Morcellation Fact Sheet

SITUATION

Minimally Invasive Surgeries (MIS) are being performed at Advocate Health Care hospitals. Nearly half of the estimated 400,000 hysterectomies performed in the United States annually for benign reasons employ these minimally invasive techniques. The most common indication for hysterectomy is uterine leiomyomas, accounting for an estimated 40% of hysterectomies. The use of Morcellation of the uterus or fibroids is one technique commonly employed in these procedures. In the case of an unsuspected underlying malignancy (mainly sarcoma), powered Morcellation has the potential to disseminate an otherwise contained malignancy which may worsen prognosis and decrease survival. In April 2014, the FDA recommended that health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids and to avoid power Morcellation in women with suspected or known uterine cancer3.

BACKGROUND 

Uterine morcellation is a procedure that is performed to reduce the size of a fibroid uterus which enables the surgeon to remove the fibroid or the entire uterus in a minimally invasive manner. In the general population, approximately 0.23% of women undergoing hysterectomy for fibroids will have an underlying leiomyosarcoma. When malignancy is present, the morcellation procedure has the potential to disseminate this throughout the abdominal cavity. The prognosis of patients with uterine leiomyosarcoma is generally poor with 5 year survival rates of about 50-60% in Stage l and about 15% in Stage II-IV disease. Nevertheless, the ability to perform these procedures in a minimally invasive manner has improved outcomes in terms of a more rapid recovery and less post-operative pain and complications, including wound complications and VTE. Although other options to a standard open laparotomy exist including vaginal hysterectomy, mini-laparotomy or performing the morcellation with in a bag, these procedures are not always feasible or acceptable to surgeons given the present technology and patient characteristics. Although presently there is no reliable method to differentiate malignant from benign fibroids prior to removal, there are clinical and epidemiologic criteria which should heighten the suspicion of malignancy Risk factors for uterine sarcoma

Age >45

Black race

Tamoxifen

Pelvic Irradiation

Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC) syndrome

Survivors of childhood retinoblastoma

 

 

ASSESSMENT 

Malignant transformation of leiomyomas is extremely rare, though age and menopausal status may influence the incidence. In one study, the incidence of leiomyosarcoma in women undergoing hysterectomy for presumed fibroids demonstrated a rising incidence from 0.2% (ages 31-40) to 1.7% (ages 61-80)2. Menopausal status (perimenopausal, and particularly postmenopausal women) demonstrated an increased risk of occult malignancy. Uterine size or rapid uterine growth has not been shown to be predictive of leiomyosarcoma. Overall, statistical evaluation of the incidence of uterine sarcoma in morcellation of uterine tissue in the studies is all relatively consistent, with an approximate risk of 2 cases per 1000 women undergoing hysterectomy or myomectomy.

RECOMMENDATION 

An effective surgical procedure for a common gynecologic problem in rare circumstances may lead to increased morbidity and decrease survival related to disseminated cancer. ACOG and AAGL have recommended that physicians should communicate the risks, benefits and alternatives of these procedures prior to planning therapy. Clinical and epidemiologic data exist which may indicate an increased relative risk of this very rare complication when power morcellation is used, particularly in some sub-groups.

 Power morcellation should not be used in women with suspected or known uterine cancer.

 Carefully consider all available treatment options for women with symptomatic uterine fibroids and discuss the benefits and risks of all treatments with patients. Consider risk factors for sarcoma when considering options and recommendations for patients.

 For patients whom morcellation is the recommended therapeutic option:

 Inform patients that their fibroid may contain occult cancer. The overall risk is approximately 2 cases per 1000 women who have surgery for myomectomy or hysterectomy.

 If unknown cancer is present, the use of power morcellation will increase the change of dissemination. It may worsen the patient's prognosis and prevent accurate diagnosis and staging.

 Alternatives to power morcellation should be discussed, including removal of intact tissue through mini-laparotomy, colpotomy incisions, or total abdominal hysterectomy, vaginal hysterectomy, or laparoscopic vaginal hysterectomy.

 For patient undergoing power morcellation in the ambulatory and inpatient settings, 2 consents must be signed and witnessed by the physician:

o General procedure consent

o Consent for power morcellation (see attached)

References:

1. Morcellation During Uterine Tissue Extraction, AAGL May 2014

2. Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas, Leibsohn S, et al,

AM J Obstet Gynecol 1990 Apr; 162(4): 968-74; discussion 974-6

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication, U.S. Food and Drug Administration, Safety Communications, April 2014 www.fda.gov

3. Power Morcellation and Occult Malignancy in Gynecologic Surgery, A Special Report. American College of Obstetricians and Gynecologists, May 2014