By Molly A. Brewer, DVM, MD, MS

Professor and Chair, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Carole and Ray Neag Comprehensive Cancer Center, University of Connecticut Health Center, Farmington

Dr. Brewer reports that she receives grant/research support from the National Cancer Institute.

SYNOPSIS: Widespread concern over malignant tumor dissemination with morcellation threatens to undermine advances in minimally invasive gynecologic surgery that have benefited women. Before providers abandon this technique, they should put the risks and benefits in perspective.

Over the last 3 decades, rapid advances in laparoscopic techniques have revolutionized gynecologic surgery, leading to a reduction in surgical morbidity and improved postoperative quality of life. In a 2009 review, Nieboer et al concluded that laparoscopic hysterectomy was preferable to abdominal hysterectomy because the return to work was quicker, the blood loss was less, the hospital stay was shorter, and the rate of wound infections was lower.1 A retrospective cohort study using data from the American College of Surgeons National Surgical Quality Improvement Program compared venous thromboembolism (VTE) events for minimally invasive surgery (MIS) for hysterectomy to an open approach when the hysterectomy was being done for benign indications. This study included 20% vaginal hysterectomies and 51% laparoscopic hysterectomies. There was no difference in VTE rates between the two approaches, so they were combined as MIS and compared to the hysterectomies done with a laparotomy incision. This study found that open hysterectomy was an independent risk factor for VTE with an odds ratio of 2.45 (95% confidence interval, 1.77-3.40) compared to an MIS hysterectomy.2

The most common reason for hysterectomy in the United States remains a fibroid uterus. As gynecologists have adopted MIS techniques, they have increasingly offered laparoscopic myomectomy as well as supracervical or total laparoscopic hysterectomy to women with large fibroid uteri. However, surgeons were met with the challenge of removing a large fibroid uterus from the pelvis using an MIS approach, which required a mini-laparotomy incision to remove either a large fibroid or a large uterus. Morcellation, which is cutting tissue into pieces so it can be removed through a smaller incision, was developed to address these limitations. The technique has greatly expanded the ability to do gynecologic procedures with MIS. The first morcellations were done by introducing a scalpel through an incision to cut the uterus into small parts. In 1993, power morcellation was developed to chop up tissue with greater efficiency, allowing the uterus to be extracted through a laparoscopic port site, thus eliminating the need for a larger incision.

In 2013, a 38-year-old physician received the unexpected postoperative diagnosis of leiomyosarcoma (LMS), a high-grade and very aggressive stromal malignancy, following total laparoscopic hysterectomy with morcellation for the treatment of her presumed fibroid uterus.3 She subsequently sued her surgeon and the manufacturer of the morcellator claiming that her cancer was upstaged to Stage IV due to the power morcellation of her uterus, which contained an undiagnosed malignancy. She has been a vocal advocate of removing power morcellation from surgical options, and in response to her advocacy, an FDA statement published in April 2014 stated “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”4 In November 2014, the FDA issued additional warnings stating “While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood. Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”5

