Fig. 8.1
Power morcellation device . The toothed grasper is used to deliver the tissue to be morcellated to the rotating cylindrical blade housed by the external beveled sheath
Prior to the adoption of power morcellation, more than 80% of gynecologic surgeons reported significant hand fatigue and even carpal tunnel syndrome associated with hand morcellation, with increasing severity correlating with greater caseloads [1]. Power morcellation was first introduced by Steiner in 1993 [2] and approved by the US Food and Drug Administration (FDA ) in 1995. The technology greatly improved the capacity to morcellate large tissues, such as the uterus or prostate, which previously required open surgery, made minimally invasive surgical techniques practical for a larger number of women, particularly obese patients, and reduced surgeon strain and injury. Such perceived benefits led to the rapid adoption of laparoscopic hysterectomy with power morcellation as the most common procedure performed for uterine fibroids .
Power Morcellation and the FDA
In April of 2014, however, the FDA issued a safety communication [3] discouraging the use of power morcellators due to the risk of potential upstaging of uterine sarcoma in undiagnosed patients. The report was prompted by the case of a Boston anesthesiologist who underwent laparoscopic hysterectomy with morcellation for presumed fibroids in 2013. Pathologic review revealed uterine leiomyosarcoma (ULMS ). At re-intervention, the sarcoma was found to have spread in the abdominal cavity, and she required aggressive treatment for this advanced stage cancer. Attributing her poor outcome to the use of morcellation during her surgery, she and her husband, a cardiothoracic surgeon, then called for an “immediate moratorium on intracorporeal morcellation during minimally invasive hysterectomy” in an open letter to President Barrack Obama, Senator Elizabeth Warren of Massachusetts, the FDA Commissioner, and the leadership of multiple professional medical organizations. Interestingly, they gave special mention to robotic-assisted surgery, criticizing Intuitive Surgical, Inc., for the absence of a “readily available warning label advising against its use to morcellate tumors with malignant potential inside the body” [4] despite concessions that the da Vinci robot is not itself a “morcellator.” This petition prompted a review of power morcellation by the FDA. In their meta-analysis of 18 studies, the FDA reported a risk of 0.28% and 0.2% for undiagnosed uterine sarcoma (any histology) and ULMS , respectively, in patients with presumed fibroids. Explaining that this risk was higher than previously estimated, the “FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids ” [3]. In November 2014, the FDA warning was upgraded to a black-box warning stating that morcellation was contraindicated in perimenopausal or postmenopausal women and in any “candidates for en-bloc tissue removal” [5], which could be literally interpreted to include all women.
While not specifically calling for a ban of power morcellators, this announcement spawned a heated debate throughout the medical and lay community. The news media has fanned the flames of public fear over the use of power morcellation with features such as “When Hysterectomy is a Death Sentence” (USA Today, February 2014), “A Surgical Procedure’s Risks, Unmentioned” (New York Times, March 2014), and “Deadly Medicine: A Common Surgery for Women and the Cancer It Leaves Behind” (Wall Street Journal, September 2014). Overall, several themes emerged from the reporting on this issue in the popular press, including the impressions that the risk of dying from cancer is high when power morcellation is used, that morcellation is directly responsible for the spread of cancer , that patient outcomes would be better if other surgical techniques are used, and that device manufacturers, hospitals, and doctors were aware of this risk and sought to cover it up.
This portrayal of the debate has resulted in a powerful community backlash. Hundreds of lawsuits against physicians and device manufacturers are pending trial in state and federal courts. The Federal Bureau of Investigation is reportedly investigating power morcellators and whether manufacturers were aware of the risk of cancer spread. Many hospitals and hospital systems across the country have halted or limited the use of power morcellation. Some insurers have stopped covering the procedure, while others, like UnitedHealth Group Inc., the nation’s largest health insurer, have begun to require prior authorizations. Johnson & Johnson, the parent company of Ethicon, Inc., manufacturer of the Gynecare Morcellex power morcellator, pulled the device from the market in July 2014. All of these restrictions have caused the vast majority of gynecologic surgeons to change their method of fibroid removal after the FDA report. One study reported that 84% of surgeons had switched methods of fibroid removal after the FDA warning from laparoscopic surgery with morcellation to mini-laparotomy [6].
