and cerebral edema, which is an important concern when using hyperosmolar solutions [1]. In our review, fluid overload complicated 0.03% (29 of 80 000) cases using the MyoSure device and 0.002% (2 of 100 000) cases using the TRUCLEAR device. Fluid overload is a clinical diagnosis, and the MAUDE database does not specify criteria on which the diagnosis of fluid overload was made for each reported case. The Smith & Nephew TRUCLEAR device requires the use of their fluid pump for proper functioning. Fluid overload accounted for only 9.5% (2 of 24) of TRUCLEAR-related adverse events reported to the MAUDE database. Conversely, any fluid management system is acceptable with use of the Hologic MyoSure system. Fluid overload was responsible for 32% (29 of 90) of all adverse events reported with use of the Hologic intrauterine reciprocating morcellator. In a prospective multicenter study by Jansen et al [2], it was concluded that fluid overload complicated 0.2% of diagnostic
Haber et al.
Hysteroscopic Morcellation
and operative hysteroscopic procedures using traditional resectoscopy. The most frequent complication demonstrated in that study was perforation of the uterine cavity, which occurred in approximately 0.76% of operative hysteroscopic cases [2]. Bleeding was noted in 0.16% of cases [2]. Using limited information provided by the MAUDE database, our study estimated that with hysteroscopic morcellation, complications such as uterine perforation occur
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in approximately 0.02% of cases, and bleeding in 0.003% of cases. Using this information, our review concluded that life-threatening complications such as fluid overload, uterine perforation, and bleeding continue to occur with hysteroscopic morcellation but less frequently than with traditional hysteroscopic resection. The MAUDE database includes both voluntary and mandated reports of adverse events of medical devices.
Table 3 Description of bowel injury Morcellator
Event
Time of injury
Management
Resection of large 4-cm submucosal myoma. Uterine perforation. Resection of 3.2-cm submucosal myoma. Uterine perforation. Resection of lateral fundal myoma. Perforation not diagnosed.
Probing base of myoma; device not activated. Repositioning device; device not activated. Unknown.
4
Resection of right lateral polyp. Perforation not diagnosed.
Unknown.
5
Removal of uterine tissue and polyp. Perforation not diagnosed.
Unknown.
6
Removal of uterine tissue. Perforation not diagnosed.
Unknown.
7
Removal of uterine tissue. High fluid deficit. Diagnostic laparoscopy did not reveal perforation.
Unknown.
8
Removal of uterine myomas. Uterine perforation.
Unknown.
9
Resection of submucosal myoma. Uterine perforation.
Probing base of myoma, device not activated.
Immediate diagnostic laparoscopy to repair of blunt serosal bowel injury. Immediate diagnostic laparoscopy to repair of bowel injury. Discharged to home immediately after surgery. Readmitted on POD 1. Diagnostic laparoscopy to repair of bowel injury. Discharged to home immediately after surgery. Readmitted on POD x. Intubation, ICU, sepsis. Unknown management of bowel perforation. Discharged to home immediately after surgery. Readmitted on POD x. Diagnostic laparoscopy to small bowel perforation diagnosis and repair. Temporary colostomy. Discharged to home immediately after surgery. Readmitted on POD 1. Small bowel resection performed. Discharged to home immediately after surgery. Readmitted on POD x. Unknown procedure to small bowel perforation diagnosis and repair. Temporary colostomy. Intubation, ICU, sepsis. Unknown procedure to diagnosis of intraabdominal abscesses 1 small bowel perforation. Unknown management. Exploratory laparotomy to small bowel perforation. Hysterectomy. Unknown management of small bowel.
Resection of submucosal myoma. Uterine perforation. Resection of uterine tissue. Uterine perforation. Myomectomy. Uterine perforation.
Unknown.
MyoSure 1 2 3
TRUCLEAR 1 2 3
ICU 5 intensive care unit; POD 5 postoperative day.
Unknown. Unknown.
