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Evaluating the Risks of Electric Uterine Morcellation FREE

Kimberly A. Kho, MD, MPH1; Ceana H. Nezhat, MD2
[+] Author Affiliations
1Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas
2Atlanta Center for Minimally Invasive Surgery and Reproductive Medicine, Atlanta, Georgia
JAMA. 2014;311(9):905-906. doi:10.1001/jama.2014.1093.
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Published online

Gynecologic surgeons, like many other surgical specialists, have embraced laparoscopic surgical techniques because they offer quicker recovery, less postoperative pain, and fewer wound complications than open procedures. The removal of large pieces of tissue through the small incisions of laparoscopy is difficult. However, this problem can be overcome by tissue morcellation, a technique of fragmenting tissue into smaller pieces that often prevents the need to enlarge established incisions. Surgeons have long used manual morcellation with a scalpel or scissors to remove masses abdominally and vaginally, but use of the technique has increased with wide adoption of laparoscopic approaches and with the introduction of laparoscopic electric morcellators in 1993.

The electric morcellator is an instrument that shaves or cores tissue into long strips for removal through laparoscopic ports of less than 2 cm. Initially used for uterine extraction, the morcellator has been used for removal of leiomyomata, kidneys, and spleens. Gynecologic surgeons use the instrument most frequently, particularly during the majority of laparoscopic and robotic-assisted supracervical hysterectomies and myomectomies. Although the precise frequency of electric morcellator use is unknown, approximately 20 000 laparoscopic and robotic supracervical hysterectomies are performed each year in the United States, and laparoscopic and robotic-assisted myomectomies are being performed with increasing frequency. Additionally, gynecologists may also use the morcellator during other types of laparoscopic or robotic-assisted hysterectomies for large uteri, even when a vaginal incision is available.

The practice of morcellation has come under scrutiny after the technique was reported to have led to dissemination of an occult leiomyosarcoma during hysterectomy for presumed leiomyomata1 and because of increasing awareness about other morcellator-related injuries.2 Although scrutiny is focused on uterine morcellation, morcellation of other organs like the spleen and kidney is also a concern. The discussion about morcellation so far has yielded as many questions as answers because the current system for monitoring surgical techniques and devices has deficiencies. The way forward in this debate, and others about surgical devices and procedures, will involve improvement in defining risks associated with adoption of new technologies, examining alternatives to potentially risky practices, communicating concerns, and instituting systems to prevent future complications.

DEFINING RISKS

Like any surgical procedure, morcellation carries a small risk of harm, but the risk is difficult to define. During morcellation, it can be difficult to prevent small tissue fragments from being inadvertently dispersed throughout the peritoneal cavity; these fragments may then implant anywhere and cause symptoms and morbidity requiring intervention. Numerous reports have documented ectopic leiomyoma, endometriosis, adenomyosis, ovarian tissue, and fragments of spleen and kidney as a result of morcellation.

Intracorporeal (ie, intra-abdominal) electric morcellation also rarely disseminates occult malignancies, including uterine sarcomas and ovarian, renal, and endometrial carcinomas.2 While cervical and endometrial cancer can be screened for preoperatively, there are no good methods to detect uterine sarcomas; these tumors usually are identified incidentally after review of the surgical specimen. Retrospective single-institution and small network reports have attempted to define the risk of occult uterine malignancy among women undergoing uterine procedures, but pooling the data for a single risk estimate is complex and prone to error given the heterogeneity of the data, including the populations examined, and likelihood of publication bias. In the United States from 1983 through 2010, 13 unexpected uterine sarcomas have been reported postoperatively among 5666 uterine procedures (risk ranging from 0% to 0.49%).39 Of the 7 reports, only 2 were limited to patients undergoing morcellation, with 2 of 1192 women developing disseminated sarcoma, both of whom were alive at 34- and 42-month follow-up.7,8 This limited experience is insufficient to estimate harm from this procedure and whether the benefit-to-harm balance is any different from other accepted medical procedures. The scarcity of data regarding preoperative prevalence of leiomyosarcoma in women undergoing myomectomy or hysterectomy with morcellation, and the lack of ability to detect the cancers, also highlight the need for research into this aggressive cancer.

