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| A '''morcellator''' is a [[surgical instrument]] used for division and removal of large masses of tissues during [[laparoscopic surgery]].<ref name=Savage2000 /> In laparoscopic hysterectomy the uterus is minced up, or morcellated, into smaller pieces inside the woman's abdominal cavity in order to extract from the abdomen. It can consist of a hollow cylinder that penetrates the abdominal wall, ending with sharp edges<ref name=Savage2000/> or cutting jaws,<ref name=sauer1996 /> through which a grasper can be inserted to pull the mass into the cylinder to cut out an extractable piece.<ref name=Savage2000/><ref name=sauer1996/> | | A '''morcellator''' is a [[surgical instrument]] used for division and removal of large masses of tissues during [[laparoscopic surgery]]. |
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| ==Morcellation devices in surgery==
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| Laparoscopic morcellation is commonly used at surgery to remove bulky specimens from the abdomen using minimally invasive techniques. Historically, morcellation was performed using a device that required the surgeon or assistant to manually 'squeeze' the handle. Other reports describe using a scalpel directly through the abdomen to create small specimens that can be drawn out of the abdominal cavity. In 1993, the first electric morcellator was introduced in the US market. It was initially used for uterine extraction, but later applied to other organs. The use of morcellators at surgery has now become commonplace, with at least 5 devices currently on the US market. Despite decades of experience, there remains limited understanding of the short-term and long-term [[sequelae]] of morcellation. Concerns have been raised about injury to surrounding organs including bowel, bladder, [[ureter]]s, [[pancreas]], [[spleen]] and major vascular structures. Long-term issues may include parasitic growth of retained tissue with the potential to cause [[Adhesion (medicine)|adhesions]], cause bowel dysfunction and potentially [[Disseminated disease|disseminate]] unrecognized cancer.
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| ==Safety concerns of morcellation devices in gynecologic surgery==
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| Morcellation is associated with spreading of cellular material of the morcellated tissue. In gynecologic surgery for [[benign tumor|benign]] pathologies there is approximately a 0.09~0.1% risk of an unexpected [[leiomyosarcoma]].<ref name=Seidman_2012 /><ref>{{Cite journal | pmid = 25790796| year = 2015| author1 = Yuk| first1 = J. S.| title = Unexpected uterine malignancy in women who have undergone myomectomy| journal = International Journal of Gynecology & Obstetrics| last2 = Ji| first2 = H. Y.| last3 = Lee| first3 = S. H.| last4 = Park| first4 = Y. S.| last5 = Lee| first5 = J. H.| doi = 10.1016/j.ijgo.2014.12.004| volume=129| pages=270–1}}</ref><ref name=Yuk_2015b /><ref name=Yuk_2018 /> After morcellation 64% of such cases may develop [[disseminated disease]] which is of particular concern because of the considerable [[Death|mortality]] of leiomyosarcoma. Morcellation of the more frequent benign leiomyoma variants may also cause disseminated disease, which while not associated with increased mortality is frequently inoperable and therefore much more difficult to manage than the original disease.<ref name=Seidman_2012 /><ref>{{Cite journal | last1 = Cucinella | first1 = G. | last2 = Granese | first2 = R. | last3 = Calagna | first3 = G. | last4 = Somigliana | first4 = E. | last5 = Perino | first5 = A. | title = Parasitic myomas after laparoscopic surgery: An emerging complication in the use of morcellator? Description of four cases | doi = 10.1016/j.fertnstert.2011.05.095 | journal = Fertility and Sterility | volume = 96 | issue = 2 | pages = e90–e96 | year = 2011 | pmid = 21719004 | pmc = }}</ref>
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| Since April 2014 the [[Food and Drug Administration]] (FDA) has discouraged its use for uterine procedures, issuing a warning that morcellators may spread occult cancer in the course of [[Uterine fibroid|fibroid]] removal.<ref name=medscape /> A second warning was followed in November of the same year.<ref name=FDA-Nov24-2014 /> [[Johnson & Johnson]] subsequently suspended sale of its morcellators until the role of morcellation "is redefined by the FDA and the medical community,"<ref name=medscape/> and later pulled its morcellators from the market.<ref>{{cite web|url=https://online.wsj.com/articles/johnson-johnson-to-call-for-voluntary-return-of-morcellators-1406754350?mod=djemalertNEWS| title=Johnson & Johnson to Call for Return of Hysterectomy Device|author1=Jon Kamp |author2=Jennifer Levitz | newspaper=[[Wall Street Journal]] |date=July 30, 2014| accessdate=July 20, 2014}}</ref> Critics of this device have mounted a high-profile campaign to have the devices recalled.<ref>[https://online.wsj.com/news/articles/SB10001424052702304071004579407600720620332 High profile campaign against device]</ref> At least one device maker has threatened legal action against what it calls "unfounded and unproven allegations."<ref>[http://www.medscape.com/viewarticle/831267 Legal action threatened against critics]</ref>
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| In the same statement the FDA discouraged the use of power morcellators in patients seeking [[hysterectomy]] (removal of uterus through lower abdomen) and [[myomectomy]] (surgery to remove uterine fibroids – also called leiomyomas) procedures, estimating that approximately 1 in 350 such patients <!-- 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.<ref name=FDA-Nov24-2014 />
