Laparoscopic dual-port contained power morcellation: An offered solution

Minimally invasive surgery utilizing laparoscopy for hysterectomy and myomectomy has become more common in women with gynecologic pathology. The benefits of this approach compared with laparotomy include decreased hospital stay, shorter recovery and, in experienced hands, significantly decreased morbidity.^1–3

Approximately 600,000 hysterectomies are performed annually in the United States—30% of which are performed laparoscopically.⁴ The primary indication for surgical intervention is uterine leiomyoma. This pathology accounts for 40% of procedures.⁵ During these surgeries, electromechanical morcellation (EMM), or open “power” morcellation, is commonly used to cut large tissue specimens into small pieces for removal and thereby avoid a larger incision. Concerns have been raised regarding the use of open power morcellation because of the risk of spreading an unrecognized malignancy.

Based on case reports and retrospective studies, the FDA issued a statement in April of this year discouraging the use of EMM for hysterectomy and myomectomy in women with uterine fibroids.⁶ The concern for inadvertent spread of an occult malignancy was the reasoning for the communication. Since that time, the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee held a public meeting in which the panel heard comments from patients, societies, and industry regarding their positions on the safety of laparoscopic power morcellation. The panel made several recommendations to the FDA but, at the time of this writing, the FDA has yet to issue a final decision.

Reaction to FDA’s action/inaction
The FDA’s “safety” communication was in response to the concern of a few who experienced a bad outcome believed to be secondary to open power morcellation of enlarged uteri or fibroid tumors. In its statement, the FDA estimated the risk of an occult sarcoma to be about 1 in 350 and stated that the risk of disseminating a sarcoma with morcellation is substantial. The FDA discouraged the use of the power morcellator during hysterectomy or myomectomy for uterine fibroids.

Many organizations, including the Society of Gynecologic Oncology, The American Association of Gynecologic Laparoscopists (AAGL), and the American College of Obstetricians and Gynecologists, issued less stringent statements regarding this technology.^7–9 These organizations stated generally that there were too few data to make a statement at that time, advocated the collection of more data, and encouraged detailed informed consent to be given to patients undergoing these procedures.

However, the FDA’s statement, and lack of a timely follow-up to clarify the role of the laparoscopic power morcellator in gynecologic surgery, has effectively stopped the use of this technology in its current form. In fact, in response to the statement, Ethicon Endosurgery has discontinued the distribution and sales of its power morcellator and many institutions have severely or completely restricted the use of this technology. The reason for these restrictions is that the medicolegal consequences of an adverse outcome would be very difficult to defend given the current, albeit premature, recommendations of the FDA. This statement makes it difficult to defend any adverse outcome that may occur in association with the use of the laparoscopic power morcellator. Furthermore, this statement by the FDA has largely prevented the medical community at large from collecting additional useful information to allow for a data-driven determination.

Power morcellation is not without risks. In fact, we outline them in this article. However, we believe that minimally invasive surgery should be allowed to continue to advance. In that vein, here we describe a technique of dual-port contained EMM. This surgical approach is performed under direct visualization—which solves the problem of poor visualization that hinders other contained EMM techniques.

Risks of power morcellation
The potential for inadvertent spread of occult malignancy is not the only risk of open EMM. Reports of disseminated leiomyomatosis, adenomyosis, and endometriosis also have been described from inadvertent tissue dispersion during open EMM with resulting ectopic reperitonealization.^10–12

The procedure itself is not without risks. A recent systematic review documented 55 major and minor complications from EMM.¹³ Multiple organ systems were injured including bowel, urinary, vascular, and others, resulting in six deaths from these complications. The investigators concluded that “laparoscopic morcellator–related injuries continue to increase and short- and long-term complications are emerging in both the medical literature and device-related databases. Surgeon inexperience is descriptively identified as one of the most common contributing factors.”

All of the above risks must be weighed against the known benefits of laparoscopic surgery and presented to each patient to assist in deciding which route of surgery should be performed.

Tissue extraction options for large specimens
Large specimen extraction options during gynecologic surgery include:

Vaginal coring. Delivery through the vagina or colpotomy during vaginal or laparoscopic hysterectomy uses the technique of coring, which has long been established in our field.