FDA Information on Power Morcellators Used
In Hysterectomy and Myomectomy
In gynecologic surgery, power morcellation is sometimes used during hysterectomy and myomectomy (fibroid tumor removal) to facilitate the removal of the uterus, fibroids (leiomyomas) and/or fallopian tubes and ovaries. It is a well-established as a minimally invasive surgical technique that reduces risk of intraoperative and postoperative morbidity and mortality. Without power morcellation, some patients may be ineligible for minimally invasive surgery and would be only eligible for an abdominal incision which carries higher risks of infection, bleeding, hernia formation and other morbidities. Mortality occurs at 3x the rate in open gynecologic surgery as with minimally invasive techniques. Power morcellation continues to be an option for some patients when performing hysterectomy or myomectomy. At the same time, it is critical to minimize the risks for patients undergoing these surgeries who may have occult gynecologic cancer.
Power morcellators use rapidly rotating blades or electrical energy within a tube, through which tissue is extracted. During morcellation, small fragments of tissue may be inadvertently disseminated
Power morcellation has come under recent scrutiny because of concern about the risk of intraperitoneal dissemination of malignant tissue, particularly uterine sarcoma. Various sources cite estimates of occult sarcomas from 2:1,000 to 1:350 cases. The overall incidence of uterine sarcomas is 0.64 per 100,000 women. With morcellation and dissemination, the 5 year survival rate is 15%; even without morcellation, a diagnosis of uterine sarcoma has a poor 5 year survival rate of 40%.
As with all procedures, a thorough patient evaluation is crucial and may include appropriate measures to diagnose a malignancy before surgery. Tests may include cervical cytology, endometrial sampling, and pelvic imaging. Other preoperative considerations may include age >35 years, menopausal status, uterine size, rapid uterine growth, or certain treatments or hereditary conditions. Although preoperative evaluation may improve detection of cancer, it has limitations and does not eliminate the possibility of an occult cancer, particularly sarcomas, if sarcoma is suspected or there is a known malignancy, power morcellation should not be used. Even screening for cervical or endometrial cancers may not be 100% detectable with morcellation.
Alternative treatment options to power morcellation may include manual extra peritoneal tissue morcellation which has been safely practiced for decades during both vaginal and open or mini-laparotomy cases and no definitive studies have shown dissemination of malignant tissue intraperitoneally. Although bags are in development to reduce dissemination risk during power morcellation, they have their limitations.
All inpatient surgical procedures are performed at St. Luke’s Hospital or St. Vincent Medical Center unless your insurance requires you go elsewhere. A surgical consent must be signed in the office prior to having your procedure scheduled.
You may stay in hospital for 1 night or longer. Or, you may go home the same day. The length of stay depends on the nature of your surgery. You will have an intravenous line to provide fluids, and a urinary catheter to drain your bladder. Drains may be present to help drain fluid from your incision. Medication to relieve pain and nausea will be available throughout your hospital stay.
After surgery, give yourself a chance to adjust and recover. Some women feel fine within a month. Many need a little extra time. Morcellation can have both physical and emotional effects that may be brief or long term. After morcellation, periods will stop with hysterectomy and reduce with myomectomy. A depressive emotional reaction to loss of the uterus, and remorse about permanent sterility is not uncommon or abnormal. Please discuss any concerns with your health care provider if persistent. Sexual response may change after hysterectomy. If pain and bleeding have been a problem, you may feel better and have more energy as your body heals. Once you have fully recovered, you can focus on enjoying your life.