After the FDA (Food and Drug Administration) safety warning issued on April 17, 2014 where it was discouraged to use the laparoscopic power morcellation for hysterectomy and myomectomy for the treatment of women with uterine fibroids, the AAGL (American Association of Gynecologic Laparoscopists) released a member update on the same topic. It was stated in this update that a task force will be assigned to perform an extensive review on the topic and come up with recommendation.
Also the ESGE (European Society for Gynecological Endoscopy) also published a statement on morcellation. It was noted that the patients should be properly informed about the benefits of minimal invasive procedures. Although the risk of a presumed fibroid being a sarcoma is considered very small, morcellation may upstage a uterine sarcoma confined to the uterus by spreading the sarcoma cells in the abdominal cavity. The FDA has based its standpoint on quotes from an FDA related radiologist. The fear of abandoning power morcellation of fibroids was raised since it seriously affects the minimal invasive approach in surgery for women. The ESGE also convened a committee to prepare a review paper on morcellation of fibroids. The review would include the risks of morcellation in regards to visceral and vascular complications, leiomyosacrcoma incidence and parasitic implantation of fibroids in the abdominal cavity.
On May 06, 2014, the AAGL released the “Morcellation During Uterine Tissue Extraction” Task Force report. The conclusion stated that all existing methods of tissue extraction have benefits and risks, which must be balanced. At this time, the AAGL report does not believe that there is a single method that can protect all patients; therefore, all current methods of tissue extraction should remain available (ie, mechanical morcellation, hysteroscopic extraction, vaginal morcellation or culdotomy). Some of the recommendations published in this report are:
- Morcellation should not be used in the setting of known malignant or pre-malignant conditions, or in risk-reducing surgery.
- Morcellation should only be considered in patients if the appropriate evaluation of the myometrium (with or without fibroids) is reassuring, and appropriate evaluation of the cervix and endometrium is also reassuring.
- For patients in whom preoperative evaluation results in an increased suspicion for malignancy, alternatives to morcellation should be employed, including laparotomy.
- As the risk of malignancy, including undetectable malignancy, is increased in postmenopausal women, alternatives to morcellation should be considered in this patient population.
-When electromechanical morcellation (EMM) is planned or considered likely, the specific risks of encountering an undetected malignancy and the likelihood of worsening the patient’s prognosis should be discussed in a patient-centered manner as part of the informed consent process so that the patient can actively be involved in the decision whether to use EMM. Patient autonomy must be respected.
-The use of morcellation within specimen retrieval pouches for containment of benign or malignant uterine tissue requires significant skill and experience, and the use of specimen retrieval pouches should be investigated further for safety and outcomes in a controlled setting.
The ESGE review paper will be published in the near future and the MESGE will keep its members up to date concerning the morcellation in endoscopic surgery.
For the moment being, the MESGE recommends that patients should be informed about the risks and benefits of tissue morcellation and also about the rarity of the incidence of leiomyosarcoma in the premenopausal age group.
MESGE executive board.