Additionally, a recent review of the Manufacturer and User Facility Device Experience (MAUDE) database of the US Food and Drug Administration (FDA) found 55 complications from 1993 through 2013, including 6 deaths, and injuries caused by the morcellator blade to almost every organ in the abdominal cavity, including bowel, vena cava, and aorta.2 Many injuries were associated with lack of surgeon experience when using the device. Furthermore, morcellator-related injuries may be underreported given the voluntary nature of adverse event reporting for medical devices. This combination of inadequate experience and lack of data about adverse events is in part a result of a system that permits adoption of innovative surgical techniques without systematic ascertainment of harm.

ALTERNATIVES TO ELECTRIC MORCELLATION

Alternatives to intracorporeal electric morcellation have been shown to have comparable, if not superior, outcomes in early studies.10 Laparoscopic-assisted minilaparotomy and tissue removal through a vaginal incision each have limitations but should theoretically minimize the risk of tissue seeding while maintaining the benefits of a minimally invasive approach and should be considered before intracorporeal electric morcellation. Manual morcellation within an endoscopic bag—during which the surgical specimen is placed in a bag laparoscopically and fragmented within the bag—is another method that can be used, and devices that allow for safe electric morcellation in a bag are being developed. Pending clarification of clinical circumstances when electric intracorporeal morcellation is advantageous, abandoning laparoscopy with its known advantages and banning the electric morcellator seem hasty, but exposing patients to even a small risk of dissemination of an occult uterine malignancy through the technique seems unwise when safer alternatives exist.

MORCELLATION AND THE INFORMED CONSENT PROCESS

Discussion of risks and benefits of a surgery and consideration of reasonable alternatives are essential steps in the preparation for surgery and fundamental to the informed consent process. Surgeons who plan to use an electric morcellator should disclose the risks of device-related complications and be explicit about the still-undefined potential for dissemination of an undetected malignancy. Patients should be informed of, and surgeons should be able to offer, alternatives to intracorporeal electric morcellation. The process requires the physician to explain risks and benefits so a patient can understand them. This is difficult when the risks are vague or unquantified because of limited data. Yet a lack of data or the rarity of an event should not preclude discussion of serious potential complications.

A TIME FOR ACTION

Surgical innovation and adoption of new instrumentation provide the promise of better patient outcomes and improved performance over existing techniques. When compared with the process of drug development, the introduction of surgical devices is less regulated, and like drugs, surgical devices and procedures often disseminate with relatively little knowledge about what effects they will have in widespread use. In the current system, once a device is approved for use, there are few requirements for ongoing reevaluation of safety and efficacy. Rare complications may become apparent only after a technique has diffused into practice. It is at this juncture where the increasing concerns about the electric morcellator are occurring.

In response to concerns about the electric morcellator, it is important to determine the risk of short- and long-term complications, and surgeons need a mechanism to be alerted of these hazards by regulators, device manufacturers, and peers. In addition, preoperative protocols are needed for detecting occult pathology prior to surgery, such as by using routine endometrial sampling, laboratory analyses, or imaging. Evidence-based action is needed but requires prospective and reliable data. Examples of this approach exist in other specialties, such as the National Surgical Quality Improvement Program database developed by the American College of Surgeons. In gynecology, the Pelvic Floor Disorders Registry was established following an FDA-mandated requirement for surveillance after a similar debate about transvaginal mesh. A nationwide registry of gynecologic surgeries, including data on devices used (such as electric morcellators), quality of outcomes, and complications, would be a critical step toward this goal.

Controversies about the role of new technologies are not new to gynecological surgery. However, the response to concerns about the risk of morcellation must include decisive, scientifically informed actions to better understand the risk and prevent complications among women for whom this procedure is considered.

ARTICLE INFORMATION

Corresponding Author: Kimberly A. Kho, MD, MPH, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390 (kimberly.kho@utsouthwestern.edu).

Published Online: February 6, 2014. doi:10.1001/jama.2014.1093.

Conflict of Interest Disclosures: Both authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Kho reported having received a grant from the National Center for Advancing Translational Sciences, National Institutes of Health. Dr Nezhat reported having served as a consultant for Karl Storz Endoscopy, having served as a medical advisor for Plasma Surgical, and having served on a scientific advisory board for SurgiQuest and currently serving as president of the American Association of Gynecologic Laparoscopists (AAGL) and on the board of trustees of the Society of Reproductive Surgeons (SRS).