The medical community overall has been frustrated by the drastic change induced by this public outcry. A recent commentary by Lisa Rosenbaum in the New England Journal of Medicine expressed this sentiment well, stating that “our capacity to speak science to emotion seems to be collapsing” [7]. Statements from gynecologists have echoed again and again the lack of solid scientific evidence to support a ban on the use of power morcellation, reiterating that minimally invasive surgery and morcellation have benefitted hundreds of thousands of women, and it would be a “disservice to deny these women this option” [8]. Statements from multiple professional societies have stressed the importance of informed consent in shared decision making for the treatment of presumed benign fibroids . While the FDA cannot control the quality of the data available, they have been harshly criticized for the choice of data included in their meta-analysis. The FDA report did not address conflicting data from multiple meta-analyses documenting cancer incidences more than an order of magnitude lower than that documented in the warning [9]. In addition, the exclusion of studies in which no cancer was diagnosed and the inclusion of cases in which morcellation should probably not have been offered may have drastically overestimated the cancer risk [10, 11]. The American Association of Gynecologic Laparoscopists’ Tissue Extraction Task Force [12] emphasized that the studies examined by the FDA were not stratified by risk factors for sarcoma and did not reflect data for reproductive-age women. The reports were retrospective, representing data from referral centers or single institutions , spanned several decades with various histopathologic criteria, and even included women with preoperative diagnoses of sarcoma. A Position Statement from the Society of Gynecologic Oncology [13] echoes these points and recognizes that ULMS and endometrial stromal sarcomas, for which there are no reliable methods to differentiate from fibroids, have a very poor prognosis even when removed intact.
While many practitione rs believe that there is a tremendous benefit in continuing to allow morcellation to be used in appropriately selected patients, the choice to do so is disappearing. While there is no denying that individuals with occult aggressive malignancies have suffered greatly from their disease, it is our responsibility to evaluate the data behind the claims in the FDA warning and determine if the conclusions are well-founded and benefit our patients and society.
“Many women choose to undergo laparoscopic hysterectomy or myomectomy because these procedures are associated with benefits such as a shorter post-operative recovery time and a reduced risk of infection compared to abdominal hysterectomy and myomectomy.” [3]
Overall, there are significant benefits to patients who undergo minimally invasive surgeries compared to open techniques [14]. Patients have smaller incisions, less post-operative pain, and shorter hospital stays [15]. In the case of hysterectomy, these benefits are even more pronounced with the assistance of the operative robot [16]. In addition to improved recovery for patients, there are fewer complications , such as wound infections, bleeding requiring transfusion, deep vein thrombosis, nerve injury, and genitourinary and gastrointestinal tract injuries [17], many of which will require readmission and reoperation. Patients undergoing open abdominal hysterectomy have a threefold greater risk of mortality than those who undergo laparoscopic hysterectomy [18].
While generally associated with improved patient outcomes, there are complications unique to the use of power morcellation devices. Direct injuries to the bowel and large vessels, while uncommon, can occur. A review of the Manufacturer and User Facility Device Experience (MAUDE) database in 2014 revealed 66 reports of direct injuries, six of which were fatal [19]. These included injuries to the small and large bowel (31/66), large blood vessels (27/66), kidney (3/66), ureter (3/66), bladder (1/66), and diaphragm (1/66). Given the millions of procedures performed, these injury rates remain very low.
An additional concern with intracorporeal morcellation of any type is the development of parasitic fibroids or iatrogenic endometriosis , which can require repeat surgical treatment. Small chips or tissue fragments released from the specimen during morcellation can implant on the peritoneum and grow to cause symptoms such as pain, gastrointestinal or ureteral obstruction, or local organ dysfunction by exerting a mass effect [20, 21]. Even if asymptomatic, identification of an unknown abdominal mass frequently necessitates additional workup and surgical removal. The risk of such masses developing after uterine fibroid removal appears to increase significantly with the use of morcellation, with an overall incidence of 0.12–0.9% [22–24]. Exposure to gonadal steroid hormones increases this risk, with both premenopausal status and hormone replacement therapy promoting parasitic fibroid development and growth.
The most concerning of the complications attributed to morcellation, however, is the risk that an unrecognized malignancy could be spread in the abdomen and pelvis, leading to poor oncologic outcomes. This is the focus of the FDA safety warning and the main target of activism opposing the use of power morcellation.
“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 long-term survival.” [3]
Obviously, the disruption of a tumor through morcellation is contrary to central oncologic principles. Histologically, the destruction of specimen architecture abolishes many of the anatomic features that allow a meaningful gross description, such as its dimensions, orientation, adjacency, borders, and margins [25]. As these specimens are often quite large, loss of these characteristics could affect the selection of parts of the tumor for histology that could be suspicious for malignancy, leading to a delayed or missed diagnosis [26, 27]. Even if a focus of cancer is discovered, tissue separation may prevent adequate determination of margins or adjacent spread, leading to suboptimal staging and over- or under-treatment.