Immediate diagnostic laparoscopy to small bowel injury diagnosis and repair. Immediate diagnostic laparoscopy to repair of blunt serosal bowel injury. Immediate diagnostic laparoscopy to small bowel injury diagnosis and repair.
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Even with government legislation requiring the reporting of complications, these events likely continue to be widely underreported. The information offered to the MAUDE database is often missing relevant data. Details such as the experience of the operating physician, an explanation of exactly how or where the complication occurred, and specific details about management of severe complications are often omitted. Our complication rate estimates are subject to limitations of both voluntary adverse event reporting and use of number of devices sold as a surrogate for total number of procedures performed. Despite these drawbacks, evaluation of the MAUDE database is helpful by bringing awareness of the estimated risk of various complications to healthcare providers. Knowing the types of complications that are most likely to occur during hysteroscopic morcellation enables appropriate counseling and consent of the patient. It also enables manufacturers to focus on patient safety initiatives. Many advantages of hysteroscopic morcellation have been discussed in recent literature, such as decreased operative time, possible lower recurrence of endometrial polyps, and less pain [7,8]. van Dongen et al [7] conducted a randomized controlled trial (RCT) to compare conventional resectoscopy and hysteroscopic morcellation among residents in training. In that study, a substantial reduction in operating room time was demonstrated when removing polyps and types I and II submucosal myomas. Polyps were removed with a 72% reduction in operating room time with use of a morcellator as compared with a resectoscope (8.7 vs 30.9 minutes), whereas types 0 and 1 myomas were removed in 61% less time (16.4 vs 42.2 minutes). Subjective surgeon and trainer visual analog scale scores for convenience of technique favored the morcellator [7]. AlHilli et al [8] compared the long-term outcomes of intrauterine morcellation of endometrial polyps via traditional hysteroscopic resection using electrocautery in an RCT of 311 women [8]. It was concluded that the recurrence rate of endometrial polyps was not statistically significant between the intrauterine morcellation and resectoscopy groups (hazard ratio, 3.3; 95% confidence interval, 0.94–11.49; p 5 .06), and there was no difference in the incidence of recurrent abnormal uterine bleeding (hazard ratio for hysteroscopic resection vs intrauterine morcellation, 1.12; 95% confidence interval, 0.64–1.98; p 5 .59) [8]. Another RCT, by Smith et al [9], included 121 women randomly allocated to undergo polyp removal via hysteroscopic morcellation performed as an outpatient office procedure compared with electrosurgical resection. It was suggested that compared with traditional electrosurgical resection for the removal of endometrial polyps, hysteroscopic morcellation is quicker to perform (5.5 vs 10.2 minutes), more successful for completing polyp removal (98% vs 83%), less painful, and more acceptable to women. Adverse events occurred 1 of 62 hysteroscopic morcellation procedures (2%) and 6 of 59 electrosurgical resection proce-
Journal of Minimally Invasive Gynecology, Vol 22, No 1, January 2015
dures (10%) (p 5 .08) [9]. The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur with traditional resectoscopy. Hysteroscopic morcellation has been reported as an effective and safe new technique to remove intrauterine lesions [3,6], but maintains the risk of severe adverse events. Preventing hysteroscopy complications begins by raising awareness of risks and precautions. The present study concludes that life-threatening complications such as fluid overload, uterine perforation, and bleeding cannot be eliminated completely with any type of hysteroscopic procedure, although they seem to occur less frequently with use of intrauterine morcellation devices compared with electrocautery resection. The primary limitations of the present study are that the adverse events reported to the MAUDE database were underreported and lacked relevant details, the number of procedures performed was estimated, and the complication rates for intrauterine morcellation and hysteroscopic resection were not matched. Intrauterine morcellation was designed to remove superficial types I and II intrauterine myomas. Hysteroscopic resection can be used to remove myomas embedded deeper in the myometrium, making it intrinsically more prone to complications. A further study must be done to match complication rates for intrauterine morcellation and hysteroscopic resection on the basis of size and type of myoma.
