The morcellation controversy: What’s next?

June 1, 2014

Institutions around the country have responded to an FDA advisory by discouraging or banning power morcellation of uterine fibroids. Innovative methods of contained morcellation are now called for.

 

 

 

 

 

Dr. Einarsson, Deputy Editor, is Associate Professor of Obstetrics and Gynecology, Harvard Medical School, and Director, Division of Minimally Invasive Gynecologic Surgery, Brigham and Women’s Hospital, Boston, Massachusetts. He holds a patent on an enclosed laparoscopic tissue extractor device and has ownership interest in Lattis Surgical.

 

I would venture to guess that most gynecologists are well aware of the recent developments surrounding laparoscopic morcellation. Things have unfolded rapidly since the December 18th, 2013 coverage by The Wall Street Journal.1

The article was sparked by the case of a physician who underwent a routine laparoscopic hysterectomy for presumed symptomatic uterine fibroids. A preoperative workup did not indicate a suspicion for malignancy, and laparoscopic morcellation was performed for tissue extraction. Unfortunately, pathologic examination revealed an occult leiomyosarcoma.

Significant media coverage followed The Wall Street Journal article and there was a strong call for a change in morcellation practices. On March 28th, 2014, Brigham and Women’s Hospital (BWH) in Boston decided to significantly limit the use of laparoscopic morcellation for patients undergoing surgery for uterine fibroids, encouraging morcellation inside of a containment bag based on pioneering work by Dr. Anthony Shibley, who first introduced this concept 2 years ago.2

On April 17th the FDA issued an advisory discouraging the use of power morcellation during hysterectomy or myomectomy for uterine fibroids. The FDA did not issue a moratorium on the use of power morcellation, but encouraged physicians to seek alternatives. That same afternoon, BWH and Massachusetts General Hospital banned all forms of laparoscopic power morcellation, including “inbag” morcellation.

Institutions in the greater Boston area gradually followed suit, as did a number of other institutions around the country. Nevertheless, several hospitals continued to allow power morcellation.

 

 

It did not take long for industry to respond. On April 28th, Ethicon (a subsidiary of Johnson & Johnson) announced that it would discontinue supplying its morcellator until further notice. At that time, the Ethicon morcellator had approximately 80% market share, so the impact of this decision will have widespread implications.

Other manufacturers have not yet followed Johnson & Johnson’s example, but they are undoubtedly reviewing the situation carefully.

Background

Electromechanical morcellation was first introduced to the market almost 20 years ago and has since enabled surgeons to offer patients a minimally invasive approach to hysterectomies and myomectomies.

The benefits of minimally invasive surgery are well known and include faster recovery, less pain, less blood loss, and lower risk of overall morbidity and mortality.3 However, laparoscopic morcellation has important drawbacks that include the risk of severe trauma, tissue disruption that makes pathologic diagnosis more difficult, and dispersion of the morcellated tissue throughout the abdominal cavity.4,5 Less-serious consequences of tissue dispersion include cases of endometriosis and adenomyosis as well as leiomyomatosis, which are estimated to occur in 0.9% of patients having laparoscopic morcellation.6

A more serious consequence is dissemination of occult malignancy. The estimated incidence of occult leiomyosarcoma in patients having surgery for presumed leiomyomata is between 1:200 and 1:1100,7,8 with the FDA quoting a risk of 1 in 350 based on its comprehensive review of the literature. Many have challenged these numbers, especially because most of the publications come from large referral centers, which could inflate the prevalence estimates.

Other unexpected pathology may also be present, and a recent study found that the overall incidence of abnormal pathology is approximately 1.2% in cases involving morcellation.9 Not all pathologies carry serious prognoses, but it is fairly clear that the prognosis for patients with leiomyosarcoma is negatively affected by distant spread.

It is worth noting that the data on the consequence of laparoscopic morcellation on patient prognosis are sparse to say the least. The 2 largest studies to date include a total of 41 patients who had leiomyosarcomas morcellated10,11 and indeed, prognosis was significantly worse in these patients compared with patients with leiomyosarcomas who underwent standard total abdominal hysterectomies.

Interestingly, only 1 of these 41 patients had laparoscopic morcellation. The other 40 patients had the specimen morcellated using a cold knife through a minilaparotomy (n=17), transvaginally (n=19), or hysteroscopically (n=4).

