Fate of laparoscopic morcellation post-FDA warning: a literature review
Abstract
In laparoscopy, tissue extraction might require morcellation for larger intra-abdominal specimens, especially in gynecological patients. specimen, the specimen needs to be reduced. The Food and Drug Administration (FDA) issued a press release in April 2014 that discouraged the use of devices used for morcellation - power morcellators. This article has the objective to review the literature related to complications by power morcellation of uterine fibroids in laparoscopy and offer recommendations to laparoscopic surgeons in gynaecology. Respecting women who have leiomyosarcoma, it can be concluded that the FDA directive was based on a misleading analysis due to inherent flaws in the trials analysed by it. Hence, the need of the hour are more accurate estimates regarding the prevalence of leiomyosarcoma among women having surgery for presumed leiomyomas. Modification of the FDA’s current restriction regarding power morcellation would empower each woman to allow surgeons and hospitals to make the most appropriate, informed choices regarding utilization of tissue extraction in individual patients undergoing uterine surgery without undermining the freedom of the woman to choose the best-suited procedure.
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Nieboer TE, Johnson N, Barlow D, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers K. Surgical approach to hysterectomy for benign gynaecological disease. The Cochrane Library. 2006.
ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009 Nov;114(5):1156-8. doi: https://doi.org/10.1097/AOG.0b013e3181c33c72.
Wiser A, Holcroft CA, Tulandi T, Abenhaim HA. Abdominal versus laparoscopic hysterectomies for benign diseases: evaluation of morbidity and mortality among 465,798 cases. Gynecological surgery. 2013 May 1;10(2):117-22.
Rosero EB, Kho KA, Joshi GP, Giesecke M, Schaffer JI. Comparison of robotic and laparoscopic hysterectomy for benign gynecologic disease. Obstet Gynecol. 2013 Oct;122(4):778-86. doi: https://dx.doi.org/10.1097%2FAOG.0b013e3182a4ee4d.
AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL practice report: Morcellation during uterine tissue extraction. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):517-30. doi: https://doi.org/10.1016/j.jmig.2014.05.010. Epub 2014 May 24.
US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. Online: http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm.2014.
Arora KS, Spillman M, Milad M. Bits and pieces: the ethics of uterine morcellation. Obstet Gynecol. 2014 Dec;124(6):1199-201. doi: https://doi.org/10.1097/AOG.0000000000000525.
Hall T, Lee SI, Boruta DM, GOODMAN A. Medical Device Safety and Surgical Dissemination of Unrecognized Uterine Malignancy: Morcellation in Minimally Invasive Gynecologic Surgery. Oncologist. 2015 Nov 1;20(11).
10. 510(k) premarket notification. Device name: KSE Steiner electromechanic morcellator. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID5K946147. Accessed June 22, 2016.
Walker JL, Piedmonte MR, Spirtos NM et al.Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer. Gynecologic Oncology Group LAP2 Study. J Clin Oncol 2012;30:695–700.
Seidman MA, Oduyebo T, Muto MG et al. Peritoneal dissemination complicating morcellation of uterine mesenchymal neoplasms. PLoSOne 2012; 7:e50058.
Cadjigal S. The morcellation controversy: A timeline. Available at http://www.medscape.com/viewarticle/824081. Accessed June 22, 2016.
SGO position statement: Morcellation. Available at https://www.sgo.org/newsroom/positionstatements-2/morcellation/. Accessed June 22, 2016.
Updated: Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. Available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm. Accessed June 22, 2016.
ACOG statement: FDA issues safety communication on laparoscopic uterine power morcellation in hysterectomy andmyomectomy. Available at http://www.acog.org/About-ACOG/Announcements/FDAIssues-Safety-Communication-on-Laparoscopic-UterinePower-Morcellation. Accessed June 22, 2016.
AAGL statement to the FDA on power morcellation. Available at http://www.aagl.org/aaglnews/aagl-statement-to-the-fda-on-powermorcellation/. Accessed June 22, 2016.
Lowes R. J&J suspends power morcellator sales over cancer risk. Available at http://www.medscape.com/viewarticle/824371. Accessed June 22, 2016.