References 1. Darwish AM, Hassan ZZ, Attia AM, Abdelraheem SS, Ahmed YM. Biological effects of distension media in bipolar versus monopolar resectoscopic myomectomy: a randomized trail. J Obstet Gynaecol Res. 2010; 36:810–817. 2. Jansen FW, Vredevoogd CB, van Ulzen K, Hermans J, Trimbos JB, Trimbos-Kemper TC. Complications of hysteroscopy: a prospective, multicenter study. Obstet Gynecol. 2000;96:266–270. 3. Emanuel MH, Wamsteker K. The intrauterine morcellator: a new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol. 2005;12:62–66. 4. Garcia A. Update on minimally invasive surgery. OBG Manage. 2011; 23:39–48. 5. Cohen S, Greenberg JA. Hysteroscopic morcellation for treating intrauterine pathology. Rev Obstet Gynecol. 2011;4:73–80. 6. Hamerlynck TW, Dietz V, Schoot BC. Clinical implementation of the hysteroscopic morcellator for removal of intrauterine myomas and polyps: a retrospective descriptive study. Gynecol Surg. 2011;8:193–196. 7. van Dongen H, Emanuel MH, Wolterbeek R, Trimbos JB, Jansen FW. Hysteroscopic morcellator for removal of intrauterine polyps and myomas: a randomized controlled pilot study among residents in training. J Minim Invasive Gynecol. 2008;15:466–471. 8. AlHilli MM, Nixon KE, Hopkins MR, Weaver AL, LaughlinTommaso SK, Famiuyide AO. Long-term outcomes after intrauterine morcellation vs hysteroscopic resection of endometrial polyps. J Minim Invasive Gynecol. 2013;20:215–221. 9. Smith PP, Middleton LJ, Connor M, Clark TJ. Hysteroscopic morcellation compared with electrical resection of endometrial polyps: a randomized controlled trial. Obstet Gynecol. 2014;123:745–751.
Hysteroscopic Morcellation: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database Karina Haber, MD*, Eleanor Hawkins, MD, Mark Levie, MD, and Scott Chudnoff, MD From the Department of Obstetrics and Gynecology, Danbury Hospital, Danbury, Connecticut (Dr. Haber), and Department of Minimally Invasive Gynecological Surgery, Montefiore Medical Center, Bronx, New York (Drs. Hawkins, Levie, and Chudnoff).
ABSTRACT Study Objective: To investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease. Design: Systematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III). Setting: N/A. Patients: Women undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator. Interventions: The MAUDE database was searched for the key words ‘‘Hysteroscope,’’ ‘‘Hysteroscopic reciprocating morcellator,’’ ‘‘Interlace,’’ ‘‘MyoSure,’’ ‘‘Smith & Nephew,’’ and ‘‘TRUCLEAR,’’ to identify reported incidences of device malfunction, injury, or death. A total of 119 adverse events were analyzed. Reports were reviewed individually and categorized by date of occurrence, type of morcellation device, type of complication, and a brief description. Each company was contacted to provide an estimate of the number of procedures performed or units sold to date. Measurements and Main Results: From 2005 to June 2014, 119 adverse events were reported to the MAUDE database. On the basis of severity, adverse events were categorized as major or minor complications. Major events included intubation/admission to an intensive care unit (n 5 14), bowel damage (n 5 12), hysterectomy (n 5 6), and death (n 5 2). Minor events included uterine perforation requiring no other treatment (n 5 29), device failure (n 5 25), uncomplicated fluid overload (n 5 19), postoperative bleeding controlled using noninvasive measures (n 5 6), and pelvic infection (n 5 4). These events were then categorized according to manufacturer. The number of adverse events reported to the MAUDE database was divided by the total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicated hysteroscopic morcellation in ,0.1% cases. Conclusions: The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur during traditional resectoscopy. On the basis of acknowledged limited information from the MAUDE database, it seems that life-threatening complications such as fluid overload, uterine perforation, and bleeding do occur with hysteroscopic morcellation but less frequently than with traditional electrocautery. Journal of Minimally Invasive Gynecology (2015) 22, 110–114 Ó 2015 AAGL. All rights reserved. Keywords:
DISCUSS
Hysteroscope; hysteroscopic reciprocating morcellator; Interlace; MyoSure; Smith & Nephew; TRUCLEAR
You can discuss this article with its authors and with other AAGL members at http://www.AAGL.org/jmig-22-2-JMIG-D-14-00347
Use your Smartphone to scan this QR code and connect to the discussion forum for this article now* * Download a free QR Code scanner by searching for ‘‘QR scanner’’ in your smartphone’s app store or app marketplace.