The heart of this debate, however, is the question of whether morcellation specifically, particularly power morcellation, results in the upstaging of malignant disease by directly spreading cancerous tissue in the surgical field or not. The significance of upstaging is particularly important for ULMS, as the 5-year survival for stage IV cancer s is very low (16–18%) in comparison to that for stage I cancers (57–95%) [28].
Multiple case reports have reiterated the risk of intraperitoneal seeding of sarcomatous tissue not seen at the initial surgery of laparoscopic myomectomy or hysterectomy using power morcellation [29, 30], which has been corroborated by larger case series that give overall upstaging rates of 15–64% [31–34]. In one such analysis at multiple institutions in Boston, eight cases of ULMS inadvertently morcellated during surgery for presumed fibroids underwent restaging procedures. Of these, three (37.5%) were upstaged. Of the five that were not upstaged, all were alive without disease more than 2 years later. Of the three that were upstaged, two died and the third was alive with signs of disease [33]. In the most widely cited study addressing ULMS upstaging risk [34], the authors retrospectively reviewed 1,091 cases of uterine morcellation. Seven cases of ULMS were identified, only one of which was initially treated at the study institution. This case did not demonstrate any dissemination at restaging surgery . The remaining six represented referrals from other institutions after various intervals, four of whom had visible reseeding at restaging surgery. Three of these patients died, two of whom were referred more than one year after their initial surgery, making it unclear if the peritoneal findings represented true dissemination or recurrence of aggressive disease. Both this and the previous study are derived from a single research group, including the same institutions over the same time period. It is unclear if these results are independent or if there is significant overlap of the patients. While this study is frequently cited as demonstrating that 57% (4/7) of ULMS demonstrate dissemination of disease after morcellation, this conclusion is somewhat misleading given the substantial bias of the population involved.
Overall, the data regarding upstaging and the direct dissemination of tumor as a result of morcellation are poor. The majority of studies have very low numbers, and few of these studies have stratified outcomes with regard to the type of morcellation (power vs. hand) or the approach (vaginal vs. laparoscopic ) used. A recent systematic review of the literature by Pritts et al. determined that upstaging at the time of completion surgery occurred for 11/27 (41%) occult ULMS in which morcellation (any type) had been used and for which staging information was available [9]. As only five of these completion surgeries were performed immediately after the initial surgery, the remaining six may represent recurrence, not seeding. As these numbers assume that all 27 patients were stage I at their initial resection, it remains unclear if these numbers overstate the true risk. It is worth noting that, while the review focused on morcellation and cancer outcomes, three of the articles they considered also included a small number of open myomectomies; six ULMS were identified from these operations, resulting in three recurrences and two deaths, a similar rate as that seen after morcellation [35–37]. From the available data, there is no definitive evidence to demonstrate that power morcellation confers worse oncologic outcomes than hand morcellation or even myomectomy [9]. This does not imply that morcellation is completely safe, but only serves to emphasize the fact that better data is needed before policy decisions are made that drastically change practice patterns affecting hundreds of thousands of women each year.
Perhaps, a better question is addressed by the second half of the FDA statement above: is morcellation associated with poorer long-term survival in uterine cancer patients? Multiple studies, all retrospective, have demonstrated worse oncologic outcomes when morcellation is used. A recent systematic review and meta-analysis demonstrated a correlation between uterine morcellation and increased intra-abdominal recurrence and mortality in patients with unsuspected ULMS [38]. Morcellation (any type) increased the overall (62% vs. 39%, Odds Ratio [OR]: 3.16) and intra-abdominal (39% vs. 9%, OR 4.11) recurrence rates as well as overall mortality (48% vs. 29%, OR 2.42). This data is difficult to interpret. Only three of the 11 studies contained in the analysis demonstrated survival differences. This included two studies by Park et al. which examined 106 patients with uterine sarcomas (50 with low-grade endometrial stromal sarcoma and 56 with ULMS) [39, 40] and a single-institution study from Boston detailing the outcomes of 58 patients with ULMS [41]. All three of these studies are limited by their retrospective nature. In addition, as it would be unethical to recommend laparoscopic hysterectomy to a patient with a known sarcoma, it is almost certain that the morcellation and non-morcellation groups represent fundamentally different populations. None of the studies provided a discussion of the type of preoperative workup, risk stratification, reason for referral, or the timing of the referral to provide a sense of the selection bias. While these data are inconclusive, there remains the suggestion that morcellation may worsen outcomes for a subset of patients with occult sarcoma, making the next step to determine the magnitude of this risk in patient s undergoing surgery for presumed fibroids.