It certainly makes sense that, as in the case of open morcellation, laparoscopic morcellation will negatively affect the prognosis in these patients. Most of the currently available data, however, are not from patients who underwent laparoscopic morcellation.

The takeaway from all this is that any kind of tissue disruption at the time of surgery may significantly worsen the prognosis for patients with an occult sarcoma or other pathology.

 

 

What should the gynecologist do?

Given the risk of occult malignancy, does it make sense to abandon all minimally invasive approaches for patients who are having surgery for symptomatic uterine fibroids?

Because a myomectomy ultimately involves some tissue disruption, should myomectomy be abandoned as a surgical procedure? What about noninvasive treatment options that leave the presumed fibroid inside the body, such as uterine artery embolization, MRI-guided focused ultrasound, and radiofrequency ablation?

It would be a step in the wrong direction to counsel all patients with symptomatic uterine fibroids to undergo total abdominal hysterectomy. That would result in increased patient morbidity and remove the option of future fertility for women who would rather retain their uterus.

In my opinion, patients with symptomatic fibroids who desire future fertility should still be offered this treatment option. However, they need to be adequately counseled that removing fibroids from the uterus involves some tissue disruption and that this must be balanced against their desire for future fertility.

One can predict that the extent of the tissue disruption and dispersion may be limited if open morcellation is avoided in these cases. In addition, it is likely that providers may counsel patients more toward a total laparoscopic hysterectomy versus a supracervical hysterectomy because the former may not involve morcellation, provided that the specimen is small enough to fit through the vagina intact.

On May 9th, ACOG released a special report titled “Power Morcellation and Occult Malignancy in Gynecologic Surgery.” It advises practitioners to quote patients a rate of 1/500 for undiagnosed sarcoma and also recommend extensive patient counseling as well as offering alternatives to laparoscopic power morcellation.12

 

 

It would be ideal to be able to predict preoperatively whether a presumed fibroid is actually a malignancy. Unfortunately we do not have reliable ways to determine this. Demographic factors such as age or rapid tumor growth are not helpful, especially because occult malignancy may be present in women in their 20s and 30s.

Preoperative imaging shows promise, but its clinical utility is yet to be determined. Two preliminary studies using MRI with lactacte dehydrogenase measurements or with diffusion-weighted imaging demonstrate promising results,12,13 but more research is needed before recommending routine MRIs before all surgeries for presumed leiomyomas.

The cost of such a measure would be significant and the chance of false-positive results is high, given the rarity of these conditions.

Future directions

The logical next step is to rapidly develop technology and techniques for contained morcellation. This enables surgeons to offer their patients a minimally invasive treatment option for uterine fibroids, but also significantly reduces or eliminates the risk of spillage or spread of occult malignancy.

Transvaginal application of specimen bags is challenging, and more innovation is needed in this area. Contained laparoscopic morcellation involves an endobag inflated with carbon dioxide with the camera and morcellator placed into the inflated bag, allowing for contained morcellation under direct visualization without tissue spillage.

My research team recently reported on our preliminary experience with this approach,15 and others are rapidly evaluating “in-bag” morcellation as well.

One important caveat is that the bags currently used for contained laparoscopic morcellation were not designed for this purpose and only one of them (the LapSac, Cook Medical) is FDA-approved for this application. Moreover, it can be challenging to place the specimen into the bag and some steps are required to effectively proceed with the contained morcellation process. Training is required for providers to use this approach safely and efficiently.

It is likely that much innovation will take place in this area in the coming months. Endobags that are specifically designed for contained morcellation will greatly facilitate this process and make it easier for surgeons to incorporate this into their practice.

Completely automatic tissue extraction devices are also being developed and may become commercially available in the next 1–2 years. These devices enable automatic morcellation in a contained environment without the need for a rotating blade or bag insufflation.16

 

 

Take-home message

It seems likely that traditional laparoscopic morcellation may eventually be replaced by contained morcellation. The FDA plans to convene a public meeting of the Obstetrics and Gynecology Medical Advisory committee this summer to potentially update its April recommendations. In the interim, surgeons must adapt to a rapidly changing environment and discuss tissue extraction options in detail with their patients.

Surgeons who work in institutions that have completely banned morcellation can offer their patients transvaginal specimen extraction or extraction via minilaparotomy.