Disclosures: None declared. Corresponding author: Karina Haber, MD, Department of Obstetrics and Gynecology, Danbury Hospital, 24 Hospital Ave, Danbury CT 06810. E-mail: [email protected] Submitted July 12, 2014. Accepted for publication August 8, 2014. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2015 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2014.08.008
Submucosal myomas and polyps often result in abnormal uterine bleeding, infertility, and possibly pelvic pain, which frequently lead to surgical intervention. Hysteroscopic resection via a loop electrode has been the contemporary treatment of choice for removal of intracavitary lesions. Normal saline solution is used universally in bipolar hysteroscopic resection and in hysteroscopic morcellation.
Haber et al.
Hysteroscopic Morcellation
Excessive absorption of distention medium can create fluid and electrolyte imbalances and ultimately lead to hyponatremia, heart failure, and pulmonary and cerebral edema [1]. Use of an isotonic distention medium substantially diminishes the complications of fluid overload that are observed with hypertonic solutions [1]. Jansen et al [2] demonstrated that the risk of fluid overload is a complication in only 0.2% of traditional resectoscopy cases. In the same study, uterine perforation was the most common complication of traditional operative and diagnostic hysteroscopy, occurring in approximately 0.76% of cases [2]. During traditional resectoscopy, visual field limitations are created by the orientation of the protruding resectoscope as well as the resected chips, increasing the risk of uterine perforation and other complications. In an attempt to overcome these issues, intrauterine morcellation was developed. Intrauterine morcellation is a non-cautery– dependent mechanical device that simultaneously cuts and aspirates polyp and/or myoma tissue [3,4]. In theory, the lack of electrocautery decreases the risk of thermal injury, and the ability to both cut and retrieve polyps improves visualization and averts the need for additional instrumentation [5,6]. Both of these concepts have been theorized to decrease potential adverse events. Although the concept of hysteroscopic morcellation is appealing, sufficient data have not been reported to well characterize the incidence of major complications. Material and Methods In 2005, the US Food and Drug Administration (FDA) approved the TRUCLEAR hysteroscopic morcellator (Smith & Nephew, Andover, MA) as the first mechanical morcellator for resection of intrauterine disease [5]. The TRUCLEAR ULTRA has a reciprocating and rotating style blade that operates at 357 bites/minute at 2500 RPM. It has a bevel on both the inner and outer sheath and has continuous outflow. When the device is turned on, both the blade and the suctioning device are activated. The removed tissue is discharged through the device, collected in a pouch, and made available for pathologic analysis [6]. The TRUCLEAR device functions with most fluid management systems [5]. The FDA approved a second hysteroscopic morcellation device in 2009, the MyoSure R Tissue Removal System (Hologic, Bedford, MA). Similar to the TRUCLEAR device, the MyoSure system relies on a suction-based, mechanical energy, rotating tubular cutting system rather than highfrequency electrical energy. The blade on the MyoSure system is a reciprocating style that operates at 157 bites/minute at 6000 RPM. The MyoSure system is compatible with all fluid management systems [6]. This review includes all adverse events reported to the FDA Manufacturer and User Device Experience (MAUDE) database from development of the first hysteroscopic morcellator in 2005 to June 2014. Information included in the MAUDE database is publically available and not individu-
111