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| The FDA says that it has known for some time that the morcellators could spread uterine cancer, but the recent {{vague|date=May 2017}} attention given to the subject because of the death of Barbara Leary led them to reopen the investigation, and they discovered a higher risk than was initially reported.<ref>{{cite web|last1=Kamp|first1=Jon|title=Women's Cancer Risk Raises Doubts About FDA Oversight|url=https://www.wsj.com/articles/womens-cancer-risk-raises-doubts-about-fda-oversight-1404842368|website=The Wall Street Journal|accessdate=17 February 2015}}</ref>{{Citation needed|date=January 2015}} Magdy Milad, chief of gynecology and gynecologic surgery at [[Northwestern Memorial Hospital]] reported that “there were times connections were made but not reported."{{Original research inline|date=January 2015}}
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| The problem of secondary [[leiomyosarcoma]] and parasitic [[leiomyoma]] after gynaecological surgeries is not new and such problems have been reported independently of the methods of surgery.{{citation needed|date=February 2015}} The surgery may not be the only or main culprit: the disseminated disease may also be the result of [[genetic predisposition|predisposition]], reduced [[paracrine]] feedback, or [[metastasis]] independent of surgery. According to some studies, there was no difference in the overall survival of women with unsuspected uterine malignancy with or without endometrial cancer between laparotomic myomectomy group and laparoscopic myomectomy group.<ref name=Yuk_2015b /><ref name=Yuk_2018 />
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| In 2017 [[Karl Storz GmbH]] was the subject of several lawsuits concerning deaths following use of morcellators that it sold; [[Ethicon]], the market leader in morcellators, had withdrawn their devices in 2014, Karl Storz had not.<ref>{{cite news|last1=Ong|first1=Matthew Bin Han|title=Anti-morcellation advocate files "wrongful death" suit against Karl Storz and Brigham & Women’s Hospital – The Cancer Letter Publications|url=https://cancerletter.com/articles/20170721_4/|work=The Cancer Letter|date=21 July 2017}}</ref>
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| ==See also==
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| *[[Instruments used in general surgery]]
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| ==References==
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| {{reflist|2|refs=
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| <ref name=Savage2000>[http://www.google.com/patents?hl=en&lr=&vid=USPAT6039748 Disposable laparoscopic morcellator], GM Savage, JJ Christian, DC Dillow - US Patent 6,039,748, 2000</ref>
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| <ref name=sauer1996>[http://www.google.com/patents?hl=en&lr=&vid=USPAT5562694 Morcellator], Jude S. Sauer, Roger J. Greenwald, Mark A. Bovard, John F. Hammond - US Patent 5562694. Issue date: Oct 8, 1996.</ref>
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| <ref name=Seidman_2012>{{Cite journal | last1 = Seidman | first1 = M. A. | last2 = Oduyebo | first2 = T. | last3 = Muto | first3 = M. G. | last4 = Crum | first4 = C. P. | last5 = Nucci | first5 = M. R. | last6 = Quade | first6 = B. J. | editor1-last = Sullivan | editor1-first = David J | title = Peritoneal Dissemination Complicating Morcellation of Uterine Mesenchymal Neoplasms | doi = 10.1371/journal.pone.0050058 | journal = PLoS ONE | volume = 7 | issue = 11 | pages = e50058 | year = 2012 | pmid = 23189178 | pmc =3506532 }}</ref>
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| <ref name=Yuk_2015b>{{Cite journal | pmid = 26577118| year = 2015| author1 = Yuk| first1 = J. S.| title = Comparison of Survival Outcomes in Women with Unsuspected Uterine Malignancy Diagnosed After Laparotomic Versus Laparoscopic Myomectomy: A National, Population-Based Study.| journal = Annals of Surgical Oncology| last2 = Ji| first2 = H. Y.| last3 = Shin| first3 = J.Y.| last4 = Kim| first4 = L.Y.| last5 = Kim| first5 = S.Y.|last6 = Lee| first6 = J. H.| doi = 10.1245/s10434-015-4976-3}}</ref>
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| <ref name=Yuk_2018>{{Cite journal | pmid = 30146112 | year = 2018| author1 = Yuk| first1 = J. S.| title = Six-year survival of patients with unsuspected uterine malignancy after laparoscopic versus laparotomic myomectomy: An 11-year national retrospective cohort study.| journal = Gynecol Oncology.| last2 = Lee| first2 = J.H.| doi = 10.1016/j.ygyno.2018.08.026}}</ref>
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| <ref name=medscape>{{cite web |url=http://www.medscape.com/viewarticle/824371?src=wnl_edit_newsal&uac=28013DZ| title=J&J Suspends Power Morcellator Sales Over Cancer Risk| author=Robert Lowes |publisher=[[Medscape]]| date=April 30, 2014| accessdate=April 30, 2014}}</ref>
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| <ref name=FDA-Nov24-2014>{{cite web |url=https://finance.yahoo.com/news/fda-strengthens-warning-device-linked-163440402.html | title=FDA strengthens warning on device linked to cancer | author=Linda a. Johnson |publisher=AP Business Writer| date=November 24, 2014| accessdate=November 24, 2014 |quote=FDA strengthens warning on gynecologic surgical device linked to spreading cancer inside women}}</ref>
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| [[Category:Surgical instruments]] | | [[Category:Surgical instruments]] |
A morcellator is a surgical instrument used for division and removal of large masses of tissues during laparoscopic surgery.