Disclaimer: The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of AAGL or SRS or their board of trustees or members.

Additional Contributions: We thank Robert Haley, MD, and Milton Packer, MD, both of University of Texas Southwestern Medical Center, for thoughtful discussions on this topic. Dr Haley and Dr Packer received no compensation.

REFERENCES

Levitz J. Doctors eye cancer risk in uterine procedure. The Wall Street Journal.http://online.wsj.com/news/articles/SB10001424052702304173704579264673929862850. Accessed February 3, 2014.
Milad  MP, Milad  EA.  Laparoscopic morcellator-related complications [published online December 9, 2013]. J Minim Invasive Gynecol. doi:10.1016/j.jmig.2013.12.003.
PubMed
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.
PubMed   |  Link to Article
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.
PubMed
Ramm  O, Gleason  JL, Segal  S, Antosh  DD, Kenton  KS.  Utility of preoperative endometrial assessment in asymptomatic women undergoing hysterectomy for pelvic floor dysfunction. Int Urogynecol J. 2012;23(7):913-917.
PubMed   |  Link to Article
Frick  AC, Walters  MD, Larkin  KS, Barber  MD.  Risk of unanticipated abnormal gynecologic pathology at the time of hysterectomy for uterovaginal prolapse. Am J Obstet Gynecol. 2010;202(5):e1-e4.
PubMed   |  Link to Article
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.
PubMed   |  Link to Article
Hagemann  IS, Hagemann  AR, LiVolsi  VA, Montone  KT, Chu  CS.  Risk of occult malignancy in morcellated hysterectomy. Int J Gynecol Pathol. 2011;30(5):476-483.
PubMed   |  Link to Article
Andy  UU, Nosti  PA, Kane  S,  et al.  Incidence of unanticipated uterine pathology at the time of minimally invasive abdominal sacrocolpopexy. J Minim Invasive Gynecol. 2014;21(1):97-100.
PubMed   |  Link to Article
Uccella  S, Cromi  A, Bogani  G, Casarin  J, Serati  M, Ghezzi  F.  Transvaginal specimen extraction at laparoscopy without concomitant hysterectomy. J Minim Invasive Gynecol. 2013;20(5):583-590.
PubMed   |  Link to Article

Figures

Tables

References

Levitz J. Doctors eye cancer risk in uterine procedure. The Wall Street Journal.http://online.wsj.com/news/articles/SB10001424052702304173704579264673929862850. Accessed February 3, 2014.
Milad  MP, Milad  EA.  Laparoscopic morcellator-related complications [published online December 9, 2013]. J Minim Invasive Gynecol. doi:10.1016/j.jmig.2013.12.003.
PubMed
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.
PubMed   |  Link to Article
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.
PubMed
Ramm  O, Gleason  JL, Segal  S, Antosh  DD, Kenton  KS.  Utility of preoperative endometrial assessment in asymptomatic women undergoing hysterectomy for pelvic floor dysfunction. Int Urogynecol J. 2012;23(7):913-917.
PubMed   |  Link to Article
Frick  AC, Walters  MD, Larkin  KS, Barber  MD.  Risk of unanticipated abnormal gynecologic pathology at the time of hysterectomy for uterovaginal prolapse. Am J Obstet Gynecol. 2010;202(5):e1-e4.
PubMed   |  Link to Article
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.
PubMed   |  Link to Article
Hagemann  IS, Hagemann  AR, LiVolsi  VA, Montone  KT, Chu  CS.  Risk of occult malignancy in morcellated hysterectomy. Int J Gynecol Pathol. 2011;30(5):476-483.
PubMed   |  Link to Article
Andy  UU, Nosti  PA, Kane  S,  et al.  Incidence of unanticipated uterine pathology at the time of minimally invasive abdominal sacrocolpopexy. J Minim Invasive Gynecol. 2014;21(1):97-100.
PubMed   |  Link to Article
Uccella  S, Cromi  A, Bogani  G, Casarin  J, Serati  M, Ghezzi  F.  Transvaginal specimen extraction at laparoscopy without concomitant hysterectomy. J Minim Invasive Gynecol. 2013;20(5):583-590.
PubMed   |  Link to Article

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