ally identifiable; therefore, it is exempt from institutional review board review. The database was searched for the key words ‘‘hysteroscope,’’ ‘‘hysteroscopic reciprocating morcellator,’’ ‘‘Interlace,’’ ‘‘MyoSure,’’ ‘‘Smith & Nephew,’’ and ‘‘TRUCLEAR,’’ to identify reported cases of device malfunction, injury, or death. Reports were reviewed individually for annotations of patient injury or death and were categorized by date reported, date of occurrence, type of morcellation device, type of complication, a brief description, and who reported the incident. Duplicate reports identified when the various search terms were used were removed. Each company was then contacted to provide an estimate of the number of units sold to date in the United States as a surrogate of the number of procedures performed. Results From 2005 to June 2014, 119 adverse events secondary to hysteroscopic intrauterine morcellation were reported to the MAUDE database in the United States. Table 1 gives the number of complications that occurred with each device, noting that TRUCLEAR was the only intrauterine morcellator available until 2009, when the MyoSure was approved by the FDA. On the basis of severity, adverse events are categorized as major or minor complications (Table 2). Major events included death, bowel injury, admission to an intensive care unit, and hysterectomy. Minor events included uterine perforation requiring no additional surgery or treatment, uncomplicated fluid overload that resolved spontaneously or with intravenous administration of furosemide (Lasix), endometritis, postoperative bleeding that was controlled via uterine tamponade, and device failure. Adverse events were then categorized according to manufacturer. Uterine perforation was the most commonly reported adverse event. In 28 of 40 cases, the information reported Table 1 Total number of adverse events reported to MAUDE database per year for each hysteroscopic morcellation device Variable
TRUCLEAR
MyoSure
Total cases, 110 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
23 NA 2 1 0 2 4 6 3 3 2
87 NA NA NA NA NA 3 11 23 44 6
MAUDE 5 Manufacturer and User Facility Device Experience database; NA 5 not applicable.
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Journal of Minimally Invasive Gynecology, Vol 22, No 1, January 2015
Table 2 Adverse events by complication and manufacturer
Major complications Death Bowel injury Intensive care unit admission Hysterectomy Unknown cause of admission Minor complications Uncomplicated fluid overload Pelvic infection Uterine perforation Postoperative bleeding, controlled Device failure
TRUCLEAR
MyoSure
6 0 3 1 1 1 17 1 0 6 1 9
31 2 9 13 5 2 65 18 4 22 5 16
to the MAUDE database included that perforation was confirmed via diagnostic hysteroscopy or laparoscopy and that no further intervention was required. In 12 patients, the reported case stated that uterine perforation was suspected because of a large fluid deficit, but did not specify that the site of perforation was visualized. More than half of reported cases mentioned that the injury was suspected during uterine sounding. Injury to the bowel was noted in 11 patients and required additional surgery (Table 3). Two patients required temporary colostomy bags and admission to the intensive care unit. Two women underwent hysterectomy ‘‘per patient request’’ after the diagnoses of uterine perforation and failed NovaSure ablation. Overall, our search produced 30 reports of fluid overload. Eight cases resolved spontaneously, 10 required intravenous furosemide therapy and no further intervention, and 11 required intubation and admission to the intensive care unit. In all reported intrauterine morcellation cases, normal saline solution was used as the distention medium. Device failure was reported in 25 cases. This included metal shavings and broken pieces of the device visualized in the uterine cavity, poor visualization, failure of outflow, and a defective device that could not be activated. In one reported case, the blade fell into the uterine cavity and could not be retrieved. Hysterectomy was performed, and the patient did well after the surgery. Bleeding was reported in 8 cases. In 5 the bleeding was controlled via uterine tamponade with the use of a Bakari balloon, and no further intervention was required. Three hysterectomies were performed as a result of excessive blood loss. There were no reports of blood transfusion. Two deaths were reported in association with the use hysteroscopic morcellation. The first patient had multiple comorbidities including chronic hypertension and obesity. While the patient was under anesthesia, desaturation occurred. Subsequent intubation and transesophageal echocardiography were performed. A pulmonary embolism was diagnosed, and the patient died. The second patient was an