Based on the effect of any method of morcellation on the prognosis of occult malignancy, morcellation should be performed in an endobag whenever possible. In cases of very large specimens that will not fit within a bag, the surgeon and the patient should have a thorough discussion regarding the pros and cons of an uncontained morcellation via a minilaparotomy. For example, this approach may be valid in the morbidly obese diabetic patient who has an elevated risk of wound infection and disruption.

Surgeons who work in institutions where laparoscopic morcellation is still allowed need to counsel their patients extensively about their options and about the risks and benefits of a minimally invasive approach to the treatment of their symptomatic uterine fibroids.

Ultimately, as innovation enters this arena, future patients will benefit as surgeons become better equipped to offer minimally invasive options for their conditions. 


 

 

References

1. Levitz, J. Doctors eye cancer risk in uterine procedure: popular technique to remove growths comes under question. The Wall Street Journal. http://online.wsj.com/news/articles/SB10001424052702304173704579264673929862850. Accessed May 14, 2014.

2. Shibley KA. Feasibility of Intra-Abdominal Tissue Isolation and Extraction, within an Artificially Created Pneumoperitoneum, at Laparoscopy for Gynecologic Procedures. J Minim Invasive Gynecol. 2012;19(6):S75.

3. Wiser A, Holcroft CA, Tulandi T, Abenhaim HA. Abdominal versus laparoscopic hysterectomies for benign diseases: evaluation of morbidity and mortality among 465,798 cases. Gynecol Surg. 2013;10:117–122.

4. Milad MP, Milad EA. Laparoscopic morcellator-related complications. J Minim Invasive Gynecol. 2014;21(3):486–491.

5. Rivard C, Salhader A, Kenton K. New challenges in detecting, grading, and staging endometrial cancer after uterine morcellation. J Minim Invasive Gynecol. 2012 May-Jun;19(3):313–316.

6. Cucinella G, Granese R, Calagna G, Somigliana E, Perino A. Parasitic myomas after laparoscopic surgery: an emerging complication in the use of morcellator? Fertil Steril. 2011;96(2):e90–96.

7. Leibsohn S, d’Ablaing G, Mishell DR Jr, Schlaerth JB. Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas. Am J Obstet Gynecol. 1990;162(4):968–974.

8. Parker WH, Fu YS, Berek JS. Uterine sarcoma in patients operated on for presumed leiomyoma and rapidly growing leiomyoma. Obstet Gynecol. 1994;83(3):414–418.

9. Seidman MA, Oduyebo T, Muto MG, Crum CP, Nucci MR, Quade BJ. Peritoneal dissemination complicating morcellation of uterine mesenchymal neoplasms. PLoS One. 2012;7(11):e50058.

10. Park JY, Park SK, Kim DY, et al. The impact of tumor morcellation during surgery on the prognosis of patients with apparently early uterine leiomyosarcoma. Gynecol Oncol. 2011 Aug;122(2):255–259.

11. Perri T, Korach J, Sadetzki S, Oberman B, Fridman E, Ben-Baruch G. Uterine leiomyosarcoma: does the primary surgical procedure matter? Int J Gynecol Cancer. 2009 Feb;19(2):257–260.

12.The American Congress of Obstetricians and Gynecologists. Power morcellation and occult malignancy in gynecologic surgery. http://www.acog.org/Resources_And_Publications/Task_Force_and_Work_Group_Reports/Power_Morcellation_and_Occult_Malignancy_in_Gynecologic_Surgery.

13. Goto A, Takeuchi S, Sugimura K, Maruo, T. Usefulness of Gd-DTPA contrast-enhanced dynamic MRI and serum determination of LDH and its isozymes in the differential diagnosis of leiomyosarcoma from degenerated leiomyoma of the uterus. Int J Gynecol Cancer. 2002 Jul-Aug;12(4):354–361.

14. Sato K, Yuasa N, Fujita M, Fukushima Y. Clinical application of diffusion-weighted imaging for preoperative differentiation between uterine leiomyoma and leiomyosarcoma. Am J Obstet Gynecol. 2014 Apr;210(4):368.e1–8.

15. Einarsson JI, Cohen SL, Fuchs N, Wang KC. In bag morcellation (IBM). J Minim Invasive Gynecol. 2014 Apr 24.

16. Isakov A, Murdaugh KM, Burke WC, et al. A new laparoscopic morcellatior using an actuated wire mesh and bag. Journal of Medical Devices. 2014;8:011009-1–7.