Although the claim is certainly plausible that morcellation may upstage a malignancy, there are little data on the effect of morcellation on upstaging, recurrence, or survival. LMS is a rare cancer and nearly always diagnosed either on frozen section or on permanent pathology because preoperative evaluation through imaging (MRI) or endometrial biopsy is not reliable.6,7 The incidence of uterine sarcoma is extremely low, with < 1% of hysterectomy specimens found to have a sarcoma. Uterine sarcomas consist of LMS, an extremely aggressive but rare malignancy; endometrial stromal sarcoma (ESS), a rare and less aggressive malignancy; and STUMP tumors (smooth muscle tumors of uncertain malignant potential), a rarer and less-aggressive sarcoma. One study found a 0.09% risk of sarcoma in a case series of 1091 patients,8 including ESS, STUMP tumors, and LMS. The most aggressive and the most worrisome of these is LMS. This study showed that 57% of the LMS recurred as disseminated disease and the majority of these patients died of their disease. More recent articles have attempted to quantitate the risk of malignancy among women undergoing surgery for fibroid uteri. Bojar et al evaluated 10,731 women who underwent laparoscopic supracervical hysterectomy; the rate of ESS was 0.04%, LMS was 0.02%, and endometrial cancer was 0.07%, supporting the contention that malignant conditions of the uterus not diagnosed prior to surgery are extremely rare.9 Liu et al evaluated two studies of survival in Stages I/II LMS10 and survival was 51-75% for Stage I and 25-60% for Stage II LMS, which is similar to the recurrence of 57% noted with morcellation.8 Given that most patients who recur do not survive their cancer, these data suggest that morcellation may only slightly increase the recurrence risk of LMS. The two studies also noted that there was a 0.2-0.8% (2/1000) risk of uterine sarcoma in patients who were not suspected of having a sarcoma.11,12 The survival for STUMP tumors and ESS is much higher than LMS, with one study of ESS showing an 89% 5-year survival for Stages I/II12 and another showing an 84% 5-year survival for Stage I and a 62% 5-year survival for Stage II.13 Another study found no difference in overall survival with morcellation vs no morcellation for Stage I LMS after adjustment for mitotic rate in the tumors,14 suggesting that the biology of the cancer rather than the mode of surgical removal is the most important prognostic factor in uterine sarcoma.

Liu et al also evaluated the potential cost differential, assuming surgery would have been performed open if morcellation were not available.10 There are approximately 600,000 hysterectomies done each year.9 In 2008, 10% of the cases were done laparoscopically and 15% of these laparoscopic cases involved morcellation. If morcellation were not available, the laparotomy rate could have increased by 15%. In real terms, this would mean an open procedure for 9000 additional women, 99,000 more days absent from work, $13.5 million more in health care spending/year, and at least 54 more VTE (0.6% greater risk of VTE).2 This would translate to even more in 2014, given the dramatic rise of MIS for hysterectomies and myomectomies.

The American College of Obstetricians and Gynecologists (ACOG) issued a statement in response to these warnings stating “We continue to believe that power morcellation has a role in gynecologic surgery. Power morcellation can make it possible for some women to undergo less-invasive laparoscopic hysterectomy or myomectomy, sparing them the longer recovery time and higher mortality rates associated with a total abdominal procedure. The FDA’s clarification of contraindications for morcellation will help to ensure that only women at low risk for an occult malignancy will undergo laparoscopic hysterectomy or myomectomy with morcellation. However, we look forward to working with the FDA to provide additional clarification regarding certain language within the contraindications that could be confusing to patients and physicians.”15 The Society of Gynecolgic Oncology (SGO) issued the following statement: “The SGO asserts that morcellation is generally contraindicated in the presence of documented or highly suspected malignancy. Women being considered for minimally invasive surgery performed by laparoscopic or robotic techniques that might require morcellation should first be evaluated for coexisting uterine or cervical malignancy. Morcellation may also be inadvisable for women with premalignant conditions or who are undergoing cancer risk-reducing surgery, in which there is some risk of occult malignancy. Thus, the SGO does advise caution when using any morcellation technique. But the SGO is not supportive of any overt restriction of power morcellation. As surgical tools, power morcellators allow thousands of women the opportunity to have minimally invasive surgery.”16