elderly woman who was not well. Per the report, the hysteroscopic morcellation procedure was uncomplicated, and the patient was discharged on the same day. She was readmitted the following day, and died shortly after. An exact cause of death was not reported. As reported by the medical director of MyoSure, approximately 80 000 hysteroscopic morcellation devices have been sold since FDA approval in 2009. A TRUCLEAR representative estimated that approximately 100 000 procedures have been performed since 2004. The number of adverse events reported to the MAUDE database was divided by total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicate 1 per 1000 cases using the MyoSure hysteroscopic morcellator and 1 of 5000 cases using the TRUCLEAR device. Discussion Current literature suggests that mechanical morcellation offers advantages over traditional resectoscopy for treatment of myomas that lie entirely in uterine cavity (type 0) and those that extend ,50% into the myometrium (type I) [4,6]. If .50% of a tumor penetrates the myometrium (type II) the risk of excessive intraoperative fluid absorption is increased, along with the risk of bleeding [4]. Hysteroscopic morcellators use mechanical energy and rely on the power of uterine contraction to adequately achieve hemostasis. If excessive bleeding does occur, the intrauterine morcellator does not have electrocoagulation or a way to cauterize open vessels, increasing the risk of excessive bleeding and intravasation of fluid. Of adverse events reported to the MAUDE database insofar as hysteroscopic morcellation, 6% were secondary to bleeding. Excessive intravasation of fluid can occur with all hysteroscopic resection techniques. Using normal saline solution as distention medium decreases the risk of pulmonary edema, hyponatremia, hypo-osmolarity, and cerebral edema, which is an important concern when using hyperosmolar solutions [1]. In our review, fluid overload complicated 0.03% (29 of 80 000) cases using the MyoSure device and 0.002% (2 of 100 000) cases using the TRUCLEAR device. Fluid overload is a clinical diagnosis, and the MAUDE database does not specify criteria on which the diagnosis of fluid overload was made for each reported case. The Smith & Nephew TRUCLEAR device requires the use of their fluid pump for proper functioning. Fluid overload accounted for only 9.5% (2 of 24) of TRUCLEAR-related adverse events reported to the MAUDE database. Conversely, any fluid management system is acceptable with use of the Hologic MyoSure system. Fluid overload was responsible for 32% (29 of 90) of all adverse events reported with use of the Hologic intrauterine reciprocating morcellator. In a prospective multicenter study by Jansen et al [2], it was concluded that fluid overload complicated 0.2% of diagnostic
Haber et al.
Hysteroscopic Morcellation
and operative hysteroscopic procedures using traditional resectoscopy. The most frequent complication demonstrated in that study was perforation of the uterine cavity, which occurred in approximately 0.76% of operative hysteroscopic cases [2]. Bleeding was noted in 0.16% of cases [2]. Using limited information provided by the MAUDE database, our study estimated that with hysteroscopic morcellation, complications such as uterine perforation occur
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in approximately 0.02% of cases, and bleeding in 0.003% of cases. Using this information, our review concluded that life-threatening complications such as fluid overload, uterine perforation, and bleeding continue to occur with hysteroscopic morcellation but less frequently than with traditional hysteroscopic resection. The MAUDE database includes both voluntary and mandated reports of adverse events of medical devices.
Table 3 Description of bowel injury Morcellator
Event
Time of injury
Management
Resection of large 4-cm submucosal myoma. Uterine perforation. Resection of 3.2-cm submucosal myoma. Uterine perforation. Resection of lateral fundal myoma. Perforation not diagnosed.