Levitz J. FBI is investigating hysterectomy device found to spread uterine cancer. Available at http://www.wsj.com/articles/fbi-is-investigatingsurgical-device-1432746641. Accessed June 22, 2016.
D'Angelo E, Prat J. Uterine sarcomas: a review. Gynecologic oncology. 2010 Jan 31;116(1):131-9.
Harlow BL, Weiss NS, Lofton S. The epidemiology of sarcomas of the uterus. Journal of the National Cancer Institute. 1986 Mar 1;76(3):399-402.
Giuntoli RL, Metzinger DS, DiMarco CS, Cha SS, Sloan JA, Keeney GL, Gostout BS. Retrospective review of 208 patients with leiomyosarcoma of the uterus: prognostic indicators, surgical management, and adjuvant therapy☆. Gynecologic oncology. 2003 Jun 30;89(3):460-9.
Milad MP, Milad EA. Laparoscopic morcellator-related complications. J Minim Invasive Gynecol. 2014 May-Jun;21(3):486-91. doi: https://doi.org/10.1016/j.jmig.2013.12.003. Epub 2013 Dec 10.
Donnez O, Jadoul P, Squifflet J, Donnez J. A series of 3190 laparoscopic hysterectomies for benign disease from 1990 to 2006: evaluation of complications compared with vaginal and abdominal procedures. BJOG. 2009 Mar;116(4):492-500. doi: https://doi.org/10.1111/j.1471-0528.2008.01966.x. Epub 2008 Nov 11.
Cucinella G, Granese R, Calagna G, Somigliana E, Perino A. Parasitic myomas after laparoscopic surgery: an emerging complication in the use of morcellator? Description of four cases. Parasitic myomas after laparoscopic surgery: an emerging complication in the use of morcellator? Description of four cases.
Leren V, Langebrekke A, Qvigstad E. Parasitic leiomyomas after laparoscopic surgery with morcellation. Acta Obstet Gynecol Scand. 2012 Oct;91(10):1233-6. doi: https://doi.org/10.1111/j.1600-0412.2012.01453.x.
Oduyebo T, Rauh-Hain AJ, Meserve EE, Seidman MA, Hinchcliff E, George S, Quade B, Nucci MR, Del Carmen MG, Muto MG. The value of re-exploration in patients with inadvertently morcellated uterine sarcoma. Gynecol Oncol. 2014 Feb;132(2):360-5. doi: https://doi.org/10.1016/j.ygyno.2013.11.024. Epub 2013 Dec 1.
Morice P, Rodriguez A, Rey A, Pautier P, Atallah D, Genestie C, Pomel C, Lhommé C, Haie-Meder C, Duvillard P, Castaigne D. Prognostic value of initial surgical procedure for patients with uterine sarcoma: analysis of 123 patients. European journal of gynaecological oncology. 2002 Dec;24(3-4):237-40.
Einstein MH, Barakat RR, Chi DS, Sonoda Y, Alektiar KM, Hensley ML, Abu-Rustum NR. Management of uterine malignancy found incidentally after supracervical hysterectomy or uterine morcellation for presumed benign disease. Int J Gynecol Cancer. 2008 Sep-Oct;18(5):1065-70. Epub 2007 Nov 6.
Hagemann IS, Hagemann AR, LiVolsi VA, Montone KT, Chu CS. Risk of occult malignancy in morcellated hysterectomy: a case series. Int J Gynecol Pathol. 2011 Sep;30(5):476-83. doi: https://doi.org/10.1097/PGP.0b013e3182107ecf.
Rivard C, Salhadar A, Kenton K. New challenges in detecting, grading, and staging endometrial cancer after uterine morcellation. J Minim Invasive Gynecol. 2012 May-Jun;19(3):313-6. doi: https://doi.org/10.1016/j.jmig.2011.12.019. Epub 2012 Mar 13.
Sinha R, Sundaram M, Lakhotia S, Kadam P, Rao G, Mahajan C. Parasitic myoma after morcellation. Journal of gynecological endoscopy and surgery. 2009 Jul 1;1(2):113.
Kamikabeya TS, Etchebehere RM, Nomelini RS, Murta EF. Gynecological malignant neoplasias diagnosed after hysterectomy performed for leiomyoma in a university hospital. Eur J Gynaecol Oncol. 2010;31(6):651-3.