COMMENTARY

So given the medico-legal climate of morcellation, what are the surgical options? I believe continuing to do minimally invasive surgery will promote better health in women. MIS includes total vaginal hysterectomy, which is an excellent option with lower cost and equivalent morbidity to laparoscopic surgery. Other options include doing the surgery laparoscopically and making a mini-laparotomy to remove the uterus or the myoma. There is interest in developing a bag to contain the uterus or the myoma and then morcellating it confined to a bag. Given that both ACOG and SGO promote the ongoing use of morcellation due to the advantages of MIS, it is clear that we need to continue to strive for minimally invasive surgery for low-risk women and should not radically change our surgical approach. Can we afford to abandon a technology that saves money and reduces morbidity? We have become a risk averse society when it comes to medical care. As a result, on May 5, 2015, Highmark Insurance stopped covering morcellation, followed by Aetna the next week, confirming that power morcellation in its current state will not continue to be a surgical option for some women. This is even more disappointing given the recent decision analysis by Siedhoff et al who found that women undergoing laparoscopic hysterectomy with morcellation for presumed fibroids had a lower overall mortality than those undergoing abdominal hysterectomy (98 vs 103/100,000).17

Medicine is an imperfect science. In the quest to seek perfection and avoid risk at all costs, we have abandoned a valuable and useful procedure. However, this may be an opportunity to enhance our vaginal surgical skills and/or continue to do MIS but remove the specimen through a mini-laparotomy. Currently, there are no data that a mini-laparotomy carries the same risks as an open laparotomy. In addition, if a bag can be developed that eradicates the potential spread of tissue, then morcellation may return to our surgical armamentarium.

References

  1. Nieboer TE, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev 2009;(3):CD003677.
  2. 2Barber EL, et al. Risk of venous thromboembolism in abdominal versus minimally invasive hysterectomy for benign conditions. Am J Obstet Gynecol 2015;212:609.e1-7.
  3. Levitz J. Fibroid Surgery Puts Doctor Fighting Cancer Diagnosis in the Spotlight. The Wall Street Journal. December 19, 2013. Available at: http://online.wsj.com/news/articles/SB10001424052702304866904579266714199128946. Accessed Aug. 27, 2015.
  4. FDA. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. April 17, 2014. Available at: http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm. Accessed Aug. 27, 2015.
  5. FDA. Updated Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm. Accessed Aug. 27, 2015.
  6. Samuel A, et al. Avoiding treatment of leiomyosarcomas: The role of magnetic resonance in focused ultrasound surgery. Fertil Steril 2008;90:850.e9-12.
  7. Sagae S, et al. Preoperative diagnosis and treatment results in 106 patients with uterine sarcoma in Hokkaido, Japan. Oncology 2004;67:33-39.
  8. Seidman MA, et al. Peritoneal dissemination complicating morcellation of uterine mesenchymal neoplasms. PLOS One 2012;7:e50058. doi:10.1371/journal.pone.0050058.
  9. Bojahr B, et al. Malignancy rate of 10,731 uteri morcellated during laparoscopic supracervical hysterectomy (LASH). Arch Gynecol Obstet 2015;292:665-672.
  10. Liu FW, et al. A critical assessment of morcellation and its impact on gynecologic surgery and the limitations of the existing literature. Am J Obstet Gynecol 2015;212:717-724.
  11. Kapp DS, et al. Prognostic factors and survival in 1396 patients with uterine leiomyosarcomas: Emphasis on impact of lymphadenectomy and oophorectomy. Cancer 2008;112:820-830.
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  15. American College of Obstetricians and Gynecologists. Power Morcellation and Occult Malignancy in Gynecologic Surgery. May 2014. Available at: www.acog.org/Resources-And-Publications/Task-Force-and-Work-Group-Reports/Power-Morcellation-and-Occult-Malignancy-in-Gynecologic-Surgery. Accessed Aug. 27, 2015.
  16. Statement of the Society of Gynecologic Oncology to the FDA’s Obstetrics and Gynecology Medical Devices Advisory Committee Concerning Safety of Laparoscopic Power Morcellation, July 10-11, 2014. Available at: https://www.sgo.org/wp-content/uploads/2014/04/SGO-Testimony-to-FDA-on-Power-Morcellation-FINAL.pdf. Accessed August 27, 2015.
  17. Siedhoff MT, et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: A decision analysis. Am J Obstet Gynecol 2015;212:591.e1-8.