“Based on an FDA analysis of currently available data, we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma .” [3]
One of the most challenging knowledge gaps in this debate is the real risk of undiagnosed sarcoma in presumed fibroids. The true prevalence has been difficult to estimate from current studies, ranging over more than an order of magnitude, from 0.45 to 0.014% [11], depending on the methodology of the study. The incidence quoted in the FDA report is derived from the analysis of a large insurance database review that identified 99 cases of uterine cancer (all histologies) in over 200,000 minimally invasive hysterectomies, only 36,000 of which used morcellation [42]. This translates to an incidence of one uterine cancer discovered in every 350 (0.28%) women undergoing minimally invasive hysterectomy for benign indications, not all of which were for fibroids. In addition, this study population was much older than that typically treated for fibroids: 67 of the 99 identified cancers were in patients over 50, so these numbers are likely not representative of the overall population seeking treatment for fibroids.
It is difficult to know what to make of this wide range of estimates. All of these studies lack risk stratification of the populations, frequently with no distinction in the types of uterine cancers, no specification of which cases utilized morcellation, and the outcomes of these cases. In the largest, most comprehensive systematic review addressing this question, Pritts et al. [9] identified 17 studies with outcomes data for patients undergoing hysterectomy or myomectomy for presumed fibroids , excluding in-bag morcellation or bag extraction. This pooled analysis of 29,877 fibroid patients provided a 0.014% rate of occult uterine malignancy. This difference likely results from multiple differences in methodology, among them is the inclusion of prospective studies, which typically describe lower rates of occult cancer. The predominant difference, however, is the restriction of this analysis to patients with presumed fibroids . While differences in methodology make this discrepancy understandable, it also makes clear the importance of asking the right questions when assessing and understanding the real risks to patients.
The vast majority of cases documenting mortality or cancer upstaging after morcellation occurred with ULMS, a disease carrying a poor prognosis even when discovered preemptively. Survival ranges from 15 to 55% depending on the number of mitoses per ten high power fields (hpf); a high-grade cancer with >10 hpf has a 5-year survival of only 15%. When embedded and confined to a uterus that is removed “en bloc,” patients have a better prognosis, increasing the best survival rates up to 83% [36, 43]. ULMS, however, is incredibly rare, with an overall incidence of only 0.64/100,000 women [44]. While ULMS comprises 70% of all uterine sarcomas, these are only 2–7% of all uterine malignancies [43, 45]. Sarcomas typically spread hematogenously or lymphatically, not usually by direct extension, which has led several groups to propose that the poor oncologic outcomes after morcellation may also result from any approach that does not isolate the uterine vasculature before manipulation by enhancing hematogenous spread [9]. This may be supported by documentation of dissemination after open myomectomy [35–37].
The risk of sarcoma in a presumed fibroid in a patient younger than 40 is incredibly rare and is highest in women over 65 [46]. As the majority of fibroid symptoms begin to regress after menopause, the population of postmenopausal women seeking surgical treatment for presumed fibroids is a fundamentally different population than a premenopausal patient with heavy menstrual bleeding or pelvic pressure. Thus, a debate about the risk and benefits of morcellation needs to address population risk stratification and the impact of treatment on already poor disease outcomes.
“While the specific estimate of this risk [of unsuspected sarcoma] may not be known with certainty, the FDA believes that the risk is higher than previously understood.” [3]
The majority of studies detailed above addressed the overall incidence of sarcoma in patients with presumed benign disease. Many surgeons, however, already perform individualized risk assessment , steering the higher risk patients away from morcellation-based procedures. To understand the danger that morcellation truly poses for unsuspecting patients, perhaps the better question to ask is: what is the risk of a patient desiring treatment for presumed fibroids who undergoes unintended morcellation of an undiagnosed ULMS with current practice patterns? In a recent retrospective study, the incidence of ULMS in women referred for treatment of fibroids was 0.54% (1:183), but rate of unintended morcellation was only 0.02% (1:4791). Of the 26 ULMS cases identified, six were diagnosed preoperatively, 14 underwent abdominal hysterectomy for suspicious risk factors, and five underwent laparotomy due to tumor size. Only one tumor was subjected to unintended morcellation in more than a decade [47]. In a retrospective cohort study of 1,004 women undergoing laparoscopic myomectomy or hysterectomy with power morcellation over more than 10 years at two institutions, two endometrial carcinomas, but no cases of ULMS, were identified [48]. In a retrospective cohort of 10,731 patients who underwent laparoscopic supracervical hysterectomy with power morcellation, an overall occult malignancy rate of 0.13% was noted, with individual incidences of 0.04% for endometrial stromal sarcoma, 0.02% (1:5365) for ULMS, and 0.07% for endometrial cancer. At a mean follow-up of 65.6 months, no recurrences were noted in 13/14 patients with malignancy: one of the two patients with occult ULMS died 13 months after surgery from peritoneal carcinomatosis and bone metastases [49].