Leung F, Terzibachian JJ. Re: "The impact of tumor morcellation during surgery on the prognosis of patients with apparently early uterine leiomyosarcoma". Gynecol Oncol. 2012 Jan;124(1):172-3; author reply 173. doi: https://doi.org/10.1016/j.ygyno.2011.08.035. Epub 2011 Sep 28.
Rowland M, Lesnock J, Edwards R, Richard S, Zorn K, Sukumvanich P, Krivak T. Occult uterine cancer in patients undergoing laparoscopic hysterectomy with morcellation. Gynecologic oncology. 2012 Oct 31;127(1):S29.
ACOG Statement on Power Morcellation. Available at http://www.acog.org/About-ACOG/News-Room/Statements/2014/ACOG-Statement-on-Power-Morcellation. Accessed on June 22,2016.
Desai VB, Guo XM, Xu X. Alterations in surgical technique after FDA statement on power morcellation. Am J Obstet Gynecol. 2015 May;212(5):685-7. doi: https://doi.org/10.1016/j.ajog.2015.02.027. Epub 2015 Feb 28.
Siedhoff MT, Wheeler SB, Rutstein SE, Geller EJ, Doll KM, Wu JM, Clarke-Pearson DL. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015 May;212(5):591.e1-8. doi: https://doi.org/10.1016/j.ajog.2015.03.006. Epub 2015 Mar 24.
Barron KI, Richard T, Robinson PS, Lamvu G. Association of the U.S. Food and Drug Administration Morcellation Warning With Rates of Minimally Invasive Hysterectomy and Myomectomy. Obstet Gynecol. 2015 Dec;126(6):1174-80. doi: https://doi.org/10.1097/AOG.0000000000001111.
Lum DA, Sokol ER, Berek JS, Schulkin J, Chen L, McElwain CA, Wright JD. Impact of the 2014 Food and Drug Administration Warnings Against Power Morcellation. J Minim Invasive Gynecol. 2016 May-Jun;23(4):548-56. doi: https://doi.org/10.1016/j.jmig.2016.01.019. Epub 2016 Jan 28.
Harris JA, Swenson CW, Uppal S, Kamdar N, Mahnert N, As-Sanie S, Morgan DM. Practice patterns and postoperative complications before and after US Food and Drug Administration safety communication on power morcellation. Am J Obstet Gynecol. 2016 Jan;214(1):98.e1-98.e13. doi: https://doi.org/10.1016/j.ajog.2015.08.047. Epub 2015 Aug 24.
Quantitative assessment of the prevalence of unsuspected uterine sarcoma in women undergoing treatment of uterine fibroids: Summary and key findings, April 2014. Available at http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM393589.pdf. Accessed June 22, 2016.
Mahnert N, Morgan D, Campbell D, Johnston C, As-Sanie S. Unexpected gynecologic malignancy diagnosed after hysterectomy performed for benign indications. Obstetrics & Gynecology. 2015 Feb 1;125(2):397-405.
Parker WH, Kaunitz AM, Pritts EA, Olive DL, Chalas E, Clarke-Pearson DL, Berek JS; Leiomyoma Morcellation Review Group. U.S. Food and Drug Administration's Guidance Regarding Morcellation of Leiomyomas: Well-Intentioned, But Is It Harmful for Women? Obstet Gynecol. 2016 Jan;127(1):18-22. doi: https://doi.org/10.1097/AOG.0000000000001157.
Pritts EA, Vanness DJ, Berek JS, Parker W, Feinberg R, Feinberg J, Olive DL. The prevalence of occult leiomyosarcoma at surgery for presumed uterine fibroids: a meta-analysis. Gynecol Surg. 2015;12(3):165-177. Epub 2015 May 19.
Bojahr B, De Wilde RL, Tchartchian G. Malignancy rate of 10,731 uteri morcellated during laparoscopic supracervical hysterectomy (LASH). Archives of gynecology and obstetrics. 2015 Sep 1;292(3):665-72.
Anupama R, Ahmad SZ, Kuriakose S, Vijaykumar DK, Pavithran K, Seethalekshmy NV. Disseminated peritoneal leiomyosarcomas after laparoscopic "myomectomy" and morcellation. J Minim Invasive Gynecol. 2011 May-Jun;18(3):386-9. doi: https://doi.org/10.1016/j.jmig.2011.01.014.