Probing base of myoma; device not activated. Repositioning device; device not activated. Unknown.
4
Resection of right lateral polyp. Perforation not diagnosed.
Unknown.
5
Removal of uterine tissue and polyp. Perforation not diagnosed.
Unknown.
6
Removal of uterine tissue. Perforation not diagnosed.
Unknown.
7
Removal of uterine tissue. High fluid deficit. Diagnostic laparoscopy did not reveal perforation.
Unknown.
8
Removal of uterine myomas. Uterine perforation.
Unknown.
9
Resection of submucosal myoma. Uterine perforation.
Probing base of myoma, device not activated.
Immediate diagnostic laparoscopy to repair of blunt serosal bowel injury. Immediate diagnostic laparoscopy to repair of bowel injury. Discharged to home immediately after surgery. Readmitted on POD 1. Diagnostic laparoscopy to repair of bowel injury. Discharged to home immediately after surgery. Readmitted on POD x. Intubation, ICU, sepsis. Unknown management of bowel perforation. Discharged to home immediately after surgery. Readmitted on POD x. Diagnostic laparoscopy to small bowel perforation diagnosis and repair. Temporary colostomy. Discharged to home immediately after surgery. Readmitted on POD 1. Small bowel resection performed. Discharged to home immediately after surgery. Readmitted on POD x. Unknown procedure to small bowel perforation diagnosis and repair. Temporary colostomy. Intubation, ICU, sepsis. Unknown procedure to diagnosis of intraabdominal abscesses 1 small bowel perforation. Unknown management. Exploratory laparotomy to small bowel perforation. Hysterectomy. Unknown management of small bowel.
Resection of submucosal myoma. Uterine perforation. Resection of uterine tissue. Uterine perforation. Myomectomy. Uterine perforation.
Unknown.
MyoSure 1 2 3
TRUCLEAR 1 2 3
ICU 5 intensive care unit; POD 5 postoperative day.
Unknown. Unknown.
Immediate diagnostic laparoscopy to small bowel injury diagnosis and repair. Immediate diagnostic laparoscopy to repair of blunt serosal bowel injury. Immediate diagnostic laparoscopy to small bowel injury diagnosis and repair.
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Even with government legislation requiring the reporting of complications, these events likely continue to be widely underreported. The information offered to the MAUDE database is often missing relevant data. Details such as the experience of the operating physician, an explanation of exactly how or where the complication occurred, and specific details about management of severe complications are often omitted. Our complication rate estimates are subject to limitations of both voluntary adverse event reporting and use of number of devices sold as a surrogate for total number of procedures performed. Despite these drawbacks, evaluation of the MAUDE database is helpful by bringing awareness of the estimated risk of various complications to healthcare providers. Knowing the types of complications that are most likely to occur during hysteroscopic morcellation enables appropriate counseling and consent of the patient. It also enables manufacturers to focus on patient safety initiatives. Many advantages of hysteroscopic morcellation have been discussed in recent literature, such as decreased operative time, possible lower recurrence of endometrial polyps, and less pain [7,8]. van Dongen et al [7] conducted a randomized controlled trial (RCT) to compare conventional resectoscopy and hysteroscopic morcellation among residents in training. In that study, a substantial reduction in operating room time was demonstrated when removing polyps and types I and II submucosal myomas. Polyps were removed with a 72% reduction in operating room time with use of a morcellator as compared with a resectoscope (8.7 vs 30.9 minutes), whereas types 0 and 1 myomas were removed in 61% less time (16.4 vs 42.2 minutes). Subjective surgeon and trainer visual analog scale scores for convenience of technique favored the morcellator [7]. AlHilli et al [8] compared the long-term outcomes of intrauterine morcellation of endometrial polyps via traditional hysteroscopic resection using electrocautery in an RCT of 311 women [8]. It was concluded that the recurrence rate of endometrial polyps was not statistically significant between the intrauterine morcellation and resectoscopy groups (hazard ratio, 3.3; 95% confidence interval, 0.94–11.49; p 5 .06), and there was no difference in the incidence of recurrent abnormal uterine bleeding (hazard ratio for hysteroscopic resection vs intrauterine morcellation, 1.12; 95% confidence interval, 0.64–1.98; p 5 .59) [8]. Another RCT, by Smith et al [9], included 121 women randomly allocated to undergo polyp removal via hysteroscopic morcellation performed as an outpatient office procedure compared with electrosurgical resection. It was suggested that compared with traditional electrosurgical resection for the removal of endometrial polyps, hysteroscopic morcellation is quicker to perform (5.5 vs 10.2 minutes), more successful for completing polyp removal (98% vs 83%), less painful, and more acceptable to women. Adverse events occurred 1 of 62 hysteroscopic morcellation procedures (2%) and 6 of 59 electrosurgical resection proce-
Journal of Minimally Invasive Gynecology, Vol 22, No 1, January 2015
dures (10%) (p 5 .08) [9]. The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur with traditional resectoscopy. Hysteroscopic morcellation has been reported as an effective and safe new technique to remove intrauterine lesions [3,6], but maintains the risk of severe adverse events. Preventing hysteroscopy complications begins by raising awareness of risks and precautions. The present study concludes that life-threatening complications such as fluid overload, uterine perforation, and bleeding cannot be eliminated completely with any type of hysteroscopic procedure, although they seem to occur less frequently with use of intrauterine morcellation devices compared with electrocautery resection. The primary limitations of the present study are that the adverse events reported to the MAUDE database were underreported and lacked relevant details, the number of procedures performed was estimated, and the complication rates for intrauterine morcellation and hysteroscopic resection were not matched. Intrauterine morcellation was designed to remove superficial types I and II intrauterine myomas. Hysteroscopic resection can be used to remove myomas embedded deeper in the myometrium, making it intrinsically more prone to complications. A further study must be done to match complication rates for intrauterine morcellation and hysteroscopic resection on the basis of size and type of myoma.
References 1. Darwish AM, Hassan ZZ, Attia AM, Abdelraheem SS, Ahmed YM. Biological effects of distension media in bipolar versus monopolar resectoscopic myomectomy: a randomized trail. J Obstet Gynaecol Res. 2010; 36:810–817. 2. Jansen FW, Vredevoogd CB, van Ulzen K, Hermans J, Trimbos JB, Trimbos-Kemper TC. Complications of hysteroscopy: a prospective, multicenter study. Obstet Gynecol. 2000;96:266–270. 3. Emanuel MH, Wamsteker K. The intrauterine morcellator: a new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol. 2005;12:62–66. 4. Garcia A. Update on minimally invasive surgery. OBG Manage. 2011; 23:39–48. 5. Cohen S, Greenberg JA. Hysteroscopic morcellation for treating intrauterine pathology. Rev Obstet Gynecol. 2011;4:73–80. 6. Hamerlynck TW, Dietz V, Schoot BC. Clinical implementation of the hysteroscopic morcellator for removal of intrauterine myomas and polyps: a retrospective descriptive study. Gynecol Surg. 2011;8:193–196. 7. van Dongen H, Emanuel MH, Wolterbeek R, Trimbos JB, Jansen FW. Hysteroscopic morcellator for removal of intrauterine polyps and myomas: a randomized controlled pilot study among residents in training. J Minim Invasive Gynecol. 2008;15:466–471. 8. AlHilli MM, Nixon KE, Hopkins MR, Weaver AL, LaughlinTommaso SK, Famiuyide AO. Long-term outcomes after intrauterine morcellation vs hysteroscopic resection of endometrial polyps. J Minim Invasive Gynecol. 2013;20:215–221. 9. Smith PP, Middleton LJ, Connor M, Clark TJ. Hysteroscopic morcellation compared with electrical resection of endometrial polyps: a randomized controlled trial. Obstet Gynecol. 2014;123:745–751.