These data are consistent across studies, but quite different from the numbers quoted in studies examined in the FDA meta-analysis. At the heart of this difference are the fundamentally different populations examined. While 0.28% of women undergoing surgery for presumed fibroid s may have an undiagnosed malignancy, the risk of such a woman undergoing morcellation for her condition appears to be much lower, approximately 0.02% or less. These data are not mutually exclusive, but are answers to completely different questions. When framed in this light, the data support equally well the possibility that a better-defined patient risk assessment would prevent at least some of the cancer morbidity and mortality due to morcellation. So the claims from practitioners that minimally invasive surgery “employing morcellation remains safe when performed by experienced, high-volume surgeons in select patients who have undergone an appropriate preoperative evaluation” [12] appear valid.
“At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.”
Preoperative Identification of Malignancy
While there is no pathognomonic set of features that can accurately rule out an unsuspected ULMS prior to hysterectomy, there are certain features that, if present in aggregate, may caution against the use of morcellation or minimally invasive removal. If there is any suspicion of malignancy, multiple evaluation methods , including assessment of individual patient risk factors, imaging, and laboratory testing, can be used to inform the surgical decision making process before intervention.
As older, postmenopausal women undergoing surgery for presumed fibroids are at higher risk of ULMS, patient age and menopausal status must be central in the evaluation of a patient’s preoperative risk of malignancy [46, 50]. Abnormal uterine bleeding in a postmenopausal woman should definitely prompt an evaluation for a malignant pathology, but the situation is more complex in a woman of childbearing age. Malignancy is more likely to be associated with non-cyclical bleeding, but this can have a myriad of causes in young, reproductive-age women. Given the relative rarity of sarcoma in this population, the pattern of bleeding is non-diagnostic. Women with specific histories of prior treatment for pelvic malignancies , particularly those who previously received tamoxifen or pelvic radiation [51], and those with certain hereditary conditions [52], such as Lynch syndrome or Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) , are at definitive higher risk of occult uterine malignancy and caution should be used in these patients when considering a minimally invasive surgical approach.
Ultrasound and Magnetic Resonance Imaging (MRI) are the most commonly used modalities to assess the uterus prior to hysterectomy. Ultrasound is more commonly used, likely due to its easy availability in the office, but MRI provides better three-dimensional spatial tissue discrimination and sensitivity [53–56]. While there are no diagnostic features for uterine sarcoma on either form of imaging [57, 58], several concerning features may raise suspicion if present. Presumed uterine fibroids containing occult malignancies tended to be larger on average than the average fibroid [59, 60], a feature that lacks clinical utility given the wide range of sizes of benign uterine leiomyomas. A rapid increase in size (within 3 months) can be concerning, but can occur with fibroids as well [61, 62], and there are at least case reports of presumed fibroids stable in size for many years that were found to contain a sarcomatous component [29]. Several reports have suggested that occult malignancies are more common in solitary presumed fibroids, with several studies showing more than 95% of cancers in solitary lesions [59, 63]. While recent studies have corroborated that occult uterine cancer is more common in solitary tumors, these overall rates are likely unrealistic. One recent case series of 15 sarcomas identified only 47% of occult ULMS in solitary lesions [60]. Certain imaging characteristics , such as irregular shape [64], “lacunes” (areas of hypointensity suggesting central necrosis in the absence of calcifications), increased peripheral and central vascularization [57, 59], and mixed echogenic and poorly echogenic regions [65] are associated with an increased risk of malignancy, but may also occur in degenerated fibroids. On MRI, regions of contrast enhancement have been helpful in distinguishing ULMS [66–68]; however, given the prevalence of fibroids, the false positive rate of approximately 15% given in these studies would misclassify tens of thousands of benign masses.