Della Badia C, Karini H. Endometrial stromal sarcoma diagnosed after uterine morcellation in laparoscopic supracervical hysterectomy. Journal of minimally invasive gynecology. 2010 Dec 31;17(6):791-3.
Park JY, Kim DY, Kim JH, Kim YM, Kim YT, Nam JH. The impact of tumor morcellation during surgery on the outcomes of patients with apparently early low-grade endometrial stromal sarcoma of the uterus. Ann Surg Oncol. 2011 Nov;18(12):3453-61. doi: https://doi.org/10.1245/s10434-011-1751-y. Epub 2011 May 4.
Park JY, Park SK, Kim DY, Kim JH, Kim YM, Kim YT, Nam JH. The impact of tumor morcellation during surgery on the prognosis of patients with apparently early uterine leiomyosarcoma. Gynecol Oncol. 2011 Aug;122(2):255-9. doi: https://doi.org/10.1016/j.ygyno.2011.04.021. Epub 2011 May 12.
Gao Z, Li L, Meng Y. A Retrospective Analysis of the Impact of Myomectomy on Survival in Uterine Sarcoma. PLoS One. 2016 Feb 1;11(2):e0148050. doi: https://dx.doi.org/10.1371%2Fjournal.pone.0148050. eCollection 2016.
Liu FW, Galvan-Turner VB, Pfaendler KS, Longoria TC, Bristow RE. A critical assessment of morcellation and its impact on gynecologic surgery and the limitations of the existing literature. Am J Obstet Gynecol. 2015 Jun;212(6):717-24. doi: https://doi.org/10.1016/j.ajog.2015.01.012. Epub 2015 Jan 9.
Wright JD, Cui RR, Wang A, Chen L, Tergas AI, Burke WM, Ananth CV, Hou JY, Neugut AI, Temkin SM, Wang YC, Hershman DL. Economic and Survival Implications of Use of Electric Power Morcellation for Hysterectomy for Presumed Benign Gynecologic Disease. J Natl Cancer Inst. 2015 Oct 8;107(11). pii: djv251. doi: 1https://doi.org/10.1093/jnci/djv251. Print 2015 Nov.
Mutch DG. Premature Judgment of Uterine Morcellation: Look at the Data Before You Leap. Journal of the National Cancer Institute. 2015 Nov 1;107(11):djv283.
Epstein AJ, Groeneveld PW, Harhay MO, Yang F, Polsky D. Impact of minimally invasive surgery on medical spending and employee absenteeism. JAMA Surg. 2013 Jul;148(7):641-7. doi: https://doi.org/10.1001/jamasurg.2013.131.
Nieboer TE, Hendriks JC, Bongers MY, Vierhout ME, Kluivers KB. Quality of life after laparoscopic and abdominal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):85-91. doi: https://doi.org/10.1097/AOG.0b013e31823d3b00.
Nagai T, Takai Y, Akahori T, Ishida H, Hanaoka T, Uotani T, Sato S, Matsunaga S, Baba K, Seki H. Highly improved accuracy of the revised PREoperative sarcoma score (rPRESS) in the decision of performing surgery for patients presenting with a uterine mass. Springerplus. 2015 Sep 17;4:520. doi: https://doi.org/10.1186/s40064-015-1318-7. eCollection 2015.
Van den Bosch T, Dueholm M, Leone FP, Valentin L, Rasmussen CK, Votino A, Van Schoubroeck D, Landolfo C, Installé AJ, Guerriero S, Exacoustos C. Terms, definitions and measurements to describe sonographic features of myometrium and uterine masses: a consensus opinion from the Morphological Uterus Sonographic Assessment (MUSA) group. Ultrasound in Obstetrics & Gynecology. 2015 Sep 1;46(3):284-98.
Wu TI, Yen TC, Lai CH. Clinical presentation and diagnosis of uterine sarcoma, including imaging. Best Practice & Research Clinical Obstetrics & Gynaecology. 2011 Dec 31;25(6):681-9.
Nitta E, Kanenishi K, Itabashi N, Tanaka H, Hata T. Real-time tissue elastography of uterine sarcoma. Archives of gynecology and obstetrics. 2014 Feb 1;289(2):463-5.