Computed tomography alone is unable to reliably distinguish occult uterine sarcoma from benign leiomyoma [69]. At the moment, there is limited utility for positron emission tomography (PET) with fluorodeoxyglucose (FDG) to assess the risk of occult malignancy. While FDG uptake is related to the presence of malignancy [70], it is also heavily influenced by estrogen status and overall cellularity [71], causing uptake levels to vary widely between tumors [72]. Alphafluorobeta-estradiol (FES) may be more sensitive than FDG in distinguishing LMS from fibroids [73], but further studies will be needed to establish its clinical utility.
There are no peripheral blood markers with any value in screening for occult uterine malignancy, but in patients with other risks factors, hematocrit, CA125, and lactate dehydrogenase (LDH) isoforms may have some limited utility. In a recent retrospective analysis of 15 patients who underwent inadvertent morcellation of ULMS for presumed fibroids in comparison to age-matched controls, a hematocrit less than 30 was independently associated with a diagnosis of ULMS [60]. As anemia is a common feature of women with symptomatic leiomyomas [74], however, hematocrit may provide little additional information to guide clinical judgment. CA125 is elevated in some leiomyosarcomas , especially those that are of advanced stage [75, 76]. While increased, there is significant overlap of these levels with those seen in healthy patients, limiting the clinical utility of this testing. The most promising laboratory testing may be the assessment of total LDH and LDH isozyme type 3 elevation. In a prospective series of 227 patients, ten with ULMS had elevated enzymes, particularly in the relative fraction of isoform type 3, in comparison to patients with degenerated fibroids [68]. While total LDH elevation is quite non-specific, measurement of the combined total and isozyme form provided a good discriminatory test. As the numbers in this study are still small, further studies will be needed to determine the reliability of LDH testing. In each of these laboratory tests, a positive result may add to a growing suspicion of cancer, but without that initial suspicion, laboratory testing provides little added information.
Several groups have also attempted to determine the benefit of histological analysis prior to surgery. While the benefit of endometrial sampling in the identification of endometrial carcinoma is well-described, less is known about any role for this procedure in the preoperative identification of uterine sarcoma. In one large retrospective series of almost 1,000 patients, 142 sarcomas were identified, 72 of which had undergone preoperative endometrial sampling . Sampling identified sarcoma in 62/72 (86%) cases, but the patient selection algorithm was not clear. If we assume that patients with abnormal uterine bleeding or other abnormal evaluation were preselected for screening, it is difficult to extrapolate what the utility of such testing would be in patients without risk factors (presumed uncomplicated fibroid) [77]. Needle biopsy without image guidance is of limited utility given frequent large areas of necrosis that could not distinguish leimomyosarcoma from degenerated fibroid; it is frequently difficult to make such distinctions, even in intact hysterectomy specimens [78, 79]. When performed in conjunction with image guidance, needle biopsy provides a negative predictive value. In a study of 435 patients, all seven patients with occult sarcomas were diagnosed by transcervical biopsy alone with a final sensitivity, specificity, positive, and negative predictive values of 100%, 98.6%, 58%, and 100.0%, respectively [80]. Use of such assessment in all patients, however, would result in high false positive rates, with significant fear, over-treatment, and cost, but might prove to be useful adjunctive testing in selected patients. There is no information on the possible local spread of sarcoma following puncture, however, and given the hematogenous pattern of spread for sarcomas, it is possible that this may outweigh the possible diagnostic benefit.
Prevention of Complications
While the data regarding outcomes is of poor quality, there is sufficient concern raised by many of these studies that morcellation may worsen outcomes for the small number of patients with an occult malignancy. Rather than banning minimally invasive approaches, it is reasonable first to consider what methods might be employed to improve outcomes and prevent the complications associated with morcellation.
While no surgery is completely risk-free, several simple techniques can be employed to minimize direct injury from power morcellation. During entry, enlargement of the skin and fascial incisions to the diameter of the morcellator reduces abdominal wall resistance and the force needed to manipulate the morcellator. The morcellator blade should be locked inside the protecting tube during insertion. Use of a midline trocar site minimizes the risk of ureteral and vessel injury at insertion and during morcellation. Sustaining adequate abdominal distension during morcellation as well as maintaining a constant awareness and direct visualization of close structures, particularly the intestines and blood vessels, decreases the risk of direct injury. It is crucial to keep the tip of the morcellator in sight, which is also facilitated by the use of a morcellator with a nozzle to promote continuous peeling rather than boring of the mass [81].