Gerges B, Mongelli M, Casikar I, Bignardi T, Condous G. 3D transvaginal sonography as pre-operative predictor of the need to morcellate in women undergoing laparoscopic hysterectomy. Ultrasound Obstet Gynecol. 2016 Jun 9. doi: https://doi.org/10.1002/uog.15991. [Epub ahead of print]
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. International Journal of Gynecological Cancer. 2002 Jul 1;12(4):354-61.
Yoshida Y, Kiyono Y, Tsujikawa T, Kurokawa T, Okazawa H, Kotsuji F. Additional value of 16α-[18F] fluoro-17β-oestradiol PET for differential diagnosis between uterine sarcoma and leiomyoma in patients with positive or equivocal findings on [18F] fluorodeoxyglucose PET. European journal of nuclear medicine and molecular imaging. 2011 Oct 1;38(10):1824-31.
Brölmann H, Tanos V, Grimbizis G, Ind T, Philips K, van den Bosch T, Sawalhe S, van den Haak L, Jansen FW, Pijnenborg J, Taran FA. Options on fibroid morcellation: a literature review. Gynecological surgery. 2015 Feb 1;12(1):3-15.
Matsuda M, Ichimura T, Kasai M, Murakami M, Kawamura N, Hayashi T, Sumi T. Preoperative diagnosis of usual leiomyoma, atypical leiomyoma, and leiomyosarcoma. Sarcoma. 2014 Oct 21;2014.
Nagai T, Takai Y, Akahori T, Ishida H, Hanaoka T, Uotani T, Sato S, Matsunaga S, Baba K, Seki H. Highly improved accuracy of the revised PREoperative sarcoma score (rPRESS) in the decision of performing surgery for patients presenting with a uterine mass. Springerplus. 2015 Sep 17;4:520. doi: 10.1186/s40064-015-1318-7. eCollection 2015.
Nagai T, Takai Y, Akahori T, Ishida H, Hanaoka T, Uotani T, Sato S, Matsunaga S, Baba K, Seki H. Highly improved accuracy of the revised PREoperative sarcoma score (rPRESS) in the decision of performing surgery for patients presenting with a uterine mass. Springerplus. 2015 Sep 17;4:520. doi: 10.1186/s40064-015-1318-7. eCollection 2015.
Serur E, Lakhi N. Laparoscopic hysterectomy with manual morcellation of the uterus: an original technique that permits the safe and quick removal of a large uterus. American journal of obstetrics and gynecology. 2011 Jun 30;204(6):566-e1.
Senapati S, Tu FF, Magrina JF. Power morcellators: a review of current practice and assessment of risk. American journal of obstetrics and gynecology. 2015 Jan 31;212(1):18-23.
Kim YW, Park BJ, Ro DY, Kim TE. Single-port laparoscopic myomectomy using a new single-port transumbilical morcellation system: initial clinical study. Journal of minimally invasive gynecology. 2010 Oct 31;17(5):587-92.
Einarsson JI, Cohen SL, Fuchs N, Wang KC. In-bag morcellation. Journal of minimally invasive gynecology. 2014 Oct 31;21(5):951-3.
Cohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, Fader AN, Shibley T. Contained power morcellation within an insufflated isolation bag. Obstetrics & Gynecology. 2014 Sep 1;124(3):491-7.
Anapolski M, Panayotopoulos D, Alkatout I, Soltesz S, Schiermeier S, Noé G. Preclinical safety testing for morcellation and extraction for an endobag with sealable ports: in vitro pilot study. Surgical endoscopy. 2016 May 18:1-7.
Aoki Y, Matsuura M, Matsuno T, Yamamoto T. Single-site in-bag morcellation achieved via direct puncture of the pneumoperitoneum cap, a cordless electric morcellator, and a 5-mm flexible scope. European Journal of Obstetrics & Gynecology and Reproductive Biology. 2016 Jun 30;201:126-30.
Serur E, Lakhi N. Tips and tricks for successful manual morcellation: a response to “vaginal morcellation: a new strategy for large gynecological malignant tumor extraction”. Gynecologic oncology. 2013 Jan 1;128(